Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2026-03-10 @ 1:09 AM
Study NCT ID:
NCT02767102
Status:
COMPLETED
Last Update Posted:
2016-05-10
First Post:
2016-04-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability and Bioactivity of Red Wine Melatonin in Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008550', 'term': 'Melatonin'}], 'ancestors': [{'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, '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': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-05', 'studyFirstSubmitDate': '2016-04-30', 'studyFirstSubmitQcDate': '2016-05-05', 'lastUpdatePostDateStruct': {'date': '2016-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse effects', 'timeFrame': 'Acute side effects during the trial recorded at each experimental day each experimental day, up to 1 day after', 'description': 'Questionnaire'}], 'primaryOutcomes': [{'measure': 'Serum and salivary melatonin after red wine intake (with or without MLT)', 'timeFrame': 'Time-course of the serum melatonin levels in healthy volunteer from 0 min to 90 min after administration of red wine. Time-course of the salivary melatonin levels in healthy volunteer from 0 min to 120 min after administration of red wine.', 'description': 'LC-MS analyses for serum and ELISA analyses for saliva'}], 'secondaryOutcomes': [{'measure': 'Antioxidant power of saliva and serum after red wine intake (with or without MLT)', 'timeFrame': 'Time-course of the serum antioxidant power in healthy volunteer from 0 min to 90 min after administration of red wine. Time-course of the salivary antioxidant power in healthy volunteer from 0 min to 120 min after administration of red wine.', 'description': 'FRAP analyses'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mediterranean diet', 'indoleamine', 'nutraceuticals', 'nutrition', 'oxidative stress'], 'conditions': ['Bioavailability']}, 'descriptionModule': {'briefSummary': 'Melatonin (MLT) is a bioactive compound in red wine. The investigators will investigate the serum and salivary concentrations and antioxidant power of MLT after the intake of a glass of red wine. Twelve healthy volunteers were recruited to receive both 125 mL of red wine rich in MLT (10 ng mL-1) and without MLT (placebo), via a randomized, cross-over, and double-blind design. Serum and salivary MLT will be measured by liquid chromatography coupled to mass spectrometry (LC-MS) and enzyme-linked immunosorbent (ELISA), respectively. The ferric ion reducing antioxidant power (FRAP) will be analyzed.', 'detailedDescription': 'Melatonin (MLT) is a bioactive compound in red wine. No information is currently available on serum and salivary concentrations of MLT after drinking a glass of red wine, containing this indoleamine. Hence, in this study, the investigators will investigate the levels of MLT, in serum and saliva, soon after the intake of the MLT-rich red wine, and, correspondingly, they will verify the antioxidant power of the same biological fluids.\n\nThis will be a randomized, crossover, double-blind, placebo-controlled study with two treatment arms. Twelve healthy volunteers will be recruited to receive both 125 mL of red wine rich in MLT (10 ng mL-1) and without MLT (placebo), via a randomized, cross-over, and double-blind design.\n\nSerum and salivary MLT will be measured by liquid chromatography coupled to mass spectrometry (LC-MS) and enzyme-linked immunosorbent (ELISA), respectively. The ferric ion reducing antioxidant power (FRAP) will be also analyzed.\n\nFor serum analyses, samples will be collected at 0, 30, 60 and 90 min. For saliva analyses, samples will be collected at 0, 45 and 120 min.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* to be healthy\n* to have normal weight (BMI 18.5-25.0)\n* to voluntarily accept to participate to the study.\n\nExclusion Criteria:\n\n* pregnancy and lactation for women;\n* supplementation with MLT and/or any other dietary supplement (vitamins, antioxidants, botanicals, phytochemicals)\n* systemic and chronic-degenerative diseases\n* abnormal hematological parameters\n* heavy smoking and alcohol drinking\n* high-intensity physical activity\n* under pharmacological treatment'}, 'identificationModule': {'nctId': 'NCT02767102', 'acronym': 'Wine-MLT', 'briefTitle': 'Bioavailability and Bioactivity of Red Wine Melatonin in Humans', 'organization': {'class': 'OTHER', 'fullName': 'University of Milan'}, 'officialTitle': 'Serum and Salivary Melatonin Levels and Antioxidant Power of Melatonin-rich Red Wine', 'orgStudyIdInfo': {'id': 'Red Wine Melatonin'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Red wine with Melatonin', 'description': 'Rosso di Marco is a wine without MLT (previous screening). This wine will be enriched with 10 ng mL-1 MLT (MLT+) and used as experimental wine.', 'interventionNames': ['Other: Red wine with melatonin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Red wine without Melatonin', 'description': 'Rosso di Marco is a wine without MLT (previous screening). This wine will be used as placebo treatment (PLC).', 'interventionNames': ['Other: Red wine without melatonin']}], 'interventions': [{'name': 'Red wine with melatonin', 'type': 'OTHER', 'description': 'Twelve healthy volunteers will be recruited to receive both 125 mL of red wine rich in MLT (10 ng mL-1)', 'armGroupLabels': ['Red wine with Melatonin']}, {'name': 'Red wine without melatonin', 'type': 'OTHER', 'description': 'Twelve healthy volunteers will be recruited to receive both 125 mL of red wine without MLT', 'armGroupLabels': ['Red wine without Melatonin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20142', 'city': 'Milan', 'state': 'Italy', 'country': 'Italy', 'facility': 'University of Milan', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Milan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'ANDREA SARDELLA', 'investigatorAffiliation': 'University of Milan'}}}}