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
NCT06916455 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 800
Last updated 2025-04-11
Summary
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.
Previous 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.
Determination 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.
Conditions
- Fatty Acids, Omega-3
Sponsors & Collaborators
-
Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
collaborator OTHER -
Universidad de Granada
lead OTHER
Principal Investigators
-
Estefanía Sánchez Rodríguez, PhD · Universidad de Granada
Eligibility
- Min Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-03-19
- Primary Completion
- 2026-04-30
- Completion
- 2026-12-31
Countries
- Spain
Study Locations
More Related Trials
-
Plasma Diurnal Variation in and Absorption of EPA and DHA
NCT02661698 ·Status: COMPLETED ·Phase: NA
-
Effects of Omega-3 Fatty Acids on Markers of Inflammation
NCT01129050 ·Status: COMPLETED ·Phase: NA
-
Effects of N-3 Intake on Lipid Profile, Biochemical and Inflammatory Markers in Subjects with Obesity
NCT04901052 ·Status: COMPLETED ·Phase: NA
-
Effects of DHA on Pro-resolving Anti-inflammatory Mediators in Obese Patients Undergoing Weight-loss Treatment
NCT01865448 ·Status: COMPLETED ·Phase: NA
-
The Effect of n-3 LCPUFA on Immune Function and Cardiovascular Risk Factors
NCT00266292 ·Status: UNKNOWN ·Phase: NA
-
Nutritional Study on the Beneficial Effects of Canned Fish Consumption on Healthy Adult Population
NCT05213273 ·Status: COMPLETED ·Phase: NA
-
Metabolism of Omega-3 and Omega-6 During Healthy Aging
NCT02957188 ·Status: COMPLETED
-
Effects of Dietary Omega-3 Fatty Acids on Reproductive Hormones in Obese Women
NCT01894581 ·Status: COMPLETED ·Phase: NA
-
n-3 Polyunsaturated Fatty Acids in Obesity
NCT00760760 ·Status: COMPLETED ·Phase: PHASE2
-
Effect of Omega-3 PUFA Supplementation in NAFLD Patients
NCT00230113 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy of a Dietary Ingredient Combination With Omega-3 for Joint Function
NCT05279573 ·Status: COMPLETED ·Phase: NA
-
Omega-3 and Cardiovascular Risk Factors and Kidney Related Biomarkers
NCT03197220 ·Status: COMPLETED ·Phase: NA
-
Genotype-related Effects of PUFA
NCT02296385 ·Status: COMPLETED ·Phase: NA
-
Fish Oil and Cardiovascular Suboptimal Health
NCT02103517 ·Status: COMPLETED ·Phase: PHASE3
-
Effects of n3 LC PUFAs on Inflammatory, Immune and Senescence Features in Polyvascular Older Subjects (OMSAGE)
NCT06666101 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
To Evaluate the Effects of Omega 3 Fatty Acids in the Context of Cancer Prevention
NCT05427604 ·Status: COMPLETED ·Phase: NA
-
Study of the Effect of Different Fish Oils on Omega-3 Index (CetoIndex)
NCT04768595 ·Status: UNKNOWN ·Phase: NA
-
Erythrocyte Omega-3 Fatty Acid Content in Elite Athletes
NCT02610270 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Lipoproteins and ImmunoMetabolism
NCT05746013 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Role of Polyunsaturated Fatty Acids (PUFA)-Gene Interactions in Heath Disparities
NCT02962128 ·Status: COMPLETED ·Phase: NA
-
Omega-3 Fatty Acids on Fasting and Postprandial Triglycerides (TG) Response - a Pilot Study
NCT05621083 ·Status: COMPLETED ·Phase: NA
-
N-3 PUFA and Rheumatoid Arthritis in Korea
NCT01618019 ·Status: COMPLETED ·Phase: NA
-
Polyunsaturated Fatty Acids Supplementation and Blood Metabolome
NCT03892486 ·Status: UNKNOWN ·Phase: NA
-
Oxidized Omega-3 Supplements With Different Oxidation
NCT01799720 ·Status: COMPLETED ·Phase: NA
-
Omega-3 Fatty Acid Supplementation in Older Adults
NCT01666392 ·Status: WITHDRAWN ·Phase: NA