Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-03-04 @ 6:58 AM
Study NCT ID:
NCT02908828
Status:
COMPLETED
Last Update Posted:
2020-09-30
First Post:
2016-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Calanus Oil Supplementation and Maximal Oxygen Uptake
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-29', 'studyFirstSubmitDate': '2016-09-14', 'studyFirstSubmitQcDate': '2016-09-17', 'lastUpdatePostDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'maximal oxygen uptake (VO2max)', 'timeFrame': '6 months', 'description': 'Measured with indirect calorimetry at a treadmill (running/walking) with gradually increasing work load until exhaustion. After 10-15 min with warmup at 70% of maximal heart rate, work load will be increased every 1-2 minute and the changes maximal oxygen uptake (VO2) will be recorded automatically.'}], 'secondaryOutcomes': [{'measure': 'Body composition (InBody, Japan)', 'timeFrame': '6 months'}, {'measure': 'Self-reported physical activity', 'timeFrame': '6 months', 'description': 'assessed with International Physical Activity Questionnaire (IPAQ) short version'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Biological Products/therapeutic use', 'Copepoda', 'Dietary Supplements', 'Fish Oils', 'Fatty Acids, Omega-3', 'Oxygen Consumption', 'Calanus', 'Maximal oxygen uptake', 'Zooplankton'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Copepod oil is extracted from the marine copepod Calanus finmarchicus, the dominant plankton species in the marine food web in the Norwegian Sea. Copepods constitute the largest renewable and harvestable resource in the Norwegian Sea and adjacent waters, and it is now developed knowledge and technology for sustainable harvesting of this "new" resource. The purpose of this study is to investigate whether Calanus copepod oil supplementation has an equivalent effect on maximal oxygen uptake in humans to that seen in experimental studies in mice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* in good health\n* Body mass index (BMI) between 18,5 and 29,9\n\nExclusion Criteria:\n\n* Medical condition limiting VO2max (COPD or asthma).\n* diagnosed coronary artery disease\n* Any other significant medical condition\n* medication effecting exercise capacity (e.i. betablockers)\n* Pregnancy\n* Participation in other clinical trials\n* Shellfish allergies\n* Systolic blood pressure \\> 170 mmHG, or diastolic BP \\> 105 mmHG.\n* contraindications for maximal exercise testing'}, 'identificationModule': {'nctId': 'NCT02908828', 'briefTitle': 'Calanus Oil Supplementation and Maximal Oxygen Uptake', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Effect of Copepod Oil Supplementation (Calanus Finmarchicus) on Endurance and VO2max in Healthy Obese Subjects', 'orgStudyIdInfo': {'id': '2015/2303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Calanus oil', 'description': '4 capsules of 500 mg Calanus oil once every day', 'interventionNames': ['Dietary Supplement: Calanus oil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '4 capsules of 500 mg dietary oil once every day', 'interventionNames': ['Dietary Supplement: placebo dietary oil']}], 'interventions': [{'name': 'Calanus oil', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Calanus oil']}, {'name': 'placebo dietary oil', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tromsø', 'country': 'Norway', 'facility': 'Institutt for Medisinsk Biologi, UiT Norges arktiske universitet', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}, {'city': 'Trondheim', 'country': 'Norway', 'facility': 'KG Jebsen-senter for Hjertetrening, NTNU', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Ulrik Wisløff, phd prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Norwegian University of Science and Technology'}, {'name': 'Trine Karlsen, phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Tromso', 'class': 'OTHER'}, {'name': 'Calanus', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}