Hemp seed protein and its hydrolysate compared with casein protein consumption in adults with hypertension: a double-blind crossover study.

BACKGROUND: The effects of consuming hemp seed protein (HSP) as well as its hydrolysate-derived bioactive peptide (HSP+) on blood pressure (BP) has not, to our knowledge, been investigated in humans. OBJECTIVES: We aimed to investigate how consumption of HSP and its hydrolysate modulates 24-h systolic (SBP) and diastolic BP (DBP) and plasma biomarkers of BP compared with casein. METHODS: In a double-blind, randomized, crossover design trial, 35 adults who had mild hypertension with SBP between 130 and 160 mmHg and DBP ≤110 mmHg were recruited. Participants were randomly assigned to varying sequences of 3 6-wk treatments, 50 g casein/d, 50 g HSP/d, or 45 g HSP plus 5 g HSP-derived bioactive peptides/d (HSP+), separated by a 2-wk washout period. Treatment effects were assessed with a linear mixed model with repeated measures. RESULTS: Compared with casein, after HSP+ consumption, 24-h SBP and 24-h DBP decreased from 135.1 and 80.0 mmHg to 128.1 ± 1.6 (P < 0.0001) and 76.0 ± 1.4 mmHg (P < 0.0001), respectively, whereas these values were 133.5 ± 1.6 and 78.9 ± 1.4 mmHg after HSP consumption (P < 0.0001). There were no differences between the HSP and HSP+ consumption in plasma angiotensin-converting enzyme (ACE) activity, renin, or nitric oxide (NO) concentrations. However, these 2 treatments were able to lower both ACE and renin activities and raise NO concentration in plasma compared with casein. CONCLUSIONS: These results suggest that hemp protein consumption, as well as in combination with bioactive peptides, may have a role in the dietary management of hypertension. This trial was registered at clinicaltrials.gov as NCT03508895.

The Hans Kai trial: study protocol of a mixed methods randomized controlled trial evaluating a peer-led health promotion program for adults with or without noncommunicable diseases.

BACKGROUND: A significant proportion of Canadian adults is impacted by chronic noncommunicable diseases. These conditions may be improved by peer-led health promotion interventions that target modifiable risk factors; however, to date, there is mixed evidence on the effectiveness of these interventions. Unlike other health promotion programs, Hans Kai is grounded in a holistic model of health that simultaneously addresses multiple determinants of health at different levels of human ecology. In Hans Kai, a set of informational sessions that are delivered in a group setting by healthcare professionals are followed by regular peer-led group meetings in a self-governed support group setting that is designed to promote implementation of newly learned health competences. The Hans Kai trial described here aims to evaluate the efficacy of the Hans Kai program in promoting the health and wellbeing of its participants and investigate the experiences of the Hans Kai participants and facilitators. METHODS: This research will involve a mixed methods trial combining an experimental component with a qualitative component. The experimental component will involve a 6-month 2-group parallel superiority randomized controlled trial (RCT) in which 105 participants will be randomly assigned to two conditions, an intervention group (n = 70) that will participate in the Hans Kai program and a control group (n = 35) that will have access to standard care using a computer-generated random sequence; blinding will not occur. The RCT will test the impact of the program on several health outcomes and will be followed by a 12-18-month observational follow-up study that will provide data on the long-term durability of the 6-month RCT health outcomes. The qualitative component will investigate the experiences of program participants (n = 30) and facilitators (n = 15) to identify the main strengths and limitations of Hans Kai, uncover potential implementation issues, and elucidate the mechanisms through which the program works. The population of interest will include adults aged 18 + with or without chronic health conditions who self-report an interest in taking control of their own health and improving their lifestyle. In the RCT, all outcomes of interest will be measured using a multi-method approach, involving self-report questionnaires and objective indicators, and within-subject mean changes in outcomes over time between the two groups will be compared to address the RCT aims. Similarly, in the qualitative component, a multi-method approach, involving in-depth individual interviews, photovoice, and online surveys, will be used to reach a deeper and more nuanced understanding of the program strengths, how the program works, and for which people it is more effective. Adaptable components of the program will also be investigated and modified according to the feedback provided by the RCT participants. In the mixed methods integration of evidence, the qualitative findings will be used to explain the quantitative RCT results. DISCUSSION: The RCT findings will help support the further development and use of Hans Kai as well as other peer-led health promotion interventions. TRIAL REGISTRATION: United Stated Clinical Trial Registry ClinicalTrials.gov (registration# NCT03949725; Protocol version 2, June 22nd, 2022).

Dietary potassium liberalization with fruit and vegetables versus potassium restriction in people with chronic kidney disease (DK-Lib CKD): a clinical trial protocol.

BACKGROUND: Potassium regulation in the body is primarily done in the kidney. In addition to this, hyperkalemia, occurs in approximately 10% of individuals with chronic kidney disease (CKD) and is associated with elevated all-cause mortality. Individuals with CKD are often told to restrict dietary potassium (K), however, this recommendation is based on low quality evidence. Reduced quality of life, limited dietary choices and nutritional deficiencies are all potential negative outcomes that may occur when restricting dietary K in CKD patients. There is a need for randomized controlled trials investigating the impact of dietary K modification on serum K concentrations in people with CKD. METHODS: A randomized 2-period crossover design comparing a liberalized K fruit and vegetable diet where participants will be required to consume ~ 3500 mg of dietary K daily, to a standard K restricted diet where participants will be required to consume < 2000 mg of dietary K daily. All participants will begin on a liberalized K run-in period for 2 weeks where they will receive fruit and vegetables home deliveries and for safety will have clinical chemistry, including serum potassium measurements taken after 1 week. Participants will then be randomized into either liberalized K or standard K diet for six weeks and then crossover to the other intervention for another 6 weeks after a 2-week washout period. DISCUSSION: 30 male and female CKD outpatients, ≥ 18 years of age, who have an estimated glomerular filtration rate (eGFR) between 15 and 45 ml/min/1.73m2 and serum K between 4.5 and 5.5 mEq/L. This design would have greater than 80% power to detect a difference of 0.35 mEq/L serum K between groups. Anthropometric measurements, clinical chemistry, dietary recalls, physical function assessments, as well as a quality of life assessments will also be measured in this trial. These findings will provide high quality evidence for, or against, recommendations for dietary K restriction in individuals living with CKD. The removal of K restriction could provide individuals living with CKD more dietary choice leading to improved dietary status and quality of life. TRIAL REGISTRATION: This trial has received approval from the University of Manitoba Research Ethics board (HS25191 (B2021:104)).

Reducing Dietary Acid With Fruit and Vegetables Versus Oral Alkali in People With Chronic Kidney Disease (ReDACKD): A Clinical Research Protocol.

Background: Individuals with chronic kidney disease (CKD) can develop metabolic acidosis which, in turn, is associated with faster progression of CKD and an increased need for dialysis. Oral sodium bicarbonate (the current standard of care therapy for metabolic acidosis) is poorly tolerated leading to low adherence. Base-producing or alkalizing Fruit and vegetables have potential as an alternative treatment for metabolic acidosis as they have been shown to reduce acid load arising from the diet. Objective: This trial will evaluate the feasibility of providing base-producing fruit and vegetables as a dietary treatment for metabolic acidosis, compared with oral sodium bicarbonate. Design: A 2-arm, open-label, dual-center, randomized controlled feasibility trial. Setting: Two Canadian sites: a nephrology clinic in Winnipeg, Manitoba, and a nephrology clinic in Halifax, Nova Scotia. Participants: Adult participants with G3-G5 CKD and metabolic acidosis. Measurements: Participants will undergo baseline measurements and attend 5 study visits over 12 months at which they will have a measurement of feasibility criteria as well as blood pressure, blood and urine biochemistry, 5-repetition chair stand test (STS5), and questionnaires to assess quality of life and symptoms. Furthermore, participants fill out Automated Self-Administered 24-hour recalls (ASA-24) in the beginning, middle, and end of trial. Methods: A total of 40 eligible participants will be randomized 1:1 to either base-producing fruit and vegetables (experimental) group or sodium bicarbonate (control) group, beginning from a daily dose of 1500 mg. Limitations: Using self-administered dietary assessments, lack of supervision over the consumption of study treatments and the possible disappointment of the control group for not receiving fruit and vegetables would be considered as limitations for this study. However, we are planning to undertake proper practices to overcome the possible limitations. These practices are discussed throughout the article in detail. Conclusions: This study will generate data on base-producing fruit and vegetables consumption as a dietary treatment for metabolic acidosis in CKD. The data will be used to design a future multi-center trial looking at slowing CKD progression in people with metabolic acidosis. Trial Registration: This study is registered on clinicaltrials.gov with the identifier NCT05113641.

Contexte: Les personnes atteintes d'insuffisance rénale chronique (IRC) courent le risque de développer une acidose métabolique, laquelle est associée à une progression plus rapide de l'IRC et à un besoin accru de dialyse. La prise de bicarbonate de sodium par voie orale (la norme actuelle de traitement de l'acidose métabolique) est mal tolérée, ce qui se traduit par une faible adhérence. Les fruit et légumes basiques ou alcalifiants ont un potentiel de traitement alternatif pour l'acidose métabolique, car il a été démontré qu'ils peuvent réduire la charge acide provenant de l'alimentation. Objectif: cet essai permettra d'évaluer la faisabilité d'un traitement alimentaire de l'acidose métabolique, en misant sur la consommation de fruit et légumes basiques ou alcalifiants, par rapport à la prise de bicarbonate de sodium par voie orale. Type d'étude: essai de faisabilité contrôlé, randomisé, ouvert, à deux bras, mené dans deux centres. Cadre: deux sites canadiens, soit une clinique de néphrologie à Winnipeg (Manitoba) et une autre à Halifax (Nouvelle-Écosse). Sujets: des patients adultes atteints d'IRC de stade G3-G5 et d'acidose métabolique. Mesures: les participants seront soumis à des mesures initiales et devront se présenter à cinq visites d'étude réparties sur 12 mois. Au cours de chacune, les patients subiront une mesure des critères de faisabilité, une mesure de la pression artérielle, un bilan sanguin et urinaire, un test de lever de chaise à cinq répétitions (STS5 ­ Five Times Sit to Stand Test) et devront répondre à des questionnaires évaluant la qualité de vie et les symptômes. Les participants devront également utiliser un outil en ligne de rappels alimentaires de 24 heures autoadministrés et automatisés (ASA24 ­ Automated Self-Administered 24-hours) au début, à mi-parcours et à la fin de l'essai. Méthodologie: 40 patients admissibles seront randomisés (1:1) dans le groupe expérimental (fruit et légumes basiques ou alcalifiants) ou dans le groupe témoin (bicarbonate de sodium) avec une dose quotidienne initiale de 1 500 mg. Limites: l'utilisation d'outils d'évaluation alimentaire autoadministrés, le manque de supervision de la consommation des traitements à l'étude et la possible déception du groupe témoin de ne pas recevoir de fruit et légumes constituent des limites pour cette étude. Nous prévoyons cependant adopter des pratiques appropriées pour surmonter ces possibles limites. Ces pratiques sont discutées plus en détail dans le manuscrit. Conclusion: cette étude produira des données sur la consommation de fruit et légumes basiques ou alcalifiants comme traitement alimentaire pour l'acidose métabolique en contexte d'IRC. Ces données seront utilisées pour concevoir un futur essai multicentrique visant à ralentir la progression de l'IRC chez les personnes atteintes d'acidose métabolique. Enregistrement de l'essai: Cette étude a reçu l'approbation du Conseil d'éthique de la recherche en santé de l'Université du Manitoba (HS24768 [B2021:025]) et est enregistrée sur ClinicalTrials.gov avec l'identifiant NCT05113641.

A clinically managed weight loss program evaluation and the impact of COVID-19.

Introduction: With the prevalence of obesity increasing, many weight-loss programs were created to aid in combating the trend. The Weight Loss Clinic (WLC) was created to provide personalized support for lifestyle changes using a multidisciplinary team with medical oversight. This study evaluated the clinically-managed weight loss program at the Wellness Institute. Methods: This was a prospective evaluation of a newly established program between January 2019-August 2020. Participants who entered the weight loss program were approached to learn about the evaluation. A total of 41 participants were included. The primary outcomes included changes in body weight and achievement of more than 5% initial body weight loss. Outcome measures were collected pre-and post-program and the data was analyzed through paired t-tests on R studio. Results: Greater body weight-loss was seen in completers pre-COVID-19 compared to those who completed during the pandemic (Mean, ±SD; 7.51 ± 6.24 kg n = 13 p < 0.001 vs. 1.75 ± 4.43 kg n = 9, p = 0.02). Completers pre-COVID-19 demonstrated improvements in waist circumference, Framingham risk score, blood pressure, hemoglobin A1C, and body fat percentage. Conclusions and implications: Though the sample size was small to show definitve evidence, the results may suggest the program worked well prior to the pandemic but the pandemic created barriers to weight-loss for participants.

Dietary Patterns and Perceptions in Older Adults With Chronic Kidney Disease in the Canadian Frailty Observation and Interventions Trial (CanFIT): A Mixed-Methods Study.

Background: People living with chronic kidney disease (CKD) have identified diet as an important aspect of their life and care. Understanding current consumption patterns in this population, and how they relate to patient perspectives of dietary recommendations, may help identify and design potential dietary intervention strategies in CKD. Objective: To investigate the dietary intake patterns of people with advanced-stage CKD, as well as subjective perspectives regarding dietary recommendations from participants and their caregivers. Design: Mixed-methods study with a sequential explanatory design. Setting: Manitoba, Canada. Participants: Individuals with late-stage CKD (CKD stages G4-G5, including dialysis) participating in the Canadian Frailty Observation and Interventions Trial (CanFIT). Methods: First, quantitative data were collected via a cross-sectional dietary assessment, using three 24-hour dietary recalls, a 36-question short diet questionnaire (SDQ), and a Nutrition Quality of Life (NQoL) tool (n = 59). Second, qualitative data were collected during 2 focus groups (n 1 = 12 and n 2 = 7) held with a subsample of individuals who had completed the dietary surveys, along with their caregivers. Focus groups explored topics related to diet and CKD; transcribed data were analyzed thematically. In the interpretation stage, the qualitative findings were combined with the quantitative results to help explain the latter and reach a deeper understanding of the subjective experiences of adults with CKD. Results: Quantitatively, nearly all (48/51; 94%) participants (mean age 70.8 ± 10.8 years) reported energy intakes below recommendations and most (86%) did not achieve recommended fiber intake. In addition, 15/21 (71%) of patients on dialysis had low protein intake. Qualitatively, 2 themes were identified: (1) Lacking/Needing dietary guidance-incomplete "information overload," and (2) Experiencing difficulty in adapting to restrictions. Within the former theme, participants spoke of getting too much information at once, often at the wrong time. Within the latter theme, participants spoke of a loss of appetite, and cheating on their dietary recommendations. Limitations: Potential recall bias recalling dietary patterns, small sample size limiting generalizability, self-selection bias. Conclusion: Despite the reported lifestyle changes made by individuals with CKD, which negatively impacted their lives, many had suboptimal nutrition, especially in terms of energy and fiber. In addition, those on dialysis were not eating enough protein, which could be due to changing dietary recommendations as CKD progresses. Qualitative findings provided additional insight into how requisite CKD-dietary changes were perceived and how participants coped with these changes. The timing and delivery of the dietary education within CKD care in Manitoba may not be working for people with CKD as they progress through the disease.

Contexte: Les personnes atteintes d'IRC mentionnent le régime alimentaire comme un aspect important de leur vie et de leurs soins. Mieux comprendre les habitudes alimentaires actuelles de cette population et leur lien avec la façon dont les patients perçoivent les recommandations diététiques pourrait contribuer à orienter et concevoir de potentielles stratégies d'intervention diététique en contexte d'IRC. Objectif: Examiner les habitudes alimentaires des personnes atteintes d'IRC à un stade avancé, ainsi que les perspectives subjectives des participants et de leurs soignants sur les recommandations alimentaires. Conception: Étude par méthode mixte avec une conception séquentielle explicative. Cadre: Manitoba, Canada. Sujets: Les personnes atteintes d'IRC de stade avancé (stades G4-G5, y compris les patients sous dialyse) qui participent à l'essai CanFIT (Canadian Frailty Observation and Interventions Trial). Méthodologie: Des données quantitatives ont d'abord été colligées au moyen d'une évaluation transversale du régime alimentaire pour trois périodes de 24 heures, d'un questionnaire abrégé de 36 questions sur le régime alimentaire et d'un outil évaluant la qualité de vie liée à l'alimentation (n=59). Des données qualitatives ont ensuite été recueillies lors de deux groupes de discussion (n1 = 12 et n2 = 7) avec un sous-échantillon constitué de personnes ayant terminé les enquêtes sur l'alimentation et leurs soignants. Les groupes de discussion ont examiné des sujets liés à l'alimentation et à l'IRC; les données transcrites ont été analysées par thème. Au stade de l'interprétation, les résultats qualitatifs ont été combinés aux résultats quantitatifs pour aider à expliquer ces derniers et mieux comprendre les expériences subjectives des adultes atteints d'IRC. Résultats: Quantitativement, presque tous les participants (48/51; 94 %) (âge moyen: 70,8 ans ±10,8 ans) ont signalé des apports énergétiques inférieurs aux recommandations et la plupart (86 %) n'atteignaient pas l'apport recommandé en fibres. Sur les 21 patients sous dialyse, 15 (71 %) consommaient peu de protéines. Qualitativement, deux thèmes ont été dégagés: 1) le manque/besoin de directives alimentaires ­ « surcharge d'information ¼ ou information incomplète; 2) la difficulté de s'adapter aux restrictions. Pour le premier thème, les participants ont mentionné recevoir trop d'informations en même temps, souvent au mauvais moment. Pour le deuxième thème, les participants ont parlé de perte d'appétit et de tricherie par rapport aux recommandations alimentaires. Limites: Un possible biais de rappel pour les habitudes alimentaires; petite taille de l'échantillon qui limite la généralisabilité; biais d'auto-sélection. Conclusion: Malgré les changements signalés par les personnes atteintes d'IRC, lesquels ont eu des répercussions négatives sur leur vie, nombre d'entre elles avaient un régime alimentaire sous-optimal, surtout en ce qui concerne l'énergie et les fibres. En outre, les patients sous dialyse ne consommaient pas suffisamment de protéines, ce qui peut être attribuable aux changements dans les recommandations alimentaires au fur et à mesure que l'IRC progresse. Les résultats qualitatifs ont permis de mieux comprendre la façon dont les restrictions alimentaires nécessaires à l'IRC ont été perçues par les participants, et la façon dont ceux-ci ont fait face à ces changements. Le moment et le mode de prestation de l'information diététique dans le cadre des soins de l'IRC au Manitoba ne conviennent peut-être pas aux personnes atteintes d'IRC à mesure qu'elles progressent dans leur maladie. Enregistrement de l'essai: L'enregistrement n'est pas nécessaire pour cet essai.

The Effects of Resistant Starch Consumption in Adult Patients With Chronic Kidney Disease: A Systematic Review.

Background: Resistant starches (RSs) are not digested by human digestive enzymes and pass through the upper digestive tract to become substrates for colonic bacteria. Resistant starch supplementation has shown promising results in altering the microbiota of animal models of chronic kidney disease (CKD). Resistant starch consumption may influence the production of uremic toxins in CKD. Objective: To conduct a systematic review to determine whether the consumption of RS reduces the progression of kidney disease in adult patients with CKD. Design: We included randomized controlled trials comparing RS supplementation to placebo, no treatment, or standard care. Cochrane Central, Embase, MEDLINE, Web of Science, and CINAHL databases were searched. There was no limitation on publication date, but only English manuscripts were included. The search was conducted in July 2020. Patients: Adult outpatient populations with CKD, using any recognized diagnostic criteria. Measurements: The primary outcome was change in glomerular filtration rate (GFR) from baseline through the end of the trial in patients not on dialysis; secondary outcomes included change in uremic toxin concentrations (p-cresol/p-cresyl sulfate [p-CS], indoxyl sulfate [IS]) and inflammatory markers (tumor necrosis factor alpha [TNF-α], C-reactive protein [CRP], interleukin 6 [IL-6]) from baseline through the end of the trial, and changes in self-reported symptom scores. Methods: The Cochrane Collaboration Risk of Bias tool was used to assess risk of bias in included studies. The systematic review results are reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. Results: We identified 4 unique studies, reported in 9 publications that met our inclusion criteria, including a total of 215 enrolled participants. Results were calculated using data from the longest reported follow-up time. The primary outcome of changes in kidney function markers was only studied in 1 trial; this trial reported an increase in creatinine and a decrease in blood urea nitrogen; no changes in GFR were reported. A review of the secondary outcomes showed an overall decline in IS, TNF-α, and IL-6, in RS groups, but with mixed results in p-CS and CRP/high-sensitivity CRP. Safety data showed that RS was well tolerated with no reports of excessive side effects. Limitations: We determined a meta-analysis was not feasible due to clinical heterogeneity between study populations and differences in reported outcomes in the included studies. Conclusion: There is limited and inconsistent evidence on the impact of RS in adult patients with CKD. Further research is needed to determine the safety and efficacy of RS supplementation in this population.

Contexte: Les amidons résistants ne sont pas dégradés par les enzymes digestives humaines; ils traversent le tube digestif supérieur et deviennent des substrats pour les bactéries du côlon. La supplémentation en amidons résistants a montré des résultats prometteurs dans la modification du microbiote chez les modèles animaux d'insuffisance rénale chronique (IRC). Dans ce contexte, la consommation d'amidons résistants pourrait avoir une incidence sur la production de toxines urémiques. Objectif: Procéder à une revue systématique afin de déterminer si la consommation d'amidons résistants limite la progression de la maladie chez les adultes atteints d'IRC. Conception de l'étude: Ont été inclus les essais contrôlés randomisés qui comparaient la supplémentation en amidons résistants à un placebo, à l'absence de traitement ou aux soins courants. La recherche a été effectuée en juillet 2020 dans les bases de données Cochrane Central, Embase, Medline, Web of Science et CINAHL. La date de publication n'était pas limitée, mais seuls les articles rédigés en anglais ont été inclus. Sujets: Des adultes atteints d'IRC et suivis en ambulatoire, selon tout critère de diagnostic reconnu. Mesures: Le principal critère d'évaluation était un changement dans le taux de filtration glomérulaire entre le début et la fin de l'essai chez les patients non dialysés. Les résultats secondaires comprenaient un changement, entre le début et la fin de l'essai, dans les concentrations de toxines urémiques (sulfate de p-crésol/crésyle, sulfate d'indoxyle) et de marqueurs d'inflammation (TNFα, CRP, IL-6), ainsi que dans les scores de symptômes auto-déclarés. Méthodologie: L'outil de Risque de Biais de la Collaboration Cochrane a été utilisé pour évaluer le risque de biais dans les études incluses. Les résultats de la revue systématique sont présentés conformément aux directives PRISMA. Résultats: Quatre études uniques, présentées dans neuf publications et portant sur un total de 215 patients, répondaient à nos critères d'inclusion. Les résultats ont été calculés à partir des données de la plus longue période de suivi rapportée. Un seul de ces essais avait examiné le critère principal d'évaluation, soit un changement dans les marqueurs de la fonction rénale. On y rapportait une augmentation du taux de créatinine et une diminution du taux de l'urée dans le sang. Aucun changement dans le débit de filtration glomérulaire n'avait été signalé. Un examen des résultats secondaires a révélé une diminution globale du sulfate d'indoxyle, du TNF alpha et d'IL-6 dans les groupes de patients qui prenaient des suppléments d'amidon résistants, mais des résultats mitigés en ce qui concerne les taux de p-CS et de CRP/hsCRP. Les données de sécurité montraient que les amidons résistants étaient bien tolérés, aucun effet secondaire important n'ayant été rapporté. Limites: Une méta-analyse n'était pas réalisable en raison de l'hétérogénéité clinique entre les populations étudiées et des différences dans les résultats rapportés dans les études incluses. Conclusion: Les données sur les effets d'une supplémentation en amidons résistants chez les adultes atteints d'IRC sont limitées et manquent d'uniformité. D'autres recherches examinant la sécurité et l'efficacité d'une supplémentation en amidons résistants dans cette population sont nécessaires.

A randomized double-blind cross-over trial to study the effects of resistant starch prebiotic in chronic kidney disease (ReSPECKD).

BACKGROUND: Chronic kidney disease (CKD) is associated with a reduced quality of life and an increased risk of kidney failure, cardiovascular events, and all-cause mortality. Accumulation of nitrogen-based uremic toxins leads to worsening of symptoms in individuals with CKD. Many uremic toxins, such as indoxyl and p-cresol sulphate, are produced exclusively by the gut microbiome through the proteolytic digestion of aromatic amino acids. Strategies to reduce the production of these toxins by the gut microbiome in individuals with CKD may lessen symptom burden and delay the onset of dialysis. One such strategy is to change the overall metabolism of the gut microbiome so that less uremic toxins are produced. This can be accomplished by manipulating the energy source available to the microbiome. Fermentable carbohydrates which reach the gut microbiome, like resistant starch (RS), have been shown to inhibit or reduce bacterial amino acid metabolism. This study aims to investigate the effects of resistant potato starch (RPS) as a prebiotic in individuals with CKD before the onset of dialysis. METHODS: This is a double-blind, randomized two-period crossover trial. Thirty-six eligible participants will consent to follow a 26-week study regimen. Participants will receive 2 sachets per day containing either 15 g of RPS (MSPrebiotic, resistant potato starch treatment) or 15 g cornstarch (Amioca TF, digestible starch control). Changes in blood uremic toxins will be investigated as the primary outcome. Secondary outcomes include the effect of RPS consumption on symptoms, quality of life and abundance, and diversity and functionality of the gut microbiome. DISCUSSION: This randomized trial will provide further insight into whether the consumption of RPS as a prebiotic will reduce uremic toxins and symptoms in individuals who have CKD. TRIAL REGISTRATION: ClinicalTrials.gov NCT04961164 . Registered on 14 July 2021.

Efficacy and safety of clinically managed weight loss programs: a systematic review and meta-analysis protocol.

BACKGROUND: Obesity has become a major driver in the burden of chronic diseases. The Canadian Clinical Practice Guidelines recommend a lifestyle intervention for the management and prevention of obesity. This includes behavior modification, dietary counseling, and physical activity. With the market overwhelmed with weight loss programs, the majority are focused on low-calorie diets and general recommendations for exercise. Most are not personalized and are not administered by healthcare professionals. An interdisciplinary team of highly trained healthcare professionals has the ability to provide medically sound and safe advice in all aspects of an individuals' life, such as lifestyle, sleep, mental health, and behaviors. A clinically managed weight loss program is defined as a team including a dietitian, exercise professional, psychologist, and/or physician or nurse practitioner oversight. With limiting results in the literature regarding clinically managed weight loss programs, it is difficult to conclude whether it may be effective. Therefore, the objective of this systematic review is to assess clinically managed weight loss programs, with a physician or nurse practitioner oversight in comparison with non-clinically managed weight loss programs with no physician oversight or nurse practitioner oversight in adults who are living with overweight or obesity. METHODS: A literature search will be executed by a knowledge synthesis librarian on MEDLINE, Cochrane Central, Embase, PsycINFO, and CINAHL. The data collected will be extracted, stored, and managed in MS Excel 2016. The extraction of the data will include study details, study population details, health team details, intervention details, and outcome details. DISCUSSION: The prevalence of obesity has been increasing throughout the decades. The results from this systematic review may aid in recommending a more clinically safe weight loss program for those who struggle with overweight or obesity. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020170014.

Effect of processing on oat ß-glucan viscosity, postprandial glycemic response and subjective measures of appetite.

Oat has procured its acclaim as a health promoting food partially due to its positive effect on glucose control. It has been demonstrated that oat ß-glucan can interfere with postprandial glucose response. A large majority of this action is attributed to the increase in viscosity due to the ß-glucan content in oat foods. While it is known that an increase in viscosity due to higher molecular weight of ß-glucan can improve its glycemic effects, it is not known if an increase in viscosity attained by processing variables can further enhance the positive effect of oat on glucose control. In the current study we have examined the effect of kilning, tempering, microwaving, cooking, soaking and flaking on oat ß-glucan viscosity. An acute randomized crossover clinical trial was also conducted to test oatmeal products containing low, medium and high ß-glucan viscosity for their effect on postprandial glycemic response. Results from the processing experiments demonstrate that kilned samples, when tempered to 25% moisture and microwaved for 2 minutes, can produce much higher final viscosity compared to other samples with similar ß-glucan content, molecular weight and solubility. However, results from the clinical trial show that the increase in the viscosity of the oat ß-glucan attained through processing in this study did not have any effect on postprandial glucose control.

The effect of dairy products and non-dairy snacks on food intake, subjective appetite and cortisol levels in children: a randomized control study.

Dairy snacks are available in various physical forms and their consumption is linked to improved metabolic health. The objective of this study was to determine the effect of dairy snacks of different physical forms on short-term food intake (FI), subjective appetite, and the stress hormone, cortisol, in children. Following a repeated-measures crossover design, 40 children aged 9-14 years randomly consumed 1 of 5 isoenergetic (180 kcal) snacks per study session. These snacks included solid (potato chips, cookies, and cheese), semi-solid (Greek yogurt), and fluid (2% fat milk) snacks. FI was measured 120 min after snack consumption. Subjective appetite was measured at 0 (immediately before the snack), 15, 30, 45, 60, 90, and 120 min. Salivary cortisol (n = 18) was measured after the Greek yogurt and cookie snacks at 0, 30, 60, 90, and 120 min. FI did not differ between snacks (P = 0.15). The Greek yogurt (P < 0.0001) and cheese (P = 0.0009) snacks reduced average appetite compared with the 2% fat milk snack. Salivary cortisol levels were not affected by snack (P = 0.84). This study demonstrates that dairy snacks are as effective as other popular snacks at influencing subsequent FI. However, solid and semi-solid dairy snacks are more effective at repressing subjective appetite than a fluid dairy snack. Registered at ClinicalTrials.gov (NCT02484625). Novelty: Milk, Greek yogurt and cheese have a similar effect on short-term food intake in children as popular potato chips and cookie snacks. Solid, semi-solid and liquid snacks have a similar effect on short-term food intake in children.

Acute effects of extruded pea fractions on glycemic response, insulin, appetite, and food intake in healthy young adults, results of a double-blind, randomized crossover trial.

Benefits of pulse consumption on glycemic control are well established; however, research examining the effects of pulse fractions incorporated into extruded products is limited. In a randomized, repeated-measures crossover study, adults (n = 26) consumed cereals made with oat flour (control), oat flour and pea starch (starch), oat flour and pea protein (protein), oat flour, pea starch and pea protein (starch+protein), oat flour, pea fibre and pea protein (fibre+protein), and pea fibre, pea starch and pea protein (fibre+starch+protein). Blood glucose (BG) and insulin concentrations, and appetite incremental area under the curve (iAUC) were calculated before (0-120 min) and after (120-200 min) the ad libitum meal for measurement of food intake. Pre-meal, overall mean BG and iAUC were lower following the protein, starch+protein, protein+fibre, and the fibre+starch+protein cereals compared with the starch and control. For pre-meal overall mean insulin concentrations, fibre+protein led to a lower response compared with control, starch+protein, and protein cereals. Fibre+starch+protein also led to lower insulin compared with protein cereal. Pre-meal insulin iAUC was lower following fibre+protein compared with control and protein cereals. The inclusion of yellow pea protein and fibre in oat-based breakfast cereal reduces postprandial glycemia; however this effect is dependent on fraction type. ClinicalTrials.gov: NCT02366572. Novelty: Inclusion of pulse protein and fibre in oat flour-based breakfast cereal reduces postprandial glucose response. The glycemic benefits of whole pulses are at least somewhat retained in some pulse fractions.

Faba bean meal, starch or protein fortification of durum wheat pasta differentially influence noodle composition, starch structure and in vitro digestibility.

Faba bean (Vicia faba L.) flour, starch concentrate (60% starch), protein concentrate (~60% protein) and protein isolate (~85% protein) were added to replace one-quarter of durum wheat semolina to enrich the nutritional quality and physiological functions of durum wheat (Triticum turgidum L.) pasta. The raw pasta samples prepared with protein concentrate or isolate had higher (p ≤ 0.001) protein and lower (p ≤ 0.001) total starch concentrations, along with increased total dietary fiber and slowly digestible starch (p ≤ 0.001) than durum wheat semolina control or those with added whole faba-bean flour or isolated starch. The faba bean fortified pasta had altered starch with increased proportion of medium B-type glucan chains and long C-type glucan chains, reduced starch digestibility and were associated with glycaemia related effects in the human diet. The faba bean fortified pasta had increased protein and dietary fiber that influenced food intake and satiety. The results suggest differential contributions of food ingredients in human health outcomes.

Acute effects of hemp protein consumption on glycemic and satiety control: results of 2 randomized crossover trials.

Research investigating hemp protein consumption on glycemic response is limited. The effects of hemp protein consumption on blood glucose (BG), insulin, and satiety compared with soybean protein and a carbohydrate control were examined. Two acute randomized repeated-measures crossover experiments were conducted. In both, participants consumed the following isocaloric treatments: 40 g of hemp protein (hemp40), 20 g of hemp protein (hemp20), 40 g of soybean protein (soy40), 20 g of soybean protein (soy20), and a carbohydrate control. In experiments 1 (n = 27) and 2 (n = 16), appetite and BG were measured before (0-60 min, pre-pizza) and after a pizza meal (80-200 min, post-pizza). In experiment 1, food intake was measured at 60 min by ad libitum meal; in experiment 2 a fixed meal was provided (based on body weight) and insulin was measured pre-pizza and post-pizza. In both experiments, BG response was affected by treatment (p < 0.01), time (p < 0.001) and time-by-treatment (p < 0.001) from 0-200 min. Protein treatments lowered 0-60-min BG overall mean and area under the curve compared with control (p < 0.05) dose-dependently. In experiment 2, hemp40 and soy40 lowered (p < 0.05) overall mean insulin concentrations compared with hemp20, soy20, and control pre-meal. Results suggest that hemp protein, like soybean, dose-dependently lowers postprandial BG and insulin concentrations compared with a carbohydrate control. Clinical trial registry: NCT02366598 (experiment 1) and NCT02458027 (experiment 2). Novelty: Hemp protein concentrate dose-dependently leads to lower postprandial BG response compared with a carbohydrate control. No differences were seen between hemp and soy protein.

Acute effects of extruded pulse snacks on glycemic response, insulin, appetite, and food intake in healthy young adults in a double blind, randomized, crossover trial.

Research indicates that the postprandial glycemic benefits of consuming whole pulses are retained when consumed in a mixed meal, pureed, and ground into flours. The glycemic benefits of pulse flours when incorporated into extruded products are unknown. In a randomized, repeated-measures crossover study, adults (n = 26) consumed extruded corn snacks made with the addition of 40% pulse flour from either whole yellow pea, split yellow pea, green lentil, chickpea, or pinto bean. The control snack was 100% corn. Food intake was measured with an ad libitum meal consumed at 120 min. Blood glucose (BG), insulin and appetite were measured regularly before (pre-meal, 0-120 min) and after (post-meal, 140-200 min) the meal. Pinto bean and chickpea snacks led to lower (p < 0.05) pre-meal BG incremental area under the curve (iAUC), compared with control, whole yellow pea and green lentil snacks. Pinto bean snack also led to lower (pre-meal BG (p < 0.05) and insulin (p < 0.05) iAUC compared with control, whole yellow pea, and split yellow pea snacks. There were no differences in food intake or appetite. These findings indicate that effects of replacing corn with pulse flours in extruded snacks on BG, and insulin are dependent on pulse type. ClinicalTrials.gov Identifier: NCT02402504. Registered on 30 March 2015. Novelty: The incorporation of pinto bean and chickpea flour into extruded corn snacks improves postprandial glycemic response. Pulse containing snacks were equally as palatable as the corn snacks. The incorporation of pulses into corn snacks increased the protein and fibre content.

A double-blind, randomized, crossover trial protocol of whole hemp seed protein and hemp seed protein hydrolysate consumption for hypertension.

BACKGROUND: Primary hypertension accounts for almost 95% of all cases of high blood pressure and is a major modifiable risk factor for cardiovascular diseases. Lifestyle interventions have been shown to prevent hypertension. One of the prominent potential therapeutic lifestyle strategies to prevent or manage hypertension is increasing dietary protein as a macronutrient or as bioactive peptides. An emerging plant-based protein source that may have anti-hypertensive properties is hemp seed. METHODS/DESIGN: A randomized, double-blind, crossover clinical trial will be conducted on 35 hypertensive participants aged 18-75 years, with a BMI between 18.5 and 40 kg/m2, systolic blood pressure (SBP) between 130 and 160 mmHg and diastolic blood pressure (DBP) ≤ 110 mmHg. The trial will be conducted for a period of 22 weeks and will consist of three treatment periods of 6 weeks, separated by 2-week washout periods. The treatments will be consumed twice a day and consist of 25 g casein, hemp seed protein (HSP), or HSP plus HSP hydrolysate (HSP+). The primary outcome of this trial is 24-h SBP, measured on the first day of first phase and the last day of each phase. Office-measured blood pressure, pulse-wave velocity and augmentation index and anthropometrics will be determined at the first and last days of each period. Also, body composition will be assessed by dual x-ray absorptiometry (DXA) scan on the first day of the first phase and within the last 2 days of each treatment period. Blood samples will be collected on the first and last 2 days of each treatment phase whereas urine samples will be collected on the first day of the first phase plus the last day of each phase to be analyzed for specific biomarkers. DISCUSSION: This trial protocol is designed to evaluate the hypotensive potential of consuming whole HSP, and HSP+, in comparison to casein protein. This study will be the first trial investigating the potential anti-hypertensive benefit of dietary hemp protein plus bioactive peptide consumption in humans. TRIAL REGISTRATION: National Clinical Trial (NCT), ID: NCT03508895. Registered on 28 June 2018. Retrospectively registered on the publicly accessible Registry Databank at ClinicalTrials.gov (http://ClinicalTrials.gov).

Faba bean protein flours added to pasta reduce post-ingestion glycaemia, and increase satiety, protein content and quality.

The hypothesis that adding faba bean (FB) flour and its macronutrient concentrated flours to pasta reduces postprandial glycaemia and increases satiety was tested in 54 young adult males. Each consumed a serving of pasta made from durum wheat semolina (DWS) alone, or DWS flour with 25% of flours from whole FB (FBF), starch concentrate (FBS), protein concentrate (FBPC), or protein isolate (FBPI). Post-consumption measurements included postprandial blood glucose, insulin, C-peptide, GLP-1 and PYY, and subjective appetite, over 120 min. Second meal effects of treatments were assessed after participants consumed either an ad libitum or fixed size meal (12 kcal kg-1) at a pizza meal at 120 min. Additions of FB flours from FBPC and FBPI reduced postprandial glycaemia and appetite, increased protein content and quality of the pastas and PYY and C-peptide responses, but had no effect on plasma insulin or GLP-1. In conclusion, DWS pastas with added faba bean protein flour reduce postprandial BG and appetite and have higher nutritional quality. The clinical trial registry number is NCT02658591 .

The Manitoba Personalized Lifestyle Research (TMPLR) study protocol: a multicentre bidirectional observational cohort study with administrative health record linkage investigating the interactions between lifestyle and health in Manitoba, Canada.

INTRODUCTION: Lifestyle factors, such as diet, physical activity and sleep, are associated with the development of many chronic diseases. The objective of The Manitoba Personalized Lifestyle Research study is to understand how these lifestyle factors interact with each other and with other factors, such as an individual's genetics and gut microbiome, to influence health. METHODS: An observational study of adults, with extensive phenotyping by objective health and lifestyle assessments, and retrospective assessment of early life experiences, with retrospective and prospective utilisation of secondary data from administrative health records. STUDY POPULATION: A planned non-random convenience sample of 840 Manitobans aged 30-46 recruited from the general population, stratified by sex (equal men and women), body mass index (BMI; 60% of participants with a BMI>25 kg/m2) and geography (25% from rural areas). These stratifications were selected based on Manitoba demographics. MEASUREMENTS: Lifestyle factors assessed will include dietary pattern, physical activity, cardiovascular fitness, and sleep. Factors such as medical history, socioeconomic status, alcohol and tobacco consumption, cognition, stress, anxiety, and early life experiences will also be documented. A maternal survey will be performed. Body composition and bone density will be measured by dual energy X-ray absorptiometry. Blood pressure, pulse wave velocity, and augmentation index will be measured on two consecutive days. Chronic disease risk biomarkers will be measured in blood and urine samples. DNA will be extracted for genetic analysis. A faecal sample will be collected for microbiome analysis. Participants may provide their Manitoba personal health information number to link their study data with administrative health records. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the University of Manitoba Health Research Ethics Board (protocol # HS18951; 05/01/2016). Data analysis, release of results and publication of manuscripts are scheduled to start in early 2019. Additional information at www.TMPLR.ca. TRIAL REGISTRATION NUMBER: NCT03674957; Pre-results.

Glycaemic and insulinaemic impact of oats soaked overnight in milk vs. cream of rice with and without sugar, nuts, and seeds: a randomized, controlled trial.

BACKGROUND/OBJECTIVES: Soaking oats overnight in milk renders them ready to eat the next morning, however, it is unknown whether oats prepared this way will retain its relatively low glycaemic and insulinaemic impact. Therefore, we compared the glycaemic, insulinaemic and subjective hunger responses elicited by oats soaked overnight in 110 g skim-milk (ONO) vs. cooked cream of rice cereal (CR), both with and without inclusions. SUBJECTS/METHODS: The project was performed at two research centers (Toronto, Winnipeg) as two separate studies each using a randomized, cross-over design with similar methods. The glycaemic and insulinaemic responses of overnight-fasted participants without diabetes (males:females: Toronto, 24:16; Winnipeg, 20:20) were measured for 3 h after consuming CR and ONO fed alone (Toronto) or with added sugar, nuts, and seeds (CRsns and ONOsns) (Winnipeg). Participants rated subjective hunger using visual analog scales. Data were analyzed by paired t-test. The primary endpoint was 0-2 h incremental area under the curve (iAUC) for glucose. RESULTS: Mean glucose iAUC was 33% less, after ONO than CR (mean difference was 39 (51-27) mmol × min/l, p < 0.0001) and 24% less, after ONOsns than CRsns (mean difference was 43 (65-21) mmol × min/l, p = 0.0003). Serum-insulin iAUC was 33% less, after ONO than CR (mean difference 57 (81-40) pmol × hl, p < 0.0001) and 32% less, after ONOsns than CRsns (966 (1360-572) pmol × h/l, p < 0.0001). In both Toronto and Winnipeg, subjective hunger ratings were similar across the two treatments. CONCLUSIONS: Oats prepared by soaking overnight in skimmed milk without and with inclusions retain their relatively low glycaemic and insulinaemic impact.

Pre- and within-meal effects of fluid dairy products on appetite, food intake, glycemia, and regulatory hormones in children.

The effect of beverages commonly consumed by children in-between or with meals on short-term food intake (FI) and glycemic control has received little attention. Therefore, 2 experiments were conducted in 9- to 14-year-old children following a randomized repeated-measures design. Experiment 1 (n = 32) compared the effects of water (control) and isocaloric (130 kcal) amounts of 2% milk, chocolate milk, yogurt drink, and fruit punch on subjective appetite and FI. Experiment 2 (n = 20) compared the effects of isocaloric (130 kcal) amounts of 2% milk and fruit punch on subjective appetite, FI, and glycemic and appetite hormone responses. One serving of the beverages was given as a pre-meal drink at baseline (0 min) and a second serving 60 min later with an ad libitum pizza meal. Meal FI in experiment 1 was lower by 14% and 10%, respectively, after chocolate milk and yogurt drink (p < 0.001), but not milk, compared with water. Cumulative energy intake (beverages plus meal) was higher after caloric beverages than water. In experiment 2, no differences occurred in pre-meal but post-meal glucose was 83% higher in overweight/obese than normal-weight children (p = 0.02). Milk led to higher pre-meal glucagon-like peptide-1 and post-meal peptide tyrosine tyrosine (PYY) than fruit punch (p < 0.01) but insulin did not differ between treatments. In conclusion, dairy products consumed before and with a meal have more favourable effects on FI, appetite, and satiety hormones than a sugar-sweetened beverage, but all caloric beverages result in more cumulative calories than if water is the beverage.