Effects of Leucine Supplement on Body Weight and Cardiometabolic Changes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Effects on Weight
研究概览
简要总结
Protein-rich diets appear to show some benefits in promoting weight loss. It is thought that increased intake of leucine may account for some of this effect. This study is designed to assess whether any of the beneficial effects of dietary leucine supplementation observed in mice also apply to humans.
Specifically, our team would like to determine whether oral leucine supplementation in overweight/obese humans increases metabolic rate, reduces body weight, improves glucose utilization and/or, reduces circulating fat levels in the blood. We hope that the results obtained from this pilot study will highlight the specific aspects of metabolic improvement associated with increased daily leucine intake. This study will should provide data that can be used to design more definitive trials with regard to dietary leucine supplementation.
Hypothesis
This pilot study is designed to accomplish the following two goals:
- to assess whether any of the beneficial effects of dietary leucine supplementation observed in mice also apply in humans. Specifically, we want to determine whether oral leucine supplementation in overweight/obese individuals' increases basal metabolic rate, reduces body weight, improves glucose tolerance and/or insulin sensitivity, and/or reduces circulating Low-density Lipoprotein (LDL)-cholesterol levels.
- To provide data that can be used to design more definitive trials with regard to dietary leucine supplementation.
We hope that the results obtained from this pilot study will highlight the specific aspects of metabolic improvement associated with increased daily leucine intake. This would in turn lead to more rigorous clinical trials involving larger sample sizes, and with diverse populations of different gender, age, and ethnic groups. Future trials may also be directed to determine minimal doses and durations of leucine supplementation that are capable of achieving clinically significant improvement in the cardio-metabolic risk profile in people.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-65 year old overweight/obese
- •healthy men and women
- •Body Mass Index (BMI) of 28-35
排除标准
- •unusual or extreme dietary or exercise habits
- •daily leucine supplement use
- •inability to follow instructions to drink liquid meals
- •type 1 diabetes or type 2 diabetes on drug treatment(diet controlled diabetics will be enrolled after consulting with their treating physicians)
- •hypothyroidism or hyperthyroidism
- •chronic wasting diseases (Acquired Immune Deficiency Syndrome (AIDS), cancers, cirrhosis, renal failure, Chronic Obstructive Pulmonary Disease (COPD), heart failure)
- •drug or alcohol abuse
- •tobacco smoker within the past 6 months
- •pregnancy or lactating
- •use of medications known to affect carbohydrate or lipid metabolism, satiety, or hunger
- •abnormal liver function tests (LFTs)
- •women who are of child bearing age without adequate birth control modality
结局指标
主要结局
Effects on Weight
时间窗: 4 weeks
Weight
时间窗: at the end of each study treatment arm (six weeks)
次要结局
- Energy Expenditure(will be measure at the end of each treatment period (6 weeks))
研究者
Henry N. Ginsberg
Herbert and Florence Irving Professor of Medicine; Director - Irving Institute for Clinical & Translational Research
Columbia University