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Completed

NCT Number: NCT01280513

Effect of Increased Protein Intake on Colonic Metabolism

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

Completed

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Key information

Conditions

Protein Fermentation Toxicity in the Colon

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KULeuven

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High protein intake

Dietary Supplement

30% of energy intake coming from proteins

Low Protein intake

Dietary Supplement

9% of energy intake coming from proteins

Primary outcomes

  1. Fecal water toxicity

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

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
First posted
Jan 20, 2011
Registry last updated
Aug 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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