Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| INCMNSZ | Other Identifier | INCMNSZ |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isocaloric diet based on NCEP-ATPIII dietary recommendations including chia and pumpkin seeds. | Experimental | Diet based on participant-specific energy expenditure. With the following macronutrient distribution: 50% carbohydrates, protein 20% and 30% fats. |
|
| Isocaloric diet based on NCEP-ATPIII dietary recommendations | Active Comparator | Diet based on participant-specific energy expenditure. With the following macronutrient distribution: 50% carbohydrates, protein 20% and 30% fats. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isocaloric diet including chia and pumpkin seeds | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum triglycerides concentration in mg/dL | Change in serum triglycerides between different nutrition interventions. | 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. | From baseline to week 4 of the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Serum total cholesterol concentration in mg/dL | Change in serum total cholesterol between different nutrition interventions. | From baseline to week 4 of the intervention |
| Serum LDL cholesterol concentration in mg/dL |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martha Guevara, MD, PhD | Contact | +52 55 5487 0900 | 2802 | martha.guevarac@incmnsz.mx |
| Armando Tovar, PhD | Contact | +52 55 5487 0900 | 2802 | armando.tovarp@incmnsz.mx |
| Name | Affiliation | Role |
|---|---|---|
| Martha Guevara | INCMNSZ | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán | Recruiting | Mexico City | Mexico City | 14080 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37730162 | Background | Ly R, MacIntyre BC, Philips SM, McGlory C, Mutch DM, Britz-McKibbin P. Lipidomic studies reveal two specific circulating phosphatidylcholines as surrogate biomarkers of the omega-3 index. J Lipid Res. 2023 Nov;64(11):100445. doi: 10.1016/j.jlr.2023.100445. Epub 2023 Sep 18. | |
| 22952598 | Background | Ottestad I, Hassani S, Borge GI, Kohler A, Vogt G, Hyotylainen T, Oresic M, Bronner KW, Holven KB, Ulven SM, Myhrstad MC. Fish oil supplementation alters the plasma lipidomic profile and increases long-chain PUFAs of phospholipids and triglycerides in healthy subjects. PLoS One. 2012;7(8):e42550. doi: 10.1371/journal.pone.0042550. Epub 2012 Aug 28. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The groups will receive the treatment simultaneously.
Not provided
Not provided
The person who will perform the biochemical determinations and the statistical analysis will be blinded from the intervention group by assigning each patient.
|
| Isocaloric diet | Other | 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. |
|
Change in serum LDL cholesterol between different nutrition interventions.
| From baseline to week 4 of the intervention |
| Serum HDL cholesterol concentration in mg/dL | Change in serum HDL cholesterol between different nutrition interventions. | From baseline to week 4 of the intervention |
| Serum lipids concentration in relative peak area | Change in serum lipids between different nutrition interventions. | 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. | From baseline to week 4 of the intervention |
| Plasma malondialdehyde concentration in nmol/mL | Change in plasma malondialdehyde between different nutrition interventions. | 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. | 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. | From baseline to week 4 of the intervention |
| Serum plasminogen concentration in mg/dL | Change in serum plasminogen between different nutrition interventions. | From baseline to week 4 of the intervention |
| Serum glucose concentration in mg/dL | Change in serum glucose between different nutrition interventions. | From baseline to week 4 of the intervention |
| Serum aspartate aminotransferase concentration in IU/mL | Change in serum aspartate aminotransferase between different nutrition interventions. | From baseline to week 4 of the intervention |
| Serum alanine aminotransferase concentration in IU/mL | Change in serum alanine aminotransferase between different nutrition interventions. | From baseline to week 4 of the intervention |
| Serum insulin concentration in micro - IU / ml | Change in serum insulin between different nutrition interventions. | 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. | From baseline to week 4 of the intervention |
| Body weight in kilograms | Change in body weight between different nutrition interventions. | From baseline to week 4 of the intervention |
| Waist circumference in centimeters | Change in waist circumference between different nutrition interventions. | From baseline to 4 week of the intervention |
| Fat mass percentage | Change in fat mass percentage between different nutrition interventions. | From baseline to 4 week of the intervention |
| Skeletal muscle mass percentage | Change in skeletal muscle mass percentage between different nutrition interventions. | From baseline to 4 week of the intervention |
| Lean mass percentage | Change in lean mass percentage between different nutrition interventions. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | From baseline to 4 week of the intervention |
| Pulse wave velocity in m/s | Change in pulse wave velocity between different nutrition interventions | From baseline to 4 week of the intervention |
| Controlled attenuation parameter in decibels per meter | Allows to evaluate the degree of steatosis by elastography. | From baseline to 4 week of the intervention |
| 34548243 | Background | Erkkila AT, Manninen S, Fredrikson L, Bhalke M, Holopainen M, Ruuth M, Lankinen M, Kakela R, Oorni K, Schwab US. Lipidomic changes of LDL after consumption of Camelina sativa oil, fatty fish and lean fish in subjects with impaired glucose metabolism-A randomized controlled trial. J Clin Lipidol. 2021 Sep-Oct;15(5):743-751. doi: 10.1016/j.jacl.2021.08.060. Epub 2021 Sep 7. |
| 26222126 | Background | Tatsuno I, Kudou K, Kagawa T. Effect of TAK-085 on Low-density Lipoprotein Particle Size in Patients with Hypertriglyceridemia: A Double-blind Randomized Clinical Study. Cardiovasc Ther. 2015 Dec;33(6):317-23. doi: 10.1111/1755-5922.12146. |
| 18938206 | Background | Makni M, Fetoui H, Gargouri NK, Garoui el M, Jaber H, Makni J, Boudawara T, Zeghal N. Hypolipidemic and hepatoprotective effects of flax and pumpkin seed mixture rich in omega-3 and omega-6 fatty acids in hypercholesterolemic rats. Food Chem Toxicol. 2008 Dec;46(12):3714-20. doi: 10.1016/j.fct.2008.09.057. Epub 2008 Oct 1. |
| 27352915 | Background | Avila-Nava A, Noriega LG, Tovar AR, Granados O, Perez-Cruz C, Pedraza-Chaverri J, Torres N. Food combination based on a pre-hispanic Mexican diet decreases metabolic and cognitive abnormalities and gut microbiota dysbiosis caused by a sucrose-enriched high-fat diet in rats. Mol Nutr Food Res. 2017 Jan;61(1). doi: 10.1002/mnfr.201501023. Epub 2016 Aug 8. |
| 28294373 | Background | Bhatt DL, Steg PG, Brinton EA, Jacobson TA, Miller M, Tardif JC, Ketchum SB, Doyle RT Jr, Murphy SA, Soni PN, Braeckman RA, Juliano RA, Ballantyne CM; REDUCE-IT Investigators. Rationale and design of REDUCE-IT: Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial. Clin Cardiol. 2017 Mar;40(3):138-148. doi: 10.1002/clc.22692. Epub 2017 Mar 15. |
| 21914258 | Background | Zheng J, Huang T, Yu Y, Hu X, Yang B, Li D. Fish consumption and CHD mortality: an updated meta-analysis of seventeen cohort studies. Public Health Nutr. 2012 Apr;15(4):725-37. doi: 10.1017/S1368980011002254. Epub 2011 Sep 14. |
| 33370175 | Background | Kontostathi M, Isou S, Mostratos D, Vasdekis V, Demertzis N, Kourounakis A, Vitsos A, Kyriazi M, Melissos D, Tsitouris C, Karalis E, Klamarias L, Dania F, Papaioannou GT, Roussis V, Polychronopoulos E, Anastassopoulou J, Theophanides T, Rallis MC, Black HS. Influence of Omega-3 Fatty Acid-Rich Fish Oils on Hyperlipidemia: Effect of Eel, Sardine, Trout, and Cod Oils on Hyperlipidemic Mice. J Med Food. 2021 Jul;24(7):749-755. doi: 10.1089/jmf.2020.0114. Epub 2020 Dec 23. |
| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided