Overweight and Obesity in Adults Receiving GLP-1RA TreatmentNCT07817823
Yeast Protein Supplementation and Muscle Preservation During GLP-1RA-Induced Weight Loss
A study testing Yeast Protein, Whey Protein and Yeast Protein/Whey Protein Blend (1:1) in people with Overweight and Obesity in Adults Receiving GLP-1RA Treatment, run by Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Overweight and Obesity in Adults Receiving GLP-1RA Treatment
- What is being tested?
- Yeast Protein, Whey Protein and Yeast Protein/Whey Protein Blend (1:1)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2026to 30 May 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Qi Song, Master contact
China1 site
Shenzhen Qianhai Taikang Hospital
Shenzhen, Guangdong, 518000
Shufang Xu, MD, 18802775169, 358228927@qq.com
Qi Song, Master, M202575871@hust.edu.cn
About this study
Official 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
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.
- Being tested
- Yeast Protein, Whey Protein, Yeast Protein/Whey Protein Blend (1:1)
- Keywords
- GLP-1 receptor agonist, Overweight, Obesity, Yeast protein, Whey protein, Lean body mass, Muscle function, Body composition, Gut microbiota
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yeast ProteinDietary 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 ProteinDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Yeast Protein Group | Experimental | Not described Receives: Dietary Supplement: Yeast Protein |
| Whey Protein Group | Active comparator | Not described Receives: Dietary Supplement: Whey Protein |
| Yeast Protein/Whey Protein Blend Group | Experimental | Not described Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Overweight and Obesity in Adults Receiving GLP-1RA TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liegang Liu, Huazhong University of Science and Technology
- Investigators
- Liegang Liu, PhD, Principal investigator, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817823
- Sponsor's protocol ID
- SQ202699
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31911785Liang 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.
PubMed 41612951Miller 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.
PubMed 24724774Eisa 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.
PubMed 41877354Alissou 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.
PubMed 41068996