WFPB Lifestyle and Muscle Mass Preservation

NCT04849689 | Completed

• 1 other identifier: KR5
• Study Type: observational
• Target: 217
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Body composition; Plant-based diet; Lifestyle; Physical activity; Support system; Muscle mass preservation; Fat loss

Outcome Measures

Primary Outcomes (3)

• Fat- free mass (FFM) change

  Muscle mass measured with bioimpedance analysis

  Baseline, up to 6 months

• Body fat mass percentage (BF %) change

  Fat mass measured with bioimpedance analysis

  Baseline, up to 6 months

• Body mass index (BMI) change

  Body mass index measured with bioimpedance analysis

  Baseline, up to 6 months

Secondary Outcomes (1)

• Correlation between BMI, BF % and FFM and phase angle

  Baseline, up to 6 months

Interventions

Whole-food, plant-based lifestyle BEHAVIORAL

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Barbara Jakše s.p.: lead

Study Sites (1)

PDP Spodnje Črnuče

Ljubljana, 1000, Slovenia

Location

Related Publications (6)

• Finucane MM, Stevens GA, Cowan MJ, Danaei G, Lin JK, Paciorek CJ, Singh GM, Gutierrez HR, Lu Y, Bahalim AN, Farzadfar F, Riley LM, Ezzati M; Global Burden of Metabolic Risk Factors of Chronic Diseases Collaborating Group (Body Mass Index). National, regional, and global trends in body-mass index since 1980: systematic analysis of health examination surveys and epidemiological studies with 960 country-years and 9.1 million participants. Lancet. 2011 Feb 12;377(9765):557-67. doi: 10.1016/S0140-6736(10)62037-5. Epub 2011 Feb 3.

  PMID: 21295846 BACKGROUND

• Turner-McGrievy GM, Barnard ND, Cohen J, Jenkins DJ, Gloede L, Green AA. Changes in nutrient intake and dietary quality among participants with type 2 diabetes following a low-fat vegan diet or a conventional diabetes diet for 22 weeks. J Am Diet Assoc. 2008 Oct;108(10):1636-45. doi: 10.1016/j.jada.2008.07.015.

  PMID: 18926128 BACKGROUND

• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

  PMID: 2748771 BACKGROUND

• Kent L, Morton D, Hurlow T, Rankin P, Hanna A, Diehl H. Long-term effectiveness of the community-based Complete Health Improvement Program (CHIP) lifestyle intervention: a cohort study. BMJ Open. 2013 Nov 20;3(11):e003751. doi: 10.1136/bmjopen-2013-003751.

  PMID: 24259389 BACKGROUND

• Johns DJ, Hartmann-Boyce J, Jebb SA, Aveyard P; Behavioural Weight Management Review Group. Diet or exercise interventions vs combined behavioral weight management programs: a systematic review and meta-analysis of direct comparisons. J Acad Nutr Diet. 2014 Oct;114(10):1557-68. doi: 10.1016/j.jand.2014.07.005.

  PMID: 25257365 BACKGROUND

• Cava E, Yeat NC, Mittendorfer B. Preserving Healthy Muscle during Weight Loss. Adv Nutr. 2017 May 15;8(3):511-519. doi: 10.3945/an.116.014506. Print 2017 May.

  PMID: 28507015 BACKGROUND

MeSH Terms

Conditions

Body Weight; Body Weight Changes; Muscular Atrophy; Motor Activity

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Behavior

Study Officials

• Stanislav Pinter, PhD

  University of Ljubljana

  STUDY CHAIR

• Bostjan Jakse, PhD student

  University of Ljubljana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 19, 2021
• Study Start: April 12, 2021
• Primary Completion: April 23, 2021
• Study Completion: April 23, 2021
• Last Updated: April 29, 2021

Record last verified: 2021-04

Locations

SL (1)