NCT01239303

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2010

Completed
20 days until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

November 8, 2011

Status Verified

November 1, 2011

Enrollment Period

1.1 years

First QC Date

November 10, 2010

Last Update Submit

November 7, 2011

Conditions

GastrointestinalHypoperfusionGut Damage

Outcome Measures

Primary Outcomes (3)

  • GI perfusion

    2 hours

  • gut damage

    5 hours

  • microcirculation

    5 hours

Secondary Outcomes (3)

  • liver damage

    5 hours

  • kidney damage

    5 hours

  • amino acid analysis

    5 hours

Study Arms (2)

citrulline

ACTIVE COMPARATOR
Dietary Supplement: Citrulline

alanine

PLACEBO COMPARATOR
Dietary Supplement: alanine

Interventions

CitrullineDIETARY_SUPPLEMENT

single dose

citrulline
alanineDIETARY_SUPPLEMENT

single dose

alanine

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male
  • age 18-35 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6202 AZ, Netherlands

Location

MeSH Terms

Interventions

CitrullineAlanine

Intervention Hierarchy (Ancestors)

Amino Acids, DiaminoAmino AcidsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD student

Study Record Dates

First Submitted

November 10, 2010

First Posted

November 11, 2010

Study Start

December 1, 2010

Primary Completion

January 1, 2012

Study Completion

February 1, 2012

Last Updated

November 8, 2011

Record last verified: 2011-11

Locations

NL(1)