WFPB Lifestyle and Muscle Mass Preservation

Body Weight Clinical Trial

— WFPBmuscle  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04849689
• Other study ID #: KR5
• Status: Completed
• Start date: April 12, 2021
• Est. completion date: April 23, 2021

Study information

• Verified date: April 2021
• Source: Barbara Jakše s.p.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: April 23, 2021
• Est. primary completion date: April 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Whole-food, plant-based lifestyle
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).

Locations

Country	Name	City	State
Slovenia	PDP Spodnje Crnuce	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
Barbara Jakše s.p.

Country where clinical trial is conducted

Slovenia, 

References & Publications (6)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fat- free mass (FFM) change	Muscle mass measured with bioimpedance analysis	Baseline, up to 6 months
Primary	Body fat mass percentage (BF %) change	Fat mass measured with bioimpedance analysis	Baseline, up to 6 months
Primary	Body mass index (BMI) change	Body mass index measured with bioimpedance analysis	Baseline, up to 6 months
Secondary	Correlation between BMI, BF % and FFM and phase angle	Correlation status of variables	Baseline, up to 6 months