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

Status: Recruiting
Location: See location...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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 and adherence to the consumption of foods rich in n-3 polyunsaturated fatty acids (PUFA) (pumpkin and chia seeds and salmon) and n-3 PUFA supplement during four weeks of a follow up dietary intervention determined by triglyceride concentration and lipoprotein composition in people with hypertriglyceridemia. The study is divided into two phases. In the first, participants' diets will be standardized, providing them with dietary recommendations for four weeks. Participants who maintain triglyceride levels \>200 mg/dL despite the recommendations will be invited to a second phase: a randomized controlled clinical trial consisting of a dietary intervention with a four-week follow-up. Participants will be randomized into three treatment groups: 1) isocaloric diet and Eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA) supplementation; 2) isocaloric diet including salmon; 3) isocaloric diet including chia and pumpkin seeds. The effect of the dietary intervention will be assessed by determining lipid composition and lipoprotein analysis, while adherence to n-3 PUFA consumption will be measured by serum fatty acid profile analysis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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⁃ Phase 1

• 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

⁃ Phase 2

• Both sexes

• Adults over 18 years of age.

• BMI \>18.5 kg/m2

• Individuals whose triglyceride concentration is greater than 200 mg/dL and less than 500 mg/dL after dietary treatment (dietary recommendations based on the National Cholesterol Education Program - Adult Treatment Panel III (NCEP-ATPIII) guidelines).

Locations
Other Locations
Mexico
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
RECRUITING
Mexico City
Contact Information
Primary
Martha Guevara, MD, PhD
martha.guevarac@incmnsz.mx
+52 55 5487 0900
Backup
Armando Tovar, PhD
armando.tovarp@incmnsz.mx
+52 55 5487 0900
Time Frame
Start Date: 2026-02-01
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 375
Treatments
Experimental: Salmon diet
Diet based on participant-specific energy expenditure. With the following macronutrient distribution: 50% carbohydrates, protein 20% and 30% fats.
Experimental: Chia and pumpkin seeds diet
Diet based on participant-specific energy expenditure. With the following macronutrient distribution: 50% carbohydrates, protein 20% and 30% fats.
Active_comparator: Diet plus fish oil
Diet based on participant-specific energy expenditure. With the following macronutrient distribution: 50% carbohydrates, protein 20% and 30% fats.
Sponsors
Leads: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

This content was sourced from clinicaltrials.gov