Effects of Wheat Biscuits Enriched with Plant Proteins Incorporated into an Energy-Restricted Dietary Plan on Postprandial Metabolic Responses of Women with Overweight/Obesity.

This study investigates the effect of daily consumption of wheat biscuits enriched with plant proteins in postprandial metabolic responses of women with overweight/obesity who follow an energy-restricted diet. Thirty apparently healthy women participated in a 12-week randomized controlled trial and were assigned either to a control (CB) or an intervention (PB) group. Participants consumed daily either a conventional (CB) or an isocaloric wheat biscuit enriched with plant proteins (PB) containing high amounts of amino acids with appetite-regulating properties, i.e., BCAAs and L-arg. At baseline and the end of the intervention, a mixed meal tolerance test was performed. The responses of glucose, insulin, ghrelin, GLP-1, and glicentin were evaluated over 180 min. After 12 weeks, both groups experienced significant decreases in body weight, fat mass, and waist circumference. In the PB group, a trend towards higher weight loss was observed, accompanied by lower carbohydrate, fat, and energy intakes (p < 0.05 compared to baseline and CB group), while decreases in fasting insulin and the HOMA-IR index were also observed (p < 0.05 compared to baseline). In both groups, similar postprandial glucose, ghrelin, and GLP-1 responses were detected, while iAUC for insulin was lower (p < 0.05). Interestingly, the iAUC of glicentin was greater in the PB group (p < 0.05 compared to baseline). Subjective appetite ratings were beneficially affected in both groups (p < 0.05). Consumption of wheat biscuits enriched in plant proteins contributed to greater weight loss, lower energy intake, and insulin resistance and had a positive impact on postprandial glicentin response, a peptide that can potentially predict long-term weight loss and decreased food intake.

Does Yogurt Enriched with Platelet-Activating Factor Inhibitors from Olive Oil By-Products Affect Gut Microbiota and Faecal Metabolites in Healthy Overweight Subjects? (A randomized, parallel, three arm trial.).

OBJECTIVE: The effect of the daily consumption of a low-fat yogurt (150 g) enriched with Platelet-Activating Factor receptor (PAF-R) antagonists, or the plain one, on gut microbiota and faecal metabolites was investigated in healthy overweight subjects. METHODS: A randomized, three-arm, double-blind, placebo-controlled, parallel-group study was performed that lasted 8 weeks. Blood and stools were collected and analyzed before and after the intervention. RESULTS: Our findings revealed that the intake of the enriched yogurt resulted in a significant increase in the levels of Bifidobacterium spp., Clostridium perfringens group and Firmicutes-to-Bacteroidetes (F/B) ratio. On the other hand, a significant increase in the levels of Lactobacillus and C. perfringens group was detected after the intake of the plain yogurt. The increase in the levels of C. perfringens group was inversely associated with the plasma catabolic enzyme of PAF, namely LpPLA2 (lipoprotein-associated phospholipase A2), a cardiovascular risk marker that has been linked with inflammation and atherosclerosis. Moreover, in the enriched with PAF-R antagonists yogurt group, the increased levels of C. perfringens group were also associated with lower PAF action assessed as ex vivo human platelet-rich plasma (PRP) aggregation. Additionally, a higher % increase in molar ratio of Branched Short Chain Fatty Acids (BSCFAs) was detected for both yogurt groups after the 8 week-intervention compared to control. The consumption of the enriched yogurt also resulted in a significant drop in faecal caproic levels and a trend for lower ratio of butyrate to total volatile fatty acids (VFAs) compared to baseline levels. CONCLUSION: Yogurt consumption seems to favorably affect gut microbiota while its enrichment with PAF-R antagonists from olive oil by-products, may provide further benefits in healthy overweight subjects. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (NCT02259205).

Alternative models to support weight loss in chronic musculoskeletal conditions: effectiveness of a physiotherapist-delivered intensive diet programme for knee osteoarthritis, the POWER randomised controlled trial.

OBJECTIVES: To determine if physiotherapists can deliver a clinically effective very low energy diet (VLED) supplementary to exercise in people with knee osteoarthritis (OA) and overweight or obesity. METHODS: 88 participants with knee OA and body mass index (BMI) >27 kg/m2 were randomised to either intervention (n=42: VLED including two daily meal replacement products supplementary to control) or control (n=46: exercise). Both interventions were delivered by unblinded physiotherapists via six videoconference sessions over 6 months. The primary outcome was the percentage change in body weight at 6 months, measured by a blinded assessor. Secondary outcomes included BMI, waist circumference, waist-to-hip ratio, self-reported measures of pain, function, satisfaction and perceived global change, and physical performance tests. RESULTS: The intervention group lost a mean (SD) of 8.1% (5.2) body weight compared with 1.0% (3.2) in the control group (mean (95% CI) between-group difference 7.2% (95% CI 5.1 to 9.3), p<0.001), with significantly lower BMI and waist circumference compared with control group at follow-up. 76% of participants in the intervention group achieved ≥5% body weight loss and 37% acheived ≥10%, compared with 12% and 0%, respectively, in the control group. More participants in the intervention group (27/38 (71.1%)) reported global knee improvement than in the control group (20/42 (47.6%)) (p=0.02). There were no between-group differences in any other secondary outcomes. No serious adverse events were reported. CONCLUSION: A VLED delivered by physiotherapists achieved clinically relevant weight loss and was safe for people with knee OA who were overweight or obese. The results have potential implications for future service models of care for OA and obesity. TRIAL REGISTRATION NUMBER: NIH, US National Library of Medicine, Clinicaltrials.gov NCT04733053 (1 February 2021).

Modelling remission from overweight type 2 diabetes reveals how altering advice may counter relapse.

The development or remission of diet-induced overweight type 2 diabetes involves many biological changes which occur over very different timescales. Remission, defined by HbA1c<6.5%, or fasting plasma glucose concentration G<126 mg/dl, may be achieved rapidly by following weight loss guidelines. However, remission is often short-term, followed by relapse. Mathematical modelling provides a way of investigating a typical situation, in which patients are advised to lose weight and then maintain fat mass, a slow variable. Remission followed by relapse, in a modelling sense, is equivalent to changing from a remission trajectory with steady state G<126 mg/dl, to a relapse trajectory with steady state G≥126 mg/dl. Modelling predicts that a trajectory which maintains weight will be a relapse trajectory, if the fat mass chosen is too high, the threshold being dependent on the lipid to carbohydrate ratio of the diet. Modelling takes into account the effects of hepatic and pancreatic lipid on hepatic insulin sensitivity and ß-cell function, respectively. This study leads to the suggestion that type 2 diabetes remission guidelines be given in terms of model parameters, not variables; that is, the patient should adhere to a given nutrition and exercise plan, rather than achieve a certain subset of variable values. The model predicts that calorie restriction, not weight loss, initiates remission from type 2 diabetes; and that advice of the form 'adhere to the diet and exercise plan' rather than 'achieve a certain weight loss' may help counter relapse.

Diet-induced Weight Loss and Phenotypic Flexibility Among Healthy Overweight Adults: A Randomized Trial.

BACKGROUND: The capacity of an individual to respond to changes in food intake so that postprandial metabolic perturbations are resolved, and metabolism returns to its pre-prandial state, is called phenotypic flexibility. This ability may be a more important indicator of current health status than metabolic markers in a fasting state. AIM: In this parallel randomized controlled trial study, an energy-restricted healthy diet and 2 dietary challenges were used to assess the effect of weight loss on phenotypic flexibility. METHODS: Seventy-two volunteers with overweight and obesity underwent a 12-wk dietary intervention. The participants were randomized to a weight loss group (WLG) with 20% less energy intake or a weight-maintenance group (WMG). At weeks 1 and 12, participants were assessed for body composition by MRI. Concurrently, markers of metabolism and insulin sensitivity were obtained from the analysis of plasma metabolome during 2 different dietary challenges-an oral glucose tolerance test (OGTT) and a mixed-meal tolerance test. RESULTS: Intended weight loss was achieved in the WLG (-5.6 kg, P < 0.0001) and induced a significant reduction in total and regional adipose tissue as well as ectopic fat in the liver. Amino acid-based markers of insulin action and resistance such as leucine and glutamate were reduced in the postprandial phase of the OGTT in the WLG by 11.5% and 28%, respectively, after body weight reduction. Weight loss correlated with the magnitude of changes in metabolic responses to dietary challenges. Large interindividual variation in metabolic responses to weight loss was observed. CONCLUSION: Application of dietary challenges increased sensitivity to detect metabolic response to weight loss intervention. Large interindividual variation was observed across a wide range of measurements allowing the identification of distinct responses to the weight loss intervention and mechanistic insight into the metabolic response to weight loss.

The relation between dietary phytochemical index and metabolic health status in overweight and obese adolescents.

Previous studies have rarely investigated dietary phytochemicals consumption in relation to metabolic health of adolescents. The current study was performed to investigate dietary phytochemical index (DPI) in relation to metabolic health status in overweight and obese adolescents. This cross-sectional study was conducted among 203 adolescents with overweight or obesity. Dietary intakes of participants were obtained through a validated 147-item food frequency questionnaire. DPI was calculated [(dietary energy derived from phytochemical-rich foods (kcal)/total daily energy intake (kcal)) ⨯100]. Glycemic and lipid profiles, blood pressure, and anthropometric indices were also measured. A metabolically unhealthy overweight/obesity (MUO) profile was determined based on the International Diabetes Federation (IDF) and IDF/Homeostasis Model Assessment Insulin Resistance (HOMA-IR) definitions. Study subjects had a mean age of 13.98 years and 50.2% of them were girls. According to IDF and IDF/HOMA-IR criteria, 38.9% (37 boys, and 42 girls) and 33% (35 boys, and 32 girls) of the study participants were respectively MUO. According to IDF and IDF/HOMA-IR definitions, adolescents in the third DPI tertile had respectively 61% (maximally-adjusted OR = 0.39, 95%CI 0.16-0.91) and 67% (maximally-adjusted OR = 0.33, 95%CI 0.13-0.83) lower odds of being MUO, compared to the first tertile. Stratified analysis by sex indicated that DPI was inversely related to MUO phenotype based on IDF criteria in girls (maximally-adjusted OR = 0.25, 95%CI 0.06-0.98), but not in boys. The current study found that adolescents with a higher dietary intake of phytochemicals have lower odds of being MUO, particularly among girls. However, further large-scale prospective cohort studies are required to confirm this finding.

Dietary Intervention on Overweight and Obesity after Confinement by COVID-19.

BACKGROUND: Obesity has become a public health problem in our society and is associated with many diseases, including type 2 diabetes mellitus, cardiovascular diseases, dyslipidemia, respiratory diseases, and cancer. Several studies relate weight loss in obese patients to improved anthropometric measurements and cardiometabolic risk. The objective of our study was to evaluate anthropometric changes, analytical parameters, insulin resistance, fatty liver, and metabolic scales, after a personalized weight loss program, through dietary advice to increase adherence to the Mediterranean diet and a motivational booster via mobile SMS messaging. METHODS: Intervention study on a sample of 1964 workers, in which different anthropometric parameters were evaluated before and after dietary intervention: the metabolic score of insulin resistance; non-alcoholic fatty liver disease using different scales; metabolic syndrome; atherogenic dyslipidemia; and the cardiometabolic index. A descriptive analysis of the categorical variables was performed, by calculating the frequency and distribution of the responses for each one. For quantitative variables, the mean and standard deviation were calculated, since they followed a normal distribution. Bivariate association analysis was performed by applying the chi-squared test (corrected by Fisher's exact statistic when conditions required it) and Student's t-test for independent samples (for comparison of means). RESULTS: The population subjected to the Mediterranean diet improved in all the variables evaluated at 12 months of follow-up and compliance with the diet. CONCLUSIONS: Dietary advice on a Mediterranean diet and its reinforcement with reminder messages through the use of mobile phones may be useful to improve the parameters evaluated in this study and reduce the cardiometabolic risk of patients.

Effect of an mHealth weight loss intervention on Healthy Eating Index diet quality: the SMARTER randomised controlled trial.

In the few weight loss studies assessing diet quality, improvements have been minimal and recommended calculation methods have not been used. This secondary analysis of a parallel group randomised trial (regsitered: https://clinicaltrials.gov/ct2/show/NCT03367936) assessed whether self-monitoring with feedback (SM + FB) v. self-monitoring alone (SM) improved diet quality. Adults with overweight/obesity (randomised: SM n 251, SM + FB n 251; analysed SM n 170, SM + FB n 186) self-monitored diet, physical activity and weight. Real-time, personalised feedback, delivered via a study-specific app up to three times daily, was based on reported energy, fat and added sugar intake. Healthy Eating Index 2015 (HEI-2015) scores were calculated from 24-hour recalls. Higher scores represent better diet quality. Data were collected August 2018 to March 2021 and analysed spring 2022. The sample was mostly female (78·9 %) and white (85·4 %). At baseline, HEI-2015 total scores and bootstrapped 95 % CI were similar by treatment group (SM + FB: 63·11 (60·41, 65·24); SM: 61·02 (58·72, 62·81)) with similar minimal improvement observed at 6 months (SM + FB: 65·42 (63·30, 67·20); SM: 63·19 (61·22, 64·97)) and 12 months (SM + FB: 63·94 (61·40, 66·29); SM: 63·56 (60·81, 65·42)). Among those who lost ≥ 5 % of baseline weight, HEI-2015 scores improved (baseline: 62·00 (58·94, 64·12); 6 months: 68·02 (65·41, 71·23); 12 months: 65·93 (63·40, 68·61)). There was no effect of the intervention on diet quality change. Clinically meaningful weight loss was related to diet quality improvement. Feedback may need to incorporate more targeted nutritional content.

Guidelines for medical nutrition treatment of overweight/obesity in China (2021).

Obesity has become a global "epidemic". At this stage, overweight / obesity has become a major public health problem that seriously affects not only adults but also children and adolescents worldwide. Medical nutritional therapy is the basic treatment for obesity and an indispensable measure for prevention and control at any stage in the course of obesity. Management of comorbidities and improving the quality of life of obese patients are also included in treatment aims. In recent years, there have been some guidelines on the nutrition management of overweight/obesity. However, the management of nutrition and lifestyle interventions must be compatible with specific regional dietary habits and social culture. To provide a clinical reference for the standardized treatment and management of overweight / obesity, guidelines for medical nutrition treatment of overweight/obesity in China (2021) were published, which cover the relationship of weight loss with different dietary patterns, meal replacement foods, biorhythms, intestinal microecology, metabolic surgery, and medical nutritional intervention, as well as weight loss in special populations. We hope the guidelines will improve the awareness of the importance of nutrition intervention in the treatment of metabolic disease, further regulate the principle and approach of medical nutrition therapy, and establish a workflow of standardized medical nutrition therapy for weight loss management so that more clinical nutrition professionals and medical staff can use it to provide better services for obese people.

The effect of omega-3 fatty acid supplementation on weight loss and cognitive function in overweight or obese individuals on weight-loss diet / El efecto de la suplementación con ácidos grasos omega-3 sobre la pérdida de peso y las funciones cognitivas en personas con sobrepeso u obesidad en dieta para adelgazar

Objective: omega-3 polyunsaturated fatty acids (PUFAs) are important nutrients that play role in obesity, body lipids, inflammation, and neural function. There is controversy in studies on the effect of omega-3 PUFA supplementation on weight loss and cognitive function. The aim of this study was to investigate the effect of omega-3 PUFA supplementation on weight loss and cognitive function in obese or overweight adults on a weight loss diet.Methods:40 adult volunteers aged 30-60 years, with body mass index (BMI) between 27.0 and 35.0 kg/m2, were randomly allocated into two groups. All subjects were involved in a weight loss diet program. The subjects in the omega-3 group (n = 20) also received daily supplementation with 1020 mg of omega-3 PUFAs (580 mg eicosapentaenoic acid (EPA), 390 mg docosahexaenoic acid (DHA), 50 mg other omega-3 PUFAs) for 12 weeks. Anthropometric measurements and body composition analysis were obtained at onset and at weeks 4, 8, and 12 of the study. The Montreal Cognitive Assessment (MoCA) test was used for evaluating cognitive functions at diet onset and at the end of week 12.Results:significant decreases were observed in weight, waist, and BMI in both groups. Abdominal fat mass and percentage decreased more in the omega-3 group than in the control group (p ≤ 0.05). MoCA scores increased in both groups within time, without statistical significance between groups.Conclusion:omega-3 PUFA supplementation augmented the reduction of abdominal fat mass and percentage in overweight or obese individuals on a weight loss diet. Further studies are required to identify the relationship and mechanisms of action of omega-3 PUFA supplementation on cognitive performance and weight loss. (AU)

Objetivo: los ácidos grasos poliinsaturados (AGPI) omega-3 son nutrientes importantes que intervienen en la obesidad, los lípidos corporales, la inflamación y las funciones neuronales. Existe controversia en los estudios sobre el efecto de la suplementación con AGPI omega-3 sobre la pérdida de peso y las funciones cognitivas. El objetivo de este estudio fue investigar el efecto de la suplementación con ácidos grasos poliinsaturados omega-3 sobre la pérdida de peso y la función cognitiva en adultos obesos o con sobrepeso que siguen una dieta para adelgazar.Métodos:40 voluntarios adultos de entre 30 y 60 años, con índice de masa corporal (IMC) entre 27,0 y 35,0 kg/m2, fueron distribuidos aleatoriamente en dos grupos. Todos los sujetos participaron en un programa de dieta para adelgazar. Los sujetos del grupo con omega-3 (n = 20) también recibieron suplementos diarios de 1020 mg de AGPI omega-3 (580 mg de ácido eicosapentaenoico (AEP), 390 mg de ácido docosahexaenoico (ADH), 50 mg de otros AGPI omega-3) durante 12 semanas. Las mediciones antropométricas y el análisis de la composición corporal se obtuvieron al inicio y a las 4, 8 y 12 semanas del estudio. La prueba de la “Evaluación Cognitiva de Montreal” (MoCA) se utilizó para evaluar las funciones cognitivas al inicio de la dieta y al final de la semana 12.Resultados:se observaron disminuciones significativas en el tiempo en el peso, la cintura y el IMC en ambos grupos. La masa y el porcentaje de grasa abdominal disminuyeron más en el grupo con omega-3 que en el de control (p ≤ 0,05). Las puntuaciones MoCA aumentaron en ambos grupos en el tiempo, sin significación estadística entre los grupos.Conclusión:la suplementación con ácidos grasos poliinsaturados omega-3 aumentó la reducción de la masa y el porcentaje de grasa abdominal en personas con sobrepeso u obesidad que siguieron una dieta para adelgazar. Se necesitan más estudios para identificar la ... (AU)

The effect of coconut oil on anthropometric measurements and irisin levels in overweight individuals.

AIM: This study aimed to discover the effects of coconut oil intake and diet therapy on anthropometric measurements, biochemical findings and irisin levels in overweight individuals. MATERIALS AND METHODS: Overweight individuals (n = 44, 19-30 years) without any chronic disease were included. In this randomized controlled crossover study, the participants were divided into two groups (Group 1: 23 people, Group 2: 21 people). In the first phase, Group 1 received diet therapy to lose 0.5-1 kg of weight per week and 20 mL of coconut oil/day, while Group 2 only received diet therapy. In the second phase, Group 1 received diet therapy while Group 2 received diet therapy and 20 mL of coconut oil/day. Anthropometric measurements were taken four times. Irisin was measured four times by enzyme-linked immunosorbent (ELISA) method and other biochemical findings were measured twice. Statistical analysis was made on SPSS 20. RESULTS: The irisin level decreased significantly when the participants only took coconut oil (p ≤ 0.05). There was a significant decrease in the participants' body weight, body mass index (BMI) level and body fat percentage (p ≤ 0.01). Insulin, total cholesterol, low density lipoproteins (LDL) cholesterol, and triglyceride (TG) levels of all participants decreased significantly (p ≤ 0.05). There was no significant difference in irisin level due to body weight loss (p ≤ 0.05); coconut oil provided a significant decrease in irisin level (p ≤ 0.05). CONCLUSION: Diet therapy and weight loss did not have an effect on irisin level, but coconut oil alone was found to reduce irisin level. Coconut oil had no impact on anthropometric and biochemical findings.

The effect of periodic ketogenic diet on newly diagnosed overweight or obese patients with type 2 diabetes.

BACKGROUND: The ketogenic diet (KD) is characterized by fat as a substitute of carbohydrates for the primary energy source. There is a large number of overweight or obese people with type 2 diabetes mellitus (T2DM), while this study aims to observe periodic ketogenic diet for effect on overweight or obese patients newly diagnosed as T2DM. METHODS: A total of 60 overweight or obese patients newly diagnosed as T2DM were randomized into two groups: KD group, which was given ketogenic diet, and control group, which was given routine diet for diabetes, 30 cases in each group. Both dietary patterns lasted 12 weeks, and during the period, the blood glucose, blood lipid, body weight, insulin, and uric acid before and after intervention, as well as the significance for relevant changes, were observed. RESULTS: For both groups, the weight, BMI(body mass index), Waist, TG (triglyceride), TC(cholesterol), LDL (low-density lipoprotein cholesterol), HDL (high-density lipoprotein cholesterol), FBG (fasting glucose), FINS (fasting insulin), HbA1c (glycosylated hemoglobin) were decreased after intervention (P < 0.05), while the decrease rates in the KD group was more significant than the control group. However, UA(serum uric acid) in the KD group showed an upward trend, while in the control group was not changed significantly (P > 0.05).The willingness to adhere to the ketogenic diet over the long term was weaker than to the routine diet for diabetes. CONCLUSION: Among the overweight or obese patients newly diagnosed as type 2 diabetes mellitus, periodic ketogenic diet can not only control the body weight, but also control blood glucose and lipid, but long-term persistence is difficult.

Effect of a Multicomponent mHealth Intervention on the Composition of Diet in a Population with Overweight and Obesity-Randomized Clinical Trial EVIDENT 3.

A balanced diet can help in the prevention of chronic diseases. The aim of this study was to evaluate the effect of an mHealth intervention on the distribution of macronutrients and the intake of food groups. A total of 650 participants were included in this multi-center, clinical, randomized, controlled trial (Evident 3 study). All participants were given brief advice about diet and exercise. The intervention group received, in addition, an app (Evident 3) for the self-recording of their diet and an activity tracker wristband for 3 months. Follow-up visits were performed at 3 and 12 months to collect the diet composition using the Food Frequency Questionnaire. There were decreases in the intake of total calories, fat, protein and carbohydrates in both groups throughout the study, without significant differences between them. The intervention group reduced the intake of cholesterol (-30.8; 95% CI -59.9, -1.7) and full-fat dairies (-23.3; 95% CI -42.8, -3.8) and increased the intake of wholemeal bread (3.3; 95% CI -6.7, 13.3) and whole-grain cereals (3.4; 95% CI -6.8, 13.7) with respect to the control group. No differences were found in the rest of the nutritional parameters. The brief advice is useful to promote a healthier diet, and the app can be a support tool to obtain changes in relevant foods, such as integral foods, and the intake of cholesterol. Trial registration: ClinicalTrials.gov with identifier NCT03175614.

Lupins and Health Outcomes: A Systematic Literature Review.

Lupins have a unique nutrient profile among legumes and may have beneficial health effects when included in the diet. The aim of this systematic review was to investigate the effects of lupin on a range of health outcome measures. Databases included MEDLINE, Embase and CINAHL, and focused on controlled intervention studies on healthy adults and those with chronic disease such as type 2 diabetes, cardiovascular disease and overweight. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses protocol was followed. Investigated intervention diets utilised whole lupin, lupin protein or lupin fibre, and outcomes were measured by markers of chronic disease, body weight and satiety. Quality assessment of results was performed using the Cochrane revised risk of bias tool. Overall, 21 studies with 998 participants were included: 12 using whole lupin, four used lupin protein and five lupin fibre. Beneficial changes were observed in 71% of studies that measured blood pressure, 83% measuring satiety and 64% measuring serum lipids. Unintended weight loss occurred in 25% of studies. Whole lupin demonstrated more consistent beneficial effects for satiety, glycaemic control and blood pressure than lupin protein or lupin fibre. Heterogeneity, low study numbers and a small participant base indicated further studies are required to strengthen current evidence particularly regarding the protein and dietary fibre components of lupin.

A Specific High-Protein Weight Loss Program Does Not Impair Renal Function in Patients Who Are Overweight/Obese.

Although high-protein diets appear to be the most efficient way to lose weight, concerns may arise about their innocuity on renal function. The objective of this study is to assess the impact of a weight loss program on renal function. A multicentric cohort-based study was performed using the RNPC© French national weight loss program. Patients with at least two creatinine measurements at the beginning of the program and at the end of the weight loss phase between 1 January 2016 and 1 July 2021 were included. Renal function was assessed by Modification of Diet in Renal Disease (MDRD) equation-based estimated glomerular filtration rate (eGFR). From 4394 patients with two creatinine measurements included, 1579 (35.9%) had normal eGFR (MDRD 90-120 mL/min/1.73 m2), 210 (4.8%) had hyperfiltration (MDRD > 120 mL/min/1.73 m2), 2383 (54.2%) had chronic kidney disease (CKD) grade 2 (MDRD 60-90 mL/min/1.73 m2), and 221 (5.0%) had CKD grade 3 (MDRD 30-60 mL/min/1.73 m2). Multivariable analyses showed no eGFR change for patients in initial CKD grade 2, normal eGFR and hyperfiltration, and a significant increase in CKD grade 3. The RNPC© program avoids renal function impairment during the two first phases, regardless of the initial eGFR.

Analysis of the SYSDIET Healthy Nordic Diet randomized trial based on metabolic profiling reveal beneficial effects on glucose metabolism and blood lipids.

BACKGROUND & AIMS: Intake assessment in multicenter trials is challenging, yet important for accurate outcome evaluation. The present study aimed to characterize a multicenter randomized controlled trial with a healthy Nordic diet (HND) compared to a Control diet (CD) by plasma and urine metabolic profiles and to associate them with cardiometabolic markers. METHODS: During 18-24 weeks of intervention, 200 participants with metabolic syndrome were advised at six centres to eat either HND (e.g. whole-grain products, berries, rapeseed oil, fish and low-fat dairy) or CD while being weight stable. Of these 166/159 completers delivered blood/urine samples. Metabolic profiles of fasting plasma and 24 h pooled urine were analysed to identify characteristic diet-related patterns. Principal components analysis (PCA) scores (i.e. PC1 and PC2 scores) were used to test their combined effect on blood glucose response (primary endpoint), serum lipoproteins, triglycerides, and inflammatory markers. RESULTS: The profiles distinguished HND and CD with AUC of 0.96 ± 0.03 and 0.93 ± 0.02 for plasma and urine, respectively, with limited heterogeneity between centers, reflecting markers of key foods. Markers of fish, whole grain and polyunsaturated lipids characterized HND, while CD was reflected by lipids containing palmitoleic acid. The PC1 scores of plasma metabolites characterizing the intervention is associated with HDL (ß = 0.05; 95% CI: 0.02, 0.08; P = 0.001) and triglycerides (ß = -0.06; 95% CI: -0.09, -0.03; P < 0.001). PC2 scores were related with glucose metabolism (2 h Glucose, ß = 0.1; 95% CI: 0.05, 0.15; P < 0.001), LDL (ß = 0.06; 95% CI: 0.01, 0.1; P = 0.02) and triglycerides (ß = 0.11; 95% CI: 0.06, 0.15; P < 0.001). For urine, the scores were related with LDL cholesterol. CONCLUSIONS: Plasma and urine metabolite profiles from SYSDIET reflected good compliance with dietary recommendations across the region. The scores of metabolites characterizing the diets associated with outcomes related with cardio-metabolic risk. Our analysis therefore offers a novel way to approach a per protocol analysis with a balanced compliance assessment in larger multicentre dietary trials. The study was registered at clinicaltrials.gov with NCT00992641.