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

Phase 1

Completed

• Conditions: Healthy; Obese
• Interventions: Dietary Supplement: Wheat bran; Dietary Supplement: Placebo

• Registration Number: NCT02796989
• Lead Sponsor: KU Leuven

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-05-27
• Study First Submitted QC: 2016-06-10
• Study First Posted: 2016-06-13
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-24
• Last Update Posted: 2021-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy - Wheat Bran	Wheat bran	Wheat bran 20 g each day
Healthy - Placebo	Placebo	Placebo 20 g each day
Obese - Wheat bran	Wheat bran	Wheat bran 20 g each day
Obese - Placebo	Placebo	Placebo 20 g each day

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Total gastrointestinal transit time	1 month
Gut permeability using 51-Cr-EDTA	1 month
Changes in gut microbiota before and after the intervention using 16S rRNA sequencing	1 month
Changes in glucose levels (mg/dL)	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
Changes in insulin levels (pmol/L)	1 month
Changes in metabolite patterns in the feces before and after the intervention using gas chromatography coupled to mass spectrometry	1 month

Trial Locations

Locations (1)

KU Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium