Study of N-3 Polyunsaturated Fatty Acid Rich Foods Including Chia and Pumpkin Seeds on Triglycerides and Lipoproteins in Adults With High Triglycerides
Led by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Updated on 2026-04-14
375
Participants Needed
1
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating how consuming Mexican foods rich in n-3 polyunsaturated fatty acids, specifically chia seeds and pumpkin seeds, affects triglyceride levels and fatty acid profiles in adults with hypertriglyceridemia. The study aims to complement the National Cholesterol Education Program Adult Treatment Panel III NCEP-ATPIII dietary guidelines to better manage this common lipid disorder linked to high mortality rates in Mexico and worldwide.
Participants will be randomly assigned to one of two groups for a 4-week dietary intervention an isocaloric diet based on NCEP-ATPIII recommendations alone or the same diet supplemented with chia and pumpkin seeds. If triglyceride levels remain above 200 mgdL after this period, participants will receive fish oil supplements for an additional 4 weeks to reinforce treatment. The diet composition includes 50% carbohydrates, 20% protein, and 30% fats, tailored to individual energy needs.
Throughout the study, participants will undergo medical history reviews, body measurements including weight and waist circumference, body composition analysis, blood pressure checks, and liver health assessments using transient elastography and pulse wave velocity. Blood samples will be collected to measure glucose, lipid profiles, inflammatory and oxidative markers, and genetic factors related to lipid metabolism. Dietary adherence will be monitored via 24-hour recalls, phone calls, and texts. The main outcomes focus on changes in serum triglycerides and fatty acid profiles over the first 4 weeks, with additional secondary measures recorded.
CONDITIONS
Brief Title
Effect of Consuming n-3 Polyunsaturated Fatty Acids Rich Foods on Triglyceride Concentration and Lipoprotein Composition
Research Team
M
Martha Guevara, MD, PhD
A
Armando Tovar, PhD
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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Lead Sponsor
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
Signing of the informed consent form
Both sexes
Adults over 18 years of age
Body mass index (BMI) greater than 18.5 kg/m2
Triglycerides between 200 and 500 mg/dL
Total cholesterol less than 240 mg/dL
You will not qualify if you...
Any type of diabetes
Kidney disease diagnosed by a physician
Acquired diseases that cause obesity and diabetes
History of cardiovascular events
Weight loss greater than 3 kg in the last 3 months
Catabolic diseases such as cancer or acquired immunodeficiency syndrome
Pregnancy
Treatment with antihypertensive drugs (including tricyclic, loop, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor blockers, alpha-blockers, calcium channel blockers, beta-blockers)
Treatment with hypoglycemic agents or insulin
Treatment with statins, fibrates, or other drugs for dyslipidemia
Use of steroid medications, chemotherapy, immunosuppressants, or radiation therapy
Use of anorectic agents or medications that accelerate weight loss
Treatment with medications influencing inflammation or triglyceride metabolism (such as corticosteroids, NSAIDs, colchicine, interleukin-1 inhibitors, metformin, glitazones, SGLT2 inhibitors, fibrates, statins, CETP inhibitors, pancreatic lipase inhibitors)
Use of anticoagulants and antiplatelets (warfarin, aspirin, clopidogrel)
Smoking cessation index (SCI) greater than 21
Tobacco index greater than 21
Consumption of large amounts of alcohol (more than 14 drinks per week for women or 21 for men)
Use of recreational psychoactive substances
Allergy or intolerance to any foods listed in the study pantry
Unwillingness to consume any foods listed in the proposed pantry
Previous supplementation with n-3 polyunsaturated fatty acids
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 4 weeks
Participants follow an isocaloric diet based on NCEP-ATPIII dietary recommendations for 4 weeks. One group receives the diet including chia and pumpkin seeds, while the other group receives only the diet. Dietary intake and adherence are monitored throughout the study with 24-hour dietary recalls, phone calls twice per week, and text messages.
Visits at the beginning and end of the 4-week period with assessments and monitoring during the period
Treatment
Duration - Additional 4 weeks
Participants who maintain triglyceride levels over 200 mg/dL after the initial dietary intervention receive fish oil supplementation in addition to the diet for an additional 4 weeks. Anthropometric measurements, body composition analysis, blood pressure, hepatic steatosis assessment, and blood sample collections are repeated at the end of this period.
Visits at the beginning and end of the 4-week supplementation period
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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