NCT01280513

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 20, 2011

Completed
Last Updated

August 2, 2012

Status Verified

August 1, 2012

Enrollment Period

8 months

First QC Date

January 19, 2011

Last Update Submit

August 1, 2012

Conditions

Protein FermentationToxicity in the Colon

Outcome Measures

Primary Outcomes (1)

  • Fecal water toxicity

    Participants were followed for 5 weeks, with measurements on 3 specific time points

Study Arms (2)

High Protein intake

EXPERIMENTAL
Dietary Supplement: High protein intake

Low Protein intake

EXPERIMENTAL
Dietary Supplement: Low Protein intake

Interventions

High protein intakeDIETARY_SUPPLEMENT

30% of energy intake coming from proteins

High Protein intake
Low Protein intakeDIETARY_SUPPLEMENT

9% of energy intake coming from proteins

Low Protein intake

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Regular eating pattern (3 meals/day)
  • Age between 18 and 45 years old
  • BMI between 18,5 and 30 kg/m²

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KULeuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 23285019DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Kristin Verbeke, Ph. D.

Study Record Dates

First Submitted

January 19, 2011

First Posted

January 20, 2011

Study Start

October 1, 2009

Primary Completion

June 1, 2010

Last Updated

August 2, 2012

Record last verified: 2012-08

Locations

BE(1)