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Completed

NCT Number: NCT03722641

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

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.

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Key information

Conditions

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aventure AB

Lund, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Bread reference

Other

Commercially available white wheat bread

Product 1: Milk

Other

Developed reference product based on milk

Product 2: Full fat milk + oat

Other

Developed product based on full fat milk with addition of oat

Product 3: Skim milk + oat, high fibre

Other

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

Other

Developed product based on skim milk with addition of oat giving a lower fiber content to the product

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Aventure AB

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 29, 2018
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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