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A plant-based diet in overweight individuals in a 16-week randomized clinical trial: metabolic benefits of plant protein.

ABSTRACT: BACKGROUND AND OBJECTIVES:A plant-based diet is an effective strategy in the treatment of obesity. In this 16-week randomized clinical trial, we tested the effect of a plant-based diet on body composition and insulin resistance. As a part of this trial, we investigated the role of plant protein on these outcomes. SUBJECTS AND METHODS:Overweight participants (n?=?75) were randomized to follow a plant-based (n?=?38) or a control diet (n?=?37). Dual X-ray Absorptiometry assessed body composition, Homeostasis Model Assessment (HOMA-IR) assessed insulin resistance, and a linear regression model was used to test the relationship between protein intake, body composition, and insulin resistance. RESULTS:The plant-based vegan diet proved to be superior to the control diet in improving body weight, fat mass, and insulin resistance markers. Only the vegan group showed significant reductions in body weight (treatment effect -6.5 [95% CI -8.9 to -4.1] kg; Gxt, p?

SUBMITTER: Kahleova H

PROVIDER: S-EPMC6221888 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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A plant-based diet in overweight individuals in a 16-week randomized clinical trial: metabolic benefits of plant protein.

Kahleova Hana H Fleeman Rebecca R Hlozkova Adela A Holubkov Richard R Barnard Neal D ND

Nutrition & diabetes 20181102 1

<h4>Background and objectives</h4>A plant-based diet is an effective strategy in the treatment of obesity. In this 16-week randomized clinical trial, we tested the effect of a plant-based diet on body composition and insulin resistance. As a part of this trial, we investigated the role of plant protein on these outcomes.<h4>Subjects and methods</h4>Overweight participants (n = 75) were randomized to follow a plant-based (n = 38) or a control diet (n = 37). Dual X-ray Absorptiometry assessed body ...[more]

PMID: 30405108

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Project description:The effects of carbohydrates on body weight and insulin sensitivity are controversial. In this 16-week randomized clinical trial, we tested the role of a low-fat, plant-based diet on body weight, body composition and insulin resistance. As a part of this trial, we investigated the role of changes in carbohydrate intake on body composition and insulin resistance. Participants (n = 75) were randomized to follow a plant-based high-carbohydrate, low-fat (vegan) diet (n = 38) or to maintain their current diet (n = 37). Dual-energy X-ray absorptiometry was used to measure body composition. Insulin resistance was assessed with the Homeostasis Model Assessment (HOMA-IR) index. A repeated measure ANOVA model was used to test the between-group differences from baseline to 16 weeks. A linear regression model was used to test the relationship between carbohydrate intake, and body composition and insulin resistance. Weight decreased significantly in the vegan group (treatment effect -6.5 [95% CI -8.9 to -4.1] kg; Gxt, p < 0.001). Fat mass was reduced in the vegan group (treatment effect -4.3 [95% CI -5.4 to -3.2] kg; Gxt, p < 0.001). HOMA-IR was reduced significantly in the vegan group (treatment effect -1.0 [95% CI -1.2 to -0.8]; Gxt, p = 0.004). Changes in consumption of carbohydrate, as a percentage of energy, correlated negatively with changes in BMI (r = -0.53, p < 0.001), fat mass (r = -0.55, p < 0.001), volume of visceral fat (r = -0.35, p = 0.006), and HOMA (r = -0.27, p = 0.04). These associations remained significant after adjustment for energy intake. Changes in consumption of total and insoluble fiber correlated negatively with changes in BMI (r = -0.43, p < 0.001; and r = -0.46, p < 0.001, respectively), fat mass (r = -0.42, p < 0.001; and r = -0.46, p < 0.001, respectively), and volume of visceral fat (r = -0.29, p = 0.03; and r = -0.32, p = 0.01, respectively). The associations between total and insoluble fiber and changes in BMI and fat mass remained significant even after adjustment for energy intake. Increased carbohydrate and fiber intake, as part of a plant-based high-carbohydrate, low-fat diet, are associated with beneficial effects on weight, body composition, and insulin resistance.

Project description:BackgroundThere is a high prevalence of gait impairments in individuals with dementia (IWD). Gait impairments are associated with increased risk of falls, disability, and economic burden for health care systems. Only few studies have investigated the effectiveness of physical activity on gait performance in IWD, reporting promising but inconsistent results. Thus, this study aimed to investigate the effectiveness of a multimodal exercise program (MEP) on gait performance in IWD.MethodsIn this parallel-group randomized controlled trial, we enrolled 319 IWD of mild to moderate severity, living in care facilities, aged ? 65?years, and being able to walk at least 10?m. The control group (n?=?118) received conventional treatment, whereas the intervention group (n?=?201) additionally participated in a 16-week MEP specifically tailored to IWD. We examined the effects of the MEP on spatiotemporal gait parameters and dual task costs by using the gait analysis system GAITRite. Additionally, we compared characteristics between positive, non-, and negative responders, and investigated the impact of changes in underlying motor and cognitive performance in the intervention group by conducting multiple regression analyses.ResultsTwo-factor analyses of variance with repeated measurements did not reveal any statistically significant time*group effects on either spatiotemporal gait parameters or dual task costs. Differences in baseline gait performance, mobility, lower limb strength, and severity of cognitive impairments were observed between positive, non-, and negative responders. Positive responders were characterized by lower motor performance compared to negative and non-responders, while non-responders showed better cognitive performance than negative responders. Changes in lower limb strength and function, mobility, executive function, attention, and working memory explained up to 39.4% of the variance of changes in gait performance.ConclusionsThe effectiveness of a standardized MEP on gait performance in IWD was limited, probably due to insufficient intensity and amount of specific walking tasks as well as the large heterogeneity of the sample. However, additional analyses revealed prerequisites of individual characteristics and impacts of changes in underlying motor and cognitive performance. Considering such factors may improve the effectiveness of a physical activity intervention among IWD.Trial registrationDRKS00010538 (German Clinical Trial Register, date of registration: 01 June 2016, retrospectively registered, https://www.drks.de/drks_web/setLocale_EN.do ).

Project description:BackgroundThe increasing prevalence of dementia in the next decades is accompanied by various societal and economic problems. Previous studies have suggested that physical activity positively affects motor and cognitive skills in individuals with dementia (IWD). However, there is insufficient evidence probably related to several methodological limitations. Moreover, to date adequate physical activity interventions specifically developed for IWD are lacking.ObjectiveThis study aims to investigate the effectiveness of a multimodal exercise program (MEP) on motor and cognitive skills in IWD in a high-quality multicenter trial.MethodsA multicenter randomized controlled trial with baseline and postassessments will be performed. It is planned to enroll 405 participants with dementia of mild to moderate stage, aged 65 years and older. The intervention group will participate in a 16-week ritualized MEP especially developed for IWD. The effectiveness of the MEP on the primary outcomes balance, mobility, and gait will be examined using a comprehensive test battery. Secondary outcomes are strength and function of lower limbs, activities of daily living, and cognition (overall cognition, language, processing speed, learning and memory, and visual spatial cognition).ResultsEnrollment for the study started in May 2015. It is planned to complete postassessments by the beginning of 2017. Results are expected to be available in the first half of 2017.ConclusionsThis study will contribute to enhancing evidence for the effects of physical activity on motor and cognitive skills in IWD. Compared to previous studies, this study is characterized by a dementia-specific intervention based on scientific knowledge, a combination of motor and cognitive tasks in the intervention, and high standards regarding methodology. Findings are highly relevant to influence the multiple motor and cognitive impairments of IWD who are often participating in limited physical activity.Trial registrationGerman Clinical Trials Register DRKS00010538; https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00010538 (Archived by WebCite at http://www.webcitation.org/6oVGMbbMD).

Project description:ImportancePsoriasis is a chronic inflammatory skin disease with unmet needs for tailored treatment and therapy de-escalation strategies.ObjectiveTo evaluate early intervention with and prolonging the dosing interval for guselkumab, a p19 subunit-targeted interleukin (IL)-23 inhibitor, in patients with moderate to severe psoriasis.Design, setting, and participantsThe GUIDE clinical trial is an ongoing phase 3b, randomized, double-blinded trial conducted across 80 centers in Germany and France comprising 3 parts evaluating the impact of early disease intervention, prolonged dosing interval, and maintenance of response following treatment withdrawal among adults with moderate to severe plaque psoriasis. In study part 2, reported herein, first and last patient visits were September 2019 and March 2022, respectively.InterventionsIn GUIDE part 1 (week [W]0-W28), patients received guselkumab, 100 mg, at W0, W4, W12, and W20. Those achieving a Psoriasis Area and Severity Index (PASI) of 0 at both W20 and W28 were termed super responders (SRes). In part 2 (W28-W68), SRes were randomized to guselkumab, 100 mg, every 8 weeks or every 16 weeks; non-SRes continued open-label guselkumab every 8 weeks.Main outcomes and measuresPrimary objective was to demonstrate noninferiority (with a 10% margin) of guselkumab every 16 weeks vs every 8 weeks dosing among SRes for maintenance of disease control (PASI <3 at W68). Biomarker substudies assessed immunologic effects in skin and blood.ResultsOverall, 822 patients received guselkumab in part 2 (297 [36.1%] SRes [every 8 weeks/every 16 weeks; n = 148/n = 149] and 525 [63.9%] non-SRes). Among SRes, mean (SD) age was 39.4 (14.1) years, 95 (32.0%) were female, and 202 (68.0%) were male. The primary end point of noninferiority for guselkumab every 16 weeks vs every 8 weeks in SRes was met (P = .001), with 91.9% (137/149; 90% CI, 87.3%-95.3%) of SRes receiving every 16 weeks and 92.6% (137/148; 90% CI, 88.0%-95.8%) of SRes receiving dosing every 8 weeks having PASI lower than 3 at W68. Clinical effects corresponded with immunologic changes; skin CD8-positive tissue-resident memory T (TRM)-cell count decreased quickly from baseline, remaining low in both dosing groups. Similarly, serum IL-17A, IL-17F, IL-22, and β defensin (BD)-2 levels decreased significantly from baseline, remaining low in both dosing groups to W68. Guselkumab was well-tolerated; no new safety signals were identified.Conclusions and relevancePsoriasis treatment guidelines lack or provide inconsistent advice on patient stratification and treatment de-escalation. We present the first randomized trial providing evidence that, in patients with early complete skin clearance at 2 consecutive visits (W20 and W28), extending the guselkumab dosing interval may control disease activity.Trial registrationClinicalTrials.gov Identifier: NCT03818035.

Project description:Dietary magnesium intake has been favorably associated with reduced risk of metabolic outcomes in observational studies; however, few randomized trials have introduced a systems-biology approach to explore molecular mechanisms of pleiotropic metabolic actions of magnesium supplementation.We examined the effects of oral magnesium supplementation on metabolic biomarkers and global genomic and proteomic profiling in overweight individuals.We undertook this randomized, crossover, pilot trial in 14 healthy, overweight volunteers [body mass index (in kg/m(2)) ?25] who were randomly assigned to receive magnesium citrate (500 mg elemental Mg/d) or a placebo for 4 wk with a 1-mo washout period. Fasting blood and urine specimens were collected according to standardized protocols. Biochemical assays were conducted on blood specimens. RNA was extracted and subsequently hybridized with the Human Gene ST 1.0 array (Affymetrix, Santa Clara, CA). Urine proteomic profiling was analyzed with the CM10 ProteinChip array (Bio-Rad Laboratories, Hercules, CA).We observed that magnesium treatment significantly decreased fasting C-peptide concentrations (change: -0.4 ng/mL after magnesium treatment compared with +0.05 ng/mL after placebo treatment; P = 0.004) and appeared to decrease fasting insulin concentrations (change: -2.2 ?U/mL after magnesium treatment compared with 0.0 ?U/mL after placebo treatment; P = 0.25). No consistent patterns were observed across inflammatory biomarkers. Gene expression profiling revealed up-regulation of 24 genes and down-regulation of 36 genes including genes related to metabolic and inflammatory pathways such as C1q and tumor necrosis factor-related protein 9 (C1QTNF9) and pro-platelet basic protein (PPBP). Urine proteomic profiling showed significant differences in the expression amounts of several peptides and proteins after treatment.Magnesium supplementation for 4 wk in overweight individuals led to distinct changes in gene expression and proteomic profiling consistent with favorable effects on several metabolic pathways. This trial was registered at clinicaltrials.gov as NCT00737815.

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A plant-based diet in overweight individuals in a 16-week randomized clinical trial: metabolic benefits of plant protein.

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A plant-based diet in overweight individuals in a 16-week randomized clinical trial: metabolic benefits of plant protein.

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