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.
The study will consist of a 4-week period in which one group of participants will be given a diet based on the NCEP-ATPIII dietary recommendations, and another group will receive the same diet plus chia and pumpkin seeds. If participants maintain triglyceride levels \>200 mg/dL, they will be given fish oil supplementation for an additional 4 weeks to reinforce the dietary treatment (NCEP-ATPIII dietary recommendations). Participants will be screened to ensure they meet the inclusion criteria. Those who agree to participate will be required to sign an informed consent form. At both the beginning and the end of the 4-week period, participants will undergo a medical history assessment, anthropometric measurements (weight, height, and waist circumference), body composition analysis (including body fat percentage, skeletal muscle mass percentage, and lean body mass percentage), blood pressure measurement, evaluation of hepatic steatosis using transient elastography and; pulse wave velocity. In addition, blood samples will be collected to determine serum glucose levels; lipid profile parameters (total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides); inflammatory, oxidative, and endothelial markers; and genetic polymorphisms related to lipid metabolism, particularly n-3 polyunsaturated fatty acids (PUFAs) (FADS1 and FADS2). Monocytes will also be isolated to assess mitochondrial function. Furthermore, serum concentrations of phosphatidylcholine species (16:0\_20:5 and 16:0\_22:6), lipoprotein composition, and fatty acid profiles will be analyzed using gas chromatography. Participants with hypertriglyceridemia will be randomly assigned to two groups. Both groups will be prescribed an isocaloric diet; however, only one group will additionally include a food rich in n-3 PUFAs: * An isocaloric diet based on NCEP-ATPIII dietary recommendations. * An isocaloric diet based on NCEP-ATPIII dietary recommendations including chia and pumpkin 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 rich in n-3 PUFA. Participants with triglyceride levels \>200 mg/dL after the 4-week dietary intervention period will receive fish oil supplementation for an additional 4 weeks. At the end of this period, anthropometric measurements (weight, height, and waist circumference), body composition analysis (including body fat percentage, skeletal muscle mass percentage, and lean body mass percentage), blood pressure measurement, and hepatic steatosis assessment using transient elastography will be repeated. Blood samples will be collected again to determine serum glucose levels and lipid profile parameters (total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides). During the whole study 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. In addition to the above, the concentration of fatty acids in serum will be evaluated and compared over a 24-hour period following the intake of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) supplements (fish oil) vs. that of foods rich in n-3 polyunsaturated fatty acids (salmon fish, Sierra fish and chia seeds and pumpkin seeds).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
375
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.
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.
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Mexico City, Mexico
RECRUITINGSerum triglycerides concentration in mg/dL
Change in serum triglycerides between different nutrition interventions.
Time frame: From baseline to week 4 of the intervention
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
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
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
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
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
Serum C-reactive protein concentration in mg/dL
Change in serum C-reactive protein between different nutrition interventions.
Time frame: From baseline to week 4 of the intervention
Plasma malondialdehyde concentration in nmol/mL
Change in plasma malondialdehyde between different nutrition interventions.
Time frame: From baseline to week 4 of the intervention
Serum Intercellular Adhesion Molecule-1 (ICAM-1) concentration in pg/mL
Change in serum ICAM-1 between different nutrition interventions.
Time frame: From baseline to week 4 of the intervention
Serum Vascular Cell Adhesion Molecule-1 (VCAM-1) concentration in pg/mL
Change in serum VCAM-1 between different nutrition interventions.
Time frame: From baseline to week 4 of the intervention
Serum plasminogen concentration in mg/dL
Change in serum plasminogen between different nutrition interventions.
Time frame: From baseline to week 4 of the intervention
Serum glucose concentration in mg/dL
Change in serum glucose between different nutrition interventions.
Time frame: From baseline to week 4 of the intervention
Serum aspartate aminotransferase concentration in IU/mL
Change in serum aspartate aminotransferase between different nutrition interventions.
Time frame: From baseline to week 4 of the intervention
Serum alanine aminotransferase concentration in IU/mL
Change in serum alanine aminotransferase between different nutrition interventions.
Time frame: From baseline to week 4 of the intervention
Serum insulin concentration in micro - IU / ml
Change in serum insulin between different nutrition interventions.
Time frame: From baseline to week 4 of the intervention
Oxygen consumption rate in pmol / number of cells
Change in oxygen consumption rate between different nutrition interventions.
Time frame: From baseline to week 4 of the intervention
Body weight in kilograms
Change in body weight between different nutrition interventions.
Time frame: From baseline to week 4 of the intervention
Waist circumference in centimeters
Change in waist circumference between different nutrition interventions.
Time frame: From baseline to 4 week of the intervention
Fat mass percentage
Change in fat mass percentage between different nutrition interventions.
Time frame: From baseline to 4 week of the intervention
Skeletal muscle mass percentage
Change in skeletal muscle mass percentage between different nutrition interventions.
Time frame: From baseline to 4 week of the intervention
Lean mass percentage
Change in lean mass percentage between different nutrition interventions.
Time frame: From baseline to 4 week of the intervention
Medium very low density lipoprotein (VLDL) particle number in nmol/L
Change in plasma medium VLDL particle number between different nutrition interventions.
Time frame: From baseline to 4 week of the intervention
Large very low density lipoprotein (VLDL) particle number in nmol/L
Change in plasma large VLDL particle number between different nutrition interventions.
Time frame: From baseline to 4 week of the intervention
Small very low density lipoprotein (VLDL) particle number in nmol/L
Change in plasma small VLDL particle number between different nutrition interventions.
Time frame: From baseline to 4 week of the intervention
Large LDL particle number in nmol/L
Change in plasma large LDL particle number between different nutrition interventions.
Time frame: From baseline to 4 week of the intervention
Medium LDL particle number in nmol/L
Change in plasma medium LDL particle number between different nutrition interventions.
Time frame: From baseline to 4 week of the intervention
Small LDL particle number in nmol/L
Change in plasma small LDL particle number between different nutrition interventions.
Time frame: From baseline to 4 week of the intervention
Large HDL particle number in nmol/L
Change in plasma large HDL particle number between different nutrition interventions.
Time frame: From baseline to 4 week of the intervention
Small HDL particle number in nmol/L
Change in plasma small HDL particle number between different nutrition interventions.
Time frame: From baseline to 4 week of the intervention
Medium HDL particle number in nmol/L
Change in plasma medium HDL particle number between different nutrition interventions.
Time frame: From baseline to 4 week of the intervention
Pulse wave velocity in m/s
Change in pulse wave velocity between different nutrition interventions
Time frame: From baseline to 4 week of the intervention
Controlled attenuation parameter in decibels per meter
Allows to evaluate the degree of steatosis by elastography.
Time frame: From baseline to 4 week of the intervention
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