Evaluation of the Intervention Effect of Yeast Protein Supplementation on Muscle Loss in Individuals Undergoing Weight Loss With Glucagon-Like Peptide-1 Receptor Agonists
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in Lean Body Mass From Baseline to Week 12
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Yeast Protein Group
干预措施: Yeast Protein (Dietary Supplement)
Yeast Protein/Whey Protein Blend Group
干预措施: Yeast Protein/Whey Protein Blend (1:1) (Dietary Supplement)
Blank Control Group
Participants receive no study protein product and continue their usual diet and clinically prescribed GLP-1RA treatment.
Whey Protein Group
干预措施: Whey Protein (Dietary Supplement)
结局指标
主要结局
Change in Lean Body Mass From Baseline to Week 12
时间窗: 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.
次要结局
未报告次要终点
研究者
Liegang Liu
Professor
Huazhong University of Science and Technology