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
  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: 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 Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • Fecal water toxicity [ Time Frame: Participants were followed for 5 weeks, with measurements on 3 specific time points ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280513

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

No publications provided by Katholieke Universiteit Leuven

Additional 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
Study First Received: January 19, 2011
Last Updated: August 1, 2012
Health Authority: Belgium: Ethics Committee

ClinicalTrials.gov processed this record on April 17, 2014