Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-02-20 @ 5:36 PM
Study NCT ID:
NCT02835651
Status:
COMPLETED
Last Update Posted:
2017-08-22
First Post:
2016-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Saturated Fatty Acids and HDL Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'D019308', 'term': 'Palmitic Acid'}, {'id': 'C031183', 'term': 'stearic acid'}], 'ancestors': [{'id': 'D010169', 'term': 'Palmitic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-21', 'studyFirstSubmitDate': '2016-05-18', 'studyFirstSubmitQcDate': '2016-07-13', 'lastUpdatePostDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cholesterol efflux capacity after dietary period high in palmitic acid compared to dietary period high in stearic acid', 'timeFrame': 'Cholesterol efflux is measured during fasted state at day 0, day 25 and day 28 of each intervention period.', 'description': 'J774 Macrophages will be used to measure ex vivo cholesterol efflux capacity of HDL particles after a diet enriched with C16:0 or C18:0. Change in ex vivo cholesterol efflux capacity between the diets will be assessed using a linear mixed model with subject as random factor and day 0 as co-variant.'}], 'secondaryOutcomes': [{'measure': 'Change in fasted lipid metabolism markers between dietary period high in palmitic acid and dietary period high in stearic acid', 'timeFrame': 'Markers for lipid metabolism will be measured during fasted state at day 0, day 14, day 25 and day 28 of each intervention period', 'description': 'Markers include fasting LDL-C \\[mmol/L\\], HDL-C \\[mmol/L\\], total cholesterol \\[mmol/L\\], non-HDL cholesterol \\[mmol/L\\] and triacylglycerol \\[mmol/L\\] concentrations. Change between diets will be assessed using a linear mixed model with subject as random factor and day 0 as co-variant.'}, {'measure': 'Change in fasted lipid ratios between dietary period high in palmitic acid and dietary period high in stearic acid', 'timeFrame': 'Markers for lipid metabolism will be measured during fasted state at day 0, day 14, day 25 and day 28 of each intervention period', 'description': 'Markers include fasting total cholesterol to HDL-C ratio and LDL-C to HDL-C ratio. Change between diets will be assessed using a linear mixed model with subject as random factor and day 0 as co-variant.'}, {'measure': 'Change in fasted apolipoproteins between dietary period high in palmitic acid and dietary period high in stearic acid', 'timeFrame': 'Apolipoproteins will be measured during fasted state at day 0, day 14, day 25 and day 28 of each intervention period', 'description': 'Apolipoproteins include fasting ApoA1 \\[μg/mL\\] and ApoB100 \\[μg/mL\\]. Change between diets will be assessed using a linear mixed model with subject as random factor and day 0 as co-variant.'}, {'measure': 'Change in postprandial triacylglycerol levels between dietary period high in palmitic acid and dietary period high in stearic acid', 'timeFrame': 'Triacylglycerol [mmol/L] is measured during postprandial state at day 28 (0 to 480 minutes after meal intake) of each intervention period', 'description': 'Change between diets will be assessed using a linear mixed model with subject as random factor and day 0 as co-variant.'}]}, 'conditionsModule': {'keywords': ['Palmitic acid', 'Stearic acid', 'HDL-metabolism', 'Human intervention study'], 'conditions': ['Dyslipidemia']}, 'referencesModule': {'references': [{'pmid': '33733339', 'type': 'DERIVED', 'citation': 'van Rooijen MA, Plat J, Zock PL, Blom WAM, Mensink RP. Effects of two consecutive mixed meals high in palmitic acid or stearic acid on 8-h postprandial lipemia and glycemia in healthy-weight and overweight men and postmenopausal women: a randomized controlled trial. Eur J Nutr. 2021 Oct;60(7):3659-3667. doi: 10.1007/s00394-021-02530-2. Epub 2021 Mar 17.'}, {'pmid': '32900520', 'type': 'DERIVED', 'citation': 'van Rooijen MA, Plat J, Blom WAM, Zock PL, Mensink RP. Dietary stearic acid and palmitic acid do not differently affect ABCA1-mediated cholesterol efflux capacity in healthy men and postmenopausal women: A randomized controlled trial. Clin Nutr. 2021 Mar;40(3):804-811. doi: 10.1016/j.clnu.2020.08.016. Epub 2020 Aug 27.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether palmitic acid (C16:0) and stearic acid (C18:0) have different effects on HDL metabolism during the fasted state.', 'detailedDescription': 'Study design:\n\nDouble blind, randomized, cross-over study with two different diets: one diet will be high in palmitic acid (C16:0) and the other diet will be high in stearic acid (C18:0). Subjects will receive both diets for 4 weeks with a wash-out period of 4-6 weeks in between. Contrast in the intakes of palmitic acid and stearic acid is 6% of energy. A postprandial test will be carried out at the end of each dietary period.\n\nStudy population:\n\nAccounting for a dropout rate of 20%, 40 healthy men and postmenopausal women, aged between 45 and 70 year, having a BMI (body mass index) between ≥ 18.0 and ≤ 30.0 kg/m2 will be recruited.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Apparently healthy men and post-menopausal women (post-menopausal for at least one year) as judged by study physician\n* BMI ≥ 18.0 and ≤ 30.0 kg/m2\n* Aged between 45 and 70 years\n* Willing to comply to study protocol during study\n* Having a general practitioner\n* Agreeing to be informed about medically relevant personal test-results by a physician\n* Informed consent signed\n* Accessible veins on arms as determined by examination at screening\n\nExclusion Criteria:\n\n* Having a medical condition which might impact study measurements\n* Use of over-the-counter and prescribed medication, which may interfere with study measurements\n* Use of oral antibiotics in 40 days or less prior to the start of the study;\n* Use of food supplements or plant-sterol/stanol-enriched foods or supplements in the three months prior to the screening and/or during the study;\n* Reported alcohol consumption ≥ 10 units/week (female) or ≥ 14 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 2 months prior to screening\n* Regular smokers (at least one cigarette (or equivalent) daily or \\>7 cigarettes (or equivalent) weekly. Smokers who cannot comfortably restrain from smoking for up to 2 days will also be excluded\n* Reported dietary habits: medically prescribed diet, allergy/intolerance to test products that will be provided during the study\n* Blood donation in the past 3 months\n* Drug abuse\n* Reported participation in another nutritional or biomedical trial 3 months prior to screening\n* Fasting triacylglycerol concentrations at screening: ≥ 4.5 mmol/L\n* Serum lipids: treatment recommended according to the "Multidisciplinary guidelines Cardiovascular risk management"\n* Fasting HbA1c ≥ 48 mmol/mol (or 6.5%)'}, 'identificationModule': {'nctId': 'NCT02835651', 'briefTitle': 'Saturated Fatty Acids and HDL Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Effects of C16:0 Versus C18:0 on HDL Metabolism and Other Cardiometabolic Risk Markers: A Dietary Intervention Study in Healthy Normal-weight and Overweight Subjects', 'orgStudyIdInfo': {'id': 'METC 15-3-052'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Palmitic acid', 'description': 'Diet rich in palmitic acid', 'interventionNames': ['Dietary Supplement: Palmitic acid']}, {'type': 'EXPERIMENTAL', 'label': 'Stearic acid', 'description': 'Diet rich in stearic acid', 'interventionNames': ['Dietary Supplement: Stearic acid']}], 'interventions': [{'name': 'Palmitic acid', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Experimental products are enriched with C16:0', 'armGroupLabels': ['Palmitic acid']}, {'name': 'Stearic acid', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Experimental products are enriched with C18:0', 'armGroupLabels': ['Stearic acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6200 MD', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Center', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Ronald P Mensink, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Unilever R&D', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}