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

Healthy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02796989
• Other study ID #: s58346
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 2016
• Est. completion date: December 2017

Study information

• Verified date: February 2021
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Obese

Intervention

Dietary Supplement:
• Wheat bran
20 g each day
• Placebo
20 g each day

Locations

Country	Name	City	State
Belgium	KU Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incremental plasma short-chain fatty acid concentrations will be measured using GC-FID after an intervention with wheat bran/placebo		1 month
Secondary	Changes in glucose levels (mg/dL)		1 month
Secondary	Changes in insulin levels (pmol/L)		1 month
Secondary	Changes in cholesterol levels (mg/dL)		1 month
Secondary	Changes in free fatty acids levels (mmol/L)		1 month
Secondary	Changes in triglyceride levels (mg/dL)		1 month
Secondary	Gut permeability using 51-Cr-EDTA		1 month
Secondary	Total gastrointestinal transit time		1 month
Secondary	Changes in gut microbiota before and after the intervention using 16S rRNA sequencing		1 month
Secondary	Changes in metabolite patterns in the feces before and after the intervention using gas chromatography coupled to mass spectrometry		1 month