Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-25 @ 5:05 PM
Study NCT ID:
NCT05385003
Status:
UNKNOWN
Last Update Posted:
2022-05-23
First Post:
2022-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Prebiotics on Hyperuricemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000861', 'term': 'Anserine'}, {'id': 'C448501', 'term': 'SFTI-1 peptide, sunflower'}], 'ancestors': [{'id': 'D004151', 'term': 'Dipeptides'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, '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': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-17', 'studyFirstSubmitDate': '2022-05-13', 'studyFirstSubmitQcDate': '2022-05-17', 'lastUpdatePostDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of serum Uric acid', 'timeFrame': 'from baseline to 12 weeks after intervention', 'description': 'change of fasting uric acid level assessed by biochemical detector'}, {'measure': 'Change of excretion of uric acid', 'timeFrame': 'from baseline to 12 weeks after intervention', 'description': 'excretion rate of uric acid assessed by secretion rate of uric acid in urine during 3 hours'}], 'secondaryOutcomes': [{'measure': 'Change of Gut microbiota', 'timeFrame': 'from baseline to 12 weeks after intervention', 'description': 'Alterations of the composition of gut microbiota evaluated by metagenomics'}, {'measure': 'Change of Microbial metabolites', 'timeFrame': 'from baseline to 12 weeks after intervention', 'description': 'Untargeted metabolomics will be used to assess the alterations of microbial metabolites with High performance liquid chromatography-mass spectrometry'}, {'measure': 'Change in blood pressure', 'timeFrame': 'from baseline to 12 weeks after intervention', 'description': 'Change in blood pressure assessed by electronic sphygmomanometer'}, {'measure': 'Change in fasting glucose', 'timeFrame': 'from baseline to 12 weeks after intervention', 'description': 'Change in fasting glucose assessed by biochemical detector'}, {'measure': 'Change in waist circumference', 'timeFrame': 'from baseline to 12 weeks after intervention', 'description': 'Change in waist circumference assessed by tape'}, {'measure': 'Change in lipid profiles', 'timeFrame': 'from baseline to 12 weeks after intervention', 'description': 'Change in total cholesterol, triglycerides, LDL-c and HDL-c assessed by biochemical detector'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Subjects With Hyperuricemia']}, 'descriptionModule': {'briefSummary': 'Hyperuricemia is a major risk factor for many chronic diseases. Recently, dysbiosis of gut microbiota has been reported to play an important role in the pathogenesis of Hyperuricemia. Animal studies have demonstrated that administration of prebiotics help delay the progression of Hyperuricemia through several mechanisms. This trial aims to examine its protective effect in humans.', 'detailedDescription': 'Hyperuricemia is a major risk factor for many chronic diseases. Recently, dysbiosis of gut microbiota has been reported to play an important role in the pathogenesis of hyperuricemia. Animal studies have demonstrated that administration of prebiotics help delay the progression of hyperuricemia through several mechanisms such as reduction in endotoxemia, and enhanced production of short-chain fatty acids.\n\nHowever, whether administration of prebiotics also has a protective effect in subjects with Hyperuricemia remain unknown.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Local residents aged between 18-65 years old;\n* Stable weight (\\<5% weight change over last 3 months);\n* Fasting uric acid was \\> 420μmol/L for male and \\> 360μmol/L for female on two different days\n* Those who have never taken uric acid lowering drugs or have stopped taking uric acid lowering drugs for at least four weeks;\n* Absence of any diet or medication that might interfere with Uric acid metabolism and gut microbiota, especially antibiotics and probiotics at least 4 weeks before recruitment.\n\nExclusion Criteria:\n\n* Acute illness or evidence of any acute or chronic inflammatory of infective diseases;\n* Participation in regular diet program more than 2 times per week in the latest 3 months prior to recruitment;\n* Mental illness rendering them unable to understand the nature, scope, and possible consequences of the study.\n* Women of childbearing age who are pregnant, breast-feeding or preparing for pregnancy; Patients who had surgery within the past six months or planned surgery during the trial period'}, 'identificationModule': {'nctId': 'NCT05385003', 'briefTitle': 'Effect of Prebiotics on Hyperuricemia', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'An Interventional Study for the Beneficial Effects of Prebiotics on Hyperuricemia in Chinese Subjects', 'orgStudyIdInfo': {'id': 'Pre-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dietary Supplement: anserine', 'description': 'Subjects are instructed to take one capsule of anserine daily for a total of 3 months', 'interventionNames': ['Dietary Supplement: anserine']}, {'type': 'EXPERIMENTAL', 'label': 'Dietary Supplement: Sunflower peptide', 'description': 'Subjects are instructed to take one capsule of Sunflower peptide daily for a total of 3 months', 'interventionNames': ['Dietary Supplement: Sunflower peptide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Dietary Supplement: Placebo control', 'description': 'Subjects are instructed to take one capsule of placebo daily for a total of 3 months', 'interventionNames': ['Dietary Supplement: Placebo control']}], 'interventions': [{'name': 'anserine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'During the study period, subjects are instructed to take one capsule of anserine daily for a total of 3 months. Aside from the prebiotic supplement, all participants are instructed to continue their normal routine and not make any changes to their exercise habits but reduce purine intake.', 'armGroupLabels': ['Dietary Supplement: anserine']}, {'name': 'Sunflower peptide', 'type': 'DIETARY_SUPPLEMENT', 'description': 'During the study period, subjects are instructed to take one capsule of Sunflower peptide daily for a total of 3 months. Aside from the prebiotic supplement, all participants are instructed to continue their normal routine and not make any changes to their exercise habits but reduce purine intake.', 'armGroupLabels': ['Dietary Supplement: Sunflower peptide']}, {'name': 'Placebo control', 'type': 'DIETARY_SUPPLEMENT', 'description': 'During the study period, subjects are instructed to take one capsule of placebo control daily for a total of 3 months. Aside from the probiotic supplement, all participants are instructed to continue their normal routine and not make any changes to their exercise habits but reduce purine intake.', 'armGroupLabels': ['Dietary Supplement: Placebo control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Xia, PhD', 'role': 'CONTACT', 'email': 'xiamin@mail.sysu.edu.cn', 'phone': '+86 20 87332433'}], 'facility': 'Department of Nutrition and Food Hygiene', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Xia, PhD', 'role': 'CONTACT', 'email': 'xiamin@mail.sysu.edu.cn', 'phone': '+86-2087332433'}], 'facility': 'Sun Yat-Sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Min Xia, PhD', 'role': 'CONTACT', 'email': 'xiamin@mail.sysu.edu.cn', 'phone': '+86-20-87332433'}], 'overallOfficials': [{'name': 'Min Xia, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Min Xia', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}