Adding chia and pumpkin seeds to a recommended diet to lower triglycerides and change blood fat composition

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with hypertriglyceridemia are randomized to a 4-week isocaloric diet based on NCEP-ATPIII recommendations with or without added Mexican n-3 PUFA–rich foods (chia and pumpkin seeds). Clinical measurements and blood samples are taken at baseline and after 4 weeks to measure triglycerides, full lipid profile, inflammatory and oxidative markers, genetic markers (FADS1/FADS2), and monocyte mitochondrial function. Participants who still have triglycerides above 200 mg/dL after 4 weeks receive fish oil supplementation for an additional 4 weeks to reinforce the dietary approach. The study is conducted at a single center with in-person visits for anthropometry, transient elastography, pulse wave velocity, and blood draws.

Why it matters

Who can join: the full rules

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.

Where it's running

• Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
  Mexico City, Mexico City, Mexico Recruiting

Study contacts

• Study coordinator: Martha Guevara, MD, PhD
• Email: martha.guevarac@incmnsz.mx
• Phone: +52 55 5487 0900

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.