Ignite Creation Date:
2025-12-24 @ 9:50 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT04075032
Status:
COMPLETED
Last Update Posted:
2020-09-10
First Post:
2019-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pomegranate Consumption by Poly-medicated Metabolic Syndrome Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000712310', 'term': 'pomegranate fruit rind'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized, double-blind, placebo-controlled and crossover trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-08', 'studyFirstSubmitDate': '2019-08-22', 'studyFirstSubmitQcDate': '2019-08-28', 'lastUpdatePostDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change (1 log units) of Bacteroidetes per gram of feces', 'timeFrame': 'Change from baseline at 30 days vs placebo', 'description': 'Modulation of gut microbiota (decrease Firmicutes to Bacteroidetes ratio)'}], 'secondaryOutcomes': [{'measure': 'Change (10%) of circulating levels of lipopolysaccharide binding protein (LBP)', 'timeFrame': 'Changes from baseline at 30 days vs placebo', 'description': 'Evaluation of metabolic endotoxemia'}, {'measure': 'Change (10%) of ghrelin, TNF-α, GLP-1, IL-6, PYY, resistin, HGF, MCP-1, C-Peptide, and BDNF (pg/mL).', 'timeFrame': 'Changes from baseline at 30 days vs placebo', 'description': 'Determination of metabolic and inflammatory markers in serum samples.'}, {'measure': 'Change (10%) of PAI-1, adiponectin, RBP4, and leptin (ug/mL).', 'timeFrame': 'Changes from baseline at 30 days vs placebo', 'description': 'Determination of fibrinolytic, inflammatory and metabolic markers in serum samples'}, {'measure': 'Change (10%) of ICAM-1, VCAM-1, and P-selectin (ng/mL)', 'timeFrame': 'Changes from baseline at 30 days vs placebo', 'description': 'Measurement of cell adhesion molecules in serum samples'}, {'measure': 'Change (10%) of blood glucose, total cholesterol, LDLc and HDLc concentrations (mg/dL)', 'timeFrame': 'Changes from baseline at 30 days vs placebo', 'description': 'Measurement of serobiochemical variables (blood glucose and lipids levels) in serum samples'}, {'measure': 'Evaluation of genotype frequencies for 60 single nucleotide polymorphisms (SNPs) related to the incidence of obesity, metabolism, diabetes and cardiovascular diseases', 'timeFrame': 'Baseline values at inclusion', 'description': 'SNP genotyping of patients (DNA extracted from whole blood)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['metabolic syndrome', 'pomegranate', 'gut microbiota', 'polyphenol', 'polymedication', 'inflammation', 'obesity', 'diabetes', 'hypertension', 'hyperlipidemia', 'urolithins'], 'conditions': ['Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'The objective is to evaluate whether the medication in polymedicated metabolic syndrome patients could determine the effects of a pomegranate extract on i) metabolic markers, ii) inflammatory markers, and iii) the modulation of the gut microbiota.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Body mass index \\>30 kg/m2 or waist circumference \\>94/80 cm (males/females) in European-Caucasians subjects, plus two of the following:\n* Triglycerides \\>150 mg/dL or under treatment against hypertrigliceridemia.\n* Fasting glucose ≥100 mg/dL\n* Diagnosed type 2 diabetes mellitus\n* HDL-cholesterol (mg/dl) \\<40/50 (males/females) or under treatment against low HDLc values.\n* Systolic blood pressure \\>130 mmHg o diastolic blood pressure \\>85 mmHg, or under anti-hypertensive drug treatment.\n\nExclusion Criteria:\n\n* Age under 18 years\n* Pregnancy or breastfeeding\n* Antibiotic treatment within one month before inclusion in the trial\n* Pomegranate allergy or intolerance (known or suspected)\n* Chronic intestinal inflammatory diseases (ulcerative colitis, Crohn's disease, etc.)\n* Malignancies\n* Consumption of botanicals or dietary supplements within one month before the inclusion and during the trial.\n* Consumption of ellagitannin-rich sources within one week before the inclusion and during the trial (pomegranate, walnuts, strawberries, raspberries, tea, blackberries and oak-aged wine)."}, 'identificationModule': {'nctId': 'NCT04075032', 'briefTitle': 'Pomegranate Consumption by Poly-medicated Metabolic Syndrome Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Research Council, Spain'}, 'officialTitle': 'Effect of a Pomegranate Extract on Metabolic and Inflammatory Markers, and the Gut Microbiota of Poly-medicated Metabolic Syndrome Patients', 'orgStudyIdInfo': {'id': 'AGL2015-64124-R(2)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pomegranate extract-1', 'description': 'Consumption of 2 daily capsules (900 mg pomegranate extract, PE) for 4 weeks', 'interventionNames': ['Dietary Supplement: Pomegranate extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo-1', 'description': 'Consumption of 2 daily capsules (900 mg microcrystalline cellulose, PLA) for 4 weeks', 'interventionNames': ['Other: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo-2', 'description': 'Consumption of 2 daily capsules (900 mg microcrystalline cellulose, PLA) for 4 weeks. This arm is the previous PE-1 after crossover and one month of wash-out', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Pomegranate extract-2', 'description': 'Consumption of 2 daily capsules (900 mg pomegranate extract, PE) for 4 weeks. This arm is the previous PLA-1 after crossover and one month of wash-out.', 'interventionNames': ['Dietary Supplement: Pomegranate extract']}], 'interventions': [{'name': 'Pomegranate extract', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Pomegranate extract consumption (900 mg/day) for 4 weeks', 'armGroupLabels': ['Pomegranate extract-1', 'Pomegranate extract-2']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo (microcrystalline cellulose) consumption (900 mg/day) for 4 weeks', 'armGroupLabels': ['Placebo-1', 'Placebo-2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30100', 'city': 'Murcia', 'country': 'Spain', 'facility': 'Spanish National Research Council (CSIC)', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}], 'overallOfficials': [{'name': 'Juan C Espín, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Spanish National Research Council (CSIC)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Research Council, Spain', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Hospital General Universitario Reina Sofía de Murcia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Professor', 'investigatorFullName': 'Juan Carlos Espín de Gea', 'investigatorAffiliation': 'National Research Council, Spain'}}}}