Efficacy of a New Delivery System for Beta-hydroxy-beta-methylbutyrate
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Decrease in muscle damage and inflammation
研究概览
简要总结
The proposed study will test efficacy of HMB in free acid gel to decrease muscle damage, diminish inflammatory response, and improve muscle strength recovery following an acute exercise stress. HMB in a free acid gel or in CaHMB capsule form will be administered as either a single dose before a bout of acute exercise or in multiple doses (one before and three daily doses for the 4 days following the acute exercise). We hypothesize that HMB in free acid gel will result in less muscle damage, diminished inflammatory response, and improved muscle strength recovery than either a placebo or CaHMB treatment following a bout of acute eccentric exercise. Our endpoints will include measurements of: (1) markers for muscle damage (CPK and LDH); (2) indicators of inflammation (CRP, TNF-α, IL-6, IL-1ra and IL-18); and (3) muscle strength recovery and soreness.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must live within 50 miles of Ames, Iowa
- •Free of cardiac, liver, pulmonary, and kidney disease
- •Free of chronic inflammatory disease including rheumatoid arthritis, osteoarthritis, inflammatory bowel disease, and psoriasis
- •Free diabetes mellitus
- •Not classified as morbidly obese (BMI must be less than 40)
- •Free of cardiac, liver, pulmonary, and kidney disease
- •No other serious medical illness
- •Normal menstrual cycle and not pregnant or lactating
- •Able to consume supplements and perform required exercise testing
排除标准
- •Live more than 50 miles from Ames, Iowa
- •Presence of cardiac, liver, pulmonary, and kidney disease
- •Presence of chronic inflammatory disease including rheumatoid arthritis, osteoarthritis, inflammatory bowel disease, and psoriasis
- •Diabetes mellitus
- •Classified as morbidly obese (BMI is greater than 40)
- •No other serious medical illness
- •Abnormal menstrual cycle, pregnant or lactating
- •Not able to consume supplements and perform required exercise testing
结局指标
主要结局
Decrease in muscle damage and inflammation
时间窗: 4 days post eccentric exercise bout
Serum analysis for markers of muscle damage (CPK) and inflammation (IL-6, IL-18, IL1ra, TNF-a, CRP) will be measured at 24, 48, 72, and 96 h post exercise bout
次要结局
- Improvement in strength recovery and decrease in soreness(4 days post eccentric exercise bout)