Effect of Different Bran-based Dietary Platforms on the Colon Metabolism in Healthy Volunteers

NCT ID: NCT02422537

Last Updated: 2017-01-31

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

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-01-31

Brief Summary

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During this project the effect of 3 different bran-based dietary platforms on the fermentation on a readily fermentable substrate will be investigated using stable isotope techniques.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Unmodified wheat bran

One single dose om 20 g

Group Type ACTIVE_COMPARATOR

Unmodified wheat bran

Intervention Type DIETARY_SUPPLEMENT

Wheat bran with reduced particle size

One single dose of 20 g

Group Type ACTIVE_COMPARATOR

Wheat bran with reduced particle size

Intervention Type DIETARY_SUPPLEMENT

Destarched pericarp-enriched wheat bran

One single dose of 20 g

Group Type ACTIVE_COMPARATOR

Destarched pericarp-enriched wheat bran

Intervention Type DIETARY_SUPPLEMENT

No bran-based dietary platform

No wheat bran fractions is administered

Group Type OTHER

No wheat bran fraction

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Unmodified wheat bran

Intervention Type DIETARY_SUPPLEMENT

Wheat bran with reduced particle size

Intervention Type DIETARY_SUPPLEMENT

Destarched pericarp-enriched wheat bran

Intervention Type DIETARY_SUPPLEMENT

No wheat bran fraction

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Healthy
* Aged between 18 and 65 years
* BMI between 18 and 27 kg/m²
* Stable eating pattern (3 meals/day on at least 5 days/week)

Exclusion Criteria

* Use of antibiotics in the month preceding the study
* 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/ UZ Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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ML11202

Identifier Type: -

Identifier Source: org_study_id

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