Intervention Study of the Ergogenic, Anti-inflammatory and Obesity Inhibitory Effects of Omega-3 Fatty Acids in 8 Year Old Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 423
- 试验地点
- 1
- 主要终点
- Total physical activity
研究概览
简要总结
This study hypothesizes that supplementation of omega-3 fatty acids (OM3) can increase physical activity, inhibit rapid gain in body weight and BMI in both sedentary and normally active 8 year old children. The purpose is secondarily to explore patterns of associations between OM3 supplementation, baseline and follow-up levels in all studied parameters. The study also aims to study if basal levels of OM3 are correlated with physical activity and to study if there is an association between basal levels of OM3 and the effect of OM3 supplementation on physical activity. To study if there is an effect of OM3 supplementation on triglyceride and LDL cholesterol levels and to study if there are more pronounced effects on children with higher levels. To study if OM3 supplementation, compared with placebo reduce weight increase among children at risk to become overweight. To study if there is an association between effects of OM3 on physical activity, weight and risk markers in blood. To study if there are any gender differences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children in second grade of Swedish primary school willing to participate
排除标准
- 未提供
研究组 & 干预措施
Placebo
50 % of included children will be randomized to this arm and will be administered placebo capsules for the 15 week intervention.
干预措施: Placebo (Dietary Supplement)
Omega-3 supplementation
50 % of all included children will be randomized to this arm and administered capsules containing an omega-3 fatty acid composition.
干预措施: Omega-3 (Dietary Supplement)
结局指标
主要结局
Total physical activity
时间窗: 15 weeks
The childrens' physical activity will be monitored during 7 consequtive days at 0 and 15 weeks with tri-axial accelerometer.
Body mass
时间窗: 15 weeks
The childrens' body mass will be measured with standardized scales at 0 and 15 weeks.
次要结局
- Childrens reported quality of life(15 weeks)
- Cardiovascular risk markers(15 weeks)
- BMI(15 weeks)
- Self reported physical activity(15 weeks)
- Perceived motor skill(15 weeks)
研究者
Claude Marcus
Professor
Karolinska Institutet