Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2026-01-01 @ 1:09 AM
Study NCT ID:
NCT03512600
Status:
COMPLETED
Last Update Posted:
2020-07-23
First Post:
2018-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Effects of the Consumption of Different Products Cocoa Derivatives at the Risk of Crystallization of Uric Acid in Urine of Volunteers.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D020347', 'term': 'Lithiasis'}], 'ancestors': [{'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2017-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-21', 'studyFirstSubmitDate': '2018-03-23', 'studyFirstSubmitQcDate': '2018-04-18', 'lastUpdatePostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ability to inhibit the crystallization of uric acid in urine collected.', 'timeFrame': '12 hours', 'description': 'Ability to inhibit the crystallization of uric acid in urine collected.'}], 'secondaryOutcomes': [{'measure': 'Concentration of theobromine in urine.', 'timeFrame': '12 hours', 'description': 'Concentration of theobromine in urine.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lithiasis', 'uric acid', 'crystallization'], 'conditions': ['Lithiasis, Urinary']}, 'descriptionModule': {'briefSummary': 'The present study aims to assess the effectiveness of theobromine, -product present in high proportion in the cacao-, to prevent the development of uric acid kidney stones.', 'detailedDescription': 'Renal lithiasis is a pathology that affects a high percentage of the population, and although it has been known for a long time, advances carried out in the treatment are limited to the surgical aspects, while the causes responsible for the formation of kidney calculus are not corrected, which leads to a high recurrence.\n\nThe "healing" of renal lithiasis inevitably goes through the elimination of the alterations related to the genesis of kidney calculus. It the case of uric acid lithiasis the most important are having urinary pH less than 5.5 and an elevated uricosuria, which can be corrected relatively easy by undergoing changes in dietary habits, and with pharmacological treatment with citrate -which produces and increase in pH- or with inhibitors of the xantino-oxidase as allopurinol. However, among the prophylactic treatments available for ural acid lithiasis, so far it does not exist one for urinary acid crystallization inhibition.\n\nRecently, the effects of theobromine as an inhibitor of the crystallization of uric acid have been described, but only in vitro. The present study aims to assess the effectiveness of theobromine, -product present in high proportion in the cacao-, to prevent the development of uric acid kidney stones.\n\nThe study is a unicentric, low intervention, non-randomized, prospective study to assess the effects of the consumption of different cocoa derivate products, in the risk of crystallization of uric acid in the urine. Participants in the study are healthy volunteers and will it will be carried out with 20 individuals who will be recruited in the Research Laboratory in Renal Lithiasis of the Baleares Isles University.\n\nPatients will take a urine test previously to undergo 4 dietary interventions, with their subsequent urine measurements. Patients will choose one diet to follow for 1 day, and will be provided with the corresponding cocoa derivate for the diet (soluble cocoa, black chocolate, chocolate with milk). The day after the diet they will take a fast-picking of urine accumulated during the night of which they followed the controlled diet (12 h nocturne sample), then follow a 6 day washout period, and select another diet to follow and repeat until they have gone through the 4 diets and measurements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Compliance in participating and collaborating in the study\n\nExclusion Criteria:\n\n* Cocoa / chocolate allergy or theobromine\n* Pregnancy, nursing period (women)\n* pharmacological treatment\n* chronic diseases (diabetes, kidney failure, heart failure, hyperuricemia, ...)'}, 'identificationModule': {'nctId': 'NCT03512600', 'briefTitle': 'Study of the Effects of the Consumption of Different Products Cocoa Derivatives at the Risk of Crystallization of Uric Acid in Urine of Volunteers.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Devicare S.L.'}, 'officialTitle': 'Study of the Effects of the Consumption of Different Products Cocoa Derivatives at the Risk of Crystallization of Uric Acid in Urine of Volunteers.', 'orgStudyIdInfo': {'id': 'IB 3475/17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'All patients will follow four different dietary interventions (with or without cacao) for 1 day prior to the taking of a urine sample.\n\nAfter the sample is taken the patient will follow a washout period of 6 days before following a different diet and this process will be repeated for each patient until they have followed the four diets.\n\n.', 'interventionNames': ['Dietary Supplement: Intervention 0', 'Dietary Supplement: Intervention 1', 'Dietary Supplement: Intervention 2', 'Dietary Supplement: Intervention 3']}], 'interventions': [{'name': 'Intervention 0', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Study group'], 'description': 'Without nutritional intervention, it will consist of normal food intake without food derived from cocoa or coffee for a period of 1 day in the group of 20 patients during meals. ( That day the patient can not consume cocoa derivates nor coffe or coffe derivates).', 'armGroupLabels': ['Study group']}, {'name': 'Intervention 1', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Study group'], 'description': 'The nutritional intervention will consist of the intake of 40 g daily a base of food derived from cocoa that will be provided to the paient (Food based on soluble cocoa) during one 1 day period in the group of 20 patients during meals.\n\nThat day the patient can not consume cocoa derivates nor coffe or coffe derivates exept the one provided.', 'armGroupLabels': ['Study group']}, {'name': 'Intervention 2', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Study Group'], 'description': 'The nutritional intervention will consist of the intake of 40 g daily a base of food derived from cacao (Food based on black chocolate) during a period of 1 day in the group of 20 patients during meals.\n\nThat day the patient can not consume cocoa derivates nor coffe or coffe derivates exept the one provided.', 'armGroupLabels': ['Study group']}, {'name': 'Intervention 3', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Study group'], 'description': 'The nutritional intervention will consist of the intake of 40 g daily a base of food derived from cocoa (Food based on chocolate with milk) for a period of 1 day in the group of 20 patients during meals.\n\nThat day the patient can not consume cocoa derivates nor coffe or coffe derivates exept the one provided.', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07122', 'city': 'Palma de Mallorca', 'state': 'Balearic Islands', 'country': 'Spain', 'facility': 'Universitat de les Illes Balears, IUNICS', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}], 'overallOfficials': [{'name': 'Fèlix Grases Freixedas', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de las Islas Baleares'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Devicare S.L.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Universidad de las Islas Baleares', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}