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

NCT ID: NCT02796989

Last Updated: 2021-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-12-31

Brief Summary

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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

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Conditions

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Healthy Obese

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Healthy - Wheat Bran

Wheat bran 20 g each day

Group Type ACTIVE_COMPARATOR

Wheat bran

Intervention Type DIETARY_SUPPLEMENT

20 g each day

Healthy - Placebo

Placebo 20 g each day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

20 g each day

Obese - Wheat bran

Wheat bran 20 g each day

Group Type ACTIVE_COMPARATOR

Wheat bran

Intervention Type DIETARY_SUPPLEMENT

20 g each day

Obese - Placebo

Placebo 20 g each day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

20 g each day

Interventions

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Wheat bran

20 g each day

Intervention Type DIETARY_SUPPLEMENT

Placebo

20 g each day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Kristin Verbeke

Professor Kristin Verbeke

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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KU Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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s58346

Identifier Type: -

Identifier Source: org_study_id

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