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WFPB Lifestyle and Muscle Mass Preservation

NCT04849689 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 217

Last updated 2021-04-29

No results posted yet for this study

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.

Conditions

  • Body Weight
  • Body Image
  • Body Weight Changes
  • Muscle Loss

Interventions

BEHAVIORAL

Whole-food, plant-based lifestyle

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).

Sponsors & Collaborators

  • Barbara Jakše s.p.

    lead OTHER

Principal Investigators

  • Stanislav Pinter, PhD · University of Ljubljana

  • Bostjan Jakse, PhD student · University of Ljubljana

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-12
Primary Completion
2021-04-23
Completion
2021-04-23

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04849689 on ClinicalTrials.gov