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OpenTrials
Completed

NCT Number: NCT04849689

WFPB Lifestyle and Muscle Mass Preservation

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.

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Key information

Conditions

Body Weight Atrophy Behavior Body Image Body Weight Changes Motor Activity Muscle Loss Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

PDP Spodnje Črnuče

Ljubljana, 1000, Slovenia

About this study

Many people are increasingly using a variety of dietary practices to manage overweight and obesity. Many people are increasingly using a variety of dietary practices to manage overweight and obesity.

Investigators will investigate the muscle mass preservation of participants on our 12-year lasting ongoing, community-based (free-living), WFPB lifestyle program during the weight/fat loss of participants.

The primary outcome is the BF %, and FFM change from initial values to FU values (for whole sample and by gender).

Secondary outcome include correlation between BMI, BF % and FFM, and PhA. Based on our experiences we believe that some participants that follow our WFPB lifestyle program may initially "afraid" to eat, according to the instructions, each meal to satiety (ad libitum). The reason lies in the typical weight loss recommendation in Western-type lifestyle that advise "eating less".

The body composition measures will include body height (BH; measured via standardized medical approved professional personal floor scale with stand (Kern, MPE 250K100HM, Kern & Sohn, Balingen, Germany), body mass (BM), BF mass and BF %, FFM, bone mineral mass (BMM), visceral fat (VF), total body water (TBW), extracellular water (ECW), intracellular water (ICW), the ratio, whole body phase angle (PhA), all via medically approved and calibrated bioelectrical impedance Tanita 780 S MA (Tanita Corporation, Tokyo, Japan) and the use of corresponding protocols (e.g., for BMI).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Using WFPB lifestyle program.
  • Were measured on a body composition analyzer at least two successive times on the same body composition montor Tanita 780 S MA, Tokyo, Japan (at baseline, follow up) in a row at different intervals (i.e., before the start of the program and as part of follow up).
  • Follow up up to 6 months
  • Baseline BMI status was not an exclusion criteria.
  • Data of participants that did not participate yet in our previous research.
  • No medication use

If the individual performed more than two consecutive measurements, only the first two were included in the analysis.

Exclusion criteria

  • Being on vegan diet before joined in our program.
  • Being adult (e.g., older than 18-years) before the start of the program.
  • Participating in our preivous research using WFPB lifestyle program.
  • Without severe chronic diseases or physical limitations (described bellow).

Treatment and study plan

Whole-food, plant-based lifestyle

Behavioral

The WFPB lifestyle program included:

  • 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).
  • Physical activity (habitual; organized and other).
  • Support system (lectures, workshops and individual nutrition counselling, grocery shopping assistance, cooking classes, regular measurements body composition, food logging, regular medical monitoring).

Primary outcomes

  1. Fat- free mass (FFM) change

    Time frame: Baseline, up to 6 months

    Muscle mass measured with bioimpedance analysis

  2. Body fat mass percentage (BF %) change

    Time frame: Baseline, up to 6 months

    Fat mass measured with bioimpedance analysis

  3. Body mass index (BMI) change

    Time frame: Baseline, up to 6 months

    Body mass index measured with bioimpedance analysis

Secondary outcomes

  1. Correlation between BMI, BF % and FFM and phase angle

    Time frame: Baseline, up to 6 months

    Correlation status of variables

Sponsors and collaborators

Lead sponsor

Barbara Jakše s.p.

Other

Registry information

Official study title

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

Acronym: WFPBmuscle

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 19, 2021
Registry last updated
Apr 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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