Yeast Protein Supplementation and Muscle Preservation During GLP-1RA-Induced Weight Loss

Condition(s) studied

Investigational drug(s) / intervention(s)

Yeast 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.

Whey 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.

Yeast 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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

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