Fatty Acids, Omega-3OMEGAPREDNCT06916455
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
An observational study of Fatty Acids, Omega-3, run by Universidad de Granada at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fatty Acids, Omega-3
- How many people
- 800 participants
- Where
- 1 siteSpain
- Study dates
- 19 Mar 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 800 volunteers in total, men and women from 37 locations in Spain distributed in 8 different areas (Nielsen Areas) covering the eastern, eastern, eastern, southern, southern, central, northwestern, northern and metropolitan areas of Madrid and Barcelona in Spain. These 800 participants will be randomized according to sex and the territory to which they belong, into three age groups: one group will be between 60 and 70 years old, another group will be between 71 and 80 years old, and the third will be made up of people over 80 years old. In addition, 100 of these subjects must be regular consumers of omega-3 supplements.
Who may be able to join
- Older than 60 years of age
Who cannot join
- Gastrointestinal diseases that affect the absorption of nutrites
- Cancer
- Chronic kidney disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Avd del Conocimiento 19
Granada, Granada, 18016
Estefanía Sánchez Rodríguez, PhD, +34677113815, estefaniasr@ugr.es
María D Mesa García, PhD, +34607505068, mdmesa@ugr.es
About this study
Official title: 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
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
- Keywords
- erythrocyte omega-3 fatty acids, population over 60 years of age, nutritional status, cardiovascular risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Validation cohort | Healthy people (n=200) over 60 year of age that will be bleeded for the validation of the dry spot methodology | |
| Exploratory cohort | Healthy people (n=600) over 60 year of age that will be study with the dry spot methodology |
What is being measured
The primary outcome is the main question the study is designed to answer.
omega-3 index
The omega-3 index measure the presence of omega-3 fatty acids in the erythrocyte membrane
Measured: At the time of enrollement
Secondary outcomes (8)
Nutritional assesment
Food frecuency questionarie
Measured: At the time of enrollement
Physical activity assesment
Physical activity questionaries
Measured: At the time of enrollement
Socioeconomic assesment
Socioeconomic questionaries
Measured: At the time of enrollement
DNA genotyping
Specific genes related to lipid metabolism and cardiovascular risk will be genotiped only in the validation cohort
Measured: At the time of enrollement
Plasma triacylglycerides
Plasma triacylglycerides only in the validation cohort
Measured: At the time of enrollement
Plasma cholesterol
Plasma Total cholesterol, HDL-Cholesterol, LDL-cholesterol only in the validation cohort
Measured: At the time of enrollement
Plasma glucose
Plasma glucose levels only in the validation cohort
Measured: At the time of enrollement
Plasma insulin
Plasma insulin levels only in the validation cohort
Measured: At the time of enrollement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start19 Mar 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty Acids, Omega-3Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
- Responsible party
- Principal investigator, María Dolores Mesa García, Universidad de Granada
- Investigators
- Estefanía Sánchez Rodríguez, PhD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916455
- Sponsor's protocol ID
- OMEGAPRED (PIP-0265-2024)
- Other IDs
- PIP-0265-2024
- Acronym
- OMEGAPRED
- Status last verified
- Apr 2025
- First submitted
- 31 Mar 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected anonimous IPD
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06916455
- Acronym / sponsor ID
- OMEGAPRED / OMEGAPRED (PIP-0265-2024)
- Conditions
- Fatty Acids, Omega-3
- Keywords
- erythrocyte omega-3 fatty acids, population over 60 years of age, nutritional status, cardiovascular risk
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Validation cohort | – | –Healthy people (n=200) over 60 year of age that will be bleeded for the validation of the dry spot methodology |
| Exploratory cohort | – | –Healthy people (n=600) over 60 year of age that will be study with the dry spot methodology |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 800 volunteers in total, men and women from 37 locations in Spain distributed in 8 different areas (Nielsen Areas) covering the eastern, eastern, eastern, southern, southern, central, northwestern, northern and metropolitan areas of Madrid and Barcelona in Spain. These 800 participants will be randomized according to sex and the territory to which they belong, into three age groups: one group will be between 60 and 70 years old, another group will be between 71 and 80 years old, and the third will be made up of people over 80 years old. In addition, 100 of these subjects must be regular consumers of omega-3 supplements.
Key inclusion criteria (1 listed)
- Older than 60 years of age
Key exclusion criteria (3 listed)
- Gastrointestinal diseases that affect the absorption of nutrites
- Cancer
- Chronic kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
omega-3 index
Time frame: At the time of enrollement
The omega-3 index measure the presence of omega-3 fatty acids in the erythrocyte membrane
8 secondary outcomes
Nutritional assesment
Time frame: At the time of enrollement
Physical activity assesment
Time frame: At the time of enrollement
Socioeconomic assesment
Time frame: At the time of enrollement
DNA genotyping
Time frame: At the time of enrollement
Plasma triacylglycerides
Time frame: At the time of enrollement
Plasma cholesterol
Time frame: At the time of enrollement
Plasma glucose
Time frame: At the time of enrollement
Plasma insulin
Time frame: At the time of enrollement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Individual participant dataSharing planned: Yes. all collected anonimous IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Estefanía Sánchez Rodríguez, PhD principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatty Acids, Omega-3, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact María D Mesa García, PhD (607505068, mdmesa@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
omega-3 index (time frame: At the time of enrollement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.