Investigating the Effectiveness of Novel Amino Acid-enriched Supplement Beverages to Determine Post-ingestion Glycemia, Insulinemia, Aminoacidemia, and Whole-body Protein Synthesis Rates in Adults Prescribed GLP-1 RA Drugs
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 8
- 主要终点
- Whole-body protein synthesis
研究概览
简要总结
GLP-1 receptor agonists have recently emerged as highly effective pharmacological agents for promoting weight loss and improving metabolic health. Despite their benefits, weight regain frequently occurs once pharmacotherapy is discontinued, highlighting the limitations of medication alone. Growing evidence suggests that combining GLP-1 therapy with structured exercise and dietary interventions may yield synergistic effects, supporting greater long-term weight maintenance and preservation of lean body mass.
This study aims to investigate the effects of a leucine-enriched multi-nutrient study product on blood levels of amino acids, glucose, and insulin, and how this study product stimulates whole-body protein growth rates. The study product ingredients are within safe and tolerable limits in humans. Understanding the effects of different multi-ingredient supplements on changes in blood amino acids, glucose, insulin, and whole-body protein synthesis will provide valuable insights for recommending appropriate supplement usage, particularly for individuals on GLP-1 drugs
详细描述
Participant Characteristics: DOB, body weight, height, biological sex, and clinical information, which are: 1. Time on GLP1 RA drugs, what kind of GLP1 RA drug, any other drugs or treatments, any vitamins, HbA1c level, C-reactive protein levels, and fasting glucose levels will be measured at baseline. Additionally, a medical screening questionnaire will be provided.
Blood Sampling (experimental): Blood sampling will be conducted while the participant lies comfortably on a medical examination bed. A flexible catheter will be inserted into a vein in the forearm using a small intravenous needle and will remain patent with a saline flush.
Breath Sampling: Breath sampling will take place while the participant sits comfortably on a medical examination bed. They will exhale a full breath into a plastic bag, and the breath will be collected for analysis.
Per-Procedural Conditions (experimental):
- Participants will be asked to maintain consistent physical activity and nutritional intake for two days before each trial.
- Blood samples will be analyzed for amino acids, blood glucose, and insulin levels.
- Breath samples will be analyzed to measure whole-body protein synthesis rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The blood and breath sample analysis will be masked from the study arms.
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be between the ages of 30 and 65 years (inclusive)
- •With type 2 diabetes, pre-diabetes, obesity, overweight, or previously diabetic, obese, or overweight
- •Need to be on GLP-1 RA medication for no more than six months after starting the prescription.
- •Need to show a recent record of weight loss of 1-5 kilograms (2-11 pounds) due to the use of the GLP1-RA medication.
排除标准
- •Smoke and use any tobacco products
- •A history of neuromuscular disorders or diseases that cause muscle and/or bone wasting
- •The chronic use of medications known to impact protein metabolism, such as corticosteroids, non-steroidal anti-inflammatory drugs, or prescription-strength acne treatments
- •Excessive alcohol consumption (more than 21 units of alcohol / week; 1 unit of alcohol is approximately 25 mL of spirits (40% alcohol), 250 mL of beer (4% alcohol) or 75 mL of wine (13% alcohol)
- •Have health problems such as: renal or gastrointestinal disorders, metabolic disease, heart disease, vascular disease, rheumatoid arthritis, poor lung function, uncontrolled blood pressure, dizziness, thyroid problems, or any other health conditions for which you are being treated that might put you at risk for this study
- •Have a dairy protein allergy
- •Participation in another nutrition or exercise research study
- •Do not understand English or have a condition the PI believes would interfere with a participants' ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put someone at undue risk
- •Use of medications known to affect protein metabolism (i.e. corticosteroids, or prescription strength acne medications)
- •Consuming a vegan diet
- •Use of an investigational drug product or nutraceutical within the last 30 days
- •Any concurrent medical, orthopedic, or psychiatric condition that, in the opinion of the Investigators, would compromise the ability to comply with the study requirements
研究组 & 干预措施
Novel LEUVATE supplement 002
amino acids
干预措施: GLP-1 (Dietary Supplement)
Standard protein dose
whole protein
干预措施: GLP-1 (Dietary Supplement)
Novel LEUVATE supplement 001
suboptimal dose of whole protein with amino acids
干预措施: GLP-1 (Dietary Supplement)
结局指标
主要结局
Whole-body protein synthesis
时间窗: 5 hours following consumption.
The rates will change over time.
次要结局
未报告次要终点
研究者
Daniel A. Traylor
Assistant Professor
Nutraceutical Innovations LLC