NCT03267745已完成不适用
Effects of Amino Acid Formulation on Healthy Men Undergoing Unilateral Knee Immobilization
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in muscle atrophy
研究概览
简要总结
This is a safety and tolerability study investigating the effect of an amino acid formulation in healthy volunteers during and after limb immobilization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Sachets with the supplement will be blinded to the participant, and research assistants. Outcomes assessors will be blinded to condition as well.
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Generally healthy, non-smoking
- •Willing and able to provide informed consent
- •Men age 20-45 years
- •BMI between 25 and 35 kg/m2
排除标准
- •Subject has any concurrent medical, orthopedic, or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements;
- •History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years;
- •Significant orthopedic, cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder (requiring ongoing medical care), or metabolic/endocrine disorder (e.g., diabetes, high cholesterol, elevated fasting blood sugar) or other disease that would preclude oral protein supplement ingestion and/or assessment of safety and study objectives;
- •Any cachexia-related condition (e.g., relating to cancer, tuberculosis or human immunodeficiency virus infection and acquired immune deficiency syndrome) or any genetic muscle diseases or disorders;
- •Current illnesses which could interfere with the study (e.g. prolonged severe diarrhea, regurgitation, difficulty swallowing);
- •Subject participated in a study of an investigational product less than 60 days or 5 half-lives of the investigational product, whichever is longer, before enrollment in this study;
- •Hypersensitivity to any of the components of the test product;
- •Excessive alcohol consumption (>21 units/week); (> 21 standard drinks/wk); e.g., 18oz glass of 5% beer - 1.5 standard drinks, a 750 mL bottle of 12% wine = 5 standard drinks.
- •Known sensitivity or allergy to amino acids or any ingredient in the test formulations;
- •Prior gastrointestinal bypass surgery (Lapband, etc.), irritable bowel disease or irritable bowel syndrome;
- •History of bleeding diathesis, platelet or coagulation disorders, or antiplatelet/anticoagulation therapy (up to 81mg of baby aspirin per day taken as a prophylactic is permitted);
- •Personal or family history of clotting disorder or deep vein thrombosis. Deep vein thrombosis is a serious, and potentially lethal, medical condition, therefore, it is imperative if you have personal or family history it is disclosed this to the research staff.
- •Concomitant use of corticosteroids, testosterone replacement therapy (ingestion, injection, or transdermal), any anabolic steroid, creatine, whey protein supplements, casein or branched-chain amino acids (BCAAs) within 45 days prior to Screening;
- •Contraindications to an MRI scan (e.g. subjects with non-removable ferromagnetic implants, pacemakers, aneurysm clips or other foreign bodies, or subjects with claustrophobic symptoms that would contraindicate an MRI scan).
- •Hemoglobin <11.5mg/dl at Screening;
- •Platelets <150,000/uL (150x109/L) at Screening.
结局指标
主要结局
Change in muscle atrophy
时间窗: day 0, day 8, day 15 and day 28
To determine the impact of an amino acid formulation on muscle atrophy after 7 days of amino acid supplementation followed by 7 days of single leg immobilization and 14 days of recovery post-immobilization muscle atrophy will be assessed utilizing percutaneous muscle biopsy to quantify fibre size in the vastus lateralis.
次要结局
- Change in muscle strength(day 0, day 8, day 15 and day 28)
- Change in muscle size(day 0, day 8, day 15 and day 28)
研究者
研究点 (2)
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