CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 217 enrolled
Drug / intervention
Whole-food, plant-based lifestylebehavioral
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04849689
NCT04849689N/ACompleted

Whole-Food, Plant-Based Lifestyle Program Preserves Muscle Mass During Body Mass/Fat Mass Loss

Barbara Jakše s.p.·observational·Posted Apr 19, 2021·Updated Apr 29, 2021

In Brief

An observational study evaluating Whole-food, plant-based lifestyle for Body Weight and 3 related conditions. Completed, enrolled 217 participants across 1 site.

Detailed Summary

Body fat (BF) and muscle mass showed opposing association with mortality. Whole-food, plant-based (WFPB) lifestyle programs has been on the rise lately especially due to impressive health benefits. The results of research on the effectiveness of popular weight loss diets in obese subjects showed 20 to 30% loss of lean muscle mass within to the total body weight loss, whereas in the whole-food, plant-based (vegan) diet the loss was up to 42%. Therefore, an open research problem is to find a way how to improve body composition in an effective and healthy way (i.e., losing of excess BF while maintaining muscle mass as much as possible) but still using stric plant-based (vegan) diet. Investigators will perform retrospective analysis of measurements of body composition and phase angle values of aprox. 200 participants who were on a WFPB lifestyle program from 2016 to 2021 and performed two successive measurements (initial and follow up (FU)), without body mass index (BMI) limitation on same medically approved and calibrated bioelectrical impedance (Tanita 780 S MA, Tokyo, Japan) and were not yet included in our previous studies. A WFPB lifestyle program were consisted of nutrition (i), (ii) physical activity and (iii) support system. Primary outcome include the following measures: BF % and FFM and to examine the change from initial values to FU values (by gender), according BMI classification (e.g,, normal, pre-obese and obese) with subanalysis for those participants who lost up to 5 kg/more and those who lost 5 kg or more of body weight.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesSlovenia
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedApr 19, 2021
Enrollment StartApr 12, 2021
Primary CompletionApr 23, 2021
TodayJul 2, 2026
Enrollment to primary: 11 daysPosted 5.2 years ago

Interventions

Whole-food, plant-based lifestylebehavioral

The WFPB lifestyle program included: 1. Nutrition/plant-based food (energy intake: at least 90% of whole-food, plant-based diet and ≤ 10% of energy intake from plant-based meal replacements (PBMR) and dietary supplements (e.g., vitamin B12, D, and EPA and DHA omega-3 fatty acids). 2. Physical activity (habitual; organized and other). 3. Support system (lectures, workshops and individual nutrition counselling, grocery shopping assistance, cooking classes, regular measurements body composition, food logging, regular medical monitoring).