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Effects of Citrulline on Gut Functioning During Excercise

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Top Institute Food and Nutrition
Information provided by (Responsible Party):
Kim van Wijck, Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01239303
First received: November 10, 2010
Last updated: November 7, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention
Gastrointestinal
Hypoperfusion
Gut Damage
 Dietary Supplement: Citrulline
Dietary Supplement: alanine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Citrulline on Gut Functioning During Excercise

Resource links provided by NLM:

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

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • GI perfusion [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • gut damage [ Time Frame: 5 hours ] [ Designated as safety issue: No ]
  • microcirculation [ Time Frame: 5 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • liver damage [ Time Frame: 5 hours ] [ Designated as safety issue: No ]
  • kidney damage [ Time Frame: 5 hours ] [ Designated as safety issue: No ]
  • amino acid analysis [ Time Frame: 5 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: December 2010
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: citrulline Dietary Supplement: Citrulline
single dose
Placebo Comparator: alanine Dietary Supplement: alanine
single dose

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01239303

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

No publications provided

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
Study First Received: November 10, 2010
Last Updated: November 7, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

ClinicalTrials.gov processed this record on May 22, 2013