Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-01-11 @ 7:01 PM
Study NCT ID:
NCT03136133
Status:
UNKNOWN
Last Update Posted:
2017-09-15
First Post:
2017-04-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protein Supplements to Cyclists
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Protein drink With matching placebo'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Crossover, placebo controlled'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-14', 'studyFirstSubmitDate': '2017-04-27', 'studyFirstSubmitQcDate': '2017-04-27', 'lastUpdatePostDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in blood glucose compared to placebo', 'timeFrame': 'Change from baseline to every 30 minutes after dosing, for 2 hours'}], 'secondaryOutcomes': [{'measure': 'Change in insulin-like peptide 5 compared to placebo', 'timeFrame': 'Change from baseline to every 30 minutes after dosing, for 2 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Reconstitution After Bicycle Intervention']}, 'referencesModule': {'references': [{'pmid': '31665070', 'type': 'DERIVED', 'citation': 'Mjos I, Thorsen E, Hausken T, Lied E, Nilsen RM, Bronstad I, Edvardsen E, Frisk B. The effect of low dose marine protein hydrolysates on short-term recovery after high intensity performance cycling: a double-blinded crossover study. J Int Soc Sports Nutr. 2019 Oct 29;16(1):48. doi: 10.1186/s12970-019-0318-3.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the effect of marine peptide combined with dietary protein on the capacity to recover after exhaustive endurance cycling as measured by exercise capacity and blood glucose homeostasis.', 'detailedDescription': 'The current study uses cyclists as test subjects since they represent a physical demanding sport requiring both high endurance capacity and muscle strength. In the recovery phase following exhaustive physical activity there is a need both for rebuilding the muscle energy stores, for muscle repair and for compensatory muscle cell development. Therefore, marine peptide combined with dietary protein will be given in order to examine the capacity to recover after exhaustive endurance cycling.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed Consent\n* The subject is a man between 40-50 years\n* The subject has a body mass index (BMI) between 19-29\n* Willing to comply with all study procedures and be available for the length of the study\n* In good general health as judged by the physician at the screening visit\n\nExclusion Criteria:\n\n* The subject has had surgery or trauma with significant blood loss or has donated blood within the last 3 months prior to the screening visit\n* Diabetes type 1 or 2, or persistent high blood sugar levels\n* The subject has tested positive for human immunodeficiency virus (HIV)\n* Hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV)\n* The subject has taken any investigational drugs within 1 month prior to screening\n* Treated with antibiotics within 3 months prior to screening (oral, parenteral or rectal), but not spray or ointment\n* Treated with steroids within 1 month prior to screening (including oral treatment)\n* Treated with medication that effects the intestinal function such as, H2- protonpump inhibitors, diuretics, antiemetics, antidepressants, antacids,'}, 'identificationModule': {'nctId': 'NCT03136133', 'briefTitle': 'Protein Supplements to Cyclists', 'organization': {'class': 'OTHER', 'fullName': 'Haukeland University Hospital'}, 'officialTitle': 'Effekt of Marine Peptide Supplementation on Recovery Following Endurance Cycling', 'orgStudyIdInfo': {'id': '2017/56'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active protein drink', 'description': 'Active protein drink', 'interventionNames': ['Dietary Supplement: Active protein drink']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo drink', 'description': 'Placebo drink', 'interventionNames': ['Dietary Supplement: Active protein drink']}], 'interventions': [{'name': 'Active protein drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Fish protein from cod to be used for man after Heavy excercise to restitute', 'armGroupLabels': ['Active protein drink', 'Placebo drink']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5021', 'city': 'Bergen', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Trygve Hausken, MD', 'role': 'CONTACT'}], 'facility': 'Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'centralContacts': [{'name': 'Trygve Hausken, MD', 'role': 'CONTACT', 'email': 'trygve.hausken@helse-bergen.no', 'phone': '+4755972134'}, {'name': 'Bente Frisk', 'role': 'CONTACT', 'email': 'bente.frisk@helse-bergen.no', 'phone': '+4755970440'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Firmenich Bjørge Biomarine As', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}