Overweight and Obesity in Adults Receiving GLP-1RA Treatment
Conditions
Keywords
GLP-1 receptor agonist, Overweight, Obesity, Yeast protein, Whey protein, Lean body mass, Muscle function, Body composition, Gut microbiota
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTYeast Protein
Participants will consume approximately 20 g of the yeast protein study product once daily for 12 weeks. The product is provided as a powder and is reconstituted with approximately 150-200 mL of warm water before consumption. The product contains yeast protein as the principal protein source.
DIETARY_SUPPLEMENTWhey Protein
Participants will consume approximately 20 g of the whey protein study product once daily for 12 weeks. The product is provided as a powder and is reconstituted with approximately 150-200 mL of warm water before consumption. The product contains whey protein as the principal protein source.
DIETARY_SUPPLEMENTYeast Protein/Whey Protein Blend (1:1)
Participants will consume approximately 20 g of the yeast protein/whey protein blend study product once daily for 12 weeks. The product is provided as a powder and is reconstituted with approximately 150-200 mL of warm water before consumption. The protein blend contains yeast protein and whey protein in a 1:1 ratio by weight.
Sponsors
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Lean Body Mass From Baseline to Week 12 | Baseline and Week 12 | Lean body mass will be measured using dual-energy X-ray absorptiometry (DXA). The primary outcome is the change in whole-body lean body mass, expressed in kilograms (kg), from baseline to week 12. A higher or lower change indicates the degree of preservation or loss of lean body mass during GLP-1RA treatment. |
Countries
China
Contacts
CONTACTShufang Xu, MD
CONTACTQi Song, Master
PRINCIPAL_INVESTIGATORLiegang Liu, PhD
Huazhong University of Science and Technology
Outcome results
None listed