NCT07817823Toborzás még nem indult
Yeast Protein Supplementation and Muscle Preservation During GLP-1RA-Induced Weight Loss
Evaluation of the Intervention Effect of Yeast Protein Supplementation on Muscle Loss in Individuals Undergoing Weight Loss With Glucagon-Like Peptide-1 Receptor Agonists
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 15.
Rövid összefoglaló (regiszter, angolul)
The goal of this clinical trial is to evaluate whether yeast protein supplementation can help preserve lean body mass and muscle function in adults with overweight or obesity receiving GLP-1 receptor agonist-related treatment for weight loss. The main questions it aims to answer are: 1. Does yeast protein supplementation reduce the loss of lean body mass during GLP-1RA-related weight loss? 2. Does yeast protein supplementation improve or preserve muscle function? 3. Does yeast protein supplementation affect metabolic status, inflammation, gut barrier function, gut microbiota, and related metabolites? Researchers will compare yeast protein with whey protein and a yeast protein/whey protein blend to evaluate the effects of different protein sources on muscle-related outcomes during GLP-1RA treatment. Participants will: 1. Take the assigned study product every day for 12 weeks, approximately 20 g per day. 2. Return used study-product sachets every 4 weeks so that adherence can be assessed and the next supply can be provided. 3. Attend study visits at baseline, week 4, and week 12 for questionnaire surveys, physical measurements, body composition assessment by DXA, muscle function tests, dietary assessment, and blood sampling. 4. Complete a simplified follow-up at week 8 to record GLP-1RA use and dose changes, study-product adherence, adverse events, and major changes in diet or physical activity. 5. Complete sleep assessment using a wearable sleep-monitoring device and the Pittsburgh Sleep Quality Index at baseline and week 12. 6. Provide stool samples at baseline and week 12 for assessment of gut microbiota and related metabolites.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 200 (tervezett)
- Első benyújtás
- 2026. szept. 9.
- Kezdés
- 2026. szept. 20.
- Elsődleges befejezés
- 2027. márc. 30.
- Fő szponzor
- Huazhong University of Science and Technology
- Betegségek
- Elhízás
- NCT-szám
- NCT07817823
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 200
- 2026. szept. 20. és az elsődleges befejezés (2027. márc. 30.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Korábbi kezelés
- Known allergy or intolerance to yeast protein, whey protein, milk-derived ingredients, or other components of the study products.
- Unable to undergo dual-energy X-ray absorptiometry (DXA) or having a contraindication to DXA examination.
- Sarcopenia at baseline, defined by appendicular skeletal muscle mass index (ASMI) <7.0 kg/m² in men or <5.4 kg/m² in women.
- Severe cardiovascular or cerebrovascular disease, hepatic or renal insufficiency, malignancy, or other diseases that may substantially affect skeletal muscle metabolism.
- Regular use of protein powder or additional protein supplementation equivalent to ≥0.3 g/kg body weight per day.
- Initiation or dose adjustment of statins within the previous 3 months, or a history of statin-associated myopathy.
- Current participation in another weight-loss program or clinical intervention trial.
- Long-term use of systemic glucocorticoids, anabolic agents, or other medications that may substantially affect protein or skeletal muscle metabolism.
- Use of other weight-loss medications, fat-loss supplements, or muscle-enhancing products within the previous 3 months, apart from the prespecified GLP-1RA-related treatment.
- Use of antibiotics, probiotics, prebiotics, or other products or medications likely to substantially affect the gut microbiota within the previous 1 month.
Kiket keres a vizsgálat
- Adults aged 25-50 years with overweight or obesity, defined as BMI ≥24.0 kg/m², who meet the clinical indication for GLP-1RA-related weight-loss treatment.
- Planning to initiate GLP-1RA treatment, or having initiated GLP-1RA treatment within the previous 4 weeks, and intending to continue treatment for at least 12 weeks.
- Able and willing to provide written informed consent and comply with the 12-week intervention, follow-up visits, dietary assessments, body composition measurements, muscle function tests, and biological sample collection.
Életkor a regiszterben: 25 év – 50 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Shenzhen Qianhai Taikang Hospital | Shenzhen | Kína | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.