Dietary Fibre and Metabolic Benefits

Study Overview
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Brief Summary
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The aim of the project is to study the connection between bacterial fermentation in the colon of prebiotic substrates and effects on systemic metabolism and appetite i healthy humans

Detailed Description
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The purpose with this project is to study the association between bacterial fermentation in the colon of specific mixtures of cereal dietary fiber and effects on systemic metabolism and appetite regulation. For this purpose, short term studies are performed in healthy adult subjects. Different cereals, cereal blends and from cereal extracted dietary fiber will be studied, as well as effects of different processing of the cereals. Cardiometabolic test markers and colonic fermentation metabolites will be followed up to 14 h after intake of the test substrates, and gut microbiota composition will be determined prior to and after the interventions.

Official Title
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Validation of a New Antidiabetic Food Concept Based on Modulation of the Gut Microbiota

Conditions
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Glucose Tolerance

Intervention / Treatment
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* Other: Cereal product 1
* Other: Cereal product 2
* Other: Cereal product 3
* Other: Cereal product 4
* Other: Cereal product 5
* Other: Control product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy adults BMI<30 non smokers consuming a non-vegetarian diet that follows the Nordic guidances Exclusion Criteria: fasting blood glucose >6.1 mmol/L known cardio-metabolic disease (e.g. diabetes, hypertension, metabolic syndrome), gastro-intestinal disorders such as IBS (irritable bowel syndrome) that can interfere with the study results, food allergies. Further no antibiotics or probiotics should have been consumed within 4 weeks prior to and during the study.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 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: Crossover randomised
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cereal product 1<br>Cereal based müsli no. 1, made from typical Swedish cereals. All experimental products have different types and amounts of dietary fibre (df). The test portion is consumed as a single evening meal prior to determinations of test variables in the morning. | Other: Cereal product 1<br>* Cereal products based on rye, barley, wheat, oat, and corn<br>|
| Experimental: Cereal product 2<br>Cereal based muesli no. 2 made from typical Swedish cereals. All experimental products have different types and amounts of df. The test portion is consumed as a single evening meal prior to determinations of test variables in the morning. | Other: Cereal product 2<br>* Cereal products based on rye, barley, wheat, oat, and corn<br>|
| Experimental: Cereal product 3<br>Cereal based muesli no.3 made from typical Swedish cereals. All experimental products have different types and amounts of df.The test portion is consumed as a single evening meal prior to determinations of test variables in the morning. | Other: Cereal product 3<br>* Cereal products based on rye, barley, wheat, oat, and corn<br>|
| Experimental: Cereal product 4<br>Cereal based muesli no. 4 made from typical Swedish cereals. All experimental products have different types and amounts of df. The test portion is consumed as a single evening meal prior to determinations of test variables in the morning. | Other: Cereal product 4<br>* Cereal products based on rye, barley, wheat, oat, and corn<br>|
| Experimental: Cereal product 5<br>Cereal based muesli no. 5 made from typical Swedish cereals. All experimental products have different types and amounts of df. The test portion is consumed as a single evening meal prior to determinations of test variables in the morning. | Other: Cereal product 5<br>* Cereal products based on rye, barley, wheat, oat, and corn<br>|
| Placebo Comparator: Control product<br>A cereal based product with low concentrations of df. The control portion is consumed as a single evening meal prior to determinations of test variables in the morning. | Other: Control product<br>* A cereal based product with low concentrations of df<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose regulation | Postprandial blood glucose regulation (incremental area under the curve) acute after intake of the test products and at forthcoming meals within 14 h after consumption of test products. | 0-14 h after intake | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum insulin | Postprandial serum insulin concentrations (incremental area under the curve) acute after intake of the test products and at forthcoming meals within 14 h after consumption of test products. | 0-14 h after intake | 
| gut microbiota composition | effects on gut microbiota composition after intake of prebiotics | first stool delivered from14 h after intake | 
| plasma GLP-1 (glucagon-like peptide-1 ), PYY (peptide tyrosine tyrosine), Ghrelin | Gastro-intestinale hormones involved in appetite and metabolic regulation | 0-14 h after intake | 
| plasma: CRP (C reactive protein ), IL (interleukin)-6, IL-18, IL-8, IL-1, IL-10, LBP (lipopolysaccharide-binding protein), (PAI-1plasminogen activator inhibitor) | Inflammatory markers in blood | 0-14 h after intake | 
| plasma GLP-2 | gut hormone involved in gut mucosa integrity | 0-14 h after intake | 
| plasma SCFA (short-chain fatty acid) | colonic fermentation metabolites | 0-14 h after intake | 
| blood lipids | cholesterol and free fatty acids in plasma | 0-14 h after intake | 
| plasma adiponectin | hormone involved in metabolic regulation | 0-14 h after intake | 
| plasma BDNF (Brain-derived neurotrophic factor) | signal protein important for brain functions, but also involved in metabolic regulation | 0-14 h after intake | 
| plasma neurotensin | a neuro peptide peptides involved in appetite and metabolic regulation | 0-14 h after intake | 
| plasma Nesfatin-1 | a neuro peptide that participates in the regulation of hunger and fat storage. | 0-14 h after intake |