Effect of Increased Protein Intake on Colonic Metabolism

Protein Fermentation Clinical Trial

Official title:

Influence of a Protein Diet on the Colonic Metabolism and Phosphorus Housekeeping in Healthy Volunteers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01280513
• Other study ID #: ML5174
• Status: Completed
• Phase: N/A
• First received: January 19, 2011
• Last updated: August 1, 2012
• Start date: October 2009

Study information

• Verified date: August 2012
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Protein Fermentation
• Toxicity in the Colon

Intervention

Dietary Supplement:
• High protein intake
30% of energy intake coming from proteins
• Low Protein intake
9% of energy intake coming from proteins

Locations

Country	Name	City	State
Belgium	KULeuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fecal water toxicity		Participants were followed for 5 weeks, with measurements on 3 specific time points	No