Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-27 @ 3:54 PM
Study NCT ID:
NCT01239303
Status:
UNKNOWN
Last Update Posted:
2011-11-08
First Post:
2010-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Citrulline on Gut Functioning During Excercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002956', 'term': 'Citrulline'}, {'id': 'D000409', 'term': 'Alanine'}], 'ancestors': [{'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2012-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-11-07', 'studyFirstSubmitDate': '2010-11-10', 'studyFirstSubmitQcDate': '2010-11-10', 'lastUpdatePostDateStruct': {'date': '2011-11-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GI perfusion', 'timeFrame': '2 hours'}, {'measure': 'gut damage', 'timeFrame': '5 hours'}, {'measure': 'microcirculation', 'timeFrame': '5 hours'}], 'secondaryOutcomes': [{'measure': 'liver damage', 'timeFrame': '5 hours'}, {'measure': 'kidney damage', 'timeFrame': '5 hours'}, {'measure': 'amino acid analysis', 'timeFrame': '5 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Gastrointestinal', 'Hypoperfusion', 'Gut Damage']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nDuring 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male\n* age 18-35 years\n\nExclusion Criteria:\n\n* not healthy\n* use of medication or related products\n* alcohol misuse\n* smoking'}, 'identificationModule': {'nctId': 'NCT01239303', 'briefTitle': 'Effects of Citrulline on Gut Functioning During Excercise', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Effects of Citrulline on Gut Functioning During Excercise', 'orgStudyIdInfo': {'id': 'MEC10-3-064'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'citrulline', 'interventionNames': ['Dietary Supplement: Citrulline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'alanine', 'interventionNames': ['Dietary Supplement: alanine']}], 'interventions': [{'name': 'Citrulline', 'type': 'DIETARY_SUPPLEMENT', 'description': 'single dose', 'armGroupLabels': ['citrulline']}, {'name': 'alanine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'single dose', 'armGroupLabels': ['alanine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6202 AZ', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Center', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Top Institute Food and Nutrition', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD student', 'investigatorFullName': 'Kim van Wijck', 'investigatorAffiliation': 'Maastricht University Medical Center'}}}}