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

Healthy Clinical Trial

Official title:

A Randomized, Single-blind, Crossover Study to Evaluate Postprandial Glycaemia in a Healthy Population After Intake of Milk and Oat Based Products

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03722641
• Other study ID #: TR1801
• Status: Completed
• Phase: N/A
• Start date: October 4, 2018
• Est. completion date: March 5, 2019

Study information

• Verified date: October 2018
• Source: Aventure AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 5, 2019
• Est. primary completion date: March 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Bread reference
Commercially available white wheat bread
• Product 1: Milk
Developed reference product based on milk
• Product 2: Full fat milk + oat
Developed product based on full fat milk with addition of oat
• Product 3: Skim milk + oat, high fibre
Developed product based on skim milk with addition of oat giving a high fiber content to the product
• Product 4: Skim milk + oat, low fibre
Developed product based on skim milk with addition of oat giving a lower fiber content to the product

Locations

Country	Name	City	State
Sweden	Aventure AB	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Aventure AB

Country where clinical trial is conducted

Sweden, 

Outcome

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