Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-25 @ 2:13 PM
Study NCT ID:
NCT06736366
Status:
COMPLETED
Last Update Posted:
2025-12-05
First Post:
2024-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study With Two Coenzyme Q10 Products
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C564403', 'term': 'Coenzyme Q10 Deficiency'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2024-12-11', 'studyFirstSubmitQcDate': '2024-12-11', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma levels of Coenzyme Q10', 'timeFrame': 'At Baseline', 'description': 'Plasma levels of Coenzyme Q10 will be measured by high-performance liquid chromatography (HPLC) with electrochemical detection and a post-analytical reducing column, using a Nanospace HPLC apparatus.'}, {'measure': 'Plasma levels of Coenzyme Q10', 'timeFrame': 'Four hours after consumption', 'description': 'Plasma levels of Coenzyme Q10 will be measured by high-performance liquid chromatography (HPLC) with electrochemical detection and a post-analytical reducing column, using a Nanospace HPLC apparatus.'}, {'measure': 'Plasma levels of Coenzyme Q10', 'timeFrame': 'Six hours after consumption', 'description': 'Plasma levels of Coenzyme Q10 will be measured by high-performance liquid chromatography (HPLC) with electrochemical detection and a post-analytical reducing column, using a Nanospace HPLC apparatus.'}, {'measure': 'Plasma levels of Coenzyme Q10', 'timeFrame': 'Twelve hours after consumption', 'description': 'Plasma levels of Coenzyme Q10 will be measured by high-performance liquid chromatography (HPLC) with electrochemical detection and a post-analytical reducing column, using a Nanospace HPLC apparatus.'}, {'measure': 'Plasma levels of Coenzyme Q10', 'timeFrame': 'Twenty-four hours after consumption', 'description': 'Plasma levels of Coenzyme Q10 will be measured by high-performance liquid chromatography (HPLC) with electrochemical detection and a post-analytical reducing column, using a Nanospace HPLC apparatus.'}, {'measure': 'Plasma levels of Coenzyme Q10', 'timeFrame': 'Forthy-eight hours after consumption', 'description': 'Plasma levels of Coenzyme Q10 will be measured by high-performance liquid chromatography (HPLC) with electrochemical detection and a post-analytical reducing column, using a Nanospace HPLC apparatus.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['single dose bioavailability', 'Coenzyme Q10'], 'conditions': ['Coenzyme Q Deficiency']}, 'descriptionModule': {'briefSummary': 'The randomized, open-label, two period crossover single-dose bioavailability study with two coenzyme Q10 products', 'detailedDescription': 'The randomized, open-label, two period crossover single-dose bioavailability study with two coenzyme Q10 products will include 35 subjects who will test two different coenzyme Q10 products. Plasma concentration of coenzyme Q10 will be measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subject informed consent form\n* aged between 50 and 65 years old\n* body mass for women 70± 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\nExclusion Criteria:\n\n* cardio-vascular diseases, diabetes, neurodegenerative diseases, gastrointestinal disorders, pregnancy, breast-feeding\n* intake of any food supplements within two week of the beginning of the study\n* drug or alcohol abuse'}, 'identificationModule': {'nctId': 'NCT06736366', 'acronym': 'Co10_2024', 'briefTitle': 'Study With Two Coenzyme Q10 Products', 'organization': {'class': 'OTHER', 'fullName': 'University of Primorska'}, 'officialTitle': 'Comparative Single-dose Bioavailability Clinical Study of Two Different Coenzyme Q10 Products', 'orgStudyIdInfo': {'id': 'Q10_2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Coenzyme Q10 (ubiquinone)', 'description': 'Synonyms: Maltodextrin, capsule (HPMC - hydroxypropyl methyl cellulose), coenzyme Q10 (ubiquinone); Dosage: 2 capsules, total 100 mg Co-Q10', 'interventionNames': ['Dietary Supplement: Dietary supplement - Experimental product']}, {'type': 'EXPERIMENTAL', 'label': 'BMT® coenzyme Q10', 'description': 'Maltodextrin, BMT® coenzyme Q10 \\[maltodextrin, coenzyme Q10 (ubiquinone), stabiliser (gum arabic), corn starch, olive oil, anti-caking agent (silicon dioxide), acidity regulators (acetic acid, citric acid)\\], capsule (HPMC - hydroxypropyl methyl cellulose); Dosage: 2 capsules, total 100 mg Co-Q10', 'interventionNames': ['Dietary Supplement: Dietary supplement - Active comparator']}], 'interventions': [{'name': 'Dietary supplement - Active comparator', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Single dose intervention with Standard product Coenzyme Q10 (ubiquinone); 2 capsules - 100 mg total coenzyme Q10', 'armGroupLabels': ['BMT® coenzyme Q10']}, {'name': 'Dietary supplement - Experimental product', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Single dose intervention with Experimental product; BMT® coenzyme Q10; 2 capsules - 100 mg total coenzyme Q10', 'armGroupLabels': ['Coenzyme Q10 (ubiquinone)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6310', 'city': 'Izola', 'state': 'Izola', 'country': 'Slovenia', 'facility': 'University of Primorska, Faculty of Health Sciences', 'geoPoint': {'lat': 45.53661, 'lon': 13.66015}}], 'overallOfficials': [{'name': 'Ana Petelin, 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': 'Biostile d.o.o.', 'class': 'UNKNOWN'}, {'name': 'QFarm s.r.l.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, PhD', 'investigatorFullName': 'Zala Jenko Praznikar', 'investigatorAffiliation': 'University of Primorska'}}}}