Effect of Consuming n-3 PUFAs Rich Foods on Triglyceride Concentration and Lipoprotein Composition

Launched by INSTITUTO NACIONAL DE CIENCIAS MEDICAS Y NUTRICION SALVADOR ZUBIRAN · May 26, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how eating foods rich in omega-3 fatty acids, like salmon, chia seeds, and pumpkin seeds, can affect triglyceride levels in people with high triglycerides (a type of fat in the blood). High triglyceride levels can lead to serious health issues, so the goal of the study is to see if these foods can help lower these levels and improve overall heart health. The trial will take place in two phases: first, participants will receive guidance on a healthy diet for four weeks. If their triglyceride levels remain high, they may enter the second phase, where they will be assigned to one of three groups to receive either omega-3 supplements, a diet including salmon, or a diet including chia and pumpkin seeds.

To be eligible for the trial, participants must be adults over 18 with a body mass index (BMI) over 18.5 and triglyceride levels between 200 and 500 mg/dL. They should not have diabetes, significant kidney disease, or other serious health conditions. Throughout the study, participants will be monitored to see how well they stick to the dietary changes and how their lipid levels change. This trial is not yet recruiting, but it's an important step in understanding how simple dietary changes can potentially improve health for those with high triglycerides.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Phase 1
• • 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
• • Phase 2
• • Both sexes
• • Adults over 18 years of age.
• • BMI \>18.5 kg/m2
• • Individuals whose triglyceride concentration is greater than 200 mg/dL and less than 500 mg/dL after dietary treatment (dietary recommendations based on the National Cholesterol Education Program - Adult Treatment Panel III (NCEP-ATPIII) guidelines).
• 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.