Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2026-01-09 @ 11:00 AM
Study NCT ID:
NCT02710461
Status:
COMPLETED
Last Update Posted:
2017-03-28
First Post:
2016-03-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Grape and Pomegranate Polyphenols in Postprandial Glucose and Related Parameters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D056128', 'term': 'Obesity, Abdominal'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009765', 'term': 'Obesity'}, {'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': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-27', 'studyFirstSubmitDate': '2016-03-12', 'studyFirstSubmitQcDate': '2016-03-12', 'lastUpdatePostDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postprandial glucose', 'timeFrame': '0-120 min.', 'description': 'Changes in blood glucose response in treatments B and C will be compared with the baseline results obtained in treatment A. This will be evaluated by area under the curve (AUC) 0-120 min after an Oral Glucose Tolerance Test (OGTT)'}], 'secondaryOutcomes': [{'measure': 'Postprandial insulin', 'timeFrame': '0-120 min.', 'description': 'Changes in blood insulin response in treatments B and C will be compared with the baseline results obtained in treatment A. This will be evaluated by area under the curve (AUC) 0-120 min after an Oral Glucose Tolerance Test (OGTT)'}, {'measure': 'Postprandial uric acid', 'timeFrame': '0-120 min.', 'description': 'Changes in blood uric acid response in treatments B and C will be compared with the baseline results obtained in treatment A. This will be evaluated by area under the curve (AUC) 0-120 min after an Oral Glucose Tolerance Test (OGTT)'}, {'measure': 'Polyphenol metabolites', 'timeFrame': '0-180 min.', 'description': 'Urinary polyphenol metabolites will be determined in samples collected in the period 0-180 min. of each intervention.'}, {'measure': 'Urinary uric acid', 'timeFrame': '0-180 min.', 'description': 'Urinary uric acid will be determined in samples collected in the period 0-180 min. of each intervention.'}, {'measure': 'Satiety', 'timeFrame': '120 min.', 'description': 'A satiety test, including 10 items, will be provided at different time points during the period 0-120 min. of each intervention.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Polyphenols', 'Grape', 'Pomegranate', 'Metabolic syndrome', 'Abdominal obesity', 'Postprandial glucose', 'Insulin resistance'], 'conditions': ['Subjects With Abdominal Obesity']}, 'descriptionModule': {'briefSummary': 'The aim of this is study is to evaluate the acute effect of grape and pomegranate polyphenols in the modulation of markers of metabolic syndrome. Most of the previous works about polyphenols have only considered a fraction of polyphenols, i.e., extractable polyphenols. As a consequence, an important amount of dietary polyphenols, the so-called non-extractable polyphenols are ignored. In contrast, the effect of both extractable and non-extractable polyphenols will be considered in this study. Furthermore, the effect of both polyphenols as present in the food matrix and metabolites derived from microbial fermentation will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Abdominal perimeter ≥102 cm. for male participants and ≥88 cm for female participants.\n* Subjects presenting some or several of these characteristics will be prioritized:\n\nFasting glucose values between 110-128 mg/dL. Triglycerides = 150-195 mg/dL. HDL-cholesterol: \\< 50 mg/dL men, \\< 40 mg/dL women. Blood pressure: systolic \\> 130 mm Hg; diastolic \\> 85 mm Hg.\n\nExclusion Criteria:\n\n* Subjects taking drugs for hyperglycaemia, hypertension or hypercholesterolaemia.\n* Volunteers participating in other studies or weight loss plans.\n* Pregnant or breastfeeding women.'}, 'identificationModule': {'nctId': 'NCT02710461', 'acronym': 'POME-GRAPE-1', 'briefTitle': 'Grape and Pomegranate Polyphenols in Postprandial Glucose and Related Parameters', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Research Council, Spain'}, 'officialTitle': 'Acute Effects of Grape and Pomegranate Polyphenols as Modulators of Metabolic Syndrome in Humans', 'orgStudyIdInfo': {'id': 'AGL2014-55102-JIN_1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subjects with abdominal obesity', 'description': 'Intervention with grape pomace and pomegranate pomace', 'interventionNames': ['Dietary Supplement: Mixture of grape pomace and pomegranate pomace']}], 'interventions': [{'name': 'Mixture of grape pomace and pomegranate pomace', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral Glucose Tolerance Test', 'armGroupLabels': ['Subjects with abdominal obesity']}, {'name': 'Mixture of grape pomace and pomegranate pomace', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral Glucose Tolerance Test right after taking the mixture of grape and pomegranate polyphenols', 'armGroupLabels': ['Subjects with abdominal obesity']}, {'name': 'Mixture of grape pomace and pomegranate pomace', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral Glucose Tolerance Test ten hours after taking the mixture of grape and pomegranate polyphenols', 'armGroupLabels': ['Subjects with abdominal obesity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28040', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Institute of Food Science, Technology and Nutrition, National Research Council (ICTAN-CSIC)', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Research Council, Spain', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Ministerio de Economía y Competitividad, Spain', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Jara Pérez-Jiménez', 'investigatorAffiliation': 'National Research Council, Spain'}}}}