Lipidomic studies reveal two specific circulating phosphatidylcholines as surrogate biomarkers of the omega-3 index.
Ritchie Ly, Brittany C MacIntyre, Stuart M Philips...
https://pubmed.ncbi.nlm.nih.gov/37730162Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID07004777
Effect of Consuming n-3 Polyunsaturated Fatty Acids Rich Foods on Triglyceride Concentration and Lipoprotein Composition in Individuals With Hypertriglyceridemia. Controlled Clinical Trial.
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
On this page
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 mg/dL 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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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
Trial Site Locations
Total: 1 location
1
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Mexico City, Mexico, 14080
Actively Recruiting
Loading map...
Research Team
M
Martha Guevara, MD, PhD
A
Armando Tovar, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Fish oil supplementation alters the plasma lipidomic profile and increases long-chain PUFAs of phospholipids and triglycerides in healthy subjects.
Inger Ottestad, Sahar Hassani, Grethe I Borge...
https://pubmed.ncbi.nlm.nih.gov/22952598Lipidomic changes of LDL after consumption of Camelina sativa oil, fatty fish and lean fish in subjects with impaired glucose metabolism-A randomized controlled trial.
Arja T Erkkilä, Suvi Manninen, Linda Fredrikson...
https://pubmed.ncbi.nlm.nih.gov/34548243Effect of TAK-085 on Low-density Lipoprotein Particle Size in Patients with Hypertriglyceridemia: A Double-blind Randomized Clinical Study.
Ichiro Tatsuno, Kentarou Kudou, Tomoya Kagawa
https://pubmed.ncbi.nlm.nih.gov/26222126Hypolipidemic and hepatoprotective effects of flax and pumpkin seed mixture rich in omega-3 and omega-6 fatty acids in hypercholesterolemic rats.
M Makni, H Fetoui, N K Gargouri...
https://pubmed.ncbi.nlm.nih.gov/18938206Food combination based on a pre-hispanic Mexican diet decreases metabolic and cognitive abnormalities and gut microbiota dysbiosis caused by a sucrose-enriched high-fat diet in rats.
Azalia Avila-Nava, Lilia G Noriega, Armando R Tovar...
https://pubmed.ncbi.nlm.nih.gov/27352915Rationale and design of REDUCE-IT: Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial.
Deepak L Bhatt, Ph Gabriel Steg, Eliot A Brinton...
https://pubmed.ncbi.nlm.nih.gov/28294373Fish consumption and CHD mortality: an updated meta-analysis of seventeen cohort studies.
Jusheng Zheng, Tao Huang, Yinghua Yu...
https://pubmed.ncbi.nlm.nih.gov/21914258Influence of Omega-3 Fatty Acid-Rich Fish Oils on Hyperlipidemia: Effect of Eel, Sardine, Trout, and Cod Oils on Hyperlipidemic Mice.
Martha Kontostathi, Sofia Isou, Dimitrios Mostratos...
https://pubmed.ncbi.nlm.nih.gov/33370175