Effect of Consuming n-3 Polyunsaturated Fatty Acids Rich Foods on Triglyceride Concentration and Lipoprotein Composition (SALVIMEX)

April 9, 2026 updated by: Martha Guevara Cruz, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Effect of Consuming n-3 Polyunsaturated Fatty Acids Rich Foods on Triglyceride Concentration and Lipoprotein Composition in Individuals With Hypertriglyceridemia. Controlled Clinical Trial.

Hypertriglyceridemia is one of the most prevalent lipid profile disorders and is linked to a large proportion of mortality in Mexico and around the world. Various international treatment guidelines for hypertriglyceridemia have suggested the consumption of foods rich in n-3 polyunsaturated fatty acids or their intake through supplementation as a complement to lifestyle changes. However, adherence to the consumption of foods and supplements containing these fatty acids is often limited due to lack of acceptance or unaffordability. For this reason the objective of the study is to evaluate the effect of including Mexican foods rich in n-3 polyunsaturated fatty acids (chia seeds and pumpkin seeds) within a diet based on NCEP-ATPIII recommendations on triacylglycerol concentration and fatty acid profile in people with hypertriglyceridemia.

The study will consist of a 4-week period in which one group of participants will be randomized into two treatment groups: 1)isocaloric diet based on the NCEP-ATPIII dietary recommendations; 2) isocaloric diet based on the NCEP-ATPIII dietary recommendations plus chia and pumpkin seeds. The effect of the dietary intervention will be assessed by concentration of triglycerides, fatty acids profile and lipoprotein analysis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will consist of a 4-week period in which one group of participants will be given a diet based on the NCEP-ATPIII dietary recommendations, and another group will receive the same diet plus chia and pumpkin seeds. If participants maintain triglyceride levels >200 mg/dL, they will be given fish oil supplementation for an additional 4 weeks to reinforce the dietary treatment (NCEP-ATPIII dietary recommendations).

Participants will be screened to ensure they meet the inclusion criteria. Those who agree to participate will be required to sign an informed consent form. At both the beginning and the end of the 4-week period, participants will undergo a medical history assessment, anthropometric measurements (weight, height, and waist circumference), body composition analysis (including body fat percentage, skeletal muscle mass percentage, and lean body mass percentage), blood pressure measurement, evaluation of hepatic steatosis using transient elastography and; pulse wave velocity.

In addition, blood samples will be collected to determine serum glucose levels; lipid profile parameters (total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides); inflammatory, oxidative, and endothelial markers; and genetic polymorphisms related to lipid metabolism, particularly n-3 polyunsaturated fatty acids (PUFAs) (FADS1 and FADS2). Monocytes will also be isolated to assess mitochondrial function.

Furthermore, serum concentrations of phosphatidylcholine species (16:0_20:5 and 16:0_22:6), lipoprotein composition, and fatty acid profiles will be analyzed using gas chromatography.

Participants with hypertriglyceridemia will be randomly assigned to two groups. Both groups will be prescribed an isocaloric diet; however, only one group will additionally include a food rich in n-3 PUFAs:

  • An isocaloric diet based on NCEP-ATPIII dietary recommendations.
  • An isocaloric diet based on NCEP-ATPIII dietary recommendations including chia and pumpkin seeds.

Resting energy expenditure wil be measured by indirect calorimetry to determine energy requirement of each participant. Distribution of micronutrients of the dietary intervention will be as follow: 50% carbohydrates, 20% protein, and 30% lipids .

This dietary intervention will last 4 weeks. To promote adherence, participants will be given foods rich in n-3 PUFA.

Participants with triglyceride levels >200 mg/dL after the 4-week dietary intervention period will receive fish oil supplementation for an additional 4 weeks. At the end of this period, anthropometric measurements (weight, height, and waist circumference), body composition analysis (including body fat percentage, skeletal muscle mass percentage, and lean body mass percentage), blood pressure measurement, and hepatic steatosis assessment using transient elastography will be repeated. Blood samples will be collected again to determine serum glucose levels and lipid profile parameters (total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides).

During the whole study dietary intake and the adherence to dietary treatment will be monitored using 24-hour dietary recalls, which will be conducted during all visits, as well as through phone calls 2 times per week and text messages.

In addition to the above, the concentration of fatty acids in serum will be evaluated and compared over a 24-hour period following the intake of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) supplements (fish oil) vs. that of foods rich in n-3 polyunsaturated fatty acids (salmon fish, Sierra fish and chia seeds and pumpkin seeds).

Study Type

Interventional

Enrollment (Estimated)

375

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • Mexico City
      • Mexico City, Mexico City, Mexico, 14080
        • Recruiting
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
        • Contact:
        • Contact:
        • Principal Investigator:
          • Martha Guevara, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Isocaloric diet based on NCEP-ATPIII dietary recommendations including chia and pumpkin seeds.
Diet based on participant-specific energy expenditure. With the following macronutrient distribution: 50% carbohydrates, protein 20% and 30% fats.
Dietary supplement: Isocaloric diet including chia and pumpkin seeds

Diet based on participant-specific energy expenditure. With the following macronutrient distribution: 50% carbohydrates, protein 20% and 30% fats.

This dietary intervention consists of a four-week follow-up period and incorporates the intake of pumpkin and chia seeds.
Active Comparator: Isocaloric diet based on NCEP-ATPIII dietary recommendations
Diet based on participant-specific energy expenditure. With the following macronutrient distribution: 50% carbohydrates, protein 20% and 30% fats.
Other: Isocaloric diet

Diet based on participant-specific energy expenditure. With the following macronutrient distribution: 50% carbohydrates, protein 20% and 30% fats.

This dietary intervention consists of a four-week follow-up period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum triglycerides concentration in mg/dL
Time Frame: From baseline to week 4 of the intervention
Change in serum triglycerides between different nutrition interventions.
From baseline to week 4 of the intervention
Serum fatty acid profile analysis by gas chromatography in microgram
Time Frame: From baseline to week 4 of the intervention
Change in serum fatty acid between different nutrition interventions.
From baseline to week 4 of the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum total cholesterol concentration in mg/dL
Time Frame: From baseline to week 4 of the intervention
Change in serum total cholesterol between different nutrition interventions.
From baseline to week 4 of the intervention
Serum LDL cholesterol concentration in mg/dL
Time Frame: From baseline to week 4 of the intervention
Change in serum LDL cholesterol between different nutrition interventions.
From baseline to week 4 of the intervention
Serum HDL cholesterol concentration in mg/dL
Time Frame: From baseline to week 4 of the intervention
Change in serum HDL cholesterol between different nutrition interventions.
From baseline to week 4 of the intervention
Serum lipids concentration in relative peak area
Time Frame: From baseline to week 4 of the intervention
Change in serum lipids between different nutrition interventions.
From baseline to week 4 of the intervention
Serum C-reactive protein concentration in mg/dL
Time Frame: From baseline to week 4 of the intervention
Change in serum C-reactive protein between different nutrition interventions.
From baseline to week 4 of the intervention
Plasma malondialdehyde concentration in nmol/mL
Time Frame: From baseline to week 4 of the intervention
Change in plasma malondialdehyde between different nutrition interventions.
From baseline to week 4 of the intervention
Serum Intercellular Adhesion Molecule-1 (ICAM-1) concentration in pg/mL
Time Frame: From baseline to week 4 of the intervention
Change in serum ICAM-1 between different nutrition interventions.
From baseline to week 4 of the intervention
Serum Vascular Cell Adhesion Molecule-1 (VCAM-1) concentration in pg/mL
Time Frame: From baseline to week 4 of the intervention
Change in serum VCAM-1 between different nutrition interventions.
From baseline to week 4 of the intervention
Serum plasminogen concentration in mg/dL
Time Frame: From baseline to week 4 of the intervention
Change in serum plasminogen between different nutrition interventions.
From baseline to week 4 of the intervention
Serum glucose concentration in mg/dL
Time Frame: From baseline to week 4 of the intervention
Change in serum glucose between different nutrition interventions.
From baseline to week 4 of the intervention
Serum aspartate aminotransferase concentration in IU/mL
Time Frame: From baseline to week 4 of the intervention
Change in serum aspartate aminotransferase between different nutrition interventions.
From baseline to week 4 of the intervention
Serum alanine aminotransferase concentration in IU/mL
Time Frame: From baseline to week 4 of the intervention
Change in serum alanine aminotransferase between different nutrition interventions.
From baseline to week 4 of the intervention
Serum insulin concentration in micro - IU / ml
Time Frame: From baseline to week 4 of the intervention
Change in serum insulin between different nutrition interventions.
From baseline to week 4 of the intervention
Oxygen consumption rate in pmol / number of cells
Time Frame: From baseline to week 4 of the intervention
Change in oxygen consumption rate between different nutrition interventions.
From baseline to week 4 of the intervention
Body weight in kilograms
Time Frame: From baseline to week 4 of the intervention
Change in body weight between different nutrition interventions.
From baseline to week 4 of the intervention
Waist circumference in centimeters
Time Frame: From baseline to 4 week of the intervention
Change in waist circumference between different nutrition interventions.
From baseline to 4 week of the intervention
Fat mass percentage
Time Frame: From baseline to 4 week of the intervention
Change in fat mass percentage between different nutrition interventions.
From baseline to 4 week of the intervention
Skeletal muscle mass percentage
Time Frame: From baseline to 4 week of the intervention
Change in skeletal muscle mass percentage between different nutrition interventions.
From baseline to 4 week of the intervention
Lean mass percentage
Time Frame: From baseline to 4 week of the intervention
Change in lean mass percentage between different nutrition interventions.
From baseline to 4 week of the intervention
Medium very low density lipoprotein (VLDL) particle number in nmol/L
Time Frame: From baseline to 4 week of the intervention
Change in plasma medium VLDL particle number between different nutrition interventions.
From baseline to 4 week of the intervention
Large very low density lipoprotein (VLDL) particle number in nmol/L
Time Frame: From baseline to 4 week of the intervention
Change in plasma large VLDL particle number between different nutrition interventions.
From baseline to 4 week of the intervention
Small very low density lipoprotein (VLDL) particle number in nmol/L
Time Frame: From baseline to 4 week of the intervention
Change in plasma small VLDL particle number between different nutrition interventions.
From baseline to 4 week of the intervention
Large LDL particle number in nmol/L
Time Frame: From baseline to 4 week of the intervention
Change in plasma large LDL particle number between different nutrition interventions.
From baseline to 4 week of the intervention
Medium LDL particle number in nmol/L
Time Frame: From baseline to 4 week of the intervention
Change in plasma medium LDL particle number between different nutrition interventions.
From baseline to 4 week of the intervention
Small LDL particle number in nmol/L
Time Frame: From baseline to 4 week of the intervention
Change in plasma small LDL particle number between different nutrition interventions.
From baseline to 4 week of the intervention
Large HDL particle number in nmol/L
Time Frame: From baseline to 4 week of the intervention
Change in plasma large HDL particle number between different nutrition interventions.
From baseline to 4 week of the intervention
Small HDL particle number in nmol/L
Time Frame: From baseline to 4 week of the intervention
Change in plasma small HDL particle number between different nutrition interventions.
From baseline to 4 week of the intervention
Medium HDL particle number in nmol/L
Time Frame: From baseline to 4 week of the intervention
Change in plasma medium HDL particle number between different nutrition interventions.
From baseline to 4 week of the intervention
Pulse wave velocity in m/s
Time Frame: From baseline to 4 week of the intervention
Change in pulse wave velocity between different nutrition interventions
From baseline to 4 week of the intervention
Controlled attenuation parameter in decibels per meter
Time Frame: From baseline to 4 week of the intervention
Allows to evaluate the degree of steatosis by elastography.
From baseline to 4 week of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Investigators

  • Study Director: Martha Guevara, INCMNSZ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

May 20, 2025

First Submitted That Met QC Criteria

May 26, 2025

First Posted (Actual)

June 4, 2025

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FNU-5515-25-27-1
  • INCMNSZ (Other Identifier: INCMNSZ)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertriglyceridemia

Clinical Trials on Isocaloric diet including chia and pumpkin seeds

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe