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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Signing of the informed consent form

Both sexes.

Adults over 18 years of age.

BMI >18.5 kg/m2.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

    Other intervention

    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.

Treatment groups

375 Participants
are divided into 2 treatment groups
Group A: Isocaloric diet based on NCEP-ATPIII dietary recommendations including chia and pumpkin seeds.Experimental treatment 1 intervention
Group B: Isocaloric diet based on NCEP-ATPIII dietary recommendationsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Serum triglycerides concentration in mg/dL

Change in serum triglycerides between different nutrition interventions.

Time frame
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.

Time frame
From baseline to week 4 of the intervention

Secondary outcomes

1

Serum total cholesterol concentration in mg/dL

Change in serum total cholesterol between different nutrition interventions.

Time frame
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.

Time frame
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.

Time frame
From baseline to week 4 of the intervention
4

Serum lipids concentration in relative peak area

Change in serum lipids between different nutrition interventions.

Time frame
From baseline to week 4 of the intervention

Other outcomes

Sponsors and contacts

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