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Effects of Citrulline on Gut Functioning During Excercise

NCT ID: NCT01239303

Last Updated: 2011-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gastrointestinal Hypoperfusion Gut Damage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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citrulline

Group Type ACTIVE_COMPARATOR

Citrulline

Intervention Type DIETARY_SUPPLEMENT

single dose

alanine

Group Type PLACEBO_COMPARATOR

alanine

Intervention Type DIETARY_SUPPLEMENT

single dose

Interventions

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Citrulline

single dose

Intervention Type DIETARY_SUPPLEMENT

alanine

single dose

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* male
* age 18-35 years

Exclusion Criteria

* not healthy
* use of medication or related products
* alcohol misuse
* smoking
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Top Institute Food and Nutrition

OTHER

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Kim van Wijck

MD, PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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MEC10-3-064

Identifier Type: -

Identifier Source: org_study_id