Evaluation of Postprandial Glycaemia in a Healthy Population After Intake of Milk and Oat Based Products
NCT ID: NCT03722641
Last Updated: 2019-07-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2018-10-04
2019-03-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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Bread reference
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread.
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
Product 1: Milk
A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread and a test product based on milk.
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
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.
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
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.
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
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
40 Years
ALL
Yes
Sponsors
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Aventure AB
INDUSTRY
Responsible Party
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Locations
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Aventure AB
Lund, , Sweden
Countries
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Other Identifiers
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TR1801
Identifier Type: -
Identifier Source: org_study_id
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