Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-02-21 @ 4:09 AM
Study NCT ID:
NCT04149158
Status:
COMPLETED
Last Update Posted:
2019-11-04
First Post:
2019-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Sinetrol® Xpur in Fat Mass Reduction on Overweight and Obese Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-31', 'studyFirstSubmitDate': '2019-10-31', 'studyFirstSubmitQcDate': '2019-10-31', 'lastUpdatePostDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in total body fat percentage loss versus bodyweight', 'timeFrame': 'week1; week16; week20'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Change in Total Body Fat Mass Percentage Loss Versus Body Weight']}, 'referencesModule': {'references': [{'pmid': '41399165', 'type': 'DERIVED', 'citation': 'Muralidharan J, Romain C, Martinez-Noguera FJ, Marin-Cascales E, Chung L, Alcaraz P, Cases J. A 16-week supplementation with a polyphenol-rich supplement, Sinetrol(R) Xpur, aids in fat loss of overweight and obese volunteers: a randomised, double-blind, parallel trial. Int J Food Sci Nutr. 2025 Dec 15:1-8. doi: 10.1080/09637486.2025.2589845. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate effects of a 16-week supplementation with a polyphenol rich extract, Sinetrol® Xpur, on fat mass accumulation and body weight management improvement.Subjects were overweight or obese and received polyphenol supplement or placebo. A 4-week follow-up as performed to evaluate its effect after supplementation stop.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'genderBased': True, 'genderDescription': 'stratification of sex (40%minimum and 60% maximum of each sex)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* overweight or obese (25 kg.m-2\\<BMI\\<42.5kg.m-2)\n* healthy\n\nExclusion Criteria:\n\n* metabolic or chronical disease with treatments (i.e.: diabetes, dyslipidemia, thyroiditis, inflammatory disease, immunological disease, infectious disease, asthma, anxiety and depression)\n* food allergy to the ingredients of the product (grapefruit, orange, caffeine, guarana)\n* involved in the prior 6 months in a chronic treatment program, eating disorders history, subjected to weight reduction by surgery\n* start or quit smoking, high alcohol consumption\n* pregnant, breastfeeding, wanting to have a baby,\n* menopausal women'}, 'identificationModule': {'nctId': 'NCT04149158', 'briefTitle': 'Evaluation of Sinetrol® Xpur in Fat Mass Reduction on Overweight and Obese Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fytexia'}, 'orgStudyIdInfo': {'id': 'SNTCT2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Verum', 'description': 'Sinetrol® Xpur', 'interventionNames': ['Dietary Supplement: Sinetrol® Xpur']}], 'interventions': [{'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo']}, {'name': 'Sinetrol® Xpur', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Verum']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Murcia', 'country': 'Spain', 'facility': 'UCAM', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}], 'overallOfficials': [{'name': 'Pedro Alcaraz Ramon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCAM'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fytexia', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}