protocolSection identificationModule nctId: NCT06364163, orgStudyIdInfo id: 697716, briefTitle: Effect of Herring Oil Concentrate on LDL Cholesterol Concentration in Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-12, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of Bergen, class: OTHER, collaborators name: The Norwegian Seafood Research Fund, descriptionModule briefSummary: High cholesterol concentration is a major risk factor for cardiovascular disease (CVD), and consumption of fish has been associated with a lower CVD risk in several studies. The beneficial health effects of consuming fish have traditionally been ascribed to the long-chain PUFA (LC-PUFA) EPA (C20:5n-3) and DHA (C22:6n-3), although consumption of fish oils or concentrates with high EPA and DHA contents does not affect the cholesterol concentration in humans and lowers the cholesterol concentration in rats and mice only when given in very high doses. Fish oils contain a plethora of fatty acids besides EPA and DHA, and in recent years, increased focus has been on the long-chain MUFA (LC-MUFA) cetoleic acid (C22:1n-11). Cetoleic acid is found in high amounts in oils from certain fish species such as herring, which has relatively low contents of both EPA and DHA. The investigators have recently summarised and meta-analysed the available literature that investigates the effects of diets containing fish oils or fish oil concentrates that have a high content of cetoleic acid but low or no content of EPA and DHA on cholesterol concentration in rodents, showing that cetoleic acid-rich fish oils and concentrates prevent high cholesterol concentration., conditionsModule conditions: High Cholesterol, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Herring oil concentrate, interventions name: Control, outcomesModule primaryOutcomes measure: Serum concentration of LDL-cholesterol, secondaryOutcomes measure: Serum concentration of HDL-cholesterol, secondaryOutcomes measure: Serum concentration of total cholesterol, secondaryOutcomes measure: Serum concentrations of apolipoproteins, secondaryOutcomes measure: Serum concentrations of amino acids metabolites, secondaryOutcomes measure: Serum concentration of one-carbon pathway metabolites, secondaryOutcomes measure: Fatty acid composition in leukocytes, secondaryOutcomes measure: Serum concentration of glucose, secondaryOutcomes measure: Serum concentration of insulin, secondaryOutcomes measure: Urine concentrations of cystatin C, secondaryOutcomes measure: Urine concentrations of T cell immunoglobulin mucin-1 (TIM-1), secondaryOutcomes measure: Body composition, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Bergen, city: Bergen, country: Norway, contacts name: Oddrun A Gudbrandsen, PhD, role: CONTACT, phone: 55975553, phoneExt: 47, email: nkjgu@uib.no, geoPoint lat: 60.39299, lon: 5.32415, hasResults: False