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

NCT07004777 | Recruiting DMC

• 2 other identifiers: FNU-5515-25-27-1INCMNSZ
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Hypertriglyceridemia

Keywords

Hypertriglyceridemia; Lipid metabolism; Dyslipidemia; Fatty Acids, Omega-3; Eicosapentaenoic Acid; Docosahexaenoic Acid; diet

Outcome Measures

Primary Outcomes (2)

• Serum triglycerides concentration in mg/dL

  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

  Change in serum fatty acid between different nutrition interventions.

  From baseline to week 4 of the intervention

Secondary Outcomes (30)

• Serum total cholesterol concentration in mg/dL

  From baseline to week 4 of the intervention

• Serum LDL cholesterol concentration in mg/dL

  From baseline to week 4 of the intervention

• Serum HDL cholesterol concentration in mg/dL

  From baseline to week 4 of the intervention

• Serum lipids concentration in relative peak area

  From baseline to week 4 of the intervention

• Serum C-reactive protein concentration in mg/dL

  From baseline to week 4 of the intervention

Study Arms (2)

Isocaloric diet based on NCEP-ATPIII dietary recommendations including chia and pumpkin seeds.

EXPERIMENTAL

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

Isocaloric diet based on NCEP-ATPIII dietary recommendations

ACTIVE COMPARATOR

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

Other: Isocaloric diet

Interventions

Isocaloric diet OTHER

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.

Isocaloric diet based on NCEP-ATPIII dietary recommendations

Isocaloric diet including chia and pumpkin seeds DIETARY_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 diet based on NCEP-ATPIII dietary recommendations including chia and pumpkin seeds.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, Mexico City, 14080, Mexico

RECRUITING

Related Publications (9)

• 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.

  PMID: 37730162 BACKGROUND

• 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.

  PMID: 22952598 BACKGROUND

• 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.

  PMID: 34548243 BACKGROUND

• 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.

  PMID: 26222126 BACKGROUND

• 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.

  PMID: 18938206 BACKGROUND

• 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.

  PMID: 27352915 BACKGROUND

• 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.

  PMID: 28294373 BACKGROUND

• 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.

  PMID: 21914258 BACKGROUND

• 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.

  PMID: 33370175 BACKGROUND

MeSH Terms

Conditions

Hypertriglyceridemia; Dyslipidemias

Condition Hierarchy (Ancestors)

Hyperlipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Martha Guevara

  INCMNSZ

  STUDY DIRECTOR

Central Study Contacts

Martha Guevara, MD, PhD

CONTACT

+52 55 5487 0900; martha.guevarac@incmnsz.mx

Armando Tovar, PhD

CONTACT

+52 55 5487 0900; armando.tovarp@incmnsz.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The person who will perform the biochemical determinations and the statistical analysis will be blinded from the intervention group by assigning each patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The groups will receive the treatment simultaneously.

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: June 4, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)