Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
Study NCT ID:
NCT03432104
Status:
COMPLETED
Last Update Posted:
2018-03-13
First Post:
2018-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Bioavailability of Phenolic Compounds From Oxxynea®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C521846', 'term': 'Oxxynea'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-12', 'studyFirstSubmitDate': '2018-02-07', 'studyFirstSubmitQcDate': '2018-02-07', 'lastUpdatePostDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in plasma concentration of phenolic metabolites after acute ingestion of the supplement/placebo', 'timeFrame': '0h, 0.5h, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 24h post-ingestion', 'description': 'Plasma samples will be collected in EDTA tubes in baseline before supplement/placebo intake (0h) and up to 24h according to the time frame. Plasma metabolites will be identified and quantified by HPLC-MS.'}], 'secondaryOutcomes': [{'measure': 'Change in urine phenolic metabolites excretion after acute ingestion of the supplement/placebo', 'timeFrame': 'Baseline (12h pre-ingestion), 0-3h, 3-6h, 6-10h, 10-14h, 14-24h, 24-32h, 32-48h post-ingestion', 'description': 'Urine samples will be collected in baseline (12h pre-ingestion) and up to 48h according to the time frame. Urine metabolites will be identified and quantified by HPLC-MS.'}, {'measure': 'Change in total circulating antioxidant defences after acute ingestion of the supplement/placebo', 'timeFrame': '0h, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 24h post-ingestion', 'description': 'Red blood cell (RBCs) samples will be collected in EDTA tubes in baseline before supplement/placebo intake (0h), 1h post-ingestion and following a cafeteria-type breakfast, and up to 24h according to the time frame.\n\nRBCs will be submitted to the KRL (Kit Radicaux Libres) test which consists in inducing a free-radical attack to RBCs and to follow hemolysis. Results will be expressed as the time required to reach 50% of maximal hemolysis.'}, {'measure': 'Change in post-prandial glycemia', 'timeFrame': '0h, 1h, 2h, 3h, 4h, 5h, 6h post-ingestion', 'description': 'Glycemia will be measured in a fasted state in baseline before supplement/placebo intake (0h), 1h post-ingestion and following a cafeteria-type breakfast, and up to 6h according to the time frame.'}, {'measure': 'Change in post-prandial insulinemia', 'timeFrame': '0h, 1h, 2h, 3h, 4h, 5h, 6h post-ingestion', 'description': 'Insulinemia will be measured in a fasted state in baseline before supplement/placebo intake (0h), 1h post-ingestion and following a cafeteria-type breakfast, and up to 6h according to the time frame.'}, {'measure': 'Change in sleepiness during the day', 'timeFrame': '0h, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h post-ingestion', 'description': 'Change in sleepiness will be assessed using the Stanford Sleepiness Scale (SSS), a 7-point self-rating scale. The scale is used to track overall alertness during the day. At each point of the time frame, volunteers will be asked to rate their feelings of sleepiness from 1 to 7 according to the following descriptors:\n\n1. Feeling active, vital, alert, or wide awake\n2. Functioning at high levels, but not at peak; able to concentrate\n3. Awake, but relaxed; responsive but not fully alert\n4. Somewhat foggy, let down\n5. Foggy; losing interest in remaining awake; slowed down\n6. Sleepy, woozy, fighting sleep; prefer to lie down\n7. No longer fighting sleep, sleep onset soon; having dream-like thoughts'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dietary Modification']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate bioavailability and pharmacokinetics of phenolic compounds from Oxxynea®, a blend of fruit and vegetable extracts, in healthy volunteers, during a randomized, double-blind and cross-over trial. After a single dose supplementation, both metabolic profile and urinary excretion will be determined over a 48h-period by means of High-Performance Liquid Chromatography coupled with a tandem mass spectrometry (HPLC-MS) to identify and quantify phenolic metabolites. In parallel, post-prandial potential anti-oxidative and anti-glycemic properties of Oxxynea® will be determined in blood, following consumption of a cafeteria-type breakfast.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* In good general health\n* Agreement to adhere to diet considerations\n\nExclusion Criteria:\n\n* Smoking\n* Pregnancy / Lactation\n* Current use of any medication or food supplement\n* Known allergic reaction to components of the supplement/placebo'}, 'identificationModule': {'nctId': 'NCT03432104', 'briefTitle': 'Evaluation of Bioavailability of Phenolic Compounds From Oxxynea®', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fytexia'}, 'officialTitle': 'Evaluation of Absorption and Metabolism of Phenolic Compounds From Oxxynea®, a Blend of Fruit and Vegetable Extracts, in Human Healthy Volunteers: a Randomized, Double-blind, Cross-over Trial', 'orgStudyIdInfo': {'id': 'OXCT2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Verum', 'description': 'This arm receives 1 x 450 mg-capsule of Oxxynea®, a blend of polyphenol-rich fruit and vegetable extracts', 'interventionNames': ['Dietary Supplement: Oxxynea®', 'Dietary Supplement: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'This arms receives 1 x 450 mg-capsule of Placebo, containing maltodextrin only', 'interventionNames': ['Dietary Supplement: Oxxynea®', 'Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Oxxynea®', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oxxynea® is a blend of polyphenol-rich extracts from olive, grape, pomegranate, green tea, grapefruit, orange and blueberry. Dosage is 1 x 450 mg-capsule.', 'armGroupLabels': ['Placebo', 'Verum']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo product is 100% maltodextrin. Dosage is 1 x 450 mg-capsule of identical appearance than the verum capsule.', 'armGroupLabels': ['Placebo', 'Verum']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Murcia', 'country': 'Spain', 'facility': 'UCAM (Universidad Catolica San Antonio de Murcia)', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}], 'overallOfficials': [{'name': 'Pedro E Alcaraz Ramon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCAM (Universidad Catolica San Antonio de Murcia)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fytexia', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}