ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Citrulline on Gut Functioning During Excercise

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01239303
Recruitment Status : Unknown
Verified November 2011 by Kim van Wijck, Maastricht University Medical Center.
Recruitment status was:  Enrolling by invitation
First Posted : November 11, 2010
Last Update Posted : November 8, 2011
Sponsor:
Collaborator:
Top Institute Food and Nutrition
Information provided by (Responsible Party):
Kim van Wijck, Maastricht University Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Hypoperfusion Gut Damage Dietary Supplement: Citrulline Dietary Supplement: alanine Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Citrulline on Gut Functioning During Excercise
Study Start Date : December 2010
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Alanine
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: citrulline Dietary Supplement: Citrulline
single dose
Placebo Comparator: alanine Dietary Supplement: alanine
single dose



Primary Outcome Measures :
  1. GI perfusion [ Time Frame: 2 hours ]
  2. gut damage [ Time Frame: 5 hours ]
  3. microcirculation [ Time Frame: 5 hours ]

Secondary Outcome Measures :
  1. liver damage [ Time Frame: 5 hours ]
  2. kidney damage [ Time Frame: 5 hours ]
  3. amino acid analysis [ Time Frame: 5 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • male
  • age 18-35 years

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01239303


Locations
Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
Top Institute Food and Nutrition

Responsible Party: Kim van Wijck, MD, PhD student, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01239303     History of Changes
Other Study ID Numbers: MEC10-3-064
First Posted: November 11, 2010    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: November 2011