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

January 19, 2011
August 1, 2012
October 2009
June 2010   (final data collection date for primary outcome measure)
Fecal water toxicity [ Time Frame: Participants were followed for 5 weeks, with measurements on 3 specific time points ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01280513 on ClinicalTrials.gov Archive Site
Not Provided
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Effect of Increased Protein Intake on Colonic Metabolism
Influence of a Protein Diet on the Colonic Metabolism and Phosphorus Housekeeping in Healthy Volunteers.

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Protein Fermentation
  • Toxicity in the Colon
  • Dietary Supplement: High protein intake
    30% of energy intake coming from proteins
  • Dietary Supplement: Low Protein intake
    9% of energy intake coming from proteins
  • Experimental: High Protein intake
    Intervention: Dietary Supplement: High protein intake
  • Experimental: Low Protein intake
    Intervention: Dietary Supplement: Low Protein intake
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.
 
Completed
20
Not Provided
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01280513
ML5174
No
Kristin Verbeke, Katholieke Universiteit Leuven
Katholieke Universiteit Leuven
Not Provided
Not Provided
Katholieke Universiteit Leuven
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP