Omega-3 Fatty Acid Dietary Intervention for Dyslipidemia of Obesity in Children 10 to <18 Years of Age: O3DI Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- change in serum triglyceride level after an 8-week diet intervention compared to baseline
研究概览
简要总结
Elevated cholesterol, including triglyceride levels, can lead to the development of cardiovascular disease in adulthood. A diet that is rich in omega-3 fatty acids (O3FA) can improve triglyceride levels in a way that is safe and does not require medication.
This is a single-center, prospective, unblinded, randomized-controlled dietary intervention study to assess the impact of an omega-3 fatty acid diet compared to a standard lifestyle intervention on serum triglyceride in patients with hypertriglyceridemia. The study consists of an 8-week dietary treatment period followed by an 8-week observation period.
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
- None
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients who are 10 -17 years of age
- •BMI greater than or equal to the 85th percentile
- •Clinical serum triglyceride level >150 mg/dl and < 500 mg/dl performed between 3 months and 1 week prior to study visit 1
- •Ability to follow the study procedures and adhere to the diet counseling recommendations
- •Written parental permission and assent are obtained prior to any research procedures
排除标准
- •Type 2 DM (hemoglobin A1C >6.6%)
- •Isotretinoin use
- •Chronic kidney disease (CKD)
- •Uncontrolled hypothyroidism
- •Warfarin use
- •Liver disease (NAFLD is allowed)
- •Renal disease
- •Corticosteroid use
- •Omega-3 fatty acid use (prescription or supplement)
- •Allergy to fish and/or nuts
- •Currently pregnant or planning to become pregnant during the course of this trial - confirmed by date of LMP/querying family
- •Any significant medical condition which the investigator believes would interfere with participation in this study
结局指标
主要结局
change in serum triglyceride level after an 8-week diet intervention compared to baseline
时间窗: 8 weeks
The study will test whether omega-3 fatty acid enriched diet is associated with a 20% or greater reduction in serum triglyceride levels.
次要结局
- change red blood cell omega-3 fatty acid content / index after an 8-week diet intervention compared to baseline(8 weeks)