Effect of Consuming n-3 Polyunsaturated Fatty Acids Rich Foods on Triglyceride Concentration and Lipoprotein Composition in Individuals With Hypertriglyceridemia. Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 375
- 试验地点
- 1
- 主要终点
- Serum triglycerides concentration in mg/dL
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The person who will perform the biochemical determinations and the statistical analysis will be blinded from the intervention group by assigning each patient.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signing of the informed consent form
- •Both sexes.
- •Adults over 18 years of age.
- •BMI >18.5 kg/m
- •Triglycerides between 200 and 500 mg/dL.
- •Total cholesterol less than 240 mg/dL
排除标准
- •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
- •People with a tobacco Index greater than
- •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.
研究组 & 干预措施
Isocaloric diet based on NCEP-ATPIII dietary recommendations including chia and pumpkin seeds.
Diet based on participant-specific energy expenditure. With the following macronutrient distribution: 50% carbohydrates, protein 20% and 30% fats.
干预措施: Isocaloric diet including chia and pumpkin seeds (Dietary Supplement)
Isocaloric diet based on NCEP-ATPIII dietary recommendations
Diet based on participant-specific energy expenditure. With the following macronutrient distribution: 50% carbohydrates, protein 20% and 30% fats.
干预措施: Isocaloric diet (Other)
结局指标
主要结局
Serum triglycerides concentration in mg/dL
时间窗: 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
时间窗: From baseline to week 4 of the intervention
Change in serum fatty acid between different nutrition interventions.
Serum triglycerides concentration in mg/dL
时间窗: From week 4 to week 8 of the intervention
Change in serum triglycerides between different nutrition interventions.
Serum fatty acid profile analysis by gas chromatography in microgram
时间窗: From week 4 to week 8 of the intervention
Change in serum fatty acid between different nutrition interventions.
次要结局
- Serum total cholesterol concentration in mg/dL(From baseline to week 4 of the intervention)
- Serum LDL cholesterol concentration in mg/dL(From baseline to week 4 of the intervention)
- Serum HDL cholesterol concentration in mg/dL(From baseline to week 4 of the intervention)
- Serum lipids concentration in relative peak area(From baseline to week 4 of the intervention)
- Serum C-reactive protein concentration in mg/dL(From baseline to week 4 of the intervention)
- Plasma malondialdehyde concentration in nmol/mL(From baseline to week 4 of the intervention)
- Serum Intercellular Adhesion Molecule-1 (ICAM-1) concentration in pg/mL(From baseline to week 4 of the intervention)
- Serum Vascular Cell Adhesion Molecule-1 (VCAM-1) concentration in pg/mL(From baseline to week 4 of the intervention)
- Serum plasminogen concentration in mg/dL(From baseline to week 4 of the intervention)
- Serum glucose concentration in mg/dL(From baseline to week 4 of the intervention)
- Serum aspartate aminotransferase concentration in IU/mL(From baseline to week 4 of the intervention)
- Serum alanine aminotransferase concentration in IU/mL(From baseline to week 4 of the intervention)
- Serum insulin concentration in micro - IU / ml(From baseline to week 4 of the intervention)
- Oxygen consumption rate in pmol / number of cells(From baseline to week 4 of the intervention)
- Body weight in kilograms(From baseline to week 4 of the intervention)
- Waist circumference in centimeters(From baseline to 4 week of the intervention)
- Fat mass percentage(From baseline to 4 week of the intervention)
- Skeletal muscle mass percentage(From baseline to 4 week of the intervention)
- Lean mass percentage(From baseline to 4 week of the intervention)
- Medium very low density lipoprotein (VLDL) particle number in nmol/L(From baseline to 4 week of the intervention)
- Large very low density lipoprotein (VLDL) particle number in nmol/L(From baseline to 4 week of the intervention)
- Small very low density lipoprotein (VLDL) particle number in nmol/L(From baseline to 4 week of the intervention)
- Large LDL particle number in nmol/L(From baseline to 4 week of the intervention)
- Medium LDL particle number in nmol/L(From baseline to 4 week of the intervention)
- Small LDL particle number in nmol/L(From baseline to 4 week of the intervention)
- Large HDL particle number in nmol/L(From baseline to 4 week of the intervention)
- Small HDL particle number in nmol/L(From baseline to 4 week of the intervention)
- Medium HDL particle number in nmol/L(From baseline to 4 week of the intervention)
- Pulse wave velocity in m/s(From baseline to 4 week of the intervention)
- Controlled attenuation parameter in decibels per meter(From baseline to 4 week of the intervention)
- Medium HDL particle number in nmol/L(From week 4 to week 8 of the intervention)
- Pulse wave velocity in m/s(From week 4 to week 8 of the intervention)
- Controlled attenuation parameter in decibels per meter(From 4 week to 8 week of intervention)
- Waist circumference in centimeters(From week 4 to week 8 of the intervention)
- Fat mass percentage(From week 4 to week 8 of the intervention)
- Skeletal muscle mass percentage(From week 4 to week 8 of the intervention)
- Lean mass percentage(From week 4 to week 8 of the intervention)
- Medium very low density lipoprotein (VLDL) particle number in nmol/L(From week 4 to week 8 of the intervention)
- Large very low density lipoprotein (VLDL) particle number in nmol/L(From week 4 to week 8 of the intervention)
- Small very low density lipoprotein (VLDL) particle number in nmol/L(From week 4 to week 8 of the intervention)
- Large LDL particle number in nmol/L(From week 4 to week 8 of the intervention)
- Medium LDL particle number in nmol/L(From week 4 to week 8 of the intervention)
- Small LDL particle number in nmol/L(From week 4 to week 8 of the intervention)
- Large HDL particle number in nmol/L(From week 4 to week 8 of the intervention)
- Small HDL particle number in nmol/L(From week 4 to week 8 of the intervention)
- Serum total cholesterol concentration in mg/dL(From week 4 to week 8 of the intervention)
- Serum LDL cholesterol concentration in mg/dL(From week 4 to week 8 of the intervention)
- Serum HDL cholesterol concentration in mg/dL(From week 4 to week 8 of the intervention)
- Serum lipids concentration in relative peak area(From week 4 to week 8 of the intervention)
- Serum C-reactive protein concentration in mg/dL(From week 4 to week 8 of the intervention)
- Plasma malondialdehyde concentration in nmol/mL(From week 4 to week 8 of the intervention)
- Serum Intercellular Adhesion Molecule-1 (ICAM-1) concentration in pg/mL(From week 4 to week 8 of the intervention)
- Serum Vascular Cell Adhesion Molecule-1 (VCAM-1) concentration in pg/mL(From week 4 to week 8 of the intervention)
- Serum plasminogen concentration in mg/dL(From week 4 to week 8 of the intervention)
- Serum glucose concentration in mg/dL(From week 4 to week 8 of the intervention)
- Serum aspartate aminotransferase concentration in IU/mL(From week 4 to week 8 of the intervention)
- Serum alanine aminotransferase concentration in IU/mL(From week 4 to week 8 of the intervention)
- Serum insulin concentration in micro - IU / ml(From week 4 to week 8 of the intervention)
- Oxygen consumption rate in pmol of oxygen per minute per cell(s)(From week 4 to week 8 of the intervention)
- Body weight in kilograms(From week 4 to week 8 of the intervention)
研究者
Martha Guevara Cruz
Principal Investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran