The Metabolic Response to Reduced Branched-chain Amino Acids in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Reduction of BCAA intake
研究概览
简要总结
Branched-chain amino acids (BCAAs) are essential nutrients that the body obtains from proteins found in food, especially meat, diary products, and legumes. Data from rodent studies suggest that reduction of dietary BCAAs will promote fat mass loss and improved control of blood glucose. The purpose of this study is to test if reduction of dietary BCAAs without reducing calorie intake will lead to similar metabolic benefits in humans. Here the investigators test the feasibility of reducing dietary BCAAs using BCAA-free meal replacement beverages for two months.
详细描述
This study, which will be completed over three months, involves replacing two meals a day with meal replacement beverages for two months, with a one month follow-up visit. These beverages will be made up by subjects using either a complete protein powder or BCAD2, a BCAA-free medical food. Participants will complete food diaries at baseline and at one month intervals during the study, and compliance will be assessed via food diaries, weekly telephone contact, and measuring returned food powder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male between the age of 35 - 65
- •BMI between 28 - 35 (mildly obese/overweight)
- •Fasting glucose level of 101 - 125 mg/dL
- •Able and willing to give written informed consent
- •Stable weight (within 5 lbs. for at least 3 months)
- •Not taking (or willing to cease taking) over the counter vitamin/mineral supplements
- •Not planning to begin an exercise or diet program
排除标准
- •Outside required age range of 35 - 65
- •BMI not within range of 28 - 35
- •Fasting glucose not within range of 101 - 125 mg/dL
- •Use of prescription medications for diabetes or weight-loss
- •Use of and unwillingness to discontinue over the counter supplements (e.g. cinnamon, chromium, protein powders) or weight loss beverage or meal plans (e.g. SlimFast or Jenny Craig).
- •Low baseline albumin or pre-albumin levels (below normal reference range)
- •Significant anemia (Hemoglobin < 11 g/dL)
- •Known bleeding disorder or platelet dysfunction
- •Already eating a low protein diet (less than 14% total caloric intake from protein), as calculated from food diaries provided by subjects
- •Participating in intensive exercise training program (high to moderate intensity exercise greater than 210 minutes per week) or planning to start new exercise program during study period.
- •Significant co-morbidities (including kidney disease, liver disease, GI disease, cardiovascular disease, respiratory disease, malnutrition, substance abuse, psychiatric disease, or a diagnosed eating disorder).
- •Planned smoking cessation or attempt at smoking cessation during study period
- •Inability to tolerate meal replacement beverages due to palatability
- •Recent weight loss (> 5 lbs within 3 months).
- •Bariatric surgery, gastric banding or liposuction
- •Current or past (within 1 year) use of illicit drugs
- •Claustrophobia
结局指标
主要结局
Reduction of BCAA intake
时间窗: 3 months
The principle outcome of this study is to determine if replacing 2/3rds of the subjects baseline protein intake with BCAA-free meal replacement beverages are a feasible method of selectively reducing BCAA consumption. Our principle outcome is to reduce BCAA intake by 50% or more in the Experimental Arm (BCAD2) of the study as compared to baseline intake.
次要结局
- HbA1c(3 months)
- Weight(3 months)
- Fat mass(3 months)
- BMI(3 months)
- Resting metabolic rate(3 months)
- Fasting blood glucose(3 months)
- Insulin(3 months)
- Glucose tolerance(3 months)