Effect of Omega-3 Fatty Acids Supplementation on Hypertriglyceridemia in Pediatric Patients With Obesity. A Randomized, Double Blind, Placebo-controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 主要终点
- Percentage Change in Serum Triglyceride Levels From Baseline to Week 12 of Study Treatment
研究概览
简要总结
The primary objective was to evaluate the safety and efficacy the 3 grams per day of omega-3 in adolescents with obesity and hypertriglyceridemia ( ≥ 150 mg/dl and ≤ 1000 mg/dl) for 12 weeks, compared with placebo. Half of subjects received 3 grams of omega 3, while the other half received placebo.
详细描述
First of all, the omega-3 free fatty acids have an important effect for lowering triglycerides through three potential mechanisms such as:
Inhibition of triacylglycerol synthesis as direct inhibition of diacyl glycerol acetyl transferase and phosphatidic acid phosphohydrolase results in lowering triacylglycerol production.
Simulation of fatty acid oxidation through activation of peroxisome proliferation activated receptor stimulates hepatic mitochondrial and peroxisomal beta oxidation of fatty acids. Decreased availability of fatty acids for triacylglycerol synthesis results in lowering plasma triacylglycerol levels Lipoprotein Lipase mediated clearance. One of the first randomized double blind placebo controlled clinical trials was managed by Harris in 1997 in adult subjects with an average age of 46 ± 11 years and severe hypertriglyceridemia (500-2000 mg / dl) 20 subjects received placebo and 22 subjects 4 grams of omega-3. The mean percent change from baseline in the omega-3 group was -45 ± 23% and in the placebo group was -16 ± 35% (p <0.0001).
Also, more clinical trials have recently been conducted with similar results such as the most recent randomized, double-blind, placebo-controlled clinical trial that was conducted by Ta-Chen Su in Taiwan in adults with hypertriglyceridemia (200-1000 mg / dl). The first group received 4 grams of omega-3 (n = 84), the second group received 2 grams of omega-3 (n = 82) and the third group received placebo (n = 87). The mean percent change from baseline in the 4 grams of omega-3 group was -32.1%, in the 2 grams group of omega-3 was -29.7% and in the placebo group was -5.4% (p <0.0001) What is more, the strongest scientific evidence in favor of supplementation of omega-3 acids fatty was determined by two meta-analysis, the first study was published by Harris in 1997 that included 72 placebo-controlled clinical trials, the study showed a reduction of 25-30% triglycerides levels with doses of 3-4 g omega-3 compared with placebo in subjects with triglycerides levels ≥500mg / dl. The second meta-analysis by Balk that included 17 clinical trials (7,803 patients) with different doses of omega-3 (0.8-5.4 g). The net reduction in triglycerides levels was -27 mg / dl (IC95% 22-30), p <0.0001 In addition, the American Heart Association based on the meta-analysis by Harris currently recommends the administration of 2 to 4 grams of omega-3 per day for the treatment of severe hypertriglyceridemia (≥500mg / dl) in adult patients.
Secondly, the Task Force for the Management of Dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS) currently recommends that if hypertriglyceridemia is not able to reduce with statins or fibrates the physician will prescribe 2-4 grams of omega-3 fatty acids to reduce triglyceride levels in adult patients.
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
- Double (Participant, Investigator)
盲法说明
The Masking intervention had made for investigation subjects and researchers
入排标准
- 年龄范围
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 10-16 years old
- •Informed consent from a parent or legal guardian of minors or adult subject
- •Written assent from the adolescent to participate in the study
- •Obese patients (Body Mass Index ≥95th percentile according to the National Center for Health Statistics, Center for Disease Control and Prevention [CDC].
- •Fasting Serum triglycerides ≥150 mg/dL and ≤1000 mg/dL.
- •Cooperation to ingest capsules (omega-3 or placebo) and taking laboratories
排除标准
- •The subjects must not had received pharmacology treatment for hypertriglyceridemia six months before and at the time of enrollment.
- •Treatment with medications that affect triglyceride levels, including oral hypoglycemic agents or insulin.
- •Pregnancy or positive urine pregnancy test for those females who have begun menstruating.
- •Known Bleeding Disorder or Coagulopathy or treatment with anticoagulant medications or low platelet counts, abnormal PT, or PTT.
- •Subjects with mental delayed.
- •Neurological disorder.
- •Subjects with Cardiopathy
- •Subjects with gastroesophageal reflux
- •Endocrinopathies such as thyroid disorder, Hypothalamic disorder and Type 1 or 2 diabetes or fasting glucose that is >=126 mg/dl.
- •Subjects with liver disease
- •Familial hypertriglyceridemia.
- •Familial hypercholesterolemia
- •Polycystic ovary syndrome
- •Use of contraceptives by any way of administration 6 months before and at the time of enrollment.
- •Use of vitamins 6 months before and at the time of enrollment.
- •Allergy to fish oil.
- •Allergy to soybean oil.
- •Elimination criteria:
- •Subject or parents´ subject either decision to discontinue of the study at any time without prejudice to further treatment.
- •Serious adverse event.
- •Safety reason as judged by the investigator.
- •Pregnancy.
研究组 & 干预措施
Omega-3 fatty acid 3 grams per day
Each capsule contains 400 mg of eicosapentaenoic acid and 200 mg of docosahexaenoic acid. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 2000 mg of eicosapentaenoic acid and 1000 mg of docosahexaenoic acid per day (3 grams of Omega 3 per day) by mouth for 12 weeks. The trademark is Omega Rx Dr.Sears Zone labs Inc.
干预措施: Omega-3 fatty acid 3 grams per day (Dietary Supplement)
Placebo
Each capsule contains 600 mg of soybean oil. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 3000 mg of soybean oil per day (3 gr soya oil per day) by mouth for 12 weeks.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Percentage Change in Serum Triglyceride Levels From Baseline to Week 12 of Study Treatment
时间窗: 12 weeks
Percentage change in serum triglyceride levels from baseline to week 12 of study treatment
Milligram Change in Serum Triglyceride Levels From Baseline to Week 12 of Study Treatment
时间窗: 12 weeks
Milligram Change in Serum Triglyceride Levels From Baseline to Week 12 of Study Treatment
次要结局
- Milligram Change in Serum HDL-C Levels From Baseline to Week 12 of Study Treatment(12 weeks)
- Percentage Change in Serum Glucose Levels From Baseline to Week 12 of Study Treatment(12 weeks)
- Percentage Change in Serum Cholesterol Levels From Baseline to Week 12 of Study Treatment(12 weeks)
- Milligram Change in Serum Cholesterol Levels From Baseline to Week 12 of Study Treatment(12 weeks)
- Percentage Change in Serum HDL-C Levels From Baseline to Week 12 of Study Treatment(12 weeks)
- Milligram Change in Glucose Levels From Baseline to Week 12 of Study Treatment(12 weeks)
- Milligram Change in Serum Uric Acid Levels From Baseline to Week 12 of Study Treatment(12 weeks)
- Percentage Change in Serum Uric Acid Levels From Baseline to Week 12 of Study Treatment(12 weeks)
研究者
Blanca Estela Del Rio Navarro
Principal Investigator
Hospital Infantil de Mexico Federico Gomez