HypertriglyceridemiaHydroxyOmegaNCT06992323
Cardiometabolic Properties of Omega-3 Functionalized With Hydroxytyrosol
A study testing EPA + HT, EPA and Sunflower Oil in people with Hypertriglyceridemia and Normal, run by National Research Council, Spain at 1 site in Spain.
Trial summary
The primary aim of this study is to investigate the potential cardioprotective effects of daily nutritional doses of eicosapentaenoic acid (EPA) enriched with hydroxytyrosol (HT) on cardiovascular health, as well as its modulatory impact on the intestinal microbiota. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertriglyceridemia, Normal
- What is being tested?
- EPA + HT, EPA and Sunflower Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSpain
- Study dates
- 17 Feb 2025to Dec 2026
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18 to 70 years old
- Hypertriglyceridemia (150-250 mg/dl) or normal levels of triglycerides levels (<150 mg/dl)
Who cannot join
- Presence of chronic illnesses
- Currently undergoing pharmacological treatment
- Smoking
- Pregnancy
- Adherence to a vegetarian or vegan diet
Trial locations and contacts
1 site in 1 country.
Spain1 site
Institute of Food Science, Food Technology and Nutrition (ICTAN), CSIC
Madrid, Madrid, 28040
About this study
Official title: Cardiometabolic Properties of Omega-3 Funcionalized With Hydroxytyrosol in Healthy and Cardiovascular Risk Population
The primary aim of this study is to investigate the potential cardioprotective effects of daily nutritional doses of eicosapentaenoic acid (EPA) enriched with hydroxytyrosol (HT) on cardiovascular health, as well as its modulatory impact on the intestinal microbiota. This investigation will be conducted through a randomized, double-blind, crossover, and controlled nutritional intervention trial. The study population will include two cohorts: one with normotriglyceridemic individuals, and another with hypertriglyceridemic individuals. Participants will be randomly allocated to one of three intervention groups: (1) EPA+HT supplementation, (2) EPA alone, or (3) a placebo consisting of sunflower oil devoid of EPA.
Read the detailed description
The product to be tested is a combination of two key components: an oily preparation containing 97% eicosapentaenoic acid (EPA) and a natural extract (Oleacore®) with a high hydroxytyrosol content (10%). Oleacore® is naturally derived from olives using exclusively physical and mechanical methods and is commercialized by Olivenova Health SL (https://olivenova.com/es/). The EPA-97% component is supplied by Beeps Holding GMBH (https://bepsholding.com/el-holding/?lang=es). Three types of nutraceutical formulations will be prepared, and study participants will consume three capsules daily to achieve the following dosages:
- 2 g of EPA + 15 mg of hydroxytyrosol (HT) (3 Type-1 capsules, EPA+HT),
- 2 g of EPA (3 Type-2 capsules, EPA), and
- 2 g of seed oil (sunflower) as a placebo (3 Type-3 capsules, Placebo).
The daily dose of 15 mg HT was selected based on the EFSA claim for the prevention of LDL oxidation , while the 2 g EPA dose was established following EFSA recommendations for triglyceride reduction.
A chronic, randomized, controlled, crossover, double-blind, free-living study design is proposed, spanning 46 weeks. Following a two-week washout period, during which the consumption of extra virgin olive oil, and olives will be restricted, participants will be grouped based on baseline characteristics (control or hypertriglyceridemia). They will then be randomized into three groups (randomization performed using SPSS software), such that one-third of participants will receive EPA+HT, another third will receive EPA without HT, and the remaining third will receive a placebo nutraceutical containing sunflower oil with no EPA or HT.
Each intervention phase will last 12 weeks. After completing one intervention, participants will undergo a four-week washout period before transitioning to the next intervention. Before the start of each phase, participants will be provided with all necessary capsules (EPA+HT, EPA, or placebo) along with detailed consumption guidelines.Volunteers will take the capsules with lunch and dinner.
Additionally, during the study, volunteers will consume a commercial olive oil with a minimal phenol content as their culinary oil. This olive oil will also be supplied by the research team for family use (1 L/2 weeks). Participants will be instructed to maintain their usual lifestyle throughout the study but will be restricted from consuming any other culinary oils apart from the one provided by the research group, as well as olives. Furthermore, the use of dietary supplements containing antioxidants, other than vitamins, will be prohibited.
Participants will attend the Human Nutrition Unit (UNH) at ICTAN-CSIC on six occasions, corresponding to the beginning and end of each intervention phase. Once eligibility has been confirmed based on the inclusion and exclusion criteria, participants will attend the UNH for signing the informed consent, receiving olive oil for household consumption, and receiving instructions to begin the study.
During visits V1-V6 (corresponding to the start and end of each intervention with the different nutraceuticals), participants will report to the UNH at ICTAN-CSIC. Upon arrival, they will provide a fasting urine sample from their first morning void and a stool sample collected within the previous 24 hours. Additionally, a trained nurse will collect a fasting blood sample (40 mL, distributed into tubes containing various anticoagulants).
Blood pressure and heart rate will also be measured. Furthermore, participants will undergo a comprehensive anthropometric and body composition assessment. Dietary habits and physical activity levels will be monitored and evaluated during these visits.
Compliance with the intervention will be monitored through monthly telephone follow-ups, the collection of unused capsules, and the measurement of specific biomarkers, including plasma phosphatidylcholine-EPA levels as a marker of omega-3 fatty acid intake and urinary HT metabolites.
- Conditions
- Hypertriglyceridemia, Normal
- Being tested
- EPA + HT, EPA, Sunflower Oil
- Keywords
- cardiovascular risk, omega 3, hydroxytyrosol, hypertriglyceridemia
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPA + HTDietary supplement
Volunteers will consume during 12 weeks 2 g/d of EPA and 15 mg/d of HT, corresponding to 3 capsules. Additionally, they will consume a commercial olive oil with a minimal phenol content as their culinary oil that will be suplied by the research team for family use (1L/2 weeks)
EPADietary supplement
Volunteers will consume during 12 weeks 2 g/d of EPA corresponding to 3 capsules. Additionally, they will consume a commercial olive oil with a minimal phenol content as their culinary oil that will be suplied by the research team for family use (1L/2 weeks)
Sunflower OilDietary supplement
Volunteers will consume during 12 weeks 2 g/d of Sunflower Oil, corresponding to 3 capsules. Additionally, they will consume a commercial olive oil with a minimal phenol content as their culinary oil that will be suplied by the research team for family use (1L/2 weeks)
| Study group | Role | What they receive |
|---|---|---|
| EPA + HT | Experimental | EPA + HT: intake of 2 g/d of EPA and 15 mg/d of HT (3 Type-1 capsules, EPA + HT) Receives: Dietary Supplement: EPA + HT |
| EPA | Experimental | EPA: intake of 2 g/d of EPA (3 Type-2 capsules, EPA) Receives: Dietary Supplement: EPA |
| Sunflower oil (SO) | Active comparator | Sunflower Oil (SO): intake of 2 g/d of SO (3 Type-3 capsules, Placebo) Receives: Dietary Supplement: Sunflower Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cholesterol concentration
Total cholesterol in serum samples will be determined following reference methods recommended by the Sociedad Española de Bioquímica Clínica y Patología Molecular (SEQC) using the Roche Cobas Integra 400 plus analyser (Roche Diagnostics).
Measured: 12 months
HDL-C, LDL-C, VLDL-C, and triglyceride concentrations
Measured in serum using reference or enzymatic methods recommended by SEQC.
Measured: 12 months
Apolipoprotein A1 and B concentrations
Measured with clinical chemistry methods based on SEQC guidelines.
Measured: 12 months
Aminotransferases: AST (ASAT) and ALT (ALAT) enzyme activity
Measured using enzymatic methods.
Measured: 12 months
Uric acid, creatinine and glucose concentrations
Measured using standardised spectrophotometric methods.
Measured: 12 months
Endothelial biomarkers
VCAM-1, ICAM-1, eNOS, E-selectin, and P-selectin concentrations will be measured in serum using ELISA.
Measured: 12 months
Platelet function markers
Leukotriene B4 and prostaglandin E2 will be measured in serum using ELISAs (Cayman kits).
Measured: 12 months
Serum cytokines (IL-6, IFN-γ, TNF-α, IL-10)
Serum concentrations of interleukin-6 (IL-6), interferon gamma (IFN-γ), tumor necrosis factor alpha (TNF-α), and interleukin-10 (IL-10) will be determined using ELISA. These biomarkers reflect both pro- and anti-inflammatory responses.
Measured: 12 months
C-Reactive Protein (CRP)
CRP will be measured using an automated ultrasensitive turbidimetric method (AU2700 Biochemistry analyser, Olympus).
Measured: 12 months
Oxidized LDL and 8-hydroxy-2'-deoxyguanosine (8-OHdG)
LDLox and 8-OHdG will be measured in serum using ELISA.
Measured: 12 months
Lipid peroxidation (TBARS)
TBARS will be measured as µM MDA equivalents using ELISA.
Measured: 12 months
TAS will be assessed using a colorimetric assay or ELISA.
TAS will be assessed using a colorimetric assay or ELISA.
Measured: 12 months
Total oxidative status (TOS)
TOS will be measured using ELISA.
Measured: 12 months
Antioxidant enzyme activities (NOX, GSH, GPx, SOD)
NADPH oxidase (NOX), glutathione (GSH), glutathione peroxidase (GPx), and superoxide dismutase (SOD) will be measured using ELISA-based methods.
Measured: 12 months
Secondary outcomes (10)
Systolic and Diastolic Blood Pressure
Systolic and diastolic blood pressure will be measured using an automatic arm sphygmomanometer (BS 150; Pic Indolor Diagnostic) at baseline and at the end of each intervention period. Measurements will be taken after the volunteer has rested on a chair for 5 minutes. Two consecutive readings will be taken on the left arm. If the values differ by more than 10-15 mmHg, a third reading will be recorded. The mean of the two (or three) closest readings will be used for analysis. Blood pressure will be expressed in mmHg..
Measured: 12 months
Resting Heart Rate
Heart rate will be measured using the same automatic arm sphygmomanometer (BS 150; Pic Indolor Diagnostic) under the same conditions as blood pressure. Volunteers will rest for 5 minutes prior to the measurement. If multiple readings are required due to variation, the mean of the two (or three) closest values will be used. Heart rate will be expressed in beats per minute (bpm).
Measured: 12 months
Fecal Short Chain Fatty Acids (SCFAs) Concentration
Short chain fatty acids (SCFAs) determination in faeces.The analytes will be analysed by gas chromatography system (Agilent Technologies Palo Alto, CA, USA) equipped with a mass spectrometer (MS) detector and Agilent DB-WAXtr column (100% polyethilen glycol, 60 m, 0.325 mm, 0250 um).
Measured: 12 months
Fecal Lactate Concentration
Lactate levels in fecal samples will be measured using an Advanced Compact Ion Chromatographic instrument IC867 (Metrohm AG, Herisau, Switzerland).
Measured: 12 months
Gut Microbiota Composition (16S rRNA Gene Profiling)
Microbial composition of fecal samples will be assessed by 16S rRNA gene amplicon sequencing. Genomic DNA will be extracted using the Quick-DNA™ Fecal/Soil Microbe Miniprep Kit (Zymo Research). Library preparation and sequencing will be conducted at Maastricht University (the Netherlands). Data analysis will be performed using the QIIME software package (v1.9.0), with taxonomic assignment based on the Greengenes database (v13.8).
Measured: 12 months
Fasting glucose
Measured using SEQC-recommended methods.
Measured: 12 months
Fasting insulin and C-peptide
Measured using immunoassays or ELISA.
Measured: 12 months
Glycated hemoglobin (HbA1c)
Measured using HPLC or immunoturbidimetric methods.
Measured: 12 months
Incretins (Glucagon and GLP-1)
Glucagon and GLP-1 concentrations will be measured using ELISA.
Measured: 12 months
Adipokines (Leptin and PAI-1)
Leptin and plasminogen activator inhibitor-1 (PAI-1) will be measured using ELISA.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start17 Feb 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Chronic, randomized, controlled, cross-over, double-blind, and free-living study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Council, Spain
- Sponsor type
- Other government
- Collaborators
- Beps Holding GmbH, Olivenova Health Sl
- Responsible party
- Principal investigator, María Raquel Mateos Briz, National Research Council, Spain
- Investigators
- Raquel Mateos Briz Tenured Scientist, Principal investigator, National Research Council (CSIC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992323
- Sponsor's protocol ID
- HYDROXYOMEGA
- Acronym
- HydroxyOmega
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiometabolic Properties of Omega-3 Funcionalized With Hydroxytyrosol in Healthy and Cardiovascular Risk Population
- ClinicalTrials.gov ID
- NCT06992323
- Acronym / sponsor ID
- HydroxyOmega / HYDROXYOMEGA
- Conditions
- Hypertriglyceridemia, Normal
- Keywords
- cardiovascular risk, omega 3, hydroxytyrosol, hypertriglyceridemia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- National Research Council, SpainOther government
- Collaborators
- Beps Holding GmbH, Olivenova Health Sl
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 May 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 primary aim of this study is to investigate the potential cardioprotective effects of daily nutritional doses of eicosapentaenoic acid (EPA) enriched with hydroxytyrosol (HT) on cardiovascular health, as well as its modulatory impact on the intestinal microbiota. This investigation will be conducted through a randomized, double-blind, crossover, and controlled nutritional intervention trial. The study population will include two cohorts: one with normotriglyceridemic individuals, and another with hypertriglyceridemic individuals. Participants will be randomly allocated to one of three intervention groups: (1) EPA+HT supplementation, (2) EPA alone, or (3) a placebo consisting of sunflower oil devoid of EPA.
Detailed description
The product to be tested is a combination of two key components: an oily preparation containing 97% eicosapentaenoic acid (EPA) and a natural extract (Oleacore®) with a high hydroxytyrosol content (10%). Oleacore® is naturally derived from olives using exclusively physical and mechanical methods and is commercialized by Olivenova Health SL (https://olivenova.com/es/). The EPA-97% component is supplied by Beeps Holding GMBH (https://bepsholding.com/el-holding/?lang=es). Three types of nutraceutical formulations will be prepared, and study participants will consume three capsules daily to achieve the following dosages:
- 2 g of EPA + 15 mg of hydroxytyrosol (HT) (3 Type-1 capsules, EPA+HT),
- 2 g of EPA (3 Type-2 capsules, EPA), and
- 2 g of seed oil (sunflower) as a placebo (3 Type-3 capsules, Placebo).
The daily dose of 15 mg HT was selected based on the EFSA claim for the prevention of LDL oxidation , while the 2 g EPA dose was established following EFSA recommendations for triglyceride reduction.
A chronic, randomized, controlled, crossover, double-blind, free-living study design is proposed, spanning 46 weeks. Following a two-week washout period, during which the consumption of extra virgin olive oil, and olives will be restricted, participants will be grouped based on baseline characteristics (control or hypertriglyceridemia). They will then be randomized into three groups (randomization performed using SPSS software), such that one-third of participants will receive EPA+HT, another third will receive EPA without HT, and the remaining third will receive a placebo nutraceutical containing sunflower oil with no EPA or HT.
Each intervention phase will last 12 weeks. After completing one intervention, participants will undergo a four-week washout period before transitioning to the next intervention. Before the start of each phase, participants will be provided with all necessary capsules (EPA+HT, EPA, or placebo) along with detailed consumption guidelines.Volunteers will take the capsules with lunch and dinner.
Additionally, during the study, volunteers will consume a commercial olive oil with a minimal phenol content as their culinary oil. This olive oil will also be supplied by the research team for family use (1 L/2 weeks). Participants will be instructed to maintain their usual lifestyle throughout the study but will be restricted from consuming any other culinary oils apart from the one provided by the research group, as well as olives. Furthermore, the use of dietary supplements containing antioxidants, other than vitamins, will be prohibited.
Participants will attend the Human Nutrition Unit (UNH) at ICTAN-CSIC on six occasions, corresponding to the beginning and end of each intervention phase. Once eligibility has been confirmed based on the inclusion and exclusion criteria, participants will attend the UNH for signing the informed consent, receiving olive oil for household consumption, and receiving instructions to begin the study.
During visits V1-V6 (corresponding to the start and end of each intervention with the different nutraceuticals), participants will report to the UNH at ICTAN-CSIC. Upon arrival, they will provide a fasting urine sample from their first morning void and a stool sample collected within the previous 24 hours. Additionally, a trained nurse will collect a fasting blood sample (40 mL, distributed into tubes containing various anticoagulants).
Blood pressure and heart rate will also be measured. Furthermore, participants will undergo a comprehensive anthropometric and body composition assessment. Dietary habits and physical activity levels will be monitored and evaluated during these visits.
Compliance with the intervention will be monitored through monthly telephone follow-ups, the collection of unused capsules, and the measurement of specific biomarkers, including plasma phosphatidylcholine-EPA levels as a marker of omega-3 fatty acid intake and urinary HT metabolites.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Chronic, randomized, controlled, cross-over, double-blind, and free-living study
| Arm | Type | Receives |
|---|---|---|
| EPA + HT | Experimental | Dietary Supplement: EPA + HTEPA + HT: intake of 2 g/d of EPA and 15 mg/d of HT (3 Type-1 capsules, EPA + HT) |
| EPA | Experimental | Dietary Supplement: EPAEPA: intake of 2 g/d of EPA (3 Type-2 capsules, EPA) |
| Sunflower oil (SO) | Active comparator | Dietary Supplement: Sunflower OilSunflower Oil (SO): intake of 2 g/d of SO (3 Type-3 capsules, Placebo) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: 18 to 70 years old
- Hypertriglyceridemia (150-250 mg/dl) or normal levels of triglycerides levels (<150 mg/dl)
Key exclusion criteria (5 listed)
- Presence of chronic illnesses
- Currently undergoing pharmacological treatment
- Smoking
- Pregnancy
- Adherence to a vegetarian or vegan diet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPA + HTVolunteers will consume during 12 weeks 2 g/d of EPA and 15 mg/d of HT, corresponding to 3 capsules. Additionally, they will consume a commercial olive oil with a minimal phenol content as their culinary oil that will be suplied by the research team for family use (1L/2 weeks) | Dietary supplement | EPA + HT |
| EPAVolunteers will consume during 12 weeks 2 g/d of EPA corresponding to 3 capsules. Additionally, they will consume a commercial olive oil with a minimal phenol content as their culinary oil that will be suplied by the research team for family use (1L/2 weeks) | Dietary supplement | EPA |
| Sunflower OilVolunteers will consume during 12 weeks 2 g/d of Sunflower Oil, corresponding to 3 capsules. Additionally, they will consume a commercial olive oil with a minimal phenol content as their culinary oil that will be suplied by the research team for family use (1L/2 weeks) | Dietary supplement | Sunflower oil (SO) |
Primary outcome
Total cholesterol concentration
Time frame: 12 months
Total cholesterol in serum samples will be determined following reference methods recommended by the Sociedad Española de Bioquímica Clínica y Patología Molecular (SEQC) using the Roche Cobas Integra 400 plus analyser (Roche Diagnostics).
HDL-C, LDL-C, VLDL-C, and triglyceride concentrations
Time frame: 12 months
Measured in serum using reference or enzymatic methods recommended by SEQC.
Apolipoprotein A1 and B concentrations
Time frame: 12 months
Measured with clinical chemistry methods based on SEQC guidelines.
Aminotransferases: AST (ASAT) and ALT (ALAT) enzyme activity
Time frame: 12 months
Measured using enzymatic methods.
Uric acid, creatinine and glucose concentrations
Time frame: 12 months
Measured using standardised spectrophotometric methods.
Endothelial biomarkers
Time frame: 12 months
VCAM-1, ICAM-1, eNOS, E-selectin, and P-selectin concentrations will be measured in serum using ELISA.
Platelet function markers
Time frame: 12 months
Leukotriene B4 and prostaglandin E2 will be measured in serum using ELISAs (Cayman kits).
Serum cytokines (IL-6, IFN-γ, TNF-α, IL-10)
Time frame: 12 months
Serum concentrations of interleukin-6 (IL-6), interferon gamma (IFN-γ), tumor necrosis factor alpha (TNF-α), and interleukin-10 (IL-10) will be determined using ELISA. These biomarkers reflect both pro- and anti-inflammatory responses.
C-Reactive Protein (CRP)
Time frame: 12 months
CRP will be measured using an automated ultrasensitive turbidimetric method (AU2700 Biochemistry analyser, Olympus).
Oxidized LDL and 8-hydroxy-2'-deoxyguanosine (8-OHdG)
Time frame: 12 months
LDLox and 8-OHdG will be measured in serum using ELISA.
Lipid peroxidation (TBARS)
Time frame: 12 months
TBARS will be measured as µM MDA equivalents using ELISA.
TAS will be assessed using a colorimetric assay or ELISA.
Time frame: 12 months
TAS will be assessed using a colorimetric assay or ELISA.
Total oxidative status (TOS)
Time frame: 12 months
TOS will be measured using ELISA.
Antioxidant enzyme activities (NOX, GSH, GPx, SOD)
Time frame: 12 months
NADPH oxidase (NOX), glutathione (GSH), glutathione peroxidase (GPx), and superoxide dismutase (SOD) will be measured using ELISA-based methods.
10 secondary outcomes
Systolic and Diastolic Blood Pressure
Time frame: 12 months
Resting Heart Rate
Time frame: 12 months
Fecal Short Chain Fatty Acids (SCFAs) Concentration
Time frame: 12 months
Fecal Lactate Concentration
Time frame: 12 months
Gut Microbiota Composition (16S rRNA Gene Profiling)
Time frame: 12 months
Fasting glucose
Time frame: 12 months
Fasting insulin and C-peptide
Time frame: 12 months
Glycated hemoglobin (HbA1c)
Time frame: 12 months
Incretins (Glucagon and GLP-1)
Time frame: 12 months
Adipokines (Leptin and PAI-1)
Time frame: 12 months
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 28 May 2025.
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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. This study is not recruiting at the moment.
Raquel Mateos Briz Tenured Scientist principal investigator
National Research Council (CSIC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EPA + HT, EPA and Sunflower Oil in people with Hypertriglyceridemia and Normal, run by National Research Council, Spain 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 2 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 28 May 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total cholesterol concentration (time frame: 12 months). The study lists 14 primary outcomes in all. 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 28 May 2025.