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HypertriglyceridemiaSALVIMEXNCT07004777

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

A study testing Isocaloric diet including chia and pumpkin seeds and Isocaloric diet in people with Hypertriglyceridemia, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Hypertriglyceridemia
What is being tested?
Isocaloric diet including chia and pumpkin seeds and Isocaloric diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
375 participants
Where
1 siteMexico
Study dates
1 Feb 2026to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Martha Guevara, MD, PhD contact

+52 55 5487 0900 ext. 2802

martha.guevarac@incmnsz.mx

Armando Tovar, PhD contact

+52 55 5487 0900 ext. 2802

armando.tovarp@incmnsz.mx

Mexico1 site, 1 recruiting

  • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

    Mexico City, Mexico City, 14080

    Martha Guevara-Cruz, MD, PhD, +525554870900 ext. 2802, martha.guevarac@incmnsz.mx

    Armando Tovar, PhD, +525554870900 ext. 2801, armando.tovarp@incmnsz.mx

    Recruiting

Other trials in Mexico

About this study

Official title: 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.

Read the 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).

Being tested
Isocaloric diet including chia and pumpkin seeds, Isocaloric diet
Keywords
Hypertriglyceridemia, Lipid metabolism, Dyslipidemia, Fatty Acids, Omega-3, Eicosapentaenoic Acid, Docosahexaenoic Acid, diet
Medical subject headings
Hypertriglyceridemia, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Isocaloric diet including chia and pumpkin seedsDietary supplement

    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.

  • Isocaloric dietOther

    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.

Study groups in NCT07004777
Study groupRoleWhat they receive
Isocaloric diet based on NCEP-ATPIII dietary recommendations including chia and pumpkin seeds.ExperimentalDiet based on participant-specific energy expenditure. With the following macronutrient distribution: 50% carbohydrates, protein 20% and 30% fats.
Receives: Dietary Supplement: Isocaloric diet including chia and pumpkin seeds
Isocaloric diet based on NCEP-ATPIII dietary recommendationsActive comparatorDiet based on participant-specific energy expenditure. With the following macronutrient distribution: 50% carbohydrates, protein 20% and 30% fats.
Receives: Other: Isocaloric diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum triglycerides concentration in mg/dL

    Change in serum triglycerides between different nutrition interventions.

    Measured: From baseline to week 4 of the intervention

  2. Serum fatty acid profile analysis by gas chromatography in microgram

    Change in serum fatty acid between different nutrition interventions.

    Measured: From baseline to week 4 of the intervention

Secondary outcomes (30)

  1. Serum total cholesterol concentration in mg/dL

    Change in serum total cholesterol between different nutrition interventions.

    Measured: From baseline to week 4 of the intervention

  2. Serum LDL cholesterol concentration in mg/dL

    Change in serum LDL cholesterol between different nutrition interventions.

    Measured: From baseline to week 4 of the intervention

  3. Serum HDL cholesterol concentration in mg/dL

    Change in serum HDL cholesterol between different nutrition interventions.

    Measured: From baseline to week 4 of the intervention

  4. Serum lipids concentration in relative peak area

    Change in serum lipids between different nutrition interventions.

    Measured: From baseline to week 4 of the intervention

  5. Serum C-reactive protein concentration in mg/dL

    Change in serum C-reactive protein between different nutrition interventions.

    Measured: From baseline to week 4 of the intervention

  6. Plasma malondialdehyde concentration in nmol/mL

    Change in plasma malondialdehyde between different nutrition interventions.

    Measured: From baseline to week 4 of the intervention

  7. Serum Intercellular Adhesion Molecule-1 (ICAM-1) concentration in pg/mL

    Change in serum ICAM-1 between different nutrition interventions.

    Measured: From baseline to week 4 of the intervention

  8. Serum Vascular Cell Adhesion Molecule-1 (VCAM-1) concentration in pg/mL

    Change in serum VCAM-1 between different nutrition interventions.

    Measured: From baseline to week 4 of the intervention

  9. Serum plasminogen concentration in mg/dL

    Change in serum plasminogen between different nutrition interventions.

    Measured: From baseline to week 4 of the intervention

  10. Serum glucose concentration in mg/dL

    Change in serum glucose between different nutrition interventions.

    Measured: From baseline to week 4 of the intervention

  11. Serum aspartate aminotransferase concentration in IU/mL

    Change in serum aspartate aminotransferase between different nutrition interventions.

    Measured: From baseline to week 4 of the intervention

  12. Serum alanine aminotransferase concentration in IU/mL

    Change in serum alanine aminotransferase between different nutrition interventions.

    Measured: From baseline to week 4 of the intervention

  13. Serum insulin concentration in micro - IU / ml

    Change in serum insulin between different nutrition interventions.

    Measured: From baseline to week 4 of the intervention

  14. Oxygen consumption rate in pmol / number of cells

    Change in oxygen consumption rate between different nutrition interventions.

    Measured: From baseline to week 4 of the intervention

  15. Body weight in kilograms

    Change in body weight between different nutrition interventions.

    Measured: From baseline to week 4 of the intervention

  16. Waist circumference in centimeters

    Change in waist circumference between different nutrition interventions.

    Measured: From baseline to 4 week of the intervention

  17. Fat mass percentage

    Change in fat mass percentage between different nutrition interventions.

    Measured: From baseline to 4 week of the intervention

  18. Skeletal muscle mass percentage

    Change in skeletal muscle mass percentage between different nutrition interventions.

    Measured: From baseline to 4 week of the intervention

  19. Lean mass percentage

    Change in lean mass percentage between different nutrition interventions.

    Measured: From baseline to 4 week of the intervention

  20. Medium very low density lipoprotein (VLDL) particle number in nmol/L

    Change in plasma medium VLDL particle number between different nutrition interventions.

    Measured: From baseline to 4 week of the intervention

  21. Large very low density lipoprotein (VLDL) particle number in nmol/L

    Change in plasma large VLDL particle number between different nutrition interventions.

    Measured: From baseline to 4 week of the intervention

  22. Small very low density lipoprotein (VLDL) particle number in nmol/L

    Change in plasma small VLDL particle number between different nutrition interventions.

    Measured: From baseline to 4 week of the intervention

  23. Large LDL particle number in nmol/L

    Change in plasma large LDL particle number between different nutrition interventions.

    Measured: From baseline to 4 week of the intervention

  24. Medium LDL particle number in nmol/L

    Change in plasma medium LDL particle number between different nutrition interventions.

    Measured: From baseline to 4 week of the intervention

  25. Small LDL particle number in nmol/L

    Change in plasma small LDL particle number between different nutrition interventions.

    Measured: From baseline to 4 week of the intervention

  26. Large HDL particle number in nmol/L

    Change in plasma large HDL particle number between different nutrition interventions.

    Measured: From baseline to 4 week of the intervention

  27. Small HDL particle number in nmol/L

    Change in plasma small HDL particle number between different nutrition interventions.

    Measured: From baseline to 4 week of the intervention

  28. Medium HDL particle number in nmol/L

    Change in plasma medium HDL particle number between different nutrition interventions.

    Measured: From baseline to 4 week of the intervention

  29. Pulse wave velocity in m/s

    Change in pulse wave velocity between different nutrition interventions

    Measured: From baseline to 4 week of the intervention

  30. Controlled attenuation parameter in decibels per meter

    Allows to evaluate the degree of steatosis by elastography.

    Measured: From baseline to 4 week of the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2025
  2. Study start1 Feb 2026
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The groups will receive the treatment simultaneously.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
375 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07004777
Sponsor's protocol ID
FNU-5515-25-27-1
Other IDs
INCMNSZ
Acronym
SALVIMEX
Status last verified
Apr 2026
First submitted
20 May 2025
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ly R, MacIntyre BC, Philips SM, McGlory C, Mutch DM, Britz-McKibbin P. Lipidomic studies reveal two specific circulating phosphatidylcholines as surrogate biomarkers of the omega-3 index. J Lipid Res. 2023 Nov;64(11):100445. doi: 10.1016/j.jlr.2023.100445. Epub 2023 Sep 18.

    PubMed 37730162

  • Ottestad I, Hassani S, Borge GI, Kohler A, Vogt G, Hyotylainen T, Oresic M, Bronner KW, Holven KB, Ulven SM, Myhrstad MC. Fish oil supplementation alters the plasma lipidomic profile and increases long-chain PUFAs of phospholipids and triglycerides in healthy subjects. PLoS One. 2012;7(8):e42550. doi: 10.1371/journal.pone.0042550. Epub 2012 Aug 28.

    PubMed 22952598

  • Erkkila AT, Manninen S, Fredrikson L, Bhalke M, Holopainen M, Ruuth M, Lankinen M, Kakela R, Oorni K, Schwab US. Lipidomic changes of LDL after consumption of Camelina sativa oil, fatty fish and lean fish in subjects with impaired glucose metabolism-A randomized controlled trial. J Clin Lipidol. 2021 Sep-Oct;15(5):743-751. doi: 10.1016/j.jacl.2021.08.060. Epub 2021 Sep 7.

    PubMed 34548243

  • Tatsuno I, Kudou K, Kagawa T. Effect of TAK-085 on Low-density Lipoprotein Particle Size in Patients with Hypertriglyceridemia: A Double-blind Randomized Clinical Study. Cardiovasc Ther. 2015 Dec;33(6):317-23. doi: 10.1111/1755-5922.12146.

    PubMed 26222126

  • Makni M, Fetoui H, Gargouri NK, Garoui el M, Jaber H, Makni J, Boudawara T, Zeghal N. Hypolipidemic and hepatoprotective effects of flax and pumpkin seed mixture rich in omega-3 and omega-6 fatty acids in hypercholesterolemic rats. Food Chem Toxicol. 2008 Dec;46(12):3714-20. doi: 10.1016/j.fct.2008.09.057. Epub 2008 Oct 1.

    PubMed 18938206

  • Avila-Nava A, Noriega LG, Tovar AR, Granados O, Perez-Cruz C, Pedraza-Chaverri J, Torres N. Food 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. Mol Nutr Food Res. 2017 Jan;61(1). doi: 10.1002/mnfr.201501023. Epub 2016 Aug 8.

    PubMed 27352915

  • Bhatt DL, Steg PG, Brinton EA, Jacobson TA, Miller M, Tardif JC, Ketchum SB, Doyle RT Jr, Murphy SA, Soni PN, Braeckman RA, Juliano RA, Ballantyne CM; REDUCE-IT Investigators. Rationale and design of REDUCE-IT: Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial. Clin Cardiol. 2017 Mar;40(3):138-148. doi: 10.1002/clc.22692. Epub 2017 Mar 15.

    PubMed 28294373

  • Zheng J, Huang T, Yu Y, Hu X, Yang B, Li D. Fish consumption and CHD mortality: an updated meta-analysis of seventeen cohort studies. Public Health Nutr. 2012 Apr;15(4):725-37. doi: 10.1017/S1368980011002254. Epub 2011 Sep 14.

    PubMed 21914258

  • Kontostathi M, Isou S, Mostratos D, Vasdekis V, Demertzis N, Kourounakis A, Vitsos A, Kyriazi M, Melissos D, Tsitouris C, Karalis E, Klamarias L, Dania F, Papaioannou GT, Roussis V, Polychronopoulos E, Anastassopoulou J, Theophanides T, Rallis MC, Black HS. Influence of Omega-3 Fatty Acid-Rich Fish Oils on Hyperlipidemia: Effect of Eel, Sardine, Trout, and Cod Oils on Hyperlipidemic Mice. J Med Food. 2021 Jul;24(7):749-755. doi: 10.1089/jmf.2020.0114. Epub 2020 Dec 23.

    PubMed 33370175

Questions about this trial

What is this clinical trial studying?

A study testing Isocaloric diet including chia and pumpkin seeds and Isocaloric diet in people with Hypertriglyceridemia, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Martha Guevara, MD, PhD (+52 55 5487 0900 ext. 2802, martha.guevarac@incmnsz.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum triglycerides concentration in mg/dL (time frame: From baseline to week 4 of the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07004777, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.

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