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RECRUITINGINTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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 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.

Who May Be Eligible (Plain English)

Who May Qualify: Phase 1 - Signing of the willing to sign a consent form 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). Who Should NOT Join This Trial: - 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 weakened immune system 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

OTHER

Isocaloric diet including chia and pumpkin seeds

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.

DIETARY_SUPPLEMENT

Isocaloric diet plus fish oil

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 EPA + DHA supplement (fish oil) to the diet.

OTHER

Isocaloric diet including salmon

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 salmon.

Locations (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Mexico City, Mexico