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

A

Aventure

Status

Completed

Conditions

Healthy

Treatments

Other: Bread reference
Other: Product 2: Full fat milk + oat
Other: Product 4: Skim milk + oat, low fibre
Other: Product 3: Skim milk + oat, high fibre
Other: Product 1: Milk

Study type

Interventional

Funder types

Industry

Identifiers

NCT03722641
TR1801

Details and patient eligibility

About

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 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.

Enrollment

20 patients

Sex

All

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

20 participants in 5 patient groups, including a placebo group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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