Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT06172335
Status:
RECRUITING
Last Update Posted:
2025-01-16
First Post:
2023-10-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Cetoleic Acid on Atherosclerosis (Ketolinsyre's Effekt på Aterosklerose)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C015058', 'term': 'cetoleic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'All participant, the major investigator, study coordinator and the study staff are blinded for the randomizing. The capsules and capsule containers will only be identifiable by the ID (identifying) numbers on the containers.\n\nAllocation of participants to the specific intervention group is carried out by a statistician and one person not involved in conducting the study.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized double-blinded controlled trial (Randomized 1:1, control:intervention).\n\nRun-in period of 3 weeks where all participants receive the control capsules.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-14', 'studyFirstSubmitDate': '2023-10-02', 'studyFirstSubmitQcDate': '2023-12-06', 'lastUpdatePostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EPA and DHA in plasma', 'timeFrame': '4 weeks intervention', 'description': 'EPA and DHA concentration in plasma measured at baseline and after 4 week intervention (and as a "control measurement" at the screening visit)'}], 'secondaryOutcomes': [{'measure': 'Lipid profile', 'timeFrame': '4 weeks intervention', 'description': 'Plasma levels of triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol, apolipoproteins (apoB and apoA), and Lp(a)'}, {'measure': 'Glucose', 'timeFrame': '4 weeks intervention', 'description': 'Serum levels of glucose'}, {'measure': 'Inflammatory markers', 'timeFrame': '4 weeks intervention', 'description': 'The concentration of circulating levels of inflammatory markers'}, {'measure': 'Gene expression, metabolome and lipidome', 'timeFrame': '4 weeks intervention', 'description': 'Changes in PBMC (peripheral blood mononuclear cell) gene expression profile. Changes in plasma metabolome and lipidome profile. Changes in PBMC epitranscriptome, as a regulator of the gene expression profile'}, {'measure': 'Resolvin', 'timeFrame': '4 weeks intervention', 'description': 'Blood levels of resolvin (omega- 3 derivates) concentration'}, {'measure': 'C-peptid', 'timeFrame': '4 weeks intervention', 'description': 'serum levels of C-peptid'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Omega 3 fatty acids', 'Sustainability', 'Cetoleic acid', 'Very long monounsaturated fatty acid', 'Cardiovascular disease prevention', 'Antiinflammation'], 'conditions': ['Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'In this Randomized Controlled Trial (RCT) we want to study the effect of an oil with high concentrations of cetoelic acid (C22:n1-11) (intervention) compared to supplements with a low concentration of cetoleic acid (control), but with equivalent content of EPA og DHA, on plasma levels of epa and dha as well as atherosclerotic markers, glucose, c-peptide and triglycerides in a patient group with a metabolically unfavorable phenotype.\n\nOur primary endpoints are changes in the concentration of EPA and DHA in plasma.', 'detailedDescription': 'This is a randomized double-blinded controlled trial (randomized 1:1). Study population: men and women 20-70 years with a metabolically unfavorable phenotype defined as: triglycerides \\> 1.7 mmol/L and waist measurement \\> 80 cm (women) and \\> 94 cm (men).\n\nStudy design:\n\n* 3 weeks run-in-period where all participants consume control capsules every morning.\n* Randomization intervention: control (1:1). All participants consume their capsules (control or intervention) for 4 weeks.\n\nThe intervention oil is consists of an oil high in cetoleic acid and the control oil is low in cetoleic acid. Both the intervention oil and the control oil are a mix of different oils; fish oils, olive oil, "high-oleic sunflower oil" and rapeseed oil so that the content of EPA, DHA and ALA is similar in the two oils.\n\nPower calculation and sample size:\n\nIt was expected a difference of 15% in n-3 between the groups after the intervention (Østbye et al. 2019, doi:10.1017/S0007114519001478).\n\nThe level of significance was set to 5% (two-sided) and the power to 80%. A total of thirty-eight subjects were required to participate in the study, but a high dropout rate was expected (20%) and it was considered necessary to include a total of seventy (n=70) subjects (thirty-five per arm).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Triglycerides \\> 1.7 mmol/L\n* Waist measurement \\> 80 cm (women) and \\> 94 cm (men)\n\nExclusion Criteria:\n\n* Chronic disease (liver/kidney/metabolism)\n* Ongoing active cancer treatment\n* Excessive alcohol consumption (\\>40g/day)\n* Pregnant/breastfeeding or planned pregnancy during the intervention\n* High intake of fish (\\>3 weekly meals)\n* Level of free thyroxine (T4) and triiodothyronine (T3) outside reference ranges.\n* Hypertension (≥ 160/ 100 mmHg)\n* Total cholesterol \\> 7.8 mmol/L\n* Blood donation during the intervention period\n* Difficulty following the protocol\n* Smoking or sniffing\n* Regular use (\\> 1 day/week) of anti-inflammatory drugs\n* Regular use of omega-3 supplements/cod liver oil\n* Drug use other than stable use of statins, hypertension drugs (Ca antagonists, diuretics and beta blockers).\n* Hormonal treatment excluding stable use of thyroxine and birth control pills/contraceptive rod'}, 'identificationModule': {'nctId': 'NCT06172335', 'briefTitle': "Effects of Cetoleic Acid on Atherosclerosis (Ketolinsyre's Effekt på Aterosklerose)", 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Effects of Ketolic Acid on Atherosclerosis Markers in High-risk Patients With Metabolic Syndrome (Effekt av Ketolinsyre på aterosklerosemarkører i høyrisikopasienter Med Metabolsk Syndrom)', 'orgStudyIdInfo': {'id': '605236'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention (Cetoleic acid)', 'description': '6 x capsules intervention oil (oil = mix of fish oils, olive oil, high-oleic sunflower oil and rapeseed oil) with high content of cetoleic acid (1780 mg/day, estimated: 29,76%) every morning for 4 weeks.', 'interventionNames': ['Dietary Supplement: Cetoleic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control oil', 'description': '6 x capsules control oil (oil= mix of fish oils, olive oil, high-oleic sunflower oil and rapeseed oil) with low content of cetoleic acid (35 mg/day, estimated 0.58%) every morning for 4 weeks.', 'interventionNames': ['Dietary Supplement: Control oil']}], 'interventions': [{'name': 'Cetoleic acid', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Very long monounsaturated fatty acid (C22:1n-11)', 'armGroupLabels': ['Intervention (Cetoleic acid)']}, {'name': 'Control oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Mix of oils with low cetoleic acid content', 'armGroupLabels': ['Control oil']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oslo', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Kirsten B Holven, Professor', 'role': 'CONTACT'}], 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'centralContacts': [{'name': 'Kirsten B. Holven, PhD', 'role': 'CONTACT', 'email': 'kirsten.holven@medisin.uio.no', 'phone': '+4722851361'}, {'name': 'Iselin S. Holen, MSc', 'role': 'CONTACT', 'email': 'ishole@ous-hf.no', 'phone': '+4722894882'}], 'overallOfficials': [{'name': 'Kirsten B. Holven, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Oslo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kirsten Bjørklund Holven', 'investigatorAffiliation': 'Oslo University Hospital'}}}}