Clinical trial NCT04849689: WFPB Lifestyle and Muscle Mass Preservation
Official title: Whole-Food, Plant-Based Lifestyle Program Preserves Muscle Mass During Body Mass/Fat Mass Loss
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Barbara Jakše s.p.
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
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).

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.

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).

Eligibility criteria: 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).

Primary outcomes:
measure: Fat- free mass (FFM) change
timeFrame: Baseline, up to 6 months
measure: Body fat mass percentage (BF %) change
timeFrame: Baseline, up to 6 months
measure: Body mass index (BMI) change
timeFrame: Baseline, up to 6 months
Secondary outcomes:
measure: Correlation between BMI, BF % and FFM and phase angle
timeFrame: Baseline, up to 6 months
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: PDP Spodnje Črnuče
Study officials:
affiliation: University of Ljubljana
name: Stanislav Pinter, PhD
role: STUDY_CHAIR
affiliation: University of Ljubljana
name: Bostjan Jakse, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.
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.
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.