NCT07004777 Effect of Consuming n-3 Polyunsaturated Fatty Acids Rich Foods on Triglyceride Concentration and Lipoprotein Composition
| NCT ID | NCT07004777 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
| Condition | Hypertriglyceridemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 375 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 375 participants in total. It began in 2026-02-01 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Hypertriglyceridemia is one of the most prevalent lipid profile disorders and is linked to a large proportion of mortality in Mexico and around the world. Various international treatment guidelines for hypertriglyceridemia have suggested the consumption of foods rich in n-3 polyunsaturated fatty acids or their intake through supplementation as a complement to lifestyle changes. However, adherence to the consumption of foods and supplements containing these fatty acids is often limited due to lack of acceptance or unaffordability. For this reason the objective of the study is to evaluate the effect of including Mexican foods rich in n-3 polyunsaturated fatty acids (chia seeds and pumpkin seeds) within a diet based on NCEP-ATPIII recommendations on triacylglycerol concentration and fatty acid profile in people with hypertriglyceridemia. The study will consist of a 4-week period in which one group of participants will be randomized into two treatment groups: 1)isocaloric diet based on the NCEP-ATPIII dietary recommendations; 2) isocaloric diet based on the NCEP-ATPIII dietary recommendations plus chia and pumpkin seeds. The effect of the dietary intervention will be assessed by concentration of triglycerides, fatty acids profile and lipoprotein analysis.
Eligibility Criteria
Inclusion Criteria: * Signing of the informed consent form * Both sexes. * Adults over 18 years of age. * BMI \>18.5 kg/m2. * Triglycerides between 200 and 500 mg/dL. * Total cholesterol less than 240 mg/dL Exclusion Criteria: * Any type of diabetes. * kidney disease diagnosed by a physician. * Acquired diseases that secondarily cause obesity and diabetes. * Patients who have suffered a cardiovascular event. * Weight loss \>3 kg in the last 3 months. * Catabolic diseases such as cancer and acquired immunodeficiency syndrome. * Pregnancy. * Treatment with any medication: * Treatment with antihypertensive drugs (tricyclic, loop, or potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers, alpha-blockers, calcium channel blockers, beta-blockers). * Treatment with hypoglycemic agents (sulfonylureas, biguanides, incretins) or - insulin and antidiabetics. * Treatment with statins, fibrates, or other drugs to control dyslipidemia. * Use of steroid medications, chemotherapy, immunosuppressants, or radiation therapy. * Anorectic agents or those that accelerate weight loss. * Treatment with any medication that influences inflammation (corticosteroids, nonsteroidal anti-inflammatory drugs, colchicine, interleukin-1 inhibitors) or triglyceride metabolism (metformin, glitazones, SGLT2 inhibitors, fibrates, statins, cholesterol ester transporter protein (CETP) inhibitors, pancreatic lipase inhibitors). * Anticoagulants and antiplatelets (warfarin, aspirin, clopidogrel). * People with a smoking cessation index (SCI) greater than 21. * People with a tobacco Index greater than 21. * Consumption of large amounts of alcohol (14 drinks for women or 21 drinks for men in a typical week). * Consumption of any recreational psychoactive substance. * Allergy or intolerance to any food listed in the proposed pantry. * Unwillingness to consume any of the foods listed in the proposed pantry. * Previous n-3 PUFA supplementation.
Contact & Investigator
Martha Guevara
STUDY DIRECTOR
INCMNSZ
Frequently Asked Questions
Who can join the NCT07004777 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hypertriglyceridemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07004777 currently recruiting?
Yes, NCT07004777 is actively recruiting participants. Contact the research team at martha.guevarac@incmnsz.mx for enrollment information.
Where is the NCT07004777 trial being conducted?
This trial is being conducted at Mexico City, Mexico.
Who is sponsoring the NCT07004777 clinical trial?
NCT07004777 is sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran. The principal investigator is Martha Guevara at INCMNSZ. The trial plans to enroll 375 participants.