Adding chia and pumpkin seeds to a recommended diet to lower triglycerides and change blood fat composition
Effect of Consuming n-3 Polyunsaturated Fatty Acids Rich Foods on Triglyceride Concentration and Lipoprotein Composition in Individuals With Hypertriglyceridemia. Controlled Clinical Trial.
This study tries to see if adding chia and pumpkin seeds to a heart-healthy (NCEP-ATPIII) diet lowers triglycerides in adults with high triglyceride levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 375 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Mexico City, Mexico City) |
| Trial ID | NCT07004777 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults over 18 with BMI >18.5 kg/m2, fasting triglycerides between 200 and 500 mg/dL, total cholesterol <240 mg/dL, not taking diabetes or lipid-lowering medications, and willing to attend in-person visits and follow dietary recommendations.
Not a fit: People with diabetes, kidney disease, recent cardiovascular events, active catabolic illness, pregnancy, or those already taking statins, fibrates, or hypoglycemic drugs are not expected to benefit from enrolling in this protocol.
Why it matters
Potential benefit: If successful, this approach could offer an affordable, food-based way to lower triglycerides and improve lipid composition using locally available seeds.
How similar studies have performed: Omega-3 supplements (fish oil/EPA) have reliably lowered triglycerides in many studies, but direct evidence for food-based interventions using chia or pumpkin seeds is more limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Mexico City, Mexico City
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.