Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-02-21 @ 9:29 PM
Study NCT ID:
NCT01566305
Status:
COMPLETED
Last Update Posted:
2018-09-06
First Post:
2012-03-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Buttermilk on Serum LDL Cholesterol Concentrations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], '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': 'D000070696', 'term': 'Buttermilk'}], 'ancestors': [{'id': 'D000088082', 'term': 'Fermented Beverages'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D043302', 'term': 'Cultured Milk Products'}, {'id': 'D008892', 'term': 'Milk'}, {'id': 'D000074421', 'term': 'Fermented Foods'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2012-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-04', 'studyFirstSubmitDate': '2012-03-27', 'studyFirstSubmitQcDate': '2012-03-27', 'lastUpdatePostDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in serum LDL cholesterol concentrations', 'timeFrame': 'LDL cholesterol will be measured at day 0, 11, 14, 56, 95 and 98 during the study'}], 'secondaryOutcomes': [{'measure': 'Changes in serum total and HDL cholesterol, triacylglycerol, apoA-I, apoB and hsCRP concentrations', 'timeFrame': 'Serum total and HDL cholesterol, triacylglycerol, apoA-I and ApoB will be measured at day 0, 11, 14, 56, 95 and 98 during the study. hsCRP concentrations will be measured at day 11, 14, 95 and 98.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypercholesterolemia', 'Buttermilk', 'Dietary Modification', 'Cardiovascular Disease']}, 'referencesModule': {'references': [{'pmid': '25456153', 'type': 'DERIVED', 'citation': 'Severins N, Mensink RP, Plat J. Effects of lutein-enriched egg yolk in buttermilk or skimmed milk on serum lipids & lipoproteins of mildly hypercholesterolemic subjects. Nutr Metab Cardiovasc Dis. 2015 Feb;25(2):210-7. doi: 10.1016/j.numecd.2014.10.003. Epub 2014 Oct 13.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.1016/j.numecd.2014.10.003', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Rationale and objective:\n\nBased on the results of a pilot study, the objective of the present study is to evaluate whether buttermilk lower serum LDL cholesterol concentrations and can prevent the serum LDL cholesterol raising effects of eggs.\n\nStudy Design:\n\nThe study has a randomized placebo-controlled factorial 2x2 design. The total study duration is 14 weeks, consisting of a 2 weeks run-in period and a 12 weeks experimental period. Subjects will be stratified for age, gender and BMI over the experimental groups.\n\nStudy population:\n\nOne hundred and eight healthy male and female subjects, aged 18-70 years, with slightly elevated serum total cholesterol concentrations (5.5-8.0 mmol/l).\n\nIntervention:\n\nDuring the entire study period, volunteers are instructed to consume a diet according to the Dutch dietary guidelines (35 en% fat (10 en% saturated fat), 50-55 en% carbohydrates). During the two weeks run-in period all subjects will drink daily at lunch 100 mL skimmed milk. During the 12 weeks experimental period, a first group of subjects will continue drinking the skimmed milk (control group), while a second group will consume a low-fat buttermilk, a third group skimmed milk enriched with egg-yolk, and a fourth group egg-yolk incorporated into a low-fat buttermilk based beverage. The egg-yolk will be enriched in lutein. Whole egg consumption (others than provided by us) is not allowed during the entire study.\n\nMain study parameters/endpoints:\n\nMeasurements will be performed during the run-in period (days 0, 11 and 14) and during the experimental period (days 56, 95 and 98). The main effects (egg-yolk and buttermilk consumption) will be calculated as the absolute differences between values obtained at the end of the experimental (average days 95 and 98) and run-in (average days 11 and 14) periods. The primary endpoint is the change in serum LDL cholesterol concentrations. Secondary endpoints are changes in serum total and HDL cholesterol, triacylglycerol, apoA-I, apoB and hsCRP concentrations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 18 and 70 years\n* Fasting serum total cholesterol between 5.5 - 8.0 mmol/l\n* Fasting plasma glucose \\< 7.0 mmol/l\n* BMI between 25-30 kg/m2\n* non-smoking\n* Willingness to abstain for the duration of the study from egg consumption\n\nExclusion Criteria:\n\n* unstable body weight (weight gain or loss \\>3 kg in the past 3 months)\n* allergic for eggs or egg-rich products\n* allergic or intolerant for cow-milk (lactose) based products\n* indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus\n* use of medication or a diet known to affect serum lipid or glucose metabolism - active cardiovascular disease (for instance congestive heart failure) or recent (\\<6 months) event, such as acute myocardial infarction or cerebro-vascular accident\n* not willing to stop the consumption of vitamin supplements, fish oil capsules or products rich in plant stanol or sterol esters 3 weeks before the start of the study\n* men: consumption of \\>21 alcohol consumptions a week\n* women: consumption of \\>14 alcohol consumptions a week\n* abuse of drugs\n* pregnant or breastfeeding women\n* participation in another biomedical study within 1 month prior to the screening visit\n* having donated blood (as blood donor) within 1 month prior to the screening visit or planning to do so during the study\n* impossible or difficult venipuncture as evidenced during the screening visits'}, 'identificationModule': {'nctId': 'NCT01566305', 'briefTitle': 'Effects of Buttermilk on Serum LDL Cholesterol Concentrations', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'The Effects of Buttermilk With or Without Lutein-enriched Egg Yolk on the Serum LDL Cholesterol Concentration of Slightly Hypercholesterolaemic Volunteers', 'orgStudyIdInfo': {'id': 'NL33461.068.10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Buttermilk with added egg yolk', 'interventionNames': ['Dietary Supplement: Buttermilk with added egg yolk']}, {'type': 'EXPERIMENTAL', 'label': 'Buttermilk without added egg-yolk', 'interventionNames': ['Dietary Supplement: Buttermilk without added egg-yolk']}, {'type': 'EXPERIMENTAL', 'label': 'Skimmed milk with added egg-yolk', 'interventionNames': ['Dietary Supplement: Skimmed milk with added egg-yolk']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Skimmed milk without added egg yolk', 'interventionNames': ['Dietary Supplement: Skimmed milk without added egg yolk']}], 'interventions': [{'name': 'Buttermilk without added egg-yolk', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Buttermilk without added egg-yolk', 'armGroupLabels': ['Buttermilk without added egg-yolk']}, {'name': 'Buttermilk with added egg yolk', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Buttermilk with added egg yolk', 'armGroupLabels': ['Buttermilk with added egg yolk']}, {'name': 'Skimmed milk with added egg-yolk', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Skimmed milk with added egg-yolk', 'armGroupLabels': ['Skimmed milk with added egg-yolk']}, {'name': 'Skimmed milk without added egg yolk', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Skimmed milk without added egg yolk', 'armGroupLabels': ['Skimmed milk without added egg yolk']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6200', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Maastricht University', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Jogchum Plat, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}