WFPB Lifestyle and Muscle Mass Preservation (WFPBmuscle)

April 27, 2021 updated by: Boštjan Jakše, Barbara Jakše s.p.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Observational

Enrollment (Actual)

217

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • PDP Spodnje Črnuče

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

We will examine the body composition data of healthy adults from Slovenia (European Union) that were without preference toward plant-based diet before entering to the program. As healthy adults we mean that used data were from participants without serious comorbidities (i.e., having autoimmune or neurodegenerative disorders), physical limitations or taking medicine (for blood pressure, blood sugar or cholesterol).

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fat- free mass (FFM) change
Time Frame: Baseline, up to 6 months
Muscle mass measured with bioimpedance analysis
Baseline, up to 6 months
Body fat mass percentage (BF %) change
Time Frame: Baseline, up to 6 months
Fat mass measured with bioimpedance analysis
Baseline, up to 6 months
Body mass index (BMI) change
Time Frame: Baseline, up to 6 months
Body mass index measured with bioimpedance analysis
Baseline, up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between BMI, BF % and FFM and phase angle
Time Frame: Baseline, up to 6 months
Correlation status of variables
Baseline, up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barbara Jakše s.p.

Investigators

  • Principal Investigator: Bostjan Jakse, PhD student, University of Ljubljana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2021

Primary Completion (Actual)

April 23, 2021

Study Completion (Actual)

April 23, 2021

Study Registration Dates

First Submitted

April 13, 2021

First Submitted That Met QC Criteria

April 16, 2021

First Posted (Actual)

April 19, 2021

Study Record Updates

Last Update Posted (Actual)

April 29, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KR5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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