Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2025-12-26 @ 11:12 AM
Study NCT ID:
NCT05272228
Status:
COMPLETED
Last Update Posted:
2022-07-21
First Post:
2022-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Single-dose Bioavailability Clinical Study of Different Coenzyme Q10 Products
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-08-04', 'releaseDate': '2022-09-01'}], 'estimatedResultsFirstSubmitDate': '2022-09-01'}}, 'conditionBrowseModule': {'meshes': [{'id': 'C564403', 'term': 'Coenzyme Q10 Deficiency'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-18', 'studyFirstSubmitDate': '2022-02-28', 'studyFirstSubmitQcDate': '2022-02-28', 'lastUpdatePostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum coenzyme Q10 concentrations', 'timeFrame': '0,2,4,6,8,12 and 24 hours after ingestion', 'description': 'Serum coenzyme Q10 concentrations will me measured in all three different coenzyme Q10 products with ELISA kit for coenzyme Q10'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['coenzyme Q10', 'single dose bioavailability'], 'conditions': ['Coenzyme Q Deficiency']}, 'descriptionModule': {'briefSummary': 'The randomized, open-label, three period crossover single-dose bioavailability study with three coenzyme Q10 products', 'detailedDescription': 'The randomized, open-label, three period crossover single-dose bioavailability study with three coenzyme Q10 products will include 25 subjects who will test three different coenzyme Q10 products. Serum concentration of coenzyme Q10 will be measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subject informed consent form\n* aged between 40 and 55 years old\n* body mass for women 65± 5 kg and for men 85± 5 kg\n* non-smoking\n* healthy, without cardio-vascular diseases, diabetes, neurodegenerative diseases\n* absence of any prescribed medication during the study\n* willing to avoid a consumption of any food supplements at least 2 weeks before and during the study\n* willing to study all study procedures\n\nExclusion Criteria:\n\n* cardio-vascular diseases,\n* diabetes,\n* neurodegenerative diseases,\n* gastrointestinal disorders\n* hypotension\n* pregnancy\n* breast-feeding\n* intake of any prescribed medication within two week of the beginning of the study\n* intake of any food supplements within two week of the beginning of the study\n* drug or alcohol abuse'}, 'identificationModule': {'nctId': 'NCT05272228', 'briefTitle': 'Comparative Single-dose Bioavailability Clinical Study of Different Coenzyme Q10 Products', 'organization': {'class': 'OTHER', 'fullName': 'University of Primorska'}, 'officialTitle': 'The Single-centre, Randomized, Comparative Single-dose Bioavailability Clinical Study of Different Coenzyme Q10 Products', 'orgStudyIdInfo': {'id': 'CoenzymeQ10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Coenzyme Q10 (ubiquinone)', 'description': 'Synonyms: Co-Q10; Ubiquinone; Ubidecarenone; 2,5-Cyclohexadiene-1,4-dione, 2- \\[(2E,6E,10E,14E,18E,22E,26E,30E,34E)-3,7,11,15,19,23,27,31,35,39-decamethyl-,6,10,14,18,22,26,30,34,38- tetracontadecaenyl\\]-5,6-dimethoxy-3-methyl CAS number: 303-98-0 Molecular formula: C59H90O4 USP standard Content: Co-Q10 (ubiquinone), bulking agent (maltodextrin), capsule (HPCM- hydroxypropyl methyl cellulose), anti-adherents (magnesium stearate and anhydrous silica) Dosage: 2 capsules, total 100 mg Co-Q10', 'interventionNames': ['Dietary Supplement: Dietary supplement - standard product']}, {'type': 'EXPERIMENTAL', 'label': 'Q10 MICROENCAPSULATED', 'description': "IP1:Q10 MICROENCAPSULATED. ENG: Ingredient BMT® Coenzyme Q10 Content Co-Q10 (ubiquinone), stabiliser (gum arabic), bulking agent (maltodextrin), capsule (HPCM- hydroxypropyl methyl cellulose), olive oil, corn starch, anti-adherents (magnesium stearate and anhydrous silica), acidity regulator (citric acid, acetic acid) HPMC capsules, size '0', 50 mg/capsule Dosage: 2 capsule, total 100 mg Co-Q10", 'interventionNames': ['Dietary Supplement: Dietary supplement - Investigational product IP1']}, {'type': 'EXPERIMENTAL', 'label': 'Final formulated product BQSM®', 'description': "IP2: Final formulated product BQSM® Ingredients: Rosehip (Rosa canina) fruit extract standardised to min. 70 % of vitamin C (L-ascorbic acid), capsule (HPCM- hydroxypropyl methyl cellulose), BMT® Coenzyme Q10 (ubiquinone), vitamin E (D-alfa tocopheryl acetate), vitamin A (retinyl acetate), L-selenomethionine, bulking agent (maltodextrin), stabiliser (gum arabic), olive oil, corn starch, anti-adherents (magnesium stearate and anhydrous silica), acidity regulator (citric acid, acetic acid) HPMC capsule, size '0', 50 mg/capsule Dosage: 2 capsule, total 100 mg Co-Q10", 'interventionNames': ['Dietary Supplement: Dietary supplement - Investigational product IP2']}], 'interventions': [{'name': 'Dietary supplement - standard product', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Single dose intervention with Standard product Coenzyme Q10 (ubiquinone) 2 capsules - 100 mg total coenzyme Q10', 'armGroupLabels': ['Coenzyme Q10 (ubiquinone)']}, {'name': 'Dietary supplement - Investigational product IP1', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Single dose intervention with Investigational product IP1; Q10 MICROENCAPSULATED 2 capsules - 100 mg total coenzyme Q10', 'armGroupLabels': ['Q10 MICROENCAPSULATED']}, {'name': 'Dietary supplement - Investigational product IP2', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Single dose intervention with Investigational product IP2; Final formulated product BQSM® 2 capsules - 100 mg total coenzyme Q10', 'armGroupLabels': ['Final formulated product BQSM®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6310', 'city': 'Izola', 'country': 'Slovenia', 'facility': 'University of Primorska', 'geoPoint': {'lat': 45.53661, 'lon': 13.66015}}], 'overallOfficials': [{'name': 'Zala Jenko-Pražnikar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Primorska, Faculty of Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Primorska', 'class': 'OTHER'}, 'collaborators': [{'name': 'Biovis d.o.o.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, PhD', 'investigatorFullName': 'Zala Jenko Praznikar', 'investigatorAffiliation': 'University of Primorska'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-09-01', 'type': 'RELEASE'}, {'date': '2023-08-04', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Zala Jenko Praznikar, Associate Professor, PhD, University of Primorska'}}}}