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NCT04849689: WFPBmuscle
WFPB Lifestyle and Muscle Mass Preservation
trial testing Whole-food, plant-based lifestyle in Body Weight in 217 participants. Completed in 23 April 2021.
23 April 2021
Quick facts
| Lead sponsor | Barbara Jakše s.p. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 217 |
| Start date | 12 April 2021 |
| Primary completion | 23 April 2021 |
| Estimated completion | 23 April 2021 |
| Sites | 1 location across Slovenia |
Drugs / interventions tested
- Whole-food, plant-based lifestyle
Conditions studied
- Body Weight — all drugs for Body Weight →
- Body Image — all drugs for Body Image →
- Body Weight Changes — all drugs for Body Weight Changes →
- Muscle Loss — all drugs for Muscle Loss →
Sponsor
Barbara Jakše s.p.
Who can join
18 and older, any sex, with Body Weight or Body Image. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04849689
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT06387901 — Investigating Paclitaxel Toxicity in Breast Cancer: the Roles of Physical Activity and Body Composition. · recruiting
- NCT06409962 — A New Technological Intervention to Address Childhood Obesity: · NA · recruiting
- NCT06406192 — Effects of FOR-Care Model on Preventive Medicine · NA · active not recruiting
Other Barbara Jakše s.p. trials
Trials by the same sponsor.
- NCT05438966 — Nutritional Status of Adult Slovenes After the Covid-19 Epidemic · completed
- NCT04379622 — Diet, Body Composition, Lifestyle and Cardiovascular Health of Healthy and Active Adults From Slovenia · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04849689 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Barbara Jakše s.p.
- Last refreshed: 29 April 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04849689.
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