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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-04

Study Completion Date

2019-03-05

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Bread reference

A standardized (50 grams carbohydrates) breakfast meal will be provided based on bread.

Group Type PLACEBO_COMPARATOR

Bread reference

Intervention Type OTHER

Commercially available white wheat bread

Product 1: Milk

Intervention Type OTHER

Developed reference product based on milk

Product 2: Full fat milk + oat

Intervention Type OTHER

Developed product based on full fat milk with addition of oat

Product 3: Skim milk + oat, high fibre

Intervention Type 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

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Bread reference

Intervention Type OTHER

Commercially available white wheat bread

Product 1: Milk

Intervention Type OTHER

Developed reference product based on milk

Product 2: Full fat milk + oat

Intervention Type OTHER

Developed product based on full fat milk with addition of oat

Product 3: Skim milk + oat, high fibre

Intervention Type 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

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Bread reference

Intervention Type OTHER

Commercially available white wheat bread

Product 1: Milk

Intervention Type OTHER

Developed reference product based on milk

Product 2: Full fat milk + oat

Intervention Type OTHER

Developed product based on full fat milk with addition of oat

Product 3: Skim milk + oat, high fibre

Intervention Type 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

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Bread reference

Intervention Type OTHER

Commercially available white wheat bread

Product 1: Milk

Intervention Type OTHER

Developed reference product based on milk

Product 2: Full fat milk + oat

Intervention Type OTHER

Developed product based on full fat milk with addition of oat

Product 3: Skim milk + oat, high fibre

Intervention Type 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

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Bread reference

Intervention Type OTHER

Commercially available white wheat bread

Product 1: Milk

Intervention Type OTHER

Developed reference product based on milk

Product 2: Full fat milk + oat

Intervention Type OTHER

Developed product based on full fat milk with addition of oat

Product 3: Skim milk + oat, high fibre

Intervention Type 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

Intervention Type OTHER

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

Intervention Type OTHER

Product 1: Milk

Developed reference product based on milk

Intervention Type OTHER

Product 2: Full fat milk + oat

Developed product based on full fat milk with addition of oat

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aventure AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Aventure AB

Lund, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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TR1801

Identifier Type: -

Identifier Source: org_study_id

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