The Effect of HMB Supplementation on Adipose Tissue Inflammation and Metabolism
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Maintenance of bone mineral density
研究概览
简要总结
This study will determine the effects of supplementing beta-hydroxy-beta-methylbutyrate (HMB) on body composition and strength changes during weight loss. When overweight and obese persons lose weight, and in particular in conjunction with dietary restrictions, muscle, bone mass, and muscle strength are also lost. HMB has been shown to preserve muscle mass and strength, and it is thought that HMB may also preserve muscle, bone, and strength during weight-loss.
详细描述
Forty obese men (BMI 35-40 kg/m2,18-40 years of age) will be randomly assigned to one of four treatment interventions: 1) Calorie restricted; 2) Calorie restricted and HMB supplemented; 3) No calorie restriction; and 4) No calorie restriction and HMB-supplemented. Over the 8 week interventional period the calorie restricted group is expected to lose 3-5% of initial body weight. Anthropometric measures will be taken weekly, and dual energy x-ray absorptiometry (DXA) body composition and strength will be measured before and after 8-weeks of intervention. Blood and urine will be collected and analyzed at 0, 4, and 8 weeks. Additionally Dietary records and questionnaires concerning quality of life will be administered, and activity will be assessed using questionnaires and pedometers. Muscle biopsies will be taken before and after the 8-week study.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Non-smoker
- •Body mass index of 35-40 kg/m2
- •Age 18-40 years
- •Weight stable for past 6 months (<5 lb. change)
- •In good health, free of chronic diseases/conditions that may impact measured outcomes
- •Willing and able to consume a weight loss diet
- •Willing and able to consume a daily nutritional supplement (in pill form)
- •Available for scheduled study commitments during the 2 months of study
排除标准
- •Take any cholesterol lowering or weight loss drugs or an drugs or supplements that affect blood lipids, insulin or body composition
- •Weigh greater 300 pounds due to weight, size and depth limitations of equipment
- •Take dietary supplements
- •Have a chronic disease such as:
- •Cardiopulmonary disease (e.g. recent myocardial infarction, unstable angina, stroke) or unstable disease
- •Severe orthopedic/musculoskeletal or neuromuscular impairments that would contradict exercise
- •Sensory impairments that interfere with following directions
- •Diagnosis if dementia
- •History of malignancy during the past 5 years
- •Diabetes mellitus
结局指标
主要结局
Maintenance of bone mineral density
时间窗: 8 weeks
Bone mineral density measured by DXA (T-score)
Maintenance of lean mass
时间窗: 8 weeks
Lean Mass measured by DXA (kg)
Maintenance of muscle strength
时间窗: 8 weeks
Muscle strength will be assessed using a Biodex Isokinetic Dynamometer (N-m)
Maintenance of hand muscle strength
时间窗: 8 weeks
Hand muscle strength will be assessed using hand grips (kg)
次要结局
未报告次要终点