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Effect of Increased Protein Intake on Colonic Metabolism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01280513
First Posted: January 20, 2011
Last Update Posted: August 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kristin Verbeke, Katholieke Universiteit Leuven
  Purpose
The purpose of this study is to modulate the protein fermentation and to investigate the effect on colon toxicity.

Condition Intervention
Protein Fermentation Toxicity in the Colon Dietary Supplement: High protein intake Dietary Supplement: Low Protein intake

Study Type: Interventional
Study Design: 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.

Further study details as provided by Kristin Verbeke, Katholieke Universiteit Leuven:

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

Enrollment: 20
Study Start Date: October 2009
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: January 19, 2011
First Posted: January 20, 2011
Last Update Posted: August 2, 2012
Last Verified: August 2012


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