Effect of Increased Protein Intake on Colonic Metabolism

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Kristin Verbeke, Katholieke Universiteit Leuven

ClinicalTrials.gov Identifier:

NCT01280513

First received: January 19, 2011

Last updated: August 1, 2012

Last verified: August 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 19, 2011
Last Updated Date	August 1, 2012
Start Date ^ICMJE	October 2009
Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 1, 2012)	Fecal water toxicity [ Time Frame: Participants were followed for 5 weeks, with measurements on 3 specific time points ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01280513 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effect of Increased Protein Intake on Colonic Metabolism
Official Title ^ICMJE	Influence of a Protein Diet on the Colonic Metabolism and Phosphorus Housekeeping in Healthy Volunteers.
Brief Summary	The purpose of this study is to modulate the protein fermentation and to investigate the effect on colon toxicity.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science
Condition ^ICMJE	Protein Fermentation Toxicity in the Colon
Intervention ^ICMJE	Dietary Supplement: High protein intake 30% of energy intake coming from proteins Dietary Supplement: Low Protein intake 9% of energy intake coming from proteins
Study Arm (s)	Experimental: High Protein intake Intervention: Dietary Supplement: High protein intake Experimental: Low Protein intake Intervention: Dietary Supplement: Low Protein intake
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	20
Completion Date	Not Provided
Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 45 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Belgium

Administrative Information
NCT Number ^ICMJE	NCT01280513
Other Study ID Numbers ^ICMJE	ML5174
Has Data Monitoring Committee	No
Responsible Party	Kristin Verbeke, Katholieke Universiteit Leuven
Study Sponsor ^ICMJE	Katholieke Universiteit Leuven
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Katholieke Universiteit Leuven
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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