NCT00798291已完成2 期
Evaluation of AN777 in Elderly Subjects
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- The primary objective is to evaluate the effect of AN777 on muscle mass change in an elderly population while on an adequate protein intake.
研究概览
简要总结
To evaluate whether AN777 with or without exercise affects muscle mass change in elderly subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject (male or female) is at least 65 years of age
- •Subject has a Geriatric Nutritional Risk Index (GNRI)of 92 or over
- •Subject has Body Mass Index (BMI) > 20.0 but <30.0
- •Subject is ambulatory
- •Subject agrees to maintain current activity level
排除标准
- •Subject has undergone major surgery, less than 4 weeks prior to enrollment in the study
- •Subject has current active malignant disease, except basal or squamous cell skin carcinoma or carcinoma in situ of the uterine cervix
- •Subject has stated immunodeficiency disorder
- •Subject has stated history of diabetes
- •Subject has stated presence of partial or full artificial limb
- •Subject has stated kidney disease
- •Subject has stated history of uncontrollable hypertension
- •Subject had myocardial infarction within the last 3 months
- •Subject had recent antibiotic use (within 1 week prior to screening).
- •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
- •Subject has stated uncontrolled severe diarrhea, nausea or vomiting
- •Subject has untreated clinically significant ascites, pleural effusion or edema
- •Subject has known dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder or any other psychological condition that may interfere with study product consumption
- •Subject is actively pursuing weight loss
- •Subject is currently taking medications/dietary supplements/substances that could profoundly modulate metabolism or weight Exceptions for multi-vitamin/mineral supplement, inhaled steroids for asthma or chronic obstructive pulmonary disease, topical or optical steroids and short-term use (less than two weeks) of dexamethasone
研究组 & 干预措施
Ad lib diet/placebo
Placebo Comparator
Ad lib diet and control product placebo
干预措施: Ad lib diet and Control placebo (Other)
Ad lib diet/AN 777
Experimental
Ad lib diet and AN 777
干预措施: Ad lib diet and An 777 (Other)
Ad lib diet/placebo/exercise
Active Comparator
Diet ad lib; exercise; and placebo
干预措施: Ad lib diet/ placebo/ exercise (Other)
Ad lib diet/ AN 777/ exercise
Experimental
Diet ad lib; AN 777; exercise
干预措施: Ad lib diet; AN 777; exercise (Other)
结局指标
主要结局
The primary objective is to evaluate the effect of AN777 on muscle mass change in an elderly population while on an adequate protein intake.
时间窗: 24 weeks
次要结局
- The secondary objective is to measure the effects of AN777 on body composition, functional outcomes, strength, and quality of life.(24 weeks)
研究者
研究点 (1)
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