Determination of the Glycemic Index of Products Varying in Levels of Refined and Whole Grain Corn: a Randomized Controlled Trial in Healthy Participants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- iAUC (incremental area under the curve)
研究概览
简要总结
Interest in identifying low GI foods and the food factors responsible for the low GI of foods has increased. Three corn products with varying levels of refined and whole grain corn will be compared to each other and to a dextrose control. It is hypothesized that higher levels of whole grain corn present in a food will decrease the rate of absorption and result in a lower postprandial glucose levels and glycemic index, and that the whole grain ingredient manufacturing process impacts whole grain ingredient benefits.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adults aged 18-75 years, inclusive.
- •BMI between 18.0 and 35.0 Kg/m
- •Willing to abstain from unusual strenuous exercise and consuming alcoholic drinks for 24 hours before study days.
- •Willing to refrain from smoking tobacco or marijuana for 12h before and during study visits.
- •Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
- •Understanding the study procedures & willing to provide informed consent to participate in the study & authorization to release relevant protected health information to the study investigator.
- •Participants must be eligible to receive income in Canada and be covered by a health insurance plan such as OHIP.
排除标准
- •Self-reported pregnant or breastfeeding women.
- •Known history of gastrointestinal disease (e.g., diverticulitis, Crohns disease, coeliac disease etc.), bariatric surgery, AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), or any condition which might, in the opinion of the medical director either: 1) make participation dangerous to the participant or to others, or 2) affect the results.
- •Use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or any medication which might, in the opinion of the medical director either: 1) make participation dangerous to the participant 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 INQUIS health and safety policies.
- •Known intolerance, sensitivity or allergy to test products.
- •Participation in any clinical trial within the past 30 days (with the exception of routine GI testing of commonly consumed foods) or any PepsiCo sponsored trial within the past 3 months.
研究组 & 干预措施
Dextrose control
Consumed at two visits (first and last of 5 test days). Solution contains 25g of available carbohydrates (27.3g dextrose monohydrate) mixed with 250 ml of water. Served with 250 ml additional water.
干预措施: Dextrose control (Other)
Control food
Refined corn snack, served with 250 ml water
干预措施: Corn snack containing 25 grams available carbohydrate (Other)
Test food A
Whole grain corn snack, manufacturer A, served with 250 ml water
干预措施: Corn snack containing 25 grams available carbohydrate (Other)
Test food B
Whole grain corn snack, manufacturer B, served with 250 ml water
干预措施: Corn snack containing 25 grams available carbohydrate (Other)
结局指标
主要结局
iAUC (incremental area under the curve)
时间窗: Change from fasting baseline (-5 minutes and 0 minutes) to 15, 30, 45, 60, 90 and 120 minutes after test snack consumed within 10 minutes
Compare the plasma glucose in mmol/L of three corn products
次要结局
- Glycemic Index (GI)(Change from fasting baseline (-5 minutes and 0 minutes) to 15, 30, 45, 60, 90 and 120 minutes after test snack consumed within 10 minutes)
- Glycemic load (GL)(Change from fasting baseline (-5 minutes and 0 minutes) to 15, 30, 45, 60, 90 and 120 minutes after test snack consumed within 10 minutes)
- Incremental glucose levels(Change from fasting baseline (-5 minutes and 0 minutes) to 15, 30, 45, 60, 90 and 120 minutes after test corn snack consumed within 10 minutes)