ADAPT-The Adaptation to High Fat Diets
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Characteristics of Individuals
研究概览
简要总结
This study is designed to predict weight gain overtime after a high fat diet.
详细描述
In the past 3 years we have identified a "thrifty-phenotype" characterized in lean men by an inability to adapt rapidly to a high fat diet and associated with a low maximal VO2 and high fasting insulin. We hypothesize that the individuals with the "thrifty phenotype" are at higher risk for becoming obese, and that exercise may be effective in overcoming this problem.
Several questions remain to be answered regarding the "thrifty" phenotype. First, given the large interindividual differences, how can we identify those at the highest risk? What are the distinguishing biochemical, endocrine and environmental characteristics of individuals that store fat when exposed to high fat diets? This is important because if these individuals can be easily identified, then dietary interventions can be targeted to this "at-risk" population.
Second, what is different about the individual with the "thrifty phenotype"? Are there cellular pathways that are dysregulated in the skeletal muscle of these individuals when compared to controls? Is the defect intrinsic, i.e. a diminished ability to conserve glucose and oxidize fat in skeletal muscle or alternately, is the phenotype due to environmental, and dietary factors such as inactivity and energy excess?
To answer these questions, we have planned a three-year project that aims to:
- Characterize the biochemical, endocrine, anthropometric and environmental characteristics of individuals with the "thrifty" phenotype.
- Identify the signaling pathways in skeletal muscle that are dysregulated in individuals with the "thrifty" phenotype through mRNA expression profiling in skeletal tissue.
- Determine the role of environmental factors such as inactivity and caloric intake vs. intrinsic (genetic) factors in the "thrifty" phenotype.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both genders and all races will be invited to participate
- •Women will be asked to participate in the follicular phase of the menstrual cycle as determined by menstrual history and a negative pregnancy test will be recorded prior to participation
- •BMI > 19 and < 35
- •Age 18-30
排除标准
- •Unwilling or unable to abstain from alcohol consumption and caffeine consumption prior to testing and laboratory
- •Significant renal, hepatic, endocrine, pulmonary, cardiac or hematological disease
- •Pregnancy
- •Corticosteroid use in previous two months
- •Chronic use of anti-diabetic, anti-hypertensive, or other medications known to affect fat metabolism
- •Use of Depo-Provera, hormone implants or estrogen replacement therapy
- •Irregular menstrual cycles
- •Post-menopausal women
- •Weight gain or loss of > 3kg in the last 6 months
- •For the MRI, the following exclusion criteria apply:
- •Individuals who have a heart pacemaker, defibrillator, or non-removable hearing aid
- •Individuals with any clips or metal plates in their head
- •Individuals who have any artificial limbs or prosthetic devices
- •Individuals who were ever injured by a metallic foreign body which was not removed
- •Individuals, who wear braces on their teeth, have non-removable false teeth, or removable bridgework
研究组 & 干预措施
Lifestyle
Measurement of body weight in a fown with light undercloting (30 minutes) and height.
干预措施: High Fat Diet (Behavioral)
DEXA Scanner
Low-dose X0rays to determine the amount of fat, bone and muscle in your body.
干预措施: Low Fat Diet (Behavioral)
结局指标
主要结局
Characteristics of Individuals
时间窗: 4 days of high fat diet
Characterize the biochemical, endocrine, anthropometric and environmental characteristics of individuals with the "thrifty" phenotype.
次要结局
- Identify the Signaling Pathways(4 days after high fat diet)