Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2026-01-01 @ 11:50 AM
Study NCT ID:
NCT01571869
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2012-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study in the Cholesterol Absorption Reduction After Consumption of Low-fat, Drinkable Fermented Milk Enriched With Plant Sterols
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010840', 'term': 'Phytosterols'}], 'ancestors': [{'id': 'D013261', 'term': 'Sterols'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D064209', 'term': 'Phytochemicals'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-06', 'studyFirstSubmitDate': '2012-04-03', 'studyFirstSubmitQcDate': '2012-04-04', 'lastUpdatePostDateStruct': {'date': '2016-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Plant sterol - hypercholesterolemia - dairy - meal'], 'conditions': ['Mildly Hypercholesterolemic Subjects']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare efficacy of a plant sterol enriched yogurt given at different moments of the day in lowering blood cholesterol of hypercholesterolemic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* male and post-menopausal female aged 40-80 years;\n* BMI between 22 and 32 kg/m2,\n* Non-smoker, Stabilized LDL-c over 3.0 mmol/L,\n* Not taking any medication known to affect lipid metabolism for at least the previous 3 month period,\n* Agree to follow the dietary recommendations in the context of their hypercholesterolemia,\n* Have to give written consent to take part in the study\n\nExclusion Criteria:\n\n* Thyroid disease, diabetes mellitus, kidney disease or liver disease, Hypertension (95\\<SBP\\>140 mmHg and/or 45\\<DBP\\>90 mmHg),\n* Previous history of symptomatic vascular disease, TG level \\> 2,8 g/l,\n* History of metabolic or gastrointestinal disease with the exception of appendicectomy,\n* Consumption of large amounts of alcohol,\n* Having undergone general anesthesia in the month prior to pre-selection,\n* Receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,\n* Having serious or acute disease likely to influence study results or involved in life time,\n* Presenting allergy or hypersensitivity to milk proteins, or refusing to consume them,\n* Refusing to stop his/her consumption of enriched plant sterol trade products during the study,\n* In a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject,\n* For female subjects: likely to change her hormonal substitutive treatment,\n* Currently in an exclusion period following participation in another clinical trial."}, 'identificationModule': {'nctId': 'NCT01571869', 'briefTitle': 'Pilot Study in the Cholesterol Absorption Reduction After Consumption of Low-fat, Drinkable Fermented Milk Enriched With Plant Sterols', 'organization': {'class': 'INDUSTRY', 'fullName': 'Danone Global Research & Innovation Center'}, 'officialTitle': 'Influence of a Meal on the Efficacy of Plant Sterol Given at Different Times of the Day in Management of Hypercholesterolemia', 'orgStudyIdInfo': {'id': 'NU142'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 = Tested product', 'interventionNames': ['Other: 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2 = Control product', 'interventionNames': ['Other: 2- Low fat drinkable fermented dairy product without plant sterols (control)']}], 'interventions': [{'name': '1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit', 'type': 'OTHER', 'description': '1-Intervention with test product (morning, evening or snack)', 'armGroupLabels': ['1 = Tested product']}, {'name': '2- Low fat drinkable fermented dairy product without plant sterols (control)', 'type': 'OTHER', 'description': '2 - Intervention with control product (morning and/or evening)', 'armGroupLabels': ['2 = Control product']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H9X 3V9', 'city': 'Ste-anne-de-bellevue', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danone Global Research & Innovation Center', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}