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

• ClinicalTrials.gov Identifier: NCT03722641
• Recruitment Status: Completed
• First Posted: October 29, 2018
• Last Update Posted: July 5, 2019
• Sponsor: Aventure AB
• Information provided by (Responsible Party): Aventure AB

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Other: Bread reference; Other: Product 1: Milk; Other: Product 2: Full fat milk + oat; Other: Product 3: Skim milk + oat, high fibre; Other: Product 4: Skim milk + oat, low fibre	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Randomized, Single-blind, Crossover Study to Evaluate Postprandial Glycaemia in a Healthy Population After Intake of Milk and Oat Based Products
• Actual Study Start Date: October 4, 2018
• Actual Primary Completion Date: March 5, 2019
• Actual Study Completion Date: March 5, 2019

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Bread reference; A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread.	Other: Bread reference; Commercially available white wheat bread; Other: Product 1: Milk; Developed reference product based on milk; Other: Product 2: Full fat milk + oat; Developed product based on full fat milk with addition of oat; Other: 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; Other: 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
Experimental: Product 1: Milk; A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on milk.	Other: Bread reference; Commercially available white wheat bread; Other: Product 1: Milk; Developed reference product based on milk; Other: Product 2: Full fat milk + oat; Developed product based on full fat milk with addition of oat; Other: 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; Other: 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
Experimental: 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.	Other: Bread reference; Commercially available white wheat bread; Other: Product 1: Milk; Developed reference product based on milk; Other: Product 2: Full fat milk + oat; Developed product based on full fat milk with addition of oat; Other: 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; Other: 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
Experimental: 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.	Other: Bread reference; Commercially available white wheat bread; Other: Product 1: Milk; Developed reference product based on milk; Other: Product 2: Full fat milk + oat; Developed product based on full fat milk with addition of oat; Other: 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; Other: 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
Experimental: 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.	Other: Bread reference; Commercially available white wheat bread; Other: Product 1: Milk; Developed reference product based on milk; Other: Product 2: Full fat milk + oat; Developed product based on full fat milk with addition of oat; Other: 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; Other: 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

Outcome Measures

Primary Outcome Measures :

1. Postprandial glycaemia capillary [ Time Frame: 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 :

1. Postprandial glycaemia intravenous [ Time Frame: 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.
2. Postprandial Cmax capillary glucose [ Time Frame: 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.
3. Postprandial Cmax venous glucose [ Time Frame: 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.
4. Postprandial glycaemia capillary [ Time Frame: 0-180 min ]
   The difference in the three-hour iAUC (0 - 180 min) of capillary blood glucose between product 1-4 and the bread reference.
5. Postprandial glycaemia venous [ Time Frame: 0-180 min ]
   The difference in the three-hour iAUC (0 - 180 min) of intravenous blood glucose between product 1-4 and the bread reference.
6. Postprandial glycaemia capillary [ Time Frame: 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.
7. Postprandial glycaemia venous [ Time Frame: 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.
8. Postprandial glycaemia Tmax capillary [ Time Frame: 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.
9. Postprandial glycaemia Tmax venous [ Time Frame: 0-180 min ]
   The difference in the Tmax of intravenous blood glucose between product 1-4 and the bread reference.
10. Postprandial insulinaemia [ Time Frame: 0-180 min ]
    The difference in the three-hour iAUC (0 - 180 min) of intravenous blood insulin between product 1-4 and the bread reference.
11. Postprandial insulinaemia [ Time Frame: 0-120 min ]
    The difference in the two-hour iAUC (0 - 120 min) of intravenous blood insulin between product 1-4 and the bread reference.
12. Postprandial insulinaemia [ Time Frame: 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.
13. Postprandial insulinaemia Cmax [ Time Frame: 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.
14. Postprandial insulinaemia Tmax [ Time Frame: 0-180 min ]
    The difference in the Tmax of intravenous blood insulin between product 1-4 and the bread reference.
15. Postprandial GLP-1 bread reference [ Time Frame: 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.
16. Postprandial GLP-1, yoghurt control [ Time Frame: 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.
17. Postprandial GLP-1 Cmax bread reference [ Time Frame: 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.
18. Postprandial GLP-1 Cmax yoghurt control [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 40 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Sweden

Aventure AB

Lund, Sweden

Sponsors and Collaborators

Aventure AB

More Information

• Responsible Party: Aventure AB
• ClinicalTrials.gov Identifier: NCT03722641
• Other Study ID Numbers: TR1801
• First Posted: October 29, 2018
• Last Update Posted: July 5, 2019
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No