Hypertriglyceridemia
Conditions
Keywords
Hypertriglyceridemia, Lipid metabolism, Dyslipidemia, Fatty Acids, Omega-3, Eicosapentaenoic Acid, Docosahexaenoic Acid, diet
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 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.
Detailed description
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).
Interventions
DIETARY_SUPPLEMENTIsocaloric 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.
OTHERIsocaloric diet
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.
Sponsors
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The person who will perform the biochemical determinations and the statistical analysis will be blinded from the intervention group by assigning each patient.
Intervention model description
The groups will receive the treatment simultaneously.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum triglycerides concentration in mg/dL | From baseline to week 4 of the intervention | Change in serum triglycerides between different nutrition interventions. |
| Serum fatty acid profile analysis by gas chromatography in microgram | From baseline to week 4 of the intervention | Change in serum fatty acid between different nutrition interventions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum total cholesterol concentration in mg/dL | From baseline to week 4 of the intervention | Change in serum total cholesterol between different nutrition interventions. |
| Serum LDL cholesterol concentration in mg/dL | From baseline to week 4 of the intervention | Change in serum LDL cholesterol between different nutrition interventions. |
| Serum HDL cholesterol concentration in mg/dL | From baseline to week 4 of the intervention | Change in serum HDL cholesterol between different nutrition interventions. |
| Serum lipids concentration in relative peak area | From baseline to week 4 of the intervention | Change in serum lipids between different nutrition interventions. |
| Serum C-reactive protein concentration in mg/dL | From baseline to week 4 of the intervention | Change in serum C-reactive protein between different nutrition interventions. |
| Plasma malondialdehyde concentration in nmol/mL | From baseline to week 4 of the intervention | Change in plasma malondialdehyde between different nutrition interventions. |
| Serum Intercellular Adhesion Molecule-1 (ICAM-1) concentration in pg/mL | From baseline to week 4 of the intervention | Change in serum ICAM-1 between different nutrition interventions. |
| Serum Vascular Cell Adhesion Molecule-1 (VCAM-1) concentration in pg/mL | From baseline to week 4 of the intervention | Change in serum VCAM-1 between different nutrition interventions. |
| Serum plasminogen concentration in mg/dL | From baseline to week 4 of the intervention | Change in serum plasminogen between different nutrition interventions. |
| Serum glucose concentration in mg/dL | From baseline to week 4 of the intervention | Change in serum glucose between different nutrition interventions. |
| Serum aspartate aminotransferase concentration in IU/mL | From baseline to week 4 of the intervention | Change in serum aspartate aminotransferase between different nutrition interventions. |
| Serum alanine aminotransferase concentration in IU/mL | From baseline to week 4 of the intervention | Change in serum alanine aminotransferase between different nutrition interventions. |
| Serum insulin concentration in micro - IU / ml | From baseline to week 4 of the intervention | Change in serum insulin between different nutrition interventions. |
| Oxygen consumption rate in pmol / number of cells | From baseline to week 4 of the intervention | Change in oxygen consumption rate between different nutrition interventions. |
| Body weight in kilograms | From baseline to week 4 of the intervention | Change in body weight between different nutrition interventions. |
| Waist circumference in centimeters | From baseline to 4 week of the intervention | Change in waist circumference between different nutrition interventions. |
| Fat mass percentage | From baseline to 4 week of the intervention | Change in fat mass percentage between different nutrition interventions. |
| Skeletal muscle mass percentage | From baseline to 4 week of the intervention | Change in skeletal muscle mass percentage between different nutrition interventions. |
| Lean mass percentage | From baseline to 4 week of the intervention | Change in lean mass percentage between different nutrition interventions. |
| Medium very low density lipoprotein (VLDL) particle number in nmol/L | From baseline to 4 week of the intervention | Change in plasma medium VLDL particle number between different nutrition interventions. |
| Large very low density lipoprotein (VLDL) particle number in nmol/L | From baseline to 4 week of the intervention | Change in plasma large VLDL particle number between different nutrition interventions. |
| Small very low density lipoprotein (VLDL) particle number in nmol/L | From baseline to 4 week of the intervention | Change in plasma small VLDL particle number between different nutrition interventions. |
| Large LDL particle number in nmol/L | From baseline to 4 week of the intervention | Change in plasma large LDL particle number between different nutrition interventions. |
| Medium LDL particle number in nmol/L | From baseline to 4 week of the intervention | Change in plasma medium LDL particle number between different nutrition interventions. |
| Small LDL particle number in nmol/L | From baseline to 4 week of the intervention | Change in plasma small LDL particle number between different nutrition interventions. |
| Large HDL particle number in nmol/L | From baseline to 4 week of the intervention | Change in plasma large HDL particle number between different nutrition interventions. |
| Small HDL particle number in nmol/L | From baseline to 4 week of the intervention | Change in plasma small HDL particle number between different nutrition interventions. |
| Medium HDL particle number in nmol/L | From baseline to 4 week of the intervention | Change in plasma medium HDL particle number between different nutrition interventions. |
| Pulse wave velocity in m/s | From baseline to 4 week of the intervention | Change in pulse wave velocity between different nutrition interventions |
| Controlled attenuation parameter in decibels per meter | From baseline to 4 week of the intervention | Allows to evaluate the degree of steatosis by elastography. |
Countries
Mexico
Contacts
CONTACTMartha Guevara, MD, PhD
CONTACTArmando Tovar, PhD
STUDY_DIRECTORMartha Guevara
INCMNSZ
Outcome results
None listed