The Impact of Modified Wheat Bran on Carbohydrate Fermentation in the Colon in Healthy and Obese Subjects

Study Overview
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Brief Summary
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During this project the effect of modified wheat bran on colon health and systemic health will be evaluated in a long-term intervention study in healthy and obese subjects.

Conditions
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Healthy, Obese

Intervention / Treatment
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* Dietary Supplement: Wheat bran
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 18 and 65 years old BMI between 18 and 25 kg/m² OR higher than 30 kg/m² Regular diet Not dieting Exclusion Criteria: Use of antibiotics in the month preceding the study Diabetes Type 1 or 2 Abdominal surgery (except from appendectomy) Use of medication that affects the gastrointestinal tract during the last 2 weeks prior to the study including spasmolytics, anti-diarrhoea medication, anti-constipation medication Use of pre- or probiotic supplements in the month preceding the study Chronic gastrointestinal diseases, such as inflammatory bowel disease (Crohn's disease, ulcerative colitis), irritable bowel disease… Pregnancy or lactation Blood donation in the last 3 months Abnormal Hb-level (Standard range between 14 and 18 g/dL for men and between 12 and 16 g/dL for women) Participation in clinical studies involving radiation exposure in the past year

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Healthy - Wheat Bran<br>Wheat bran 20 g each day | Dietary Supplement: Wheat bran<br>* 20 g each day<br>|
| Placebo Comparator: Healthy - Placebo<br>Placebo 20 g each day | Dietary Supplement: Placebo<br>* 20 g each day<br>|
| Active Comparator: Obese - Wheat bran<br>Wheat bran 20 g each day | Dietary Supplement: Wheat bran<br>* 20 g each day<br>|
| Placebo Comparator: Obese - Placebo<br>Placebo 20 g each day | Dietary Supplement: Placebo<br>* 20 g each day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incremental plasma short-chain fatty acid concentrations will be measured using GC-FID after an intervention with wheat bran/placebo |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in glucose levels (mg/dL) |  | 1 month | 
| Changes in insulin levels (pmol/L) |  | 1 month | 
| Changes in cholesterol levels (mg/dL) |  | 1 month | 
| Changes in free fatty acids levels (mmol/L) |  | 1 month | 
| Changes in triglyceride levels (mg/dL) |  | 1 month | 
| Gut permeability using 51-Cr-EDTA |  | 1 month | 
| Total gastrointestinal transit time |  | 1 month | 
| Changes in gut microbiota before and after the intervention using 16S rRNA sequencing |  | 1 month | 
| Changes in metabolite patterns in the feces before and after the intervention using gas chromatography coupled to mass spectrometry |  | 1 month |