NCT02616159已完成不适用
A Randomized, Controlled, Double-Blind Crossover Trial to Assess Effect of Oatmeal Varieties on Glycemic and Insulinemic Responses in Healthy Individuals
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- peak rise of blood glucose
研究概览
简要总结
The objectives of this study are to compare the glycemic and insulinemic responses over 3 hours elicited by 3 oatmeal varieties compared to each other and to controls of ready to eat and hot cereals.
详细描述
Participant eligibility will be screened at visit 1. The study will be a randomized, cross-over design. Participants will come to the study site on 5 separate occasions separated by a 2-day to 2-week washout period. Participants will arrive to the lab in a fasted state. 2 fasting blood samples will be collected, and further blood sampled will be taken over a 3-hour period post study product consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or non-pregnant females, 18-75 years of age, inclusive
- •Body mass index (BMI) ≥ 20.0 and < 35 kg/m² at screening (visit 1).
- •Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial and to refrain from smoking for 12hr prior to each visit.
- •Willing to maintain current dietary supplement use throughout the trial. On test days, subject agrees not to take any dietary supplements until dismissal from the GI labs. Failure to comply will result in a rescheduled test visit.
- •Normal fasting serum glucose (<7.0mmol/L capillary corresponding to whole blood glucose <6.3mmol/L).
- •Willing to abstain from alcohol consumption and avoid vigorous physical activity for 24 h prior to all test visits.
- •Absence of health conditions that would prevent fulfillment of study requirements as judged by the Investigator on the basis of medical history.
- •Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.
排除标准
- •Failure to meet any one of the inclusion criteria
- •Known history of AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, biliary or GI disorders.
- •Use of medications known to influence carbohydrate metabolism, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or with any condition which might, in the opinion of Dr. Wolever, the president of GI Testing, either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
- •Major trauma or surgical event within 3 months of screening.
- •Unwillingness or inability to comply with the experimental procedures and to follow GI Labs safety guidelines.
- •Known intolerance, sensitivity or allergy to any ingredients in the study products.
- •Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc).
结局指标
主要结局
peak rise of blood glucose
时间窗: 3 hours post dose
次要结局
- Incremental area under the blood glucose and insulin response curves(0-3 hours post dose)
- Peak rise of insulin(0-3 hours post dose)
- Peak glucose and insulin concentrations(0-3 hours post dose)
- Blood glucose and insulin concentrations at each time point over a 3hr period(0-3 hours post dose)
研究者
研究点 (1)
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