Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2026-01-04 @ 4:24 PM
Study NCT ID:
NCT01046968
Status:
COMPLETED
Last Update Posted:
2010-01-12
First Post:
2010-01-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lepticore in Metabolic Syndrome and Weight Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], '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'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-11', 'studyFirstSubmitDate': '2010-01-11', 'studyFirstSubmitQcDate': '2010-01-11', 'lastUpdatePostDateStruct': {'date': '2010-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of symptoms of metabolic syndrome', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in weight', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Obesity', 'metabolic syndrome', 'C-reactive protein', 'Leptin'], 'conditions': ['Obesity', 'Hyperlipidemia', 'Hyperglycemia']}, 'descriptionModule': {'briefSummary': 'Metabolic syndrome is directly related to obesity. This study investigated the use of a plant based formulation to improve on the condition of people with metabolic syndrome.', 'detailedDescription': 'LeptiCore is a proprietary combination of various ingredients which have been shown to have properties which could be beneficial to weight loss in obese and overweight human subjects. This study evaluates the effect of Lepticore on bodyweight as well as parameters associated with obesity and metabolic syndrome.\n\nThe study was an 8 week randomized, double-blind, placebo-controlled design involving 92 obese (mean BMI\\>30kg/m2) participants (37 males; 55 females; ages 19-52; mean age = 30.7). The participants were randomly divided into three groups: placebo (n=30), LeptiCore formula A (low dose) (n=31) and LeptiCore formula B (high dose) (n=31). Capsules containing the placebo or active formulations were administered twice daily before meals with 300 ml of water. None of the participants followed any specific diet nor took any weight-reducing medications for the duration of the study. A total of 12 anthropomorphic and serological measurements were taken at the beginning of the study and after 2, 4, 6, and 8 weeks of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '52 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\>30 kg/m2\n* Total cholesterol \\>200 mg/dl\n* LDL cholesterol \\>160 mg/dl\n* HDL cholesterol \\<40 mg/dl; triglycerides \\>150 mg/dl\n* Fasting blood glucose \\>100 mg/dl\n* Blood pressure \\>130/85 mmHg.\n\nExclusion Criteria:\n\n* Morbid obesity (BMI \\>40 kg/m2 )\n* Diabetes mellitus requiring daily insulin management\n* Pregnancy/lactation\n* Active infection\n* Systemic disease such as HIV/AIDS,\n* Use of any cholesterol-lowering medications 30 days prior to study\n* Enrollment in another clinical study within the past 6 months.'}, 'identificationModule': {'nctId': 'NCT01046968', 'briefTitle': 'Lepticore in Metabolic Syndrome and Weight Loss', 'organization': {'class': 'OTHER', 'fullName': 'University of Yaounde 1'}, 'officialTitle': 'The Use of LeptiCore® in Reducing Fat Gain and Managing Weight Loss in Patients With Metabolic Syndrome', 'orgStudyIdInfo': {'id': 'LNNB232'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lepticore', 'interventionNames': ['Dietary Supplement: Lepticore']}], 'interventions': [{'name': 'Lepticore', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Plant based polysaccharides'], 'description': '300 mg twice daily', 'armGroupLabels': ['Lepticore']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8418', 'city': 'Yaoundé', 'state': 'Centre Region', 'country': 'Cameroon', 'facility': 'Laboratory of Nutrition and Nutritional Biochemistry', 'geoPoint': {'lat': 3.86667, 'lon': 11.51667}}], 'overallOfficials': [{'name': 'Julius E Oben, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Yaounde 1'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Yaounde 1', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cameroon Nutritional Science Society', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Pr. Julius Oben - Head of Laboratory of Nutrition & Nutritional Biochemistry', 'oldOrganization': 'University of Yaounde 1'}}}}