Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:11 PM
Study NCT ID:
NCT05126056
Status:
UNKNOWN
Last Update Posted:
2021-12-03
First Post:
2021-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lipid Lowering Effect of Plant Stanol Ester in a Drinkable Non-dairy Product
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'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': 'ESTIMATED', 'count': 55}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-02', 'studyFirstSubmitDate': '2021-11-09', 'studyFirstSubmitQcDate': '2021-11-17', 'lastUpdatePostDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in low-density lipoprotein (LDL) cholesterol concentration (%)', 'timeFrame': '0 vs 3 weeks', 'description': 'Mean relative change in serum LDL cholesterol concentration during the intervention'}], 'secondaryOutcomes': [{'measure': 'LDL cholesterol concentration', 'timeFrame': '0 vs 3 weeks', 'description': 'Mean absolute change in serum LDL cholesterol concentration during the intervention between test and control group'}, {'measure': 'total cholesterol concentration', 'timeFrame': '0 vs 3 weeks', 'description': 'Changes in serum total cholesterol concentration during the intervention'}, {'measure': 'High density lipoprotein (HDL) cholesterol concentration', 'timeFrame': '0 vs 3 weeks', 'description': 'Changes in serum HDL cholesterol concentration during the intervention'}, {'measure': 'non-HDL cholesterol concentration', 'timeFrame': '0 vs 3 weeks', 'description': 'Changes in serum non-HDL cholesterol concentration during the intervention'}, {'measure': 'Total triglyceride concentration', 'timeFrame': '0 vs 3 weeks', 'description': 'Changes in serum triglycerides concentrations'}, {'measure': 'Nuclear magnetic resonance (NMR) blood biomarkers', 'timeFrame': '0 vs 3 weeks', 'description': 'Changes in specific NMR blood biomarkers'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': 'The aim is to determine the effect of investigational products on serum LDL cholesterol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed written informed consent\n* Mildly or moderately elevated plasma cholesterol levels (plasma total cholesterol 5.5-8.0 mmol/l)\n* Plasma triglyceride levels ≤ 4.0 mmol/l\n* Age 18-65 years\n\nExclusion Criteria:\n\n* Intolerance to oats or other ingredients of the test products\n* Severe obesity (BMI ≥ 32 kg/m2)\n* Consumption of lipid/cholesterol lowering medication (e.g. ezetimibe, PCSK9 inhibitors, resins, fibrates) 1 month prior to the screening visit and throughout the study. Statin treatment is allowed at stable dose.\n* Consumption of plant stanol or plant sterol containing food products or supplements or other foods or supplements such as beta-glucan enriched foods, red rice, berberine or any combination of these used for cholesterol lowering purpose 1 month prior the study entry (baseline blood sample)\n* History of malignant diseases like cancer within five years prior to recruitment\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* Celiac disease\n* Medically prescribed diet/treatment for slimming or a special diet like very low calorie diet or use of prescribed an obesity drug (e.g. Orlistat, Victoza)\n* Alcohol abuse (\\> 4 portion/per day) or recreational drug abuse\n* Pregnancy or planned pregnancy or lactating\n* Clinically significant abnormalities in screening labs\n* Participation in another clinical trial in the preceding 3 months'}, 'identificationModule': {'nctId': 'NCT05126056', 'briefTitle': 'Lipid Lowering Effect of Plant Stanol Ester in a Drinkable Non-dairy Product', 'organization': {'class': 'INDUSTRY', 'fullName': 'Raisio Group'}, 'officialTitle': 'Lipid Lowering Effect of Plant Stanol Ester in a Drinkable Non-dairy Product', 'orgStudyIdInfo': {'id': 'NGH2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator', 'description': 'Products that contain plant stanol ester. Product with active ingredient', 'interventionNames': ['Other: Plant stanol ester']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo comparator', 'description': 'Placebo product. Product without active ingredient', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Plant stanol ester', 'type': 'OTHER', 'description': 'Product with active ingredient vs product without active ingredient', 'armGroupLabels': ['Active Comparator']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['Placebo comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00330', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Nightingale Health plc', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'Helena Gylling', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helsinki University Hospital, Helsinki, Finland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Raisio Group', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}