[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fatty-acids-omega-3\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fatty-acids-omega-3":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,55,104],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100399795","targeting-risk-factors-for-diabetes-in-subjects-with-normal-blood-cholesterol-using-omega-3-fatty-acids-100399795",false,"NCT04485871","Targeting Risk Factors for Diabetes in Subjects With Normal Blood Cholesterol Using Omega-3 Fatty Acids","White Adipose Tissue LDL Receptors and Omega-3 as Modulators of the Risk for Type 2 Diabetes in Subjects With Normal Plasma LDL Cholesterol","Inclusion Criteria:\n\nMen and post-menopausal women:\n\n* Having a body mass index (BMI= 25-40 kg\u002Fm2)\n* Aged between 45 and 74 years\n* Having confirmed menopausal status (FSH ≥ 30 U\u002Fl)\n* Non-smoker\n* Sedentary (less than 2 hours of structured physical exercise (ex: sports club) per week)\n* Low alcohol consumption: less than 2 alcoholic drinks\u002Fday\n\nExclusion Criteria:\n\n* Plasma LDL cholesterol \\> 3.5 mmol\u002FL (i.e. \\> 75th percentile in a Canadian population).\n* Elevated risk of cardiovascular disease (≥ 20% of calculated Framingham Risk Score) who would require immediate medical intervention by lipid-lowering agents.\n* Prior history of cardiovascular events (like stroke, transient ischemic attack, myocardial infarction, angina, heart failure…)\n* Systolic blood pressure \\> 140 mmHg or diastolic blood pressure \\> 90 mmHg\n* Type 1 or 2 diabetes or fasting glucose \\> 7.0 mmol\u002FL\n* Prior history of cancer within the last 3 years\n* Thyroid disease - untreated or unstable\n* Anemia - Hb \\\u003C 120 g\u002FL\n* Renal dysfunction or plasma creatinine \\> 100 µmol\u002FL\n* Hepatic dysfunction - AST\u002FALT \\> 3 times normal limit\n* Blood coagulation problems (i.e. bleeding predisposition)\n* Autoimmune and chronic inflammatory disease (i.e. celiac, inflammatory bowel, Graves, multiple sclerosis, psoriasis, rheumatoid arthritis, and lupus).Known history of difficulties accessing a vein\n* Claustrophobia\n* Sleep apnea\n* Seizures\n* Concomitant medications: Hormone replacement therapy (except thyroid hormone at a stable dose), systemic corticosteroids, anti-psychotic medications and psycho-active medication, anticoagulant or anti-aggregates treatment (Aspirin, NSAIDs, warfarin, coumadin..), adrenergic agonist, anti-hypertensive drugs, weight-loss medication, lipid lowering medication\n* Known substance abuse\n* Already taking more than 250 mg of omega-3 supplements (EPA\u002FDHA) per day\n* Allergy to seafood or fish\n* Allergy to Xylocaine\n* Unable to eat the components of the high fat meal (croissant, cheese, bacon, brownies)\n* None compliance to the study requirements (i.e. not being fasting) or cancellation of the same scheduled testing visit more than once.\n* Lack of time to participate in the full length of the study (33 weeks)\n* Have exceeded the annual total allowed radiation dose (like X-ray scans and\u002For tomography in the previous year or in the year to come) according to the physician's judgement.\n* All other medical or psychological conditions deemed inappropriate according to the physician",true,"ALL","45 Years","74 Years",{"count":21,"type":22},48,"ESTIMATED","INTERVENTIONAL",[25],"NA","Every 3 minutes a new case of diabetes is diagnosed in Canada, mostly type 2 diabetes (T2D) increasing the risk for heart disease. T2D and heart disease share many common risk factors such as aging, obesity and unhealthy lifestyle.\n\nParadoxically however, while lowering blood LDL, commonly known as \"bad cholesterol\", is protective against heart disease, research over the past 10 years have shown that the lower is blood LDL, the higher is the chance of developing T2D. This phenomena is happening whether blood LDL is lowered by a common drug against heart disease called Statins, or by being born with certain variations in genes, some of which are very common (\\~80% of people have them).\n\nTo date, it is unclear why lowering blood LDL is associated with higher risk for diabetes, and whether this can be treated naturally with certain nutrients.\n\nInvestigators believe that lowering blood LDL by forcing LDL entry into the body tissue through their receptors promotes T2D. This is because investigators have shown that LDL entry into human fat tissue induces fat tissue dysfunction, which would promote T2D especially in subjects with excess weight.\n\nOn the other hand, investigators have shown that omega-3 fatty acids (omega-3) can directly treat the same defects induced by LDL entry into fat tissue. Omega-3 is a unique type of fat that is found mostly in fish oil.\n\nThus the objectives of this clinical trial to be conducted in 48 subjects with normal blood LDL are to explore if:\n\n1. Subjects with higher LDL receptors and LDL entry into fat tissue have higher risk factors for T2D compared to subjects with lower LDL receptors and LDL entry into fat tissue\n2. 6-month supplementation of omega-3 from fish oil can treat subjects with higher LDL receptors and LDL entry into fat tissue reducing their risk for T2D.\n\nThis study will thus explore and attempt to treat a new risk factor for T2D using an inexpensive and widely accessible nutraceutical, which would aid in preventing T2D in humans.",[28,29,30,31],"Type 2 Diabetes","Inflammation","Insulin Sensitivity\u002FResistance","Fatty Acids, Omega-3",[33,34,35,36,37,38,39,40,41],"Proprotein Convertase Subtilisin \u002F kexin Type 9 (PCSK9)","NLRP3 inflammasome","Eicosapentaenoic acid (EPA)","Docosahexaenoic acid (DHA)","White adipose tissue","Fat metabolism","ApoB-lipoproteins","LDL receptors (LDLR)","Cluster of differentiation 36 (CD36)","RECRUITING","2026-03-11",{"date":45,"type":46},"2026-03-12","ACTUAL",{"date":48,"type":46},"2019-12-19",{"date":50,"type":22},"2027-05-31",{"name":52,"class":53},"Institut de Recherches Cliniques de Montreal","OTHER",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":16,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":23,"phases":65,"briefSummary":67,"conditions":68,"keywords":74,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":54},"100623137","phase-2-ala-enriched-nutrition-for-prevention-of-cognitive-decline-in-apoe4-older-adults-100623137","NCT07392723","ALA-enriched Nutrition for Prevention of Cognitive Decline in APOE4 Older Adults","Alpha Linolenic Acid-enriched Nutrition for Prevention of Cognitive Decline in APOE4 Older Adults With Mild Cognitive Impairment: Targeting Cerebrovascular and Blood-brain Barrier Health","Inclusion Criteria:\n\n* Age 60 years or older\n* Have amnestic Mild Cognitive Impairment (MCI) - memory problems that do not interfere with daily life.\n* Carry at least one APOE4 gene allele (determined by a blood test).\n* Be fluent in English or Spanish.\n* Have a study partner (family member or friend) who can provide information about daily function.\n* Have the ability to give informed consent and comply with study visits and procedures.\n\nExclusion Criteria:\n\n* A diagnosis of dementia or any other brain disease that significantly affects thinking or memory (e.g., Alzheimer's disease, Parkinson's disease, schizophrenia, epilepsy, traumatic brain injury).\n* History of stroke or other major neurological condition.\n* Short life expectancy due to end-stage disease or other serious medical condition.\n* Active cancer treatment that could interfere with study participation.\n* Allergy or sensitivity to flaxseed oil or corn oil.\n* Current use of flaxseed, flax oil, or fish oil supplements more than once per week.\n* MRI contraindications, such as pacemakers, metallic implants, or severe claustrophobia.\n* Current or past history of prostate cancer, regardless of remission status, OR a prostate-specific antigen (PSA) level \\> 20 ng\u002FmL at screening.\n* Use of experimental Alzheimer's treatments (e.g., amyloid monoclonal antibodies) unless on a stable regimen as confirmed by the treating physician.","60 Years",{"count":64,"type":22},20,[66],"PHASE2","This randomized, double-blind, placebo-controlled pilot trial will evaluate the effects of alpha-linolenic acid (ALA) supplementation on cognitive function, blood-brain barrier integrity, and brain vascular health in older adults with mild cognitive impairment and APOE4 genotype. By targeting the endogenous synthesis of docosahexaenoic acid (DHA) through ALA supplementation, the investigators aim to overcome the limitations of direct DHA supplementation, particularly in APOE4 carriers who exhibit low brain DHA levels and impaired blood-brain barrier function. This innovative approach offers a safe, cost-effective, and easily implementable therapeutic strategy for older adults at high risk for Alzheimer's dementia, especially APOE4 carriers, addressing a critical need given the limited cognitive benefits and significant adverse events of current amyloid-clearing drugs in this population.",[69,70,71,72,73,31],"Cognitive Dysfunction","Alzheimer Disease","Blood-Brain Barrier","Apolipoprotein E, Deficiency or Defect of","Brain Aging",[75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94],"Alpha-Linolenic Acid","Flaxseed Oil","Apolipoprotein E4","Nutritional Intervention","APOE4 Dysfunction","Cognitive Function","Brain MRI","Blood Biomarkers","Vascular Integrity","Neurodegeneration","Aging Brain","Memory Loss Prevention","AD Prevention Trial","Alzheimer's Disease","Cognitive decline prevention","Blood-brain barrier","Dementia prevention","Older adults","Biomarkers","Magnetic resonance imaging (MRI)","2026-01-30",{"date":97,"type":46},"2026-02-06",{"date":99,"type":46},"2025-01-12",{"date":101,"type":22},"2027-10",{"name":103,"class":53},"Michal Schnaider Beeri, Ph.D.",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":16,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":114,"phases":4,"briefSummary":115,"conditions":116,"keywords":117,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":54},"100586521","evaluation-of-the-nutritional-status-of-omega-3-fatty-acids-and-the-possible-influences-of-dietary-patterns-and-different-socioeconomic-factors-in-a-spanish-population-over-60-years-of-age-100586521","NCT06916455","Evaluation of the Nutritional Status of Omega-3 Fatty Acids and the Possible Influences of Dietary Patterns and Different Socioeconomic Factors, in a Spanish Population Over 60 Years of Age","Evaluation of the Nutritional Status of Omega-3 Fatty Acids and the Possible Influences of Dietary Patterns and Different Socioeconomic Factors in a Spanish Population Over 60 Years of Age","OMEGAPRED","Inclusion Criteria:\n\n* Older than 60 years of age\n\nExclusion Criteria: Diseases that affect nutritional status\n\n* Gastrointestinal diseases that affect the absorption of nutrites\n* Cancer\n* Chronic kidney disease",{"count":113,"type":22},800,"OBSERVATIONAL","The long-chain polyunsaturated fatty acids (PUFA) of the n-3 or omega-3 series and, in particular, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), both derived from the essential fatty acid alpha-linolenic acid, are part of all cell membranes and from them derive numerous compounds such as prostaglandins, thromboxanes, leukotrienes, resolvins, protectins and maresins that play numerous biological roles, most notably in the control of body homeostasis, blood coagulation and inflammation. The omega-3 index is a biomarker that reflects the nutritional status of n-3 PUFA, as well as cardiometabolic risk and cardiovascular health. This index is determined as the sum of the percentages in weight of EPA and DHA over the total of fatty acids present in the erythrocyte membranes.\n\nPrevious studies carried out in Spain, such as ANIBES, indicate that in adults, and especially in those over 60 years of age, the intake of n-3 PUFA is well below the international recommendations, which is directly related to a low intake of fish, since both EPA and DHA are abundant in oily fish. However, in Spain, the nutritional status of omega-3 PUFA and their possible association with a higher prevalence of cardiometabolic risk is unknown, as well as the relationships with food intake and the cultural and socioeconomic status of the population. Therefore, the main objective of the present study is to evaluate the omega-3 index in the Spanish population over 60 years of age and to establish whether there are differences by sex, as well as in the different Spanish communities. In addition, we will study the possible associations between the omega-3 index and food intake, particularly of fish and omega-3 PUFA-rich supplements, as well as their possible associations with cardiometabolic risk indicators and cultural and socioeconomic conditions of the population.\n\nDetermination of the omega-3 index usually requires an invasive venous blood collection followed by processing for separation of erythrocytes and extraction and methylation of their membrane lipids followed by chromatographic analysis. But fatty acids can also be determined on whole blood using less invasive methods, such as obtaining drops of blood with a lancet and depositing them on chromatographic paper impregnated with an antioxidant (dried spots). All this makes sampling much easier, although the result of the omega-3 index has to be corrected because it is affected by the lipid composition present in the plasma. For this reason, this project aims to carry out a validation study between the results of the fatty acid profile obtained in erythrocytes and in whole blood in the Spanish population (medamediantedried spots). In short, the results obtained will be used to calculate regression lines that allow us to evaluate the omega-3 index in erythrocytes in the adult Spanish population from different regions of Spain by means of a minimally invasive methodology. For this purpose, 800 participants aged 60 years or more will be recruited from different regions of Spain, randomized by age and sex for each region; at least 100 of the total number of participants should be frequent consumers of omega-3 supplements; if this figure is not obtained, an active search will be carried out until this number is reached (booster). All of them will be interviewed to complete different questionnaires on cultural and socioeconomic status, history of metabolic disease and cardiovascular health, and questionnaires on frequency of consumption and food intake reminders as established by the European Union. With the help of health personnel from different pharmacies and in mutual agreement with the General Council of Pharmaceutical Associations of Spain, a whole blood sample will be taken by lancet, which will be used to quantify the omega-3 index. For the validation study it will be necessary to obtain whole venous blood extracted by venipuncture from a subsample of 200 participants. This sample will be processed and will be used to determine the fatty acid profile in whole blood and in erythrocytes, which will be related by means of multiple linear and bivariate regression models with the fatty acid profile obtained in the dried spots. Cardiometabolic risk markers will also be determined in these 200 subjects, which will be used to establish relationships with the calculated omega-3 status.",[31],[118,119,120,121],"erythrocyte omega-3 fatty acids","population over 60 years of age","nutritional status","cardiovascular risk","2025-04-08",{"date":124,"type":46},"2025-04-11",{"date":126,"type":46},"2025-03-19",{"date":128,"type":22},"2026-12-31",{"name":130,"class":53},"Universidad de Granada"]