NCT05291806已完成不适用
Second Meal Effects of a Wholegrain Cereal Product on Blood Glucose Response
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aventure AB
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Postprandial capillary blood glucose iAUC (0-120 min)
研究概览
简要总结
The aim of this study is to investigate second meal effects of a wholegrain cereal product on blood glucose response. The wholegrain cereal product will be consumed in the evening and blood glucose analyzed after a standardized breakfast meal the following morning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- 是
入选标准
- •Male or Female, 35 to 65 years of age
- •BMI 18.5-29.9 kg/m2
- •Agree to maintain consistent dietary habits and physical activity levels for the duration of the study.
- •Healthy as determined by medical history and information provided by the volunteer.
- •Willingness to complete questionnaires and follow instructions associated with the study and to complete all visits.
- •Has given voluntary, written, informed consent to participate in the study.
排除标准
- •Elevated fasting blood glucose (above 6.1 mmol/L at fasting on visit 1, 2, 3 or 4)
- •Women who are pregnant or breast feeding
- •Any medical condition(s) or medication(s) known to significantly affect glucose metabolism. Significance to be assessed by the QI
- •Use of medication, over-the-counter medication, natural health products or dietary supplements/probiotics that may affect glucose metabolism is prohibited during this study. Significance to be assessed by the QI. Participants who are taking allowed prescribed medications must agree to maintain their current method and dosing regimen during the course of the study unless other is recommended by their physician.
- •Known Type I or Type II diabetes, including women who previously have had gestational diabetes.
- •Use of antibiotics within 2 weeks of enrollment
- •Metabolic diseases and/or chronic gastrointestinal diseases (IBS, Crohns etc.)
- •Allergy to ingredients included in investigational product, reference, or standardized meal
- •Participants restricted to a vegetarian or vegan diet
- •Intolerance to gluten
- •Individuals who are averse to venous catheterization or capillary blood sampling
- •Currently active smokers (or using other tobacco products, and e-cigarettes)
- •Unstable medical conditions as determined by QI
- •Participation in other clinical research trials
- •Individuals who are cognitively impaired and/or who are unable to give informed consent
- •Acute infection
- •Any other condition which in the QI's opinion may adversely affect the individual's ability to complete the study or its measures or which may pose significant risk to the individual
研究组 & 干预措施
Reference
Placebo Comparator
干预措施: Reference Product (Other)
Cut cereal kernels Dose A
Active Comparator
干预措施: Wholegrain product Dose A, cut kernels (Other)
Whole cereal kernels Dose A
Active Comparator
干预措施: Wholegrain product Dose A (Other)
Whole cereal kernels Dose B
Active Comparator
干预措施: Wholegrain product Dose B (Other)
结局指标
主要结局
Postprandial capillary blood glucose iAUC (0-120 min)
时间窗: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
The change in capillary blood glucose between wholegrain products and reference in the total incremental area under the curve iAUC(0-120 min) after the standardized breakfast meal.
次要结局
- Fasting capillary blood glucose(Outcome measures will be assessed just before the standardized meal is consumed.)
- Postprandial Insulin Cmax(Outcome measures will be assessed just before and immediately after the standardized meal is consumed.)
- Postprandial Insulin Tmax(Outcome measures will be assessed just before and immediately after the standardized meal is consumed.)
- Postprandial insulin iAUC (0-60 min)(Outcome measures will be assessed just before and immediately after the standardized meal is consumed.)
- Postprandial capillary blood glucose Cmax(Outcome measures will be assessed just before and immediately after the standardized meal is consumed.)
- Postprandial capillary blood glucose iAUC (0-60 min)(Outcome measures will be assessed just before and immediately after the standardized meal is consumed.)
- Postprandial capillary blood glucose 2-hour iPeak(0-120 min) (incremental maximum value)(Outcome measures will be assessed just before and immediately after the standardized meal is consumed.)
- Postprandial Insulin iAUC(0-120 min)(Outcome measures will be assessed just before and immediately after the standardized meal is consumed.)
- Fasting Insulin(Outcome measures will be assessed just before and immediately after the standardized meal is consumed.)
- Postprandial venous blood insulin 2-hour iPeak(0-120 min) (incremental maximum value)(Outcome measures will be assessed just before and immediately after the standardized meal is consumed.)
- Postprandial capillary blood glucose Tmax(Outcome measures will be assessed just before and immediately after the standardized meal is consumed.)
研究者
研究点 (1)
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