Role of Slowly Digesible Starch on Diabetes Risk Factors In Pre-diabetic People
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Insulin Sensitivity and Secretion
研究概览
简要总结
The purpose of this study is to determine the effect of a slowly digesting starch on gut bacteria, sugar and fat metabolism, hunger hormones, and body fat in people with pre-diabetes.
详细描述
In a double blind randomized controlled clinical trial, the investigators will test the effect of slowly digesting starch (amylose) versus a placebo starch (amylopectin) on risk factors for type 2 diabetes. For the study, about 95 obese participants (ages 35-65) with pre-diabetes (impaired fasting glucose) will consume a yogurt containing about 45 g of either the experimental or placebo starch daily for 3 months. The investigators will test the hypothesis that, compared to controls, a daily intake of 45 g of amylose for 3 months will improve risk factors for the development of type 2 diabetes (insulin sensitivity and secretion) by decreasing ectopic fat depots and decreasing inflammation in parallel with a change in colonic microbial populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a body mass index between 30 and 44.9 kg/m2
- •Are 35-65 years of age
- •Have pre-diabetes, which means impaired fasting glucose (IFG)
- •Are willing to complete nutritional and activity questionnaires and 2-3 weeks of baseline testing
- •Are willing to enroll in the 3-month intervention and maintain the same level of exercise during the study
- •Are willing to maintain weight throughout the study
排除标准
- •Have evidence of cardiovascular disease, diabetes, symptomatic cholelithiasis (gallstones), or cancer
- •Have a fasting blood glucose less than 100 mg/dL or greater than 125 mg/dL
- •Have an average screening blood pressure > 150/100 mm Hg
- •Are a pre-menopausal woman but do not have a regular menstrual cycle
- •Are pregnant or breastfeeding
- •Chronically use medications including diuretics, steroids, and adrenergic-stimulating agents
- •Have emotional problems such as clinical depression or other diagnosed psychological conditions
- •Use hormonal contraceptives, oral or parenteral glucocorticoids, or any other medication known to influence glucose or insulin homeostasis (balance), within 1 month of study
- •Have a clinically significant gastrointestinal malabsorption syndrome, chronic diarrhea, or use antibiotics within one month of study
- •Have abnormal laboratory markers (e.g., elevated potassium levels, hemoglobin or hematocrit below the lower limit of normal)
- •Chronically consume alcohol (> 4 servings per day) or actively smoke cigarettes (> 1/4 pack per day)
- •Are on any chronic medication that has not had a stable dose for 1 month or longer
- •Are required to perform of any kind of heavy physical activity
- •Have metal objects in the body, such as a pacemaker, metal pins, bullet, etc.
研究组 & 干预措施
Experimental Starch
Yogurt with about 45 g/day of slowly digestible starch (amylose).
干预措施: Amylopectin (Dietary Supplement)
Placebo Starch
Yogurt with about 45 g/day of placebo starch (amylopectin).
干预措施: Amylose (Dietary Supplement)
结局指标
主要结局
Insulin Sensitivity and Secretion
时间窗: 3 months
Insulin sensitivity and secretion will be assessed via a Frequently Sampled Intravenous Glucose Tolerance Test (FSIGTT).
次要结局
- Body Composition(3 months)
- Gut Microbiota(3 months)
- Satiety(3 months)
- Hunger(3 months)
研究者
Eric Ravussin
Principal Investigator
Pennington Biomedical Research Center