Role of Colonic Events on Metabolism and Appetite Control: A Synbiotic Approach

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate food factors related to colonically derived regulation of glucose metabolism (and related parameters) and satiety using a semi-acute meal study in healthy subjects as experimental model.

Official Title
-----------------
Prebiotics and Probiotics as Means to Modulate Colonic Events, With Specific Focus on Metabolism and Satiety

Conditions
-----------------
Obesity, Metabolic Syndrome

Intervention / Treatment
-----------------
* Other: test meal
* Other: reference


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal fasting blood glucose, BMI 19-25 kg/m2, for women: hormon based contraceptives Exclusion Criteria: gastrointestinal diseases or food allergies e.g. lactose-, gluten intolerance, metabolic disorders e.g. diabetes, tobacco/snuff users. Antibiotic or probiotic usage within two weeks, and during the study. Vegetarians

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: + ind.CHO + prebiotics<br>test meal: intrinsic indigestible carbohydrates in combination with a combined probiotic supplement. | Other: test meal<br> <br> |
| Experimental: + ind.CHO - prebiotics<br>test meal: intrinsic indigestible carbohydrates in combination with placebo probiotic supplement. | Other: test meal<br> <br> |
| Experimental: - ind.CHO - prebiotics<br>reference: no ind. carbohydrates and no probiotic supplement | Other: reference<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in concentration of risk markers in blood, measured post-prandial after a breakfast meal. | Variables (blood glucose, insulin, incretin, inflammatory markers, markers of colonic fermentation) are measured after two-weeks ingestion of test products. The experimental day is terminated after a lunch meal. | Post-prandially after breakfast, 0-210 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| voluntary energy intake | Energy intake at lunch is measured after two-weeks ingestion of test products. The experimental day is terminated after the lunch meal. | Post-prandially after breakfast, 0-210 min | 
| Subjective satiety | The subjective sensation of satiety, hunger and desire to eat is measured using a (VAS) questionnaire. | post-prandially after breakfast, 0-210 min | 
| Differences in gut microbiota | The effect on gut microbiota of 14 days intake of test- and reference product are investigated in faecal samples. | Faecal samples are collected after 14 days intake of test- and reference product |