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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Obese
• Intervention / Treatment: Dietary supplement: Wheat bran; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • KU Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Healthy - Wheat Bran; Wheat bran 20 g each day	Dietary supplement: Wheat bran; 20 g each day
Placebo Comparator: Healthy - Placebo; Placebo 20 g each day	Dietary supplement: Placebo; 20 g each day
Active Comparator: Obese - Wheat bran; Wheat bran 20 g each day	Dietary supplement: Wheat bran; 20 g each day
Placebo Comparator: Obese - Placebo; Placebo 20 g each day	Dietary supplement: Placebo; 20 g each day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: KU Leuven

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: May 27, 2016
• First Submitted That Met QC Criteria: June 10, 2016
• First Posted (Estimate): June 13, 2016

Study Record Updates

• Last Update Posted (Actual): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 24, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: s58346