CompletedNCT01280513Updated Aug 2, 2012

Effect of Increased Protein Intake on Colonic Metabolism

An interventional study of High protein intake and Low Protein intake in Protein Fermentation and Toxicity in the Colon, sponsored by KU Leuven. Completed at 1 site in Belgium. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-08-02.

Sponsored by KU Leuven · Not applicable, Interventional, and Basic science

Phase: Not applicable
Study type: Interventional
Enrollment: 20
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: All

Study summary

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

Conditions studied

Protein Fermentation
Toxicity in the Colon

In context

Lead sponsor

KU Leuven is the lead sponsor of 358 studies on the registry; 62 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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

Phase: Not applicable
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 20 participants (actual)

Study arms

Experimental
High Protein intake
Dietary Supplement: High protein intake
Experimental
Low Protein intake
Dietary Supplement: Low Protein intake

Interventions

Dietary supplementHigh protein intake
30% of energy intake coming from proteins
Dietary supplementLow Protein intake
9% of energy intake coming from proteins

What researchers measure

Primary outcomes

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

Study locations

1 site

KULeuven
Leuven, Vlaams-Brabant 3000, Belgium

References and documents

Publications

Windey K, De Preter V, Louat T, Schuit F, Herman J, Vansant G, Verbeke K. Modulation of protein fermentation does not affect fecal water toxicity: a randomized cross-over study in healthy subjects. PLoS One. 2012;7(12):e52387. doi: 10.1371/journal.pone.0052387. Epub 2012 Dec 20. PubMed 23285019 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 2, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01280513
Lead sponsor: KU Leuven
Responsible party: Kristin Verbeke (Professor Kristin Verbeke, Ph. D., KU Leuven) — Principal investigator
First posted: Jan 20, 2011
Start date: Oct 2009
Primary completion: Jun 2010
Last update: Aug 2, 2012

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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