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Effect of Increased Protein Intake on Colonic Metabolism

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ClinicalTrials.gov Identifier: NCT01280513
Recruitment Status : Completed
First Posted : January 20, 2011
Last Update Posted : August 2, 2012
Sponsor:
Information provided by (Responsible Party):
Kristin Verbeke, Katholieke Universiteit Leuven

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

Condition or disease Intervention/treatment Phase
Protein Fermentation Toxicity in the Colon Dietary Supplement: High protein intake Dietary Supplement: Low Protein intake Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Influence of a Protein Diet on the Colonic Metabolism and Phosphorus Housekeeping in Healthy Volunteers.
Study Start Date : October 2009
Actual Primary Completion Date : June 2010

Arm Intervention/treatment
Experimental: High Protein intake Dietary Supplement: High protein intake
30% of energy intake coming from proteins

Experimental: Low Protein intake Dietary Supplement: Low Protein intake
9% of energy intake coming from proteins




Primary Outcome Measures :
  1. Fecal water toxicity [ Time Frame: Participants were followed for 5 weeks, with measurements on 3 specific time points ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01280513


Locations
Belgium
KULeuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Katholieke Universiteit Leuven

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kristin Verbeke, Professor Kristin Verbeke, Ph. D., Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01280513     History of Changes
Other Study ID Numbers: ML5174
First Posted: January 20, 2011    Key Record Dates
Last Update Posted: August 2, 2012
Last Verified: August 2012