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

• Sponsor: KU Leuven (Other)
• Overall Status: Completed
• CT.gov ID: NCT02796989
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 4
• Duration (Months): 21
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy; Obese	Dietary Supplement: Wheat bran; Dietary Supplement: Placebo	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Dec 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Changes in glucose levels (mg/dL) [1 month]

2. Changes in insulin levels (pmol/L) [1 month]

3. Changes in cholesterol levels (mg/dL) [1 month]

4. Changes in free fatty acids levels (mmol/L) [1 month]

5. Changes in triglyceride levels (mg/dL) [1 month]

6. Gut permeability using 51-Cr-EDTA [1 month]

7. Total gastrointestinal transit time [1 month]

8. Changes in gut microbiota before and after the intervention using 16S rRNA sequencing [1 month]

9. Changes in metabolite patterns in the feces before and after the intervention using gas chromatography coupled to mass spectrometry [1 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KU Leuven	Leuven	Vlaams-Brabant	Belgium	3000

Sponsors and Collaborators

• KU Leuven

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kristin Verbeke, Professor Kristin Verbeke, KU Leuven
• ClinicalTrials.gov Identifier: NCT02796989
• Other Study ID Numbers: s58346
• First Posted: Jun 13, 2016
• Last Update Posted: Feb 26, 2021
• Last Verified: Feb 1, 2021

Study Results

No Results Posted as of Feb 26, 2021