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

NCT07817823 | Not Yet Recruiting DMC

• 1 other identifier: SQ202699
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity in Adults Receiving GLP-1RA Treatment

Keywords

GLP-1 receptor agonist; Overweight; Obesity; Yeast protein; Whey protein; Lean body mass; Muscle function; Body composition; Gut microbiota

Outcome Measures

Primary Outcomes (1)

• Change in Lean Body Mass From Baseline to 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.

  Baseline and Week 12

Study Arms (4)

Yeast Protein Group

EXPERIMENTAL

Dietary Supplement: Yeast Protein

Whey Protein Group

ACTIVE COMPARATOR

Dietary Supplement: Whey Protein

Yeast Protein/Whey Protein Blend Group

EXPERIMENTAL

Dietary Supplement: Yeast Protein/Whey Protein Blend (1:1)

Blank Control Group

NO INTERVENTION

Participants receive no study protein product and continue their usual diet and clinically prescribed GLP-1RA treatment.

Interventions

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.

Yeast Protein Group

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.

Whey Protein Group

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.

Yeast Protein/Whey Protein Blend Group

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Shenzhen Qianhai Taikang Hospital

Shenzhen, Guangdong, 518000, China

Location

Related Publications (5)

• Lustgarten MS. The Role of the Gut Microbiome on Skeletal Muscle Mass and Physical Function: 2019 Update. Front Physiol. 2019 Nov 26;10:1435. doi: 10.3389/fphys.2019.01435. eCollection 2019.

  PMID: 31911785 RESULT

• Liang Y, Liu Q, Zhang X, Li B, Hou T. Multi-omics-guided discovery: yeast protein alleviates glucocorticoid-induced muscle atrophy through dual activation of IGF-1/PI3K/Akt/FOXO and CaMKK/AMPK signaling pathways. Food Funct. 2026 Feb 23;17(4):1857-1875. doi: 10.1039/d5fo04912a.

  PMID: 41612951 RESULT

• Miller PE, Alexander DD, Perez V. Effects of whey protein and resistance exercise on body composition: a meta-analysis of randomized controlled trials. J Am Coll Nutr. 2014;33(2):163-75. doi: 10.1080/07315724.2013.875365.

  PMID: 24724774 RESULT

• Eisa N, Barood O. Lean Mass Changes With Incretin Therapy Versus Lifestyle Intervention: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. Diabetes Obes Metab. 2026 Jun;28(6):4818-4827. doi: 10.1111/dom.70666. Epub 2026 Mar 24.

  PMID: 41877354 RESULT

• Alissou M, Demangeat T, Folope V, Van Elslande H, Lelandais H, Blanchemaison J, Cailleaux PE, Guney S, Aupetit A, Aubourg A, Rapp C, Petit A, Godin M, Vignal L, Grigioni S, Dechelotte P, Colange G, Coeffier M, Achamrah N. Impact of Semaglutide on fat mass, lean mass and muscle function in patients with obesity: The SEMALEAN study. Diabetes Obes Metab. 2026 Jan;28(1):112-121. doi: 10.1111/dom.70141. Epub 2025 Oct 9.

  PMID: 41068996 RESULT

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Fungal Proteins; Whey Proteins

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Liegang Liu, PhD

  Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shufang Xu, MD

CONTACT

18802775169; 358228927@qq.com

Qi Song, Master

CONTACT

M202575871@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 14, 2026
• Study Start: September 20, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)