Fat Cell Size and Overfeeding and Etopic Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Determine the effect of 8-weeks 40% high fat overfeeding in 40 healthy, young adults on adipose and skeletal muscle characteristics, ectopic fat accumulation, insulin sensitivity, and metabolic flexibility.
研究概览
简要总结
It has been shown that large fat cells are associated with more risks for insulin resistance and more cardiovascular risk factors such as high cholesterol or triglycerides.
详细描述
This study will look at fat cell size and how it affects fat deposition, insulin resistance and muscle oxidative capacity. A comparison will be made with the differences between participants with larger versus smaller fat cells in insulin resistance and blood levels of lipids. The study will also determine if characteristics of fat cells and muscle can predict the development of weight gain-induced insulin resistance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Your Body Mass Index (height to weight ratio) is 22.5 to 32.5 (inclusive).
- •You are 18-40 years of age.
- •You are willing to enroll in an 8 week overfeeding study causing a 5-8 % weight gain.
- •You are willing to eat all your meals from Pennington and only meals from Pennington for approximately 10 weeks total, even when you are full. Prior to overfeeding 2 Meals per day will be served at Pennington with lunch packed for at least 7 days. After that time participants will receive and eat all (overfeeding) meals at PBRC for 8 weeks. Post-overfeeding will consists of weight-maintenance diet for 1 week. All meals will be monitored at Pennington.
- •You are willing to maintain the same level of exercise after enrollment in the study throughout the length of the study.
- •You are willing to complete nutritional and activity questionnaires.
排除标准
- •You weight > 300 lbs
- •You have a history of cardiovascular disease or diabetes.
- •You have a fasting blood glucose > 110 mg/dL.
- •You have an average screening blood pressure > 140/
- •You have liver disease.
- •You have thyroid disease.
- •Have Acid Reflux
- •Had cancer in the last 5 years (Some skin cancers OK)
- •Have had an Eating Disorders
- •You are pregnant or breastfeeding.
- •You have gained or lost more than 3kg in the last 3 months
- •You require chronic use of medications including diuretics, steroids and adrenergic-stimulating agents.
- •You or a member of your family has a history of blood clots (deep vein thrombosis or pulmonary embolism)
- •You have poor circulation, history of bypass operation in your legs, blood coagulation disorders, diagnosed peripheral arterial or vascular disease, cramping pain in your leg muscle during exercise or nerve damage to your legs
- •You have varicose veins (per discretion of MD or NP)
- •You have had previous GI surgery, obstructive disease of the GI tract, hyper motility disorder or a history of problems of impairment of the gag reflex.
- •You have emotional problems such as clinical depression or other diagnosed psychological conditions.
- •You are claustrophobic.
- •You have metal objects in your body such as implanted rods or surgical clips or magnetic objects that are incompatible with the MRI/MRS.
- •You smoke or use tobacco products
结局指标
主要结局
Determine the effect of 8-weeks 40% high fat overfeeding in 40 healthy, young adults on adipose and skeletal muscle characteristics, ectopic fat accumulation, insulin sensitivity, and metabolic flexibility.
时间窗: 10 months
This study will investigate how fat cell size (independent of total fat mass) affects metabolic outcomes of overfeeding, including changes in fat deposition, insulin sensitivity and muscle oxidative capacity. It has been shown that large fat cells relative to fat mass are associated with higher risks for insulin resistance and type 2 diabetes.
次要结局
- Circadian Blood Pressure variability(10 Months)
- Fat Deposition(10 Months)
- Muscle Oxidative Capacity(10 Months)
- Insulin Sensitivity(10 months)
- Resting Endothelial function testing(10 Months)
研究者
Eric Ravussin
Principal Investigator
Pennington Biomedical Research Center