Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT00815451
Status:
UNKNOWN
Last Update Posted:
2009-09-18
First Post:
2008-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Polyphenol-rich Dark Chocolate on Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-09-17', 'studyFirstSubmitDate': '2008-12-29', 'studyFirstSubmitQcDate': '2008-12-29', 'lastUpdatePostDateStruct': {'date': '2009-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'adiponectin', 'timeFrame': 'week 0, 4, 6, 10'}], 'secondaryOutcomes': [{'measure': 'insulin sensitivity', 'timeFrame': 'week 0, 4, 6, 10'}, {'measure': 'blood pressure', 'timeFrame': 'week 0, 4, 6, 10'}, {'measure': 'lipid profile', 'timeFrame': 'week 0, 4, 6, 10'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the effect of polyphenol-rich dark chocolate (DC) on insulin resistance, adiponectin , blood pressure (BP), lipid profile in obese subjects and determine possible associations between all assessed parameters.\n\nIt hypothesizes that consumption of polyphenol-rich Dc could lower fasting glucose levels, insulin resistance and improve BP, total cholesterol, low-density lipoprotein (LDL) and triglycerides while increasing adiponectin and high-density lipoprotein (HDL) in overweight or obese individuals.', 'detailedDescription': "It is well acknowledged that the main mechanism by which cocoa and DC polyphenols improve fasting glucose levels, insulin sensitivity, BP and lipid profile in healthy individuals and those with hypertension and/or impaired glucose-tolerance, involves increased nitric oxide (NO) bioavailability. NO is essential for the regulation of blood pressure, glucose and lipid balance. This is evident in that e-NOsynthase knockout mice exhibit insulin resistance, hypertension and hyperlipidemia, a cluster of diseases that is also observed in the metabolic syndrome. Recently, it was shown that adiponectin regulates eNOsynthase activity through the phosphatidylinositol 3-kinase-dependent pathway wherein eNOsynthase is phosphorylated by 5'-AMP-activated protein kinase at Ser1179 and that plasma adiponectin levels are inversely correlated with BMI, waist-to-hip ratio, fasting plasma glucose, insulin, triglyceride, hyperinsulinemia, and glucose intolerance and positively with HDL-cholesterol, but not BP. This suggests a strong link between impaired NO bioavailability, adiponectin levels and obesity. Indeed, apart from exhibiting impaired NO bioavailability, obese individuals also have decreased plasma adiponectin levels. Since cocoa and DC are known to modulate NO activity, investigating the impact of cocoa or DC polyphenols on adiponectin levels and observing a correlation between its levels and improved fasting glucose levels, insulin resistance, BP and lipid profile is essential in improving our understanding of the relationship between diet and health, particularly that polyphenols in apples, oolong and green tea polyphenols have been previously shown to influence adiponectin levels.\n\nThis study uses a randomised single-blind, placebo-controlled design. Following a 1-week run-in phase, each group will be randomised to one of the two groups: placebo-polyphenol-rich DC, polyphenol-rich DC-placebo. Subjects will follow each diet for 4weeks, after which they will cross-over to the next diet separated by a 2-week washout period and until each subject completes both interventions."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy female volunteers\n* Aged 18-50 years\n* Group 1 will consist of volunteers with BMI of 18-25 kg/m2\n* Group 2 will consist of women with BMI of 25-35 kg/m2\n\nExclusion Criteria:\n\n* Cardiovascular disease\n* Hypertension\n* Diabetes\n* Smokers\n* People taking dietary supplements\n* Hypertension or cholesterol-lowering drugs\n* Those with high cocoa or DC intake, soy or nut allergies'}, 'identificationModule': {'nctId': 'NCT00815451', 'briefTitle': 'Effect of Polyphenol-rich Dark Chocolate on Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Queen Margaret University'}, 'officialTitle': 'Effect of Polyphenols on Glucoregulatory Biomarkers, Blood Pressure and Lipid Profile in Overweight and Obese Subjects', 'orgStudyIdInfo': {'id': '1-salmoosawi'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo dark chocolate', 'description': 'polyphenol-poor dark chocolate', 'interventionNames': ['Dietary Supplement: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'polyphenol-rich dark chocolate', 'interventionNames': ['Dietary Supplement: Acticoa polyphenol-rich dark chocolate']}], 'interventions': [{'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['barry callebaut'], 'description': 'polyphenol-free dark chocolate 20g to be distributed throughout the day for 4 weeks', 'armGroupLabels': ['placebo dark chocolate']}, {'name': 'Acticoa polyphenol-rich dark chocolate', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['barry callebaut, acticoa'], 'description': '20g to be distributed throughout the day for 4 weeks', 'armGroupLabels': ['polyphenol-rich dark chocolate']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'eh21 6uu', 'city': 'Musselburgh', 'state': 'east lothian', 'country': 'United Kingdom', 'facility': 'Queen margaret university', 'geoPoint': {'lat': 55.9417, 'lon': -3.04991}}], 'overallOfficials': [{'name': 'suzana h almoosawi, BScHons HN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'QMU'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queen Margaret University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'suzana almoosawi', 'oldOrganization': 'PhD student QMU'}}}}