Evaluation of the Safety and Efficacy of Omega-3 Fish Oil Dietary Supplementation in Biometric Measurement, Lipid Profile, Serum Markers for Inflammation, and Insulin Resistance in Overweight Children and Adolescents
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- To compare effects between Omega 3 fish oil and placebo
研究概览
简要总结
Children with an excess in body weight, increase the risk of obesity-related co-morbidities and cardiovascular diseases. Childhood obesity may be due to diets laden with fat and lack of physical activity. Omega-3 fish oil is a supplementation that may promote a greater reduction of pro-inflammatory mediators; combined with exercise and nutritional regimens it may also help improve glycemic, lipid markers, and body composition in overweight children and adolescents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 8-18 years old
- •BMI ≥95th percentile
- •Patient & parent/guardian consent to participate
- •Attendance of Risk Factor Reduction lifestyle modification program
排除标准
- •Major surgical Procedure within 1 year
- •Significant cardiovascular disease or other morbidity that preclude patients from following dietary regimen or exercising.
- •Mentally Challenged
- •Currently taking fish oil supplements, unless 1 month wash-out period is achieved.
结局指标
主要结局
To compare effects between Omega 3 fish oil and placebo
时间窗: 3 months
To compare the effect of Omega 3 fish oil dietary supplementation versus placebo on biometric measurement, lipid profile, serum markers for inflammation and insulin resistance in overweight children and adolescents undergoing treatment with a low-glycemic load diet and exercise.
次要结局
- To compare effects between Omega 3 fish oil and placebo(3 months)