Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT07004777

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

Led by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Updated on 2026-04-14

375

Participants Needed

1

Research Sites

73 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official 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

Eligible

You may qualify if you...

  • Signing of the informed consent form
  • Both sexes
  • Adults over 18 years of age
  • Body mass index greater than 18.5 kg/m2
  • Triglycerides between 200 and 500 mg/dL
  • Total cholesterol less than 240 mg/dL
Not Eligible

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 medications
  • Treatment with hypoglycemic agents, insulin, or antidiabetics
  • Treatment with statins, fibrates, or other dyslipidemia drugs
  • Use of steroids, chemotherapy, immunosuppressants, or radiation therapy
  • Use of anorectic agents or weight loss accelerators
  • Treatment with medications affecting inflammation or triglyceride metabolism
  • Use of anticoagulants or antiplatelets
  • Smoking cessation index greater than 21
  • Tobacco index greater than 21
  • Excessive alcohol consumption (more than 14 drinks per week for women or 21 for men)
  • Use of recreational psychoactive substances
  • Allergy or intolerance to foods in the study pantry
  • Unwillingness to consume foods in the study pantry
  • Previous supplementation with n-3 polyunsaturated fatty acids

AI-Screening

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Trial Site Locations

Total: 1 location

1

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, Mexico City, Mexico, 14080

Actively Recruiting

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Research Team

M

Martha Guevara, MD, PhD

CONTACT

A

Armando Tovar, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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