Effects of Citrulline on Gut Functioning During Excercise

Hypoperfusion Clinical Trial

Official title:

Effects of Citrulline on Gut Functioning During Excercise

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01239303
• Other study ID #: MEC10-3-064
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 10, 2010
• Last updated: November 7, 2011
• Start date: December 2010
• Est. completion date: February 2012

Study information

• Verified date: November 2011
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: February 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• male

• age 18-35 years

Exclusion Criteria:

• not healthy

• use of medication or related products

• alcohol misuse

• smoking

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gastrointestinal
• Gut Damage
• Hypoperfusion

Intervention

Dietary Supplement:
• Citrulline
single dose
• alanine
single dose

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Top Institute Food and Nutrition

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GI perfusion		2 hours	No
Primary	gut damage		5 hours	No
Primary	microcirculation		5 hours	No
Secondary	liver damage		5 hours	No
Secondary	kidney damage		5 hours	No
Secondary	amino acid analysis		5 hours	No