NCT00945581已完成1 期
Evaluation of AN777 on Elderly Subjects During Bed Rest and Recovery
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Lower extremity muscle strength changes after 10 days of bed rest, followed by changes after an 8-week recovery period.
研究概览
简要总结
The primary objectives are to evaluate the effect of AN777 on muscle strength loss that occurs during bed rest, and to investigate whether AN777, in association with resistance training, will support muscle strength recovery following bed rest in healthy elderly subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject (male or female) is > 60 to < 79 years of age.
- •Subject has Body Mass Index (BMI)> 20 <
- •Subject is ambulatory with an SPPB score of >
- •Subject agrees to comply with prescribed activity level.
排除标准
- •Subject has undergone major surgery, less than 4 weeks prior to enrollment in the study.
- •Subject has stated active malignant disease, except basal or squamous cell skin carcinoma or carcinoma in situ of the uterine cervix.
- •Subject has stated history of diabetes or fasting glucose value > 126 mg/dL.
- •Subject has stated presence of partial or full artificial limb.
- •Subject has stated kidney disease or serum creatinine > 1.4 mg/dL.
- •Subject has evidence of cardiovascular disease assessed during resting or exercise EKG.
- •Subject has untreated hypothyroidism with TSH levels greater than 5.5 microUnits/ml.
- •Subject has serum glutamate pyruvate transaminase (SGPT) levels greater than two times upper limit of laboratory-designated normal value.
- •Subject has a history of allergy to any of the ingredients in the study products.
- •Subject has an obstruction of the gastrointestinal tract precluding ingestion of the study product, inflammatory bowel disease, short bowel syndrome or other major gastrointestinal disease such as gastroesophageal reflux disease, gastroparesis, peptic ulcer disease, celiac disease, intestinal dysmotility, diverticulitis, ischemic colitis.
- •Subject has stated uncontrolled severe diarrhea, nausea or vomiting.
- •Subject is actively pursuing weight loss.
- •Subject is currently taking medications/dietary supplements/substances that could modulate metabolism or weight in the opinion of the principal investigator or physician, e.g. progestational agents, steroids, growth hormone, dronabinol, marijuana, beta-hydroxyl-beta-methylbutyrate (HMB), free amino acid supplements, dietary supplements to aid weight loss. Exceptions for multi-vitamin/mineral supplement, inhaled steroids for asthma, topical or optical steroids and short-term use (less than two weeks) of Dexamethasone.
- •Subject cannot refrain from smoking/discontinue the use of nicotine or tobacco.
- •Subject has a stated history of Deep Vein Thrombosis (DVT) or a known hypercoaguable condition.
- •Subject cannot discontinue current anticoagulant therapy.
- •Subject has refractory anemia with hemoglobin value < 11.5 g/dL.
结局指标
主要结局
Lower extremity muscle strength changes after 10 days of bed rest, followed by changes after an 8-week recovery period.
时间窗: 10 weeks
次要结局
- Total lean mass(10 weeks)
- physical activity levels(10 weeks)
- Lower extremity lean body mass(10 weeks)
- Muscle functionality(10 weeks)
研究者
研究点 (2)
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