Effect of Increased Protein Intake on Colonic Metabolism

NCT ID: NCT01280513

Last Updated: 2012-08-02

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Brief Summary

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The purpose of this study is to modulate the protein fermentation and to investigate the effect on colon toxicity.

Detailed Description

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Conditions

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Protein Fermentation Toxicity in the Colon

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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High Protein intake

Group Type EXPERIMENTAL

High protein intake

Intervention Type DIETARY_SUPPLEMENT

30% of energy intake coming from proteins

Low Protein intake

Group Type EXPERIMENTAL

Low Protein intake

Intervention Type DIETARY_SUPPLEMENT

9% of energy intake coming from proteins

Interventions

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High protein intake

30% of energy intake coming from proteins

Intervention Type DIETARY_SUPPLEMENT

Low Protein intake

9% of energy intake coming from proteins

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Healthy
* Regular eating pattern (3 meals/day)
* Age between 18 and 45 years old
* BMI between 18,5 and 30 kg/m²

Exclusion Criteria

* Intake of antibiotics in the last month before the study
* Abdominal surgeries in the past (accept appendectomy)
* Consulting a dietician/following a diet
* Vegetarian
* Intake of pre- and/or probiotics
* Exposure to radioactivity in the year proceeding the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 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, Ph. D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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KULeuven

Leuven, Vlaams-Brabant, Belgium

Site Status

Countries

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Belgium

References

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Windey K, De Preter V, Louat T, Schuit F, Herman J, Vansant G, Verbeke K. Modulation of protein fermentation does not affect fecal water toxicity: a randomized cross-over study in healthy subjects. PLoS One. 2012;7(12):e52387. doi: 10.1371/journal.pone.0052387. Epub 2012 Dec 20.

Reference Type DERIVED
PMID: 23285019 (View on PubMed)

Other Identifiers

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ML5174

Identifier Type: -

Identifier Source: org_study_id