Prebiotic Effects on Glucose Tolerance

Study Overview
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Brief Summary
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The primary purpose of this project is to evaluate effects in healthy humans on glucose tolerance of cereal products with high amounts of fermentable dietary fibre. Secondary issues are to investigate effects of the test foods on subjective appetite variables, mood variables and gut microbiota composition. The test food products will be consumed in the evening and test variables will be determined the next morning. The study will apply a randomized crossover study design.

Official Title
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Validation of a New Antidiabetic Food Concept Based on the Modulation of the Intestinal Flora

Conditions
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Diet Prevention of Metabolic Diseases

Intervention / Treatment
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* Other: Cereal based products


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI 18.5 - 25 kg/m2 age 20-40 years normal diet healthy Exclusion Criteria: fasting blood glucose >6.1 diagnosed or known disease known gastrointestinal disorder food allergies or intolerance special diet regiments smokers

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized crossover study design. Healthy young adult volunteers.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Reference product<br>Commercial cereals and a commercial yogurt | Other: Cereal based products<br>* The cereal products are made from common Swedish cereals.<br>|
| Experimental: Test product A<br>Specific designed cereals A and yogurt | Other: Cereal based products<br>* The cereal products are made from common Swedish cereals.<br>|
| Experimental: Test product B<br>Specific designed cereals B and yogurt | Other: Cereal based products<br>* The cereal products are made from common Swedish cereals.<br>|
| Experimental: Test product C<br>Specific designed cereals C and yogurt | Other: Cereal based products<br>* The cereal products are made from common Swedish cereals.<br>|
| Experimental: Test product D<br>Specific designed cereals D and yogurt | Other: Cereal based products<br>* The cereal products are made from common Swedish cereals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose tolerance | The incremental (3 hours) blood glucose area under the curve after a standardized breakfast, following consumption of the test- or reference products the previous evening. Glucose concentrations will be analysed from capillary blood at fasting and at 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min and 180 min after the standardized breakfast. | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective appetite variables | Determination of appetite variables (satiety, hunger and desire to eat) at fasting in the morning and after the standardized breakfast following consumption of the test- or reference products the previous evening. The appetite sensations will be determined at fasting and then at 30 min, 60 min, 90 min, 120 min, 150 min and at 180 min. The variables will be determined by registration on a 0-100 mm visual analogue scales (VAS). Higher ratings are considered to be better for the rating of satiety meanwhile lower ratings are considered to be better for hunger and desire to eat. | 3 hours | 
| Mood parameters | Determination of mood variables (activity and valence) at fasting in the morning and after the andardized breakfast, following consumption of the test- or reference products the previous evening. The mood variables will be determined at fasting and then at 60 min, 120 min and at 180 min. The variables will be determined by registration on a 0-100 mm visual analogue scales (VAS). | 3 hours | 
| Breath hydrogen | Determination of breath hydrogen concentrations will be performed at fasting and after the standardized breakfast, following consumption of the test- or reference products the previous evening. Breath hydrogen will be determined at fasting and then at 30 min, 60 min, 90 min, 120 min, 150 min and at 180 min. Breath hydrogen will be measured by exhaling in a portable measuring device. | 3 hours |