Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-02-28 @ 10:39 PM
Study NCT ID:
NCT03284918
Status:
COMPLETED
Last Update Posted:
2017-09-15
First Post:
2017-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lipid Lowering Effect of a Cereal Based Snack Bar With Added Plant Stanol Ester
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C407042', 'term': 'plant stanol ester'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-13', 'studyFirstSubmitDate': '2017-09-13', 'studyFirstSubmitQcDate': '2017-09-13', 'lastUpdatePostDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage change in serum LDL cholesterol', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Absolute change in serum LDL cholesterol (mmol/l)', 'timeFrame': '4 weeks'}, {'measure': 'Absolute and percentage change in serum total, HDL- and non-HDL cholesterol and serum total triglycerides', 'timeFrame': '4 weeks'}]}, 'conditionsModule': {'conditions': ['Hypercholesterolemia', 'Hyperlipidemias', 'Dyslipidemias']}, 'referencesModule': {'references': [{'pmid': '29854447', 'type': 'DERIVED', 'citation': 'Sarkkinen E, Lyyra M, Nieminen S, Kuusisto P, Wester I. Cereal-Based Snack Bar with Added Plant Stanol Ester (Benecol(R)) Consumed between Meals Lowers Serum Total and LDL Cholesterol Effectively in Mildly to Moderately Hypercholesterolemic Subjects. Cholesterol. 2018 May 2;2018:1463628. doi: 10.1155/2018/1463628. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate the cholesterol lowering efficacy of a cereal based snack bar with added plant stanol ester when used between meals as part of a habitual diet by subjects with mild to moderate hypercholesterolemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Serum total cholesterol 5.2-8.5 mmol/l\n* Serum triglycerides \\< 3 mmol/l\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Abnormal liver, kidney and thyroid function\n* Use of lipid lowering medication\n* Consumption of other plant sterol or plant stanol containing food products or supplements, or other foods or supplements for cholesterol lowering 1 month prior to visit 2\n* History of unstable coronary artery disease (myocardial infarction, coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months\n* Diagnosed type 1 or type 2 diabetes requiring medical treatment\n* History of recent temporal ischemic attack or malignant diseases (\\< 5 yrs)\n* Celiac disease, or allergy or intolerance to the ingredients of the test products\n* Medically prescribed diet/medication for slimming or a special diet like very low calorie diet or obesity drug, or vegan and gluten-free diet\n* Subjects with alcohol abuse (\\> 4 portion per day)\n* Pregnancy or planned pregnancy or lactating'}, 'identificationModule': {'nctId': 'NCT03284918', 'briefTitle': 'Lipid Lowering Effect of a Cereal Based Snack Bar With Added Plant Stanol Ester', 'organization': {'class': 'INDUSTRY', 'fullName': 'Raisio Group'}, 'officialTitle': 'Effect of a Cereal Based Snack Bar With Added Plant Stanol Ester on Serum Total and Lipoprotein Lipids', 'orgStudyIdInfo': {'id': 'MFRA004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Plant stanol ester', 'description': 'Cereal based snack bar with added plant stanol ester (0.8 g plant stanols/bar). Two bars consumed daily as a snack, between meals, for 4 weeks (1.6 g plant stanols/d).', 'interventionNames': ['Dietary Supplement: Plant stanol ester']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Cereal based snack bar without plant stanol ester. Two bars consumed daily as a snack, between meals, for 4 weeks (0 g plant stanols/d).', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Plant stanol ester', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Plant stanol ester']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Raisio Group', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Oy Medfiles Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}