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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02796989

Enrollment

Registered

2016-06-13

Start date

2016-03-31

Completion date

2017-12-31

Last updated

2021-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Obese

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.

Interventions

DIETARY_SUPPLEMENTWheat bran

20 g each day

DIETARY_SUPPLEMENTPlacebo

20 g each day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

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

Measure	Time frame
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
Changes in glucose levels (mg/dL)	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
Gut permeability using 51-Cr-EDTA	1 month

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026