An interventional study of Isocaloric diet including chia and pumpkin seeds and Isocaloric diet in Hypertriglyceridemia, sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran. Recruiting at 1 site in Mexico. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Not applicable, Interventional, and Treatment
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:
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).
324 studies on the registry are indexed under Hypertriglyceridemia; 38 are open to participants now.
This study's planned enrollment of 375 is above the median of 66 across 288 interventional studies indexed under Hypertriglyceridemia.
Browse Hypertriglyceridemia studies →Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran is the lead sponsor of 144 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diet based on participant-specific energy expenditure. With the following macronutrient distribution: 50% carbohydrates, protein 20% and 30% fats.
Dietary Supplement: 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.
Other: Isocaloric 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 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.
Serum 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
Plan to share: No
Started Feb 2026 (actual). Primary completion is estimated for Dec 2026, 10 months after the start.
Of 42 non-industry interventional studies with no phase under Hypertriglyceridemia, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 39. This study's planned 10 months is below that.
Counting every sponsor, half of 45 studies reached it within 23 months; a quarter within 7 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
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