Effect of Consuming n-3 PUFAs Rich Foods on Triglyceride Concentration and Lipoprotein Composition (SALVIMEX)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status: Enrolling

Conditions: Hypertriglyceridemia

Treatments: Other: Isocaloric diet including salmon; Other: Isocaloric diet including chia and pumpkin seeds; Dietary Supplement: Isocaloric diet plus fish oil

Study type: Interventional

Funder types: Other

Identifiers

NCT07004777

FNU-5515-25-27-1

INCMNSZ

Details and patient eligibility

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 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.

Full description

The study is divided into two phases. The first phase is a prospective study with a 4-week follow-up to standardize the participants' diet. The second phase is a randomized controlled clinical trial consisting of a dietary intervention with a four-week follow-up.

Phase 1

Participants' diets will be standardized using dietary recommendations based on guidelines. Individuals who agree to participate will be required to sign an informed consent form. At baseline and at the end of this phase, participants will undergo a medical history questionaire, anthropometric assessments (weight, height, and waist circumference), body composition analysis (body fat percentage, skeletal muscle mass percentage, and lean muscle mass percentage), blood pressure measurement, and cardiometabolic risk score evaluation. Additionally, blood samples will be collected to determine serum concentrations of glucose, lipid profile parameters (total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, and triglycerides) as well as for the isolation of monocytes to determine mitochondrial function. It will be recommended to the participants to continue with the dietary recommendations until transitioning to the clinical trial, where those whose triglyceride concentrations remain >200 mg/dL will be invited to participate.

Phase 2

Participants with hypertriglyceridemia will be randomly assigned to three groups, each of which will be prescribed an isocaloric diet including a food or supplement rich in n-3 PUFA:

• An isocaloric diet and EPA+DHA supplement
• An isocaloric diet including salmon
• An isocaloric diet including chia 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 or supplements rich in n-3 PUFA.

The same assessments conducted in the previous phase will be repeated at the start and at the end of the 4 week-follow-up period of the intervention. Additionally, other parameters will be evaluated, including insulin levels; inflammatory markers ; endothelial markers and intercellular adhesion molecule-1, cardiometabolic risk markers ; oxidative stress markers; liver function tests ; and pulse wave velocity. Lipid composition and lipoprotein analysis will also be determined to evaluate the effect. As well as the concentration of serum fatty acid profile analysis to evaluate the adherence to PUFA-n3.

In both phases, 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.

Enrollment: 375 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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).

Exclusion criteria

• 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).
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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375 participants in 3 patient groups

Salmon diet

Experimental group

Description:

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

Treatment:

Other: Isocaloric diet including salmon

Chia and pumpkin seeds diet

Experimental group

Description:

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

Treatment:

Other: Isocaloric diet including chia and pumpkin seeds

Diet plus fish oil

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Isocaloric diet plus fish oil