Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07817823

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

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shenzhen Qianhai Taikang Hospital

Shenzhen, Guangdong, 518000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Yeast Protein

Dietary Supplement

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

Dietary Supplement

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)

Dietary Supplement

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.

Primary outcomes

  1. Change in Lean Body Mass From Baseline to Week 12

    Time frame: 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.

Interested in participating?

Not yet recruiting

Trial opening soon.

Get Notified

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Registry information

Official study title

Evaluation of the Intervention Effect of Yeast Protein Supplementation on Muscle Loss in Individuals Undergoing Weight Loss With Glucagon-Like Peptide-1 Receptor Agonists

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 14, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.