Dietary Cocoa for Inhibition of Metabolic Endotoxemia and Glucose Intolerance
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
- Change in insulin sensitivity
研究概览
简要总结
The purpose of this study is to determine the impact of consuming cocoa on blood glucose levels, glucose metabolism, and other markers of pre-diabetes in overweight and/or obese individuals. Our hypothesis is that consumption of cocoa improves insulin sensitivity and glucose metabolism in subjects at risk for developing type-2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index (BMI) greater than or equal to 25 and less than
- •Have at least one of the following: 1) impaired fasting glucose (IFG) after an overnight fast with plasma glucose concentration between 100-125 mg/dl, 2) impaired glucose tolerance (IGT) as identified by the standard Oral Glucose Tolerance Test (OGTT) with 2 hour plasma glucose concentration between 140-200 mg/dl following 75 g glucose OGTT, 3) HbA1c levels between 5.7-6.4% or 4) considered at risk to developing type 2 diabetes by the American Diabetes Association risk assessment. If subjects are above the prediabetic range for any of these tests (indicating they may be type 2 diabetic), they will be excluded and referred to their physician.
- •Weight stable (+/-2 kg) for the last 6 months.
- •Sedentary to recreationally active (less than 2 d/wk, 20 min/d).
- •Have a blood pressure that is less than 160/100 mmHg, total cholesterol that is less than 300 mg/dl and a triglyceride concentration of less than 450 mg/dl.
排除标准
- •Past or current history of coronary heart disease, stroke or major cardiovascular disease events, respiratory diseases, endocrine or metabolic diseases (including type 1 and type 2 diabetes), inflammatory bowel disease, cancer, or neurological or hematological disorders that would compromise the study or the health of the subject.
- •Past or current history of gastrointestinal disorders (including lactose intolerance, ulcers, cancer (stomach, intestinal, colon, pancreatic, liver, etc) NASH, NAFLD, cirrhosis, IBD/IBS, celiac disease, etc).
- •Current use of any medication including but not limited to cholesterol lowering medication (including fibric acid derivatives and niacin), antibiotics, immunosuppressive drugs, azole antifungals, non-steroidal anti-inflammatory drugs (NSAIDs), hormone replacement therapy or antioxidants/supplements.
- •Use of antibiotics, prebiotics, or probiotics within the prior 3 months.
- •Smoking or other tobacco use
- •Habitual consumption of alcohol more than 2 servings/d for males and 1 serving/d for females.
- •Strict vegetarians or vegans, or strong aversions to major food groups that may be part of the controlled diet.
- •Recent surgery
- •History of alcohol or drug abuse.
- •Pregnant or plan to become pregnant
- •Allergic to either lidocaine or bupivacaine
结局指标
主要结局
Change in insulin sensitivity
时间窗: Baseline and 4 weeks
Insulin sensitivity will be determined using Bergman's minimal model (MINMOD Millennium software) via a frequently sampled intravenous glucose tolerance test (IVGTT). Fasting baseline blood samples will be taken prior to the dextrose injection (0.3 g/kg; 50% solution) at minute 0. Venous samples will be collected at minutes 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 16, and 18. Insulin (0.025 U/kg) will be injected at minute 20. Venous sampling will continue at minutes 22, 23, 24, 25, 27, 30, 40, 50, 60, 70, 80, 90, 100, 120, 150, and 180. Glucose concentration will be immediately analyzed an automated glucose oxidase analyzer. Insulin will be later measured from serum using the Immulite 1000 immunoassay analyzer.
次要结局
- Change in skeletal muscle metabolic flexibility(Baseline and 4 weeks)
- Change in hormone secretion response to a mixed meal(Baseline and 1 week)
- Change in blood glucose response to a mixed meal(Baseline and 1 week)
- Change in blood endotoxin levels(Baseline and 4 weeks)
- Change in gut permeability(Baseline and 4 weeks)
研究者
Andrew P. Neilson
Assistant Professor
Virginia Polytechnic Institute and State University