Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2026-02-22 @ 6:47 PM
Study NCT ID:
NCT03312816
Status:
COMPLETED
Last Update Posted:
2018-06-07
First Post:
2017-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Oxidized Plant Sterols on Serum Concentrations of Plant Sterol Oxidation Products (POP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-12-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-06', 'studyFirstSubmitDate': '2017-10-12', 'studyFirstSubmitQcDate': '2017-10-12', 'lastUpdatePostDateStruct': {'date': '2018-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'POP (plant sterol oxidation products) value', 'timeFrame': '0 to 42 days', 'description': 'To estimate the change from baseline in serum POP concentration after intake of various POP doses.'}], 'secondaryOutcomes': [{'measure': 'COP (cholesterol oxidation products) value', 'timeFrame': '0 to 42 days', 'description': 'To estimate the change from baseline in serum COP concentrations after intake of various POP doses.'}, {'measure': 'Ratio of serum POP concentration', 'timeFrame': '0 to 42 days', 'description': 'To estimate the ratio of serum POP concentrations vs. COP concentrations after intake of various POP doses.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The study is a randomised, double-blind, placebocontrolled, parallel dose-response study with four study arms. Sixty subjects will be randomly allocated to consume study products containing varying amounts of plant sterol (PS) oxidation products (POP) or placebo for 6 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Apparently healthy men and women as judged by study physician.\n* BMI \\> 18 and \\< 35 kg/m2.\n* Total cholesterol levels at screening ≥5.0 and ≤8.0 mmol/L\n* Blood pressure, heart rate, haematological and clinical chemical parameters within the normal reference range as judged by the study physician.\n\nExclusion Criteria:\n\n* Recently (\\<6 months) diagnosed with cardiovascular event(s) (stroke, TIA (Transient ischemic attack), angina, myocardial infarction, heart failure), revascularization or systemic inflammatory conditions.\n* Use of plant-sterol/stanol-enriched foods or supplements in the three months prior to the screening and/or during the study.\n* Use of over-the-counter and prescribed medication which may interfere with study measurements (i.e. statins, ezetimibe, fibrates, diabetic drugs, angiotensin receptor blockers (ARB) and ACE (Angiotensin-converting enzyme) inhibitors)), to be judged by the principal investigator.\n* Use of oral antibiotics (with the exception of topical antibiotics) in 40 days or less prior to Day -2.\n* Pregnant or lactating women.\n* Reported alcohol consumption \\> 14 units/week (female) or \\> 21 units/week (male).\n* Reported intense sporting activities \\> 10 hours/week.\n* Reported weight loss or gain of 3 kg or more during a period of 6 months prior to screening.\n* Currently on a medically- or self-prescribed diet, or slimming diet, or the intention to use any kind of diet during the study.\n* Currently smoking or being a non-smoker for less than 6 months and reported use of any nicotine containing products in the 6 months prior to screening and/or during the study.'}, 'identificationModule': {'nctId': 'NCT03312816', 'briefTitle': 'Effect of Oxidized Plant Sterols on Serum Concentrations of Plant Sterol Oxidation Products (POP)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Unilever R&D'}, 'officialTitle': 'The Effect of Oxidized Plant Sterol Intake on Serum Concentrations of Plant Sterol Oxidation Products (POP)', 'orgStudyIdInfo': {'id': 'FDS-SCC-2838'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '0 mg/d added POP', 'interventionNames': ['Other: cookies enriched with POP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'low dosage', 'description': 'low added POP', 'interventionNames': ['Other: cookies enriched with POP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Medium dose', 'description': 'medium added POP', 'interventionNames': ['Other: cookies enriched with POP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hige dose', 'description': 'high added POP', 'interventionNames': ['Other: cookies enriched with POP']}], 'interventions': [{'name': 'cookies enriched with POP', 'type': 'OTHER', 'description': 'Cookies', 'armGroupLabels': ['Hige dose', 'Medium dose', 'Placebo', 'low dosage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Research Organisation GmbH', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Christian Keicher, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charité Research Organisation GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unilever R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}