Effects of Citrulline on Gut Functioning During Excercise

November 7, 2011 updated by: Kim van Wijck, Maastricht University Medical Center
During exercise, splanchnic perfusion is compromised, resulting in organ damage in healthy individuals. Improving the availability of NO might result increase splanchnic perfusion and prevent organ damage during exercise.

Study Overview

Detailed Description

The gastrointestinal (GI) tract plays an important role in the human body. The wall of the GI system regulates digestion and absorption of nutrients and it also has a very important function as a barrier between internal and external environment. The penetration of harmful substances and microbiota of the GI lumen (external environment) to the systemic circulation (internal environment) depends on this barrier. Previous studies have shown that exercise in healthy subjects provides hypoperfusion of the splanchnic area, resulting in intestinal damage, increased small intestinal permeability and liver damage. Similar splanchnic hypoperfusion occurs in patients with compromised circulation.

During episodes of splanchnic hypoperfusion, the de novo synthesis of nitric oxide (nitric oxide, NO) from arginine is compromised. This impaired NO synthesis may play a role in the development of organ dysfunction during exercise. L-citrulline administration, a precursor of arginine and NO, may result in improved NO availability and organ perfusion, thereby preventing organ damage.

Study Type

Interventional

Enrollment (Anticipated)

30

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

    • Limburg
      • Maastricht, Limburg, Netherlands, 6202 AZ
        • Maastricht University Medical Center

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 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • male
  • age 18-35 years

Exclusion Criteria:

  • not healthy
  • use of medication or related products
  • alcohol misuse
  • smoking

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: citrulline
single dose
Placebo Comparator: alanine
single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
GI perfusion
Time Frame: 2 hours
2 hours
gut damage
Time Frame: 5 hours
5 hours
microcirculation
Time Frame: 5 hours
5 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
liver damage
Time Frame: 5 hours
5 hours
kidney damage
Time Frame: 5 hours
5 hours
amino acid analysis
Time Frame: 5 hours
5 hours

Collaborators and Investigators

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

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

December 1, 2010

Primary Completion (Anticipated)

January 1, 2012

Study Completion (Anticipated)

February 1, 2012

Study Registration Dates

First Submitted

November 10, 2010

First Submitted That Met QC Criteria

November 10, 2010

First Posted (Estimate)

November 11, 2010

Study Record Updates

Last Update Posted (Estimate)

November 8, 2011

Last Update Submitted That Met QC Criteria

November 7, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • MEC10-3-064

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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