Effects of L-Carnitine and Coenzyme Q10 Supplementation on Lower Urinary Tract Symptoms in Men with Benign Prostatic Hyperplasia: A Randomized, Controlled, Clinical Trial.

The prevalence of benign prostatic hyperplasia (BPH) and its associated lower urinary tract symptoms (LUTS) increases with age. Considering that BPH drug treatment is associated with complications, this study aimed to investigate the effects of L-carnitine (LC) and Coenzyme Q10 (CoQ10) supplementation as an adjunct therapy to finasteride in the management of LUTS in older men affected with BPH. Fifty eligible volunteers (25 per group) were randomly assigned to either intervention (finasteride + LC and CoQ10 supplements) or control (finasteride + placebo) groups. International prostate symptom score (IPSS), international index of erectile function (IIEF), quality of life index (QoL), as well as serum levels of Prostate-specific antigen (PSA), were assessed. Prostate ultrasound evaluation was also performed, before and after 8 wk of intervention. Supplementation with LC and CoQ10 led to a significant decrease in prostate volume (p < 0.001) as well as a significant increase in IIEF (p < 0.001), compared to the control group. However, there were no significant between-group differences in IPSS (p = 0.503), QoL scores (p = 0.339), and PSA levels (p = 0.482). CoQ10 and LC supplements might be beneficial in combination with standard therapies in the management of BPH and its related complications.

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.

Effects of probiotic and magnesium co-supplementation on mood, cognition, intestinal barrier function and inflammation in individuals with obesity and depressed mood: A randomized, double-blind placebo-controlled clinical trial.

Background: The co-occurrence of obesity and mood impairments named as "metabolic mood syndrome" (MMS) is often neglected in the obesity management. This study aimed to evaluate effects of Probio-Tec ®BG-VCap-6.5 and magnesium co-supplementation on mood, cognition, intestinal barrier function and serum C reactive protein (CRP) levels in participants with obesity and depressed mood. Design: Seventy-four eligible participants were randomly allocated to either Probio-Tec®BG-VCap-6.5 [containing Lactobacillus rhamnosus (LGG®) and Bifidobacterium animalis subsp. Lactis (BB-12®)] + Magnesium chloride or placebo for 9 weeks. Sociodemographic data were collected in the beginning. Anthropometric, dietary and physical activity (PA) assessments were carried out. Beck Depression Inventory-II (BDI-II) and Montreal Cognitive Assessment (MoCA) scores were assessed through validated questionnaires. Fasting plasma zonulin, lipopolysaccharide (LPS) and (CRP) were measured by ELIZA kits. Results: Of seventy-four participants (mean age 37.51 ± 8.10), 52 completed the study. Changes in serum LPS and zonulin were not different significantly between groups (-3.04 ± 44.75 ng/dl, 0.11 ± 5.13, ng/dl, p > 0.05 for LPS and 1.40 ± 48.78 ng/dl, -0.17 ± 6.60, p > 0.05 for zonulin, respectively). CRP levels reduced significantly in intervention group compared to placebo [-474.75 (-1,300.00, -125.00) mg/l vs. 175.20 (-957.75, 1,683.25) mg/l, p = 0.016]. Changes in BDI-II and MoCA scores were not significantly different between intervention (-7.13 ± 5.67, 1.20 ± 2.16, respectively) and placebo (-5.42 ± 6.71, 1.94 ± 1.86, respectively) groups (p > 0.05). Conclusion: Nine weeks of probiotic and magnesium co-supplementation resulted in decreased CRP levels as an indicator of inflammatory state with no significant effects on mood, cognition and intestinal integrity in individuals with obesity and depressed mood.

Royal jelly does not improve markers of glycemia: A systematic review and meta-analysis of Randomized Clinical Trials.

Bee products including propolis, bee wax, pollen and royal jelly (RJ) have been used as medicine from ancient times. A vast number of in-vivo and in-vitro studies as well as clinical trials have been conducted to investigate potential health related properties of RJ. A growing number of clinical trials have been performed to assess effects of RJ ingestion on different metabolic markers including glycemia, with diverse results. In the current meataanalysis, we aimed to evaluate effects of RJ ingestion on glycemic markers compared with placebo and set directions for future research. Electronic databases including Scopus, Pubmed, Scholar, Cochrane, Proquest, SID and Magiran were searched and 5 eligible studies were included in the quantitative analysis. Review Manager Software was used for statistical analysis and random effects model was used for pooling data. A total of 205 participants for FPG and 130 participants for HbA1c were included. The overall analysis revealed that RJ consumption reduced FPG by 0.95 mg/dl (95% CI: -5.83 to 3.87; p = 0.69; I2 = 0%; Tau2 = 0.00) and HbA1c by 0.32 (95% CI: -0.87 to 0.23; p = 0.25; I2 = 69 %; Tau2 = 0.16) which were not statistically significant. Funnel plot demonstrated no publication bias. In conclusion, RJ supplementation did not beneficially affect markers of glycemia. However, due to methodology issues and potential confounders like diet as well as diverse populations, we recommend future studies well designed and well controlled for major confounders so we can update these data to more precise results and more accurate conclusion.

Meta-Analysis: Effects of Zinc Supplementation Alone or with Multi-Nutrients, on Glucose Control and Lipid Levels in Patients with Type 2 Diabetes.

The present study aims to assess the effects of zinc supplementation on metabolic parameters in patients with type 2 diabetes. A literature search was conducted in PubMedTM, Google ScholarTM, and ScopusTM up to March 2018. Twenty randomized controlled trials met the predefined inclusion criteria and were included in the meta-analysis. Weighted mean difference (WMD) with 95% confidence intervals (CIs) were calculated for net changes in glycemic indices including fasting blood glucose (FBG) and hemoglobin A1c (HbA1c), and in lipid markers including total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-c), and high density lipoprotein cholesterol (HDL-c). Subgroup analyses were performed based on intervention and study quality. Compared to controls, zinc supplementation significantly reduced the concentrations of both FBG and HbA1c (FBG WMD: -19.66 mg/dL, 95% CI: -33.71, -5.62; HbA1c WMD: -0.43 mg/dL, 95% CI: -0.80, -0.07). The pooled estimate showed a significant decrease in serum TC and LDL-c, and increase in serum HDL-c levels in treatment group compared with the control group (TC WMD: -18.51 mg/dL, 95% CI: -21.36, -15.66; LDL-c WMD: -4.80 mg/dL, 95% CI: -6.07, -3.53; HDL-c WMD: 1.45 mg/dL, 95% CI: 1.40, 1.51). Subgroup analysis of "no co-supplement" intervention demonstrated significant differences for mean changes in HDL-c and FBG levels, whereas subgroup analysis of high quality studies showed significant differences for mean changes of LDL-c, HDL-c, and FBG levels. Results suggested that zinc supplementation reduces FBG, HbA1c and LDL-c levels and increases HDL-C levels; however, these changes were related to intervention and quality of studies.

Effect of L-citrulline supplementation on blood pressure: a systematic review and meta-analysis of randomized controlled trials.

The objective of this study was to systematically investigate the efficacy of oral L-citrulline supplementation on systolic and diastolic blood pressure. Studies were identified by a search of electronic databases from inception to April 2018, and combined and stratified analyses were used. Fifteen trials were identified, and data from 424 participants were included. Pooled analysis showed significant reductions in systolic blood pressure by -7.54 mmHg (95% confidence interval (CI): -9.44, -5.63; P < 0.001, I2 = 14%) and diastolic blood pressure by -3.77 mmHg (95% CI: -5.67, -1.86, P < 0.001, I2 = 42%) following oral supplementation of L-citrulline or a watermelon extract. No changes were detected in controls. Significant heterogeneity (I2 = 42%, P = 0.04) was found for diastolic blood pressure, and subgroup analysis showed significant improvements in systolic and diastolic blood pressure, particularly for study durations: ≥6 weeks, lower doses: ≤4 g/day, and in participants with higher baseline values: ≥130/85 mmHg. In conclusion, L-citrulline improves systolic and diastolic blood pressure and may be more efficacious in pre-hypertensive and hypertensive populations.

Effects of Prebiotic and Synbiotic Supplementation on Glycaemia and Lipid Profile in Type 2 Diabetes: A Meta-Analysis of Randomized Controlled Trials.

Purpose: Diabetes Mellitus (T2DM) as a chronic disease, is on rise in parallel with other non-communicable diseases. Several studies have shown that probiotics and prebiotics might exert beneficial effects in chronic diseases including diabetes. Because of controversial results from different trials, the present study aims to assess the effects of prebiotic/synbiotic consumption on metabolic parameters in patients with type2 diabetes. Methods: A systematic literature search was performed on randomized controlled trial published in PubMed/Medline, SciVerse Scopus, Google scholar, SID and Magiran up to March 2018. Of a total number of 255 studies found in initial literature search, ten randomized controlled trials were included in the meta-analysis. The pooled mean net change were calculated in fasting blood-glucose [FBG], Hemoglobin A1c [HbA1c] and lipid markers (total cholesterol [TC], triglyceride [TG], low-density lipoprotein cholesterol [LDL-C], high density lipoprotein cholesterol [HDL-C]). The meta-analyses was conducted using Revman Software (v5.3). Results: The pooled estimate indicated a significant difference for the mean change in FBG, HbA1c and HDL in treatment group in comparison with control group. Subgroup analysis by intervention showed a significant difference in TG, LDL and HDL (synbiotic group) and in TG, TC, FBG, HDL and HbA1c (prebiotic group) compared with placebo. In another subgroup analysis, high quality studies showed significant reductions in TG, TC, FBG and HbA1c in intervention group compared with placebo group. Conclusion: In summary, diets supplemented with either prebiotics or synbiotics can result in improvements in lipid metabolism and glucose homeostasis in type 2 diabetic patients.

The effects of probiotic supplementation on markers of blood lipids, and blood pressure in patients with prediabetes: a randomized clinical trial.

BACKGROUND: Prediabetes is a high-risk condition for type 2 diabetes mellitus. The growing prevalence of diabetes emphasizes on the necessity of concentrating on various strategies to prediabetes prevention and management. Probiotics as a group of functional foods might exert antidiabetic effects. This study aimed to assess the effects of probiotic administration on blood lipid profile and blood pressure in patients with prediabetes. METHODS: This randomized controlled trial consisted of 60 prediabetic patients, aged 25-65 years old, that were randomly assigned to the intervention (receiving 500 mg probiotic capsules, n = 30) or control group (receiving placebo, n = 30) for 8-week period. Demographic and anthropometric data were collected at baseline. Blood samples were collected at baseline and after 8 weeks for biochemical measurements. Blood pressure was measured at the baseline an after 8 weeks of intervention. Data regarding dietary intakes and physical activity were also collected during the study. We used SPSS software version 16 (SPSS Inc. Chicago, USA) for data analyzing. RESULTS: Probiotic supplementation did not contribute to significant changes in total cholesterol, low-density lipoprotein (LDL)-cholesterol, high-density lipoprotein (HDL)-cholesterol, Triglycerides (TG), TG/LDL and LDL/HDL ratios, after 8 weeks. After adjusting for potential confounders, HDL-cholesterol reduced significantly in the placebo group compared with probiotic group. Percent change in systolic blood pressure was significantly different in the probiotic group in comparison with a placebo group (-3.10 ± 2.22 vs. 3.24 ± 1.96, P = 0.01), although this significance did not exist anymore after adjusting for confounders (P > 0.05). CONCLUSIONS: Our study showed that probiotics did not have significant effects on lipid markers although they had positive effects on systolic blood pressure.