Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-02-24 @ 8:51 AM
Study NCT ID:
NCT02635594
Status:
COMPLETED
Last Update Posted:
2016-09-07
First Post:
2015-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Carnipure® Tartrate on Postprandial Endothelial Function and Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002331', 'term': 'Carnitine'}], 'ancestors': [{'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-06', 'studyFirstSubmitDate': '2015-12-10', 'studyFirstSubmitQcDate': '2015-12-16', 'lastUpdatePostDateStruct': {'date': '2016-09-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'after 4 weeks supplementation', 'description': 'Adverse events assessed after 4 weeks supplementation with verum and placebo'}, {'measure': 'Blood routine parameters', 'timeFrame': 'at screening and after 4 weeks supplementation', 'description': 'Blood routine parameters (differentiated haemogram; blood lipids; glucose; kreatinin) as safety parameters assessed at screening and after 4 weeks supplementation with verum and placebo'}, {'measure': 'Tolerability (questionnaire)', 'timeFrame': 'after 4 weeks supplementation', 'description': 'Tolerability assessed after 4 weeks supplementation with verum in comparison to placebo'}], 'primaryOutcomes': [{'measure': 'postprandial endothelial function', 'timeFrame': 'after 4 weeks supplementation', 'description': 'postprandial endothelial function assessed after 4 weeks supplementation with verum in comparison to placebo'}], 'secondaryOutcomes': [{'measure': 'Maximal strength (Nm) before and after exhaustive exercise', 'timeFrame': 'immediately before, 0h, 2h, 24h, 48h,', 'description': 'Maxiaml strength assessed after 4 weeks supplementation with verum in comparison to placebo at different time points, each (pre exhaustive exercise, immediately after, 2h, 24h and 48h after)'}, {'measure': 'pain before and after exhaustive exercise (VAS)', 'timeFrame': 'immediately before, 0h, 2h, 24h, 48h,', 'description': 'Pain assessed after 4 weeks supplementation with verum in comparison to placebo at different time points, each (pre exhaustive exercise, immediately after, 2h, 24h and 48h after)'}, {'measure': 'Creatin Kinase (CK) before and after exhaustive exercise', 'timeFrame': 'immediately before, 0h, 2h, 24h, 48h,', 'description': 'Assessement of CK after 4 weeks supplementation with verum in comparison to placebo at different time points, each (pre exhaustive exercise, immediately after, 2h, 24h and 48h after)'}, {'measure': 'Myoglobine (Mb) before and after exhaustive exercise', 'timeFrame': 'immediately before, 0h, 2h, 24h, 48h,', 'description': 'Assessement of Mb after 4 weeks supplementation with verum in comparison to placebo at different time points, each (pre exhaustive exercise, immediately after, 2h, 24h and 48h after)'}, {'measure': 'Biomarker for vascular health', 'timeFrame': 'after 4 weeks supplementation', 'description': 'Biomarker for vascular health assessed after 4 weeks supplementation with verum in comparison to placebo'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers', 'Recovery', 'Endothelial Function']}, 'descriptionModule': {'briefSummary': 'Investigation of 4 weeks supplementation with Carnipure® tartrate on endothelial function and parameters of recovery after physical exertion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men and women between 25 and 45 years\n* Body mass index (BMI) between 20 and 30 kg/m²\n* Non-smoker\n* Physically active 1-2 times per week\n\nExclusion Criteria:\n\n1. Competitive athlete or performance of high intensity training\n2. Vegan\n3. Nutrition with high portion of meat (\\> 3 times meat per week).\n4. Injury at the finger\n5. History or presence of significant cardiovascular disease or co-morbidities (i.e., diabetes, etc.)\n6. Known allergy to ingredients of study preparation\n7. Disturbed absorption due to changes in the gastrointestinal tract (e.g., resections, diverticula, blind-loop syndrome)\n8. Hypo/ hypertension or taking anti hypo/ hypertension medication\n9. Untreated thyroid dysfunction\n10. Atherosclerosis or other relevant musculoskeletal diseases/ injuries\n11. Anemia (women: Hb \\<11 g/ dl; men: 12.5 g/ dl)\n12. Eating disorder\n13. Present or recent use of drugs and dietary supplements that affect the endothelial function, re-covery or lipid status 2 months before or during the study (e.g. L-Carnitine, Arginine, omega3 FA, polyphenol rich supplements (e.g. OPC, cacao, etc) antihypertensive drugs, anti hyperlipidemic drugs, regular intake of protein-shakes etc.)\n14. Subjects not willing to abstain from intake of analgesic medication 24 hours prior to and during visit 1b and 3b.\n15. Female patients that are pregnant or nursing\n16. Night shift worker\n17. Donation of blood or similar blood loss within the previous 30 days before screening;\n18. Participation in a clinical trial with an investigational product within 30 days before screening\n19. Known alcohol abuse or drug abuse\n20. Known infection of human immunodeficiency virus (HIV) or hepatitis B or C\n21. Known lactose intolerance, dairy protein allergy or allergy to nuts'}, 'identificationModule': {'nctId': 'NCT02635594', 'briefTitle': 'Effects of Carnipure® Tartrate on Postprandial Endothelial Function and Recovery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lonza Ltd.'}, 'officialTitle': 'Effects of Carnipure® Tartrate on Postprandial Endothelial Function and Recovery From Physical Exertion in Healthy People - a Randomized, Double-blind, Placebo-controlled, Two-way Cross-over Study', 'orgStudyIdInfo': {'id': 'BTS884/15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Carnipure® tartrate', 'description': '1000mg of L-Carnitine provided as 1475mg Carnipure® tartrate', 'interventionNames': ['Dietary Supplement: L-Carnitine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '1000mg cellulose + 475mg L-tartaric acid', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'L-Carnitine', 'type': 'DIETARY_SUPPLEMENT', 'description': '1000mg of L-Carnitine provided as 1475mg Carnipure® tartrate', 'armGroupLabels': ['Carnipure® tartrate']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '1000mg cellulose + 475mg L-tartaric acid', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73728', 'city': 'Esslingen am Neckar', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'BioTeSys GmbH', 'geoPoint': {'lat': 48.73961, 'lon': 9.30473}}], 'overallOfficials': [{'name': 'Daniel Menzel, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BioTeSys GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lonza Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}