Effect of Increased Protein Intake on Colonic Metabolism

August 1, 2012 updated by: Kristin Verbeke, KU Leuven

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • KULeuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fecal water toxicity
Time Frame: Participants were followed for 5 weeks, with measurements on 3 specific time points
Participants were followed for 5 weeks, with measurements on 3 specific time points

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

January 19, 2011

First Submitted That Met QC Criteria

January 19, 2011

First Posted (Estimate)

January 20, 2011

Study Record Updates

Last Update Posted (Estimate)

August 2, 2012

Last Update Submitted That Met QC Criteria

August 1, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • ML5174

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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