Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-01-15 @ 3:00 AM
Study NCT ID:
NCT02630602
Status:
COMPLETED
Last Update Posted:
2015-12-15
First Post:
2015-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Goat Cheese Effect in Lipid Profile Change
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-14', 'studyFirstSubmitDate': '2015-12-11', 'studyFirstSubmitQcDate': '2015-12-14', 'lastUpdatePostDateStruct': {'date': '2015-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change from baseline total cholesterol', 'timeFrame': '0 and 12 weeks'}, {'measure': 'change from baseline Low density lipoprotein cholesterol', 'timeFrame': '0 and 12 weeks'}, {'measure': 'change from baseline High density lipoprotein cholesterol', 'timeFrame': '0 and 12 weeks'}], 'secondaryOutcomes': [{'measure': 'change from baseline Triglycerides', 'timeFrame': '0 and 12 weeks'}, {'measure': 'change from baseline Apolipoprotein A1', 'timeFrame': '0 and 12 weeks'}, {'measure': 'change from baseline Apolipoprotein B', 'timeFrame': '0 and 12 weeks'}, {'measure': 'change from baseline Free fatty acids (FFA) in the plasma', 'timeFrame': '0 and 12 weeks'}, {'measure': 'change from baseline Erythrocyte membrane fatty acid composition', 'timeFrame': '0 and 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Obesity and Overweight']}, 'descriptionModule': {'briefSummary': 'The purpose this study was to evaluate the therapeutic effect of a functional goat cheese on obese and overweight people with altered lipid profile. The functional goat cheese containing polyunsaturated fatty acid, in amounts exceeding other cheese, was developed to benefit cardiovascular health of people who need to normalize lipid profile; which in the long term can contribute to the prevention of cardiovascular diseases.', 'detailedDescription': 'A randomized, parallel, double-blind, controlled is being performing to evaluate the effect of a functional goat cheese on lipid profile in overweight or obese volunteers who need a special diet.\n\nWere included 60 volunteers (men and women) aged between 18 and 65 years (IMC ≥27\\<40 Kg/m2) with a cardiovascular risk (\\<10%). The volunteers are being followed at La Paz University Hospital of Madrid. For 12 weeks, the volunteers should consume 60 g of cheese daily (functional cheese or control cheese) and to receive advice to follow a balanced and individualized hypocaloric diet as well as physical activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteers with overweight type II or obesity type I or II (IMC ≥27\\<40 Kg/m2).\n* Cardiovascular risk \\< 10% and almost two of follow factors:\n\nMen ≥ 45 years old or women ≥ 55 years old; Familiar background of premature cardiovascular disease; HDL cholesterol \\<40 mg/dL for men and \\<50 mg/dL for women; Total cholesterol ≥ 200 mg/dL; Triglycerides ≥ 150 mg/dL and \\< 200 mg/dL; LDL ≥ 130 mg/dL and \\< 160 mg/dL; Smoker\n\n* Accept advises to perform a balanced hypocaloric diet and regular practice of physical activity.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Individuals with Diabetes Mellitus type 1;\n* Individuals with Diabetes Mellitus type 2, using medication;\n* Individuals with Dyslipidemia, using drug;\n* Individuals with high blood pressure, using medication;\n* Individuals with allergies to dairy protein;\n* Individuals with severe diseases (hepatic, kidney, cancer…);\n* Individuals with drugs or supplements consumption to weight lost;\n* Individuals that consume drugs, ω-3 supplements or supplement that can modify the lipid and / or glucose profile (statins, fibrates, diuretics, corticosteroids, insulin…);\n* Individuals who have participated in programs and / or clinical trials of weight control in the last 6 months;\n* Individuals with increased alcohol consumption 30g/day;\n* Individuals that stop smoking in the next 20 weeks (during the study);\n* Individuals with mental disease or low cognitive function;\n* Pregnant women or breastfeeding;\n* Individuals with intensive physical activity;\n* Individuals with physical problems complying with the recommendations of physical activity and diet general recommendations.'}, 'identificationModule': {'nctId': 'NCT02630602', 'acronym': 'LODYN', 'briefTitle': 'Functional Goat Cheese Effect in Lipid Profile Change', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Investigación Hospital Universitario La Paz'}, 'officialTitle': 'Functional Goat Cheese Effect in Lipid Profile Change', 'orgStudyIdInfo': {'id': 'LODYN 4092'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Functional goat cheese', 'description': 'The functional cheese is rich in conjugated linoleic acid (CLA) and omega-3. It was used for obese and overweight people, who need a special diet advice to control of lipid profile. 9,3% of polyunsaturated fatty acids 60 g per day during 12 weeks', 'interventionNames': ['Dietary Supplement: Functional goat cheese']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control cheese', 'description': 'Control cheese, not enriched with conjugated linoleic acid (CLA) and omega-3 4.1% of polyunsaturated fatty acids. 60 g per day during 12 weeks', 'interventionNames': ['Dietary Supplement: Control cheese']}], 'interventions': [{'name': 'Functional goat cheese', 'type': 'DIETARY_SUPPLEMENT', 'description': '60 g per day during 12 weeks', 'armGroupLabels': ['Functional goat cheese']}, {'name': 'Control cheese', 'type': 'DIETARY_SUPPLEMENT', 'description': '60 g per day during 12 weeks', 'armGroupLabels': ['Control cheese']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28046', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'La Paz University Hospital', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Carmen Gomez, MD. PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HOSPITAL LA PAZ'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Investigación Hospital Universitario La Paz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}