Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-26 @ 1:27 AM
Study NCT ID:
NCT04744233
Status:
COMPLETED
Last Update Posted:
2021-02-09
First Post:
2021-01-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioavailability of Carotenoids From Orange Juice in a Cross-over Study in Healthy Subjects.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Multiple dose cross-over study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2002-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-05', 'studyFirstSubmitDate': '2021-01-27', 'studyFirstSubmitQcDate': '2021-02-04', 'lastUpdatePostDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2002-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the effect of dairy intake of orange juice elaborated with four different procedures on the serum carotenoid concentrations of healthy adults.', 'timeFrame': '6 months', 'description': 'Assessment of the effect of dairy intake of orange juice elaborated with low temperature pasterurization (LP), high-pressure processing (HPP), pulsed electric fields (PEF) and freshly squeezd (FS) on the serum carotenoid concentrations of healthy adults.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Biological Availability', 'Carotenoids', 'Lutein', 'Humans']}, 'descriptionModule': {'briefSummary': 'Commercially available fruit juices are obtained after applying industrial technologies to preserve and extend the shelf-life by inactivation of microorganism and enzymes. These are traditional thermal treatment (eg. pasteurization, sterilization) that causes losses of nutritional and bioactive compounds, changes physicochemical properties (colour, flavor and texture) and can modify their bioavailabilities. Thus, the traditional thermal processing is being replaced by less intense thermal technologies (e.g. low-temperature pasteurization / refrigerated storage) and non-thermal treatments such as the high-pressure processing (HPP) and the pulsed electric fields (PEF) as an alternative to enhace food safety and shelf-life without compromising organoleptic qualities (retain the flavour, color healthiness of fresh foods) and keeping their health-promoting capacity. The beneficial health effect derived from the orange juice intake is partly related to the bioavailability of their bioactive compounds.\n\nThe aim of this study was to assess the effect of the intake of freshly squeezed orange juice (Citrus sinensis L.) and processed orange juice elaborated with different treatments (low pasteurization / refrigerated storage, high-pressure processing, pulsed electric fields) on the main serum carotenoid concentrations in a cross-over study in apparently healthy subjects using multiple dosis.', 'detailedDescription': 'Methods Twelve healthy subjects (6 men), age 20-32 y, were enrolled in a cross-over study, to consume 500 mL of orange juice/day during 14 days periods. All volunteers consumed the LP and HPP, six consumed PEF or FS-orange juice. Fasted blood was collected at baseline and on days 7 and 14. Carotenoid concentrations in serum and orange juice were analyzed by high performance liquid chromatogry (HPLC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '32 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age (20- 32 y)\n* body mass index (BMI)\n* serum cholesterol and triglycerides concentrations within the normal range\n* serum retinol within the range 31 - 70 µg/dL.\n\nExclusion Criteria:\n\n* vitamin / mineral supplements intake\n* regular medication\n* pregnancy or lactating\n* chronic disease\n* smoking habit.'}, 'identificationModule': {'nctId': 'NCT04744233', 'briefTitle': 'Bioavailability of Carotenoids From Orange Juice in a Cross-over Study in Healthy Subjects.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Instituto de Ciencia y Tecnología de Alimentos y Nutrición'}, 'officialTitle': 'Effect of Traditional and Emerging Conservation Technologies on Bioactive Compounds and Their Antioxidant Capacity in Plant Foods', 'orgStudyIdInfo': {'id': 'CAM-HUPH-IF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Freshly squeezed orange juice (FS)', 'description': 'Subjects were enrolled to consume 500 mL of orange juice/day during three consecutive 14 days periods separated by 1 - 1.5 month washouts. The orange juice assayed was freshly squeezed (FS). Six subjects consumed FS-orange juice.', 'interventionNames': ['Other: Orange juice']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Commercially available low pasteurized orange juice (LP)', 'description': 'Subjects were enrolled to consume 500 mL of orange juice/day during three consecutive 14 days periods separated by 1 - 1.5 month washouts. The orange juices assayed was commercially available low pasteurized juice (LP). All participants consumed the LP orange juices.', 'interventionNames': ['Other: Orange juice']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High-pressure processed orange juice(HPP)', 'description': 'Subjects were enrolled to consume 500 mL of orange juice/day during three consecutive 14 days periods separated by 1 - 1.5 month washouts. The orange juices assayed was high-pressure processed (HPP). All participants consumed the HPP orange juices.', 'interventionNames': ['Other: Orange juice']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pulsed electric fields treated orange juice (PEF)', 'description': 'Subjects were enrolled to consume 500 mL of orange juice/day during three consecutive 14 days periods separated by 1 - 1.5 month washouts. The orange juices assayed was those treated with pulsed electric fields (PEF). Six participants consumed the PEF-orange juice.', 'interventionNames': ['Other: Orange juice']}], 'interventions': [{'name': 'Orange juice', 'type': 'OTHER', 'description': 'Subjects were enrolled to consume 500 mL of orange juice/day during three consecutive 14 days periods separated by 1 - 1.5 month washouts. The orange juices assayed were: freshly squeezed (FS), commercially available low pasteurized juice (LP) and juices treated by high-pressure processing (HPP) and by pulsed electric fields (PEF). All participants consumed the LP and the HPP orange juices. Six subjects consumed PEF-orange juice and other six consumed the FS-orange juice.', 'armGroupLabels': ['Commercially available low pasteurized orange juice (LP)', 'Freshly squeezed orange juice (FS)', 'High-pressure processed orange juice(HPP)', 'Pulsed electric fields treated orange juice (PEF)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Begoña Olmedilla-Alonso', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Olmedilla-Alonso', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto de Ciencia y Tecnología de Alimentos y Nutrición'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Ciencia y Tecnología de Alimentos y Nutrición', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Comunidad de Madrid', 'class': 'OTHER'}, {'name': 'Instituto de Salud Carlos III', 'class': 'OTHER_GOV'}, {'name': 'Puerta de Hierro University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Scientist. Ph.D.', 'investigatorFullName': 'Begoña Olmedilla', 'investigatorAffiliation': 'Instituto de Ciencia y Tecnología de Alimentos y Nutrición'}}}}