Effect of Resveratrol on Age-related Insulin Resistance and Inflammation in Humans
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Peripheral Insulin Sensitivity (RD) Measured by the Change in Glucose Rates of Disappearance With Resveratrol or Placebo at Baseline and at 4 Weeks.
研究概览
简要总结
Resveratrol is a natural polyphenol (a compound containing a phenol functional group) that can be found in many plants. The purpose of this research is to study the effects of resveratrol on the action of insulin (a hormone produced in the body by the pancreas that regulates the amount of sugar in the blood), fat accumulation, and inflammation in the body.
详细描述
Participants will meet with the study team to discuss dietary recommendations. Each participant will be instructed to follow a standardized diet plan and to avoid vigorous exercise before beginning the study. Participants will be given a 28 day supply of resveratrol capsules (Two 500 mg capsules taken twice a day). A comprehensive study of whole-body insulin action called a pancreatic clamp will be done and small samples of fat and muscle will be taken before and after the administration of resveratrol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI: 26-35
- •Non-smoker
- •Normal screening labs (CMC, chemistry, LFTs PT/PTT)
- •Good IV access
排除标准
- •High cholesterol
- •<4 week history of participation in another drug trial
- •Severe hypertension
- •Heart disease
- •Liver disease of liver abnormalities
- •Cerebrovascular disease, i.e. stroke
- •Bleeding disorders
- •Muscle disease
- •Hepatitis (all types)
- •Mentally disabled persons
- •Pregnant women
- •Allergies to Novocaine, Lidocaine, Benzocaine
- •Subjects on the following medications:
- •Anticoagulant and antiplatelet drugs
- •Anti-epileptic drugs
- •Mexiletene
- •Quinidine
- •Cyclosporine
- •Tacrolimus
- •HIV protease inhibitors
研究组 & 干预措施
Resveratrol
Each participant will receive a 28 days' supply of resveratrol capsules on day 0.
干预措施: Resveratrol (Drug)
结局指标
主要结局
Peripheral Insulin Sensitivity (RD) Measured by the Change in Glucose Rates of Disappearance With Resveratrol or Placebo at Baseline and at 4 Weeks.
时间窗: 4 weeks
We will measure peripheral insulin sensitivity by determining the rate of glucose uptake (RD). RD will be measured using a 6 hours stepped pancreatic clamp study procedure under various treatment conditions (eg, resveratrol or placebo). by monitoring changes in the level of a non-radioactive, naturally occurring form of glucose (sugar).
次要结局
- Endogenous Glucose Production (EGP), With Resveratrol or Placebo at Baseline and at 4 Weeks.(4 weeks)
- Effects of Resveratrol on Skeletal Muscle Mitochondrial Numbers(4 weeks)
- Gene Expression in Whole Fat Tissue , Before and After 4 Weeks' Resveratrol and Placebo. Ratio From Baseline Versus at 4 Weeks(4 weeks)
- Muscle Mitochondrial Area(4 Weeks)
研究者
Meredith Hawkins
Principal Investigator
Albert Einstein College of Medicine