Clinical trial NCT07004777: Effect of Consuming n-3 PUFAs Rich Foods on Triglyceride Concentration and Lipoprotein Composition
Official title: Effect of Consuming n-3 Polyunsaturated Fatty Acids Rich Foods on Triglyceride Concentration and Lipoprotein Composition in Individuals With Hypertriglyceridemia. Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertriglyceridemia
Keywords: Hypertriglyceridemia
Lipid metabolism
Dyslipidemia
Fatty Acids, Omega-3
Eicosapentaenoic Acid
Docosahexaenoic Acid
diet
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The groups will receive the treatment simultaneously.
Primary purpose: TREATMENT

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 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Serum triglycerides concentration in mg/dL
timeFrame: From week 4 to week 8 of the intervention
measure: Serum fatty acid profile analysis by gas chromatography in microgram
timeFrame: From week 4 to week 8 of the intervention
Secondary outcomes:
measure: Serum total cholesterol concentration in mg/dL
timeFrame: From week 4 to week 8 of the intervention
measure: Serum LDL cholesterol concentration in mg/dL
timeFrame: From week 4 to week 8 of the intervention
measure: Serum HDL cholesterol concentration in mg/dL
timeFrame: From week 4 to week 8 of the intervention
measure: Serum lipids concentration in relative peak area
timeFrame: From week 4 to week 8 of the intervention
measure: Serum C-reactive protein concentration in mg/dL
timeFrame: From week 4 to week 8 of the intervention
measure: Plasma malondialdehyde concentration in nmol/mL
timeFrame: From week 4 to week 8 of the intervention
measure: Serum Intercellular Adhesion Molecule-1 (ICAM-1) concentration in pg/mL
timeFrame: From week 4 to week 8 of the intervention
measure: Serum Vascular Cell Adhesion Molecule-1 (VCAM-1) concentration in pg/mL
timeFrame: From week 4 to week 8 of the intervention
measure: Serum plasminogen concentration in mg/dL
timeFrame: From week 4 to week 8 of the intervention
measure: Serum glucose concentration in mg/dL
timeFrame: From week 4 to week 8 of the intervention
measure: Serum aspartate aminotransferase concentration in IU/mL
timeFrame: From week 4 to week 8 of the intervention
measure: Serum alanine aminotransferase concentration in IU/mL
timeFrame: From week 4 to week 8 of the intervention
measure: Serum insulin concentration in micro - IU / ml
timeFrame: From week 4 to week 8 of the intervention
measure: Oxygen consumption rate in pmol of oxygen per minute per cell(s)
timeFrame: From week 4 to week 8 of the intervention
measure: Body weight in kilograms
timeFrame: From week 4 to week 8 of the intervention
measure: Waist circumference in centimeters
timeFrame: From week 4 to week 8 of the intervention
measure: Fat mass percentage
timeFrame: From week 4 to week 8 of the intervention
measure: Skeletal muscle mass percentage
timeFrame: From week 4 to week 8 of the intervention
measure: Lean mass percentage
timeFrame: From week 4 to week 8 of the intervention
measure: Medium very low density lipoprotein (VLDL) particle number in nmol/L
timeFrame: From week 4 to week 8 of the intervention
measure: Large very low density lipoprotein (VLDL) particle number in nmol/L
timeFrame: From week 4 to week 8 of the intervention
measure: Small very low density lipoprotein (VLDL) particle number in nmol/L
timeFrame: From week 4 to week 8 of the intervention
measure: Large LDL particle number in nmol/L
timeFrame: From week 4 to week 8 of the intervention
measure: Medium LDL particle number in nmol/L
timeFrame: From week 4 to week 8 of the intervention
measure: Small LDL particle number in nmol/L
timeFrame: From week 4 to week 8 of the intervention
measure: Large HDL particle number in nmol/L
timeFrame: From week 4 to week 8 of the intervention
measure: Small HDL particle number in nmol/L
timeFrame: From week 4 to week 8 of the intervention
measure: Medium HDL particle number in nmol/L
timeFrame: From week 4 to week 8 of the intervention
measure: Pulse wave velocity in m/s
timeFrame: From week 4 to week 8 of the intervention
measure: Controlled attenuation parameter in decibels per meter
timeFrame: From 4 week to 8 week of intervention
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
state: Mexico City
Study officials:
affiliation: INCMNSZ
name: Martha Guevara
role: STUDY_DIRECTOR
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