Evaluation of Postprandial Glycaemia in a Healthy Population After Intake of Milk and Oat Based Products

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Bread reference

• Registration Number: NCT03722641
• Lead Sponsor: Aventure AB

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2018-10
• Study Start: 2018-10-04
• Study First Submitted: 2018-10-24
• Study First Submitted QC: 2018-10-25
• Study First Posted: 2018-10-29
• Primary Completion: 2019-03-05
• Study Completion: 2019-03-05
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Male or female 20 to 40 years of age
2. BMI 20-27 (±0.5) kg/m²
3. Agree to maintain consistent dietary habits and physical activity levels for the duration of the study
4. Healthy as determined by medical history and information provided by the volunteer
5. Willingness to complete questionnaires and follow instructions associated with the study and to complete all visits
6. Has given voluntary, written, informed consent to participate in the study

Exclusion Criteria

1. Elevated fasting blood glucose (at or above 6.1 mmol/L at fasting on visit 2, 3, 4 or 5)
2. Elevated fasting insulin (above 25 mIE/L)
3. Women who are pregnant or breast feeding
4. Any medical condition(s) or medication(s) known to significantly affect glucose metabolism. Significance to be assessed by the SI
5. 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.
6. Known Type I or Type II diabetes, including women who previously have had gestational diabetes.
7. Use of antibiotics within 2 weeks of enrollment
8. Metabolic diseases and/or chronic gastrointestinal diseases (IBS, Crohns etc.)
9. Allergy to ingredients included in investigational product, placebo or standardized meal
10. Participants restricted to a vegetarian or vegan diet
11. Intolerance to lactose or gluten
12. Individuals who are averse to venous catheterization or capillary blood sampling
13. Currently active smokers (or using other tobacco products, and e-cigarettes)
14. Unstable medical conditions as determined by SI
15. Participation in other clinical research trials
16. Individuals who are cognitively impaired and/or who are unable to give informed consent
17. Acute infection
18. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Product 2: Full fat milk + oat	Bread reference	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.
Product 3: Skim milk + oat, high fibre	Bread reference	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.
Bread reference	Bread reference	A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread.
Product 1: Milk	Bread reference	A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on milk.
Product 4: Skim milk + oat, low fibre	Bread reference	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.

Primary Outcome Measures

Name	Time	Method
Postprandial glycaemia capillary	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.

Secondary Outcome Measures

Name	Time	Method
Postprandial glycaemia Tmax capillary	0-180 min	The difference in the Tmax (the time to maximum concentration) of capillary blood glucose between product 1-4 and the bread reference.
Postprandial GLP-1 Cmax bread reference	0-60 min	The difference in the one-hour Cmax (0 - 60 min) of intravenous blood GLP-1 between product 1-4 and the bread reference.
Postprandial glycaemia intravenous	0-120 min	The difference in the two-hour iAUC (0 - 120 min) for intravenous blood glucose between product 1-4 and the bread reference.
Postprandial Cmax venous glucose	0-180 min	The difference in the three-hour Cmax (0 - 180 min) of intravenous blood glucose between product 1-4 and the bread reference.
Postprandial glycaemia capillary	0-60 min	The difference in the one-hour iAUC (0 - 60 min) of capillary blood glucose between product 1-4 and the bread reference.
Postprandial insulinaemia Tmax	0-180 min	The difference in the Tmax of intravenous blood insulin between product 1-4 and the bread reference.
Postprandial Cmax capillary glucose	0-180 min	The difference in the three-hour Cmax (0 - 180 min) of capillary blood glucose between product 1-4 and the bread reference.
Postprandial glycaemia Tmax venous	0-180 min	The difference in the Tmax of intravenous blood glucose between product 1-4 and the bread reference.
Postprandial insulinaemia Cmax	0-180 min	The difference in the three-hour Cmax (0 - 180 min) of intravenous blood insulin between product 1-4 and the bread reference.
Postprandial GLP-1 Cmax yoghurt control	0-60 min	The difference in the one-hour Cmax (0 - 60 min) of intravenous blood GLP-1 between products 2-4 and product 1.
Postprandial glycaemia venous	0-60 min	The difference in the one-hour iAUC (0 - 60 min) of intravenous blood glucose between product 1-4 and the bread reference.
Postprandial insulinaemia	0-60 min	The difference in the one-hour iAUC (0 - 60 min) of intravenous blood insulin between product 1-4 and the bread reference.
Postprandial GLP-1, yoghurt control	0-60 min	The difference in the one-hour iAUC (0 - 60 min) of intravenous blood GLP-1 between products 2-4 and product 1.
Postprandial GLP-1 bread reference	0-60 min	The difference in the one-hour iAUC (0 - 60 min) of intravenous blood GLP-1 between product 1-4 and the bread reference.

Trial Locations

Locations (1)

Aventure AB; 🇸🇪 Lund, Sweden