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Completed

NCT Number: NCT02422537

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

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.

Completed

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KU Leuven/ UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Unmodified wheat bran

Dietary Supplement

Wheat bran with reduced particle size

Dietary Supplement

Destarched pericarp-enriched wheat bran

Dietary Supplement

No wheat bran fraction

Dietary Supplement

Primary outcomes

  1. Quantification of acetate, propionate and butyrate production in the colon after consumption of each bran-based dietary platform

    Time frame: 2 years

Secondary outcomes

  1. Estimation of the site of fermentation of a readily fermentable carbohydrate in the presence of different bran-based dietary platforms

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

The Effect of One Single Dose of Different Bran-based Dietary Platforms on the Colon Metabolism - A Study With (Stable) Isotopes in Healthy Volunteers

Important dates

Study start
2015
Primary completion
2015
Study completion
2017
First posted
Apr 21, 2015
Registry last updated
Jan 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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