A Randomized, Single-blind, Crossover Study to Evaluate Postprandial Glycaemia in a Healthy Population After Intake of Milk and Oat Based Products
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aventure AB
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Postprandial glycaemia capillary
研究概览
简要总结
The objective of this study is to investigate the effect on postprandial glycaemia in a healthy population after intake of milk and oat based products.
详细描述
Postprandial glycaemia, insulinaemia and GLP-1 will be measured after intake of test meals with equal amount of carbohydrates (adjusted using bread) and equal amount of total water.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female 20 to 40 years of age
- •BMI 20-27 (±0.5) 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 (at or above 6.1 mmol/L at fasting on visit 2, 3, 4 or 5)
- •Elevated fasting insulin (above 25 mIE/L)
- •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 SI
- •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 SI. Participants who are taking allowed prescribed medications must agree to maintain their current method and dosing regimen during the course of the study unless 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, placebo or standardized meal
- •Participants restricted to a vegetarian or vegan diet
- •Intolerance to lactose or 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 SI
- •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 SI'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
Bread reference
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread.
干预措施: Bread reference (Other)
Bread reference
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread.
干预措施: Product 1: Milk (Other)
Bread reference
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread.
干预措施: Product 2: Full fat milk + oat (Other)
Bread reference
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread.
干预措施: Product 3: Skim milk + oat, high fibre (Other)
Bread reference
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread.
干预措施: Product 4: Skim milk + oat, low fibre (Other)
Product 1: Milk
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on milk.
干预措施: Bread reference (Other)
Product 1: Milk
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on milk.
干预措施: Product 1: Milk (Other)
Product 1: Milk
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on milk.
干预措施: Product 2: Full fat milk + oat (Other)
Product 1: Milk
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on milk.
干预措施: Product 3: Skim milk + oat, high fibre (Other)
Product 1: Milk
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on milk.
干预措施: Product 4: Skim milk + oat, low fibre (Other)
Product 2: Full fat milk + oat
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on full fat milk and oat with high fiber content.
干预措施: Bread reference (Other)
Product 2: Full fat milk + oat
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on full fat milk and oat with high fiber content.
干预措施: Product 1: Milk (Other)
Product 2: Full fat milk + oat
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on full fat milk and oat with high fiber content.
干预措施: Product 2: Full fat milk + oat (Other)
Product 2: Full fat milk + oat
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on full fat milk and oat with high fiber content.
干预措施: Product 3: Skim milk + oat, high fibre (Other)
Product 2: Full fat milk + oat
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on full fat milk and oat with high fiber content.
干预措施: Product 4: Skim milk + oat, low fibre (Other)
Product 3: Skim milk + oat, high fibre
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on skim milk and oat with high fiber content.
干预措施: Bread reference (Other)
Product 3: Skim milk + oat, high fibre
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on skim milk and oat with high fiber content.
干预措施: Product 1: Milk (Other)
Product 3: Skim milk + oat, high fibre
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on skim milk and oat with high fiber content.
干预措施: Product 2: Full fat milk + oat (Other)
Product 3: Skim milk + oat, high fibre
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on skim milk and oat with high fiber content.
干预措施: Product 3: Skim milk + oat, high fibre (Other)
Product 3: Skim milk + oat, high fibre
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on skim milk and oat with high fiber content.
干预措施: Product 4: Skim milk + oat, low fibre (Other)
Product 4: Skim milk + oat, low fibre
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on skim milk and oat with low fiber content.
干预措施: Bread reference (Other)
Product 4: Skim milk + oat, low fibre
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on skim milk and oat with low fiber content.
干预措施: Product 1: Milk (Other)
Product 4: Skim milk + oat, low fibre
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on skim milk and oat with low fiber content.
干预措施: Product 2: Full fat milk + oat (Other)
Product 4: Skim milk + oat, low fibre
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on skim milk and oat with low fiber content.
干预措施: Product 3: Skim milk + oat, high fibre (Other)
Product 4: Skim milk + oat, low fibre
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on skim milk and oat with low fiber content.
干预措施: Product 4: Skim milk + oat, low fibre (Other)
结局指标
主要结局
Postprandial glycaemia capillary
时间窗: 0-120 min after consumption
Primary outcome is the difference in the two-hour incremental area under the curve (iAUC (0 - 120 min)) for capillary blood glucose between product 1-4 and the bread reference.
次要结局
- Postprandial glycaemia Tmax capillary(0-180 min)
- Postprandial GLP-1 Cmax bread reference(0-60 min)
- Postprandial glycaemia intravenous(0-120 min)
- Postprandial Cmax venous glucose(0-180 min)
- Postprandial glycaemia capillary(0-60 min)
- Postprandial insulinaemia Tmax(0-180 min)
- Postprandial Cmax capillary glucose(0-180 min)
- Postprandial glycaemia Tmax venous(0-180 min)
- Postprandial insulinaemia Cmax(0-180 min)
- Postprandial GLP-1 Cmax yoghurt control(0-60 min)
- Postprandial glycaemia venous(0-60 min)
- Postprandial insulinaemia(0-60 min)
- Postprandial GLP-1, yoghurt control(0-60 min)
- Postprandial GLP-1 bread reference(0-60 min)
- Postprandial glycaemia capillary(0-180 min)
- Postprandial glycaemia venous(0-180 min)
- Postprandial insulinaemia(0-180 min)
- Postprandial insulinaemia(0-120 min)