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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: March 5, 2019

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Placebo Comparator: Bread reference
    • A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread.
  • Experimental: Product 1: Milk
    • A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on milk.
  • 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.
  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Aventure AB
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.