The Effect of Oily Fish and Poultry on Children's Cardiometabolic Health and Cognitive Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 199
- 试验地点
- 1
- 主要终点
- Blood pressure
研究概览
简要总结
The purpose of FiSK Junior is to investigate whether intake of oily fish compared to poultry affects cardiovascular risk markers, cognitive function, and behaviour in healthy children.
详细描述
The FiSK Junior study compares the effects of consuming oily fish versus poultry (control) in healthy 8-9 year-old Danish children. The children will be randomized to consume approximately 300 g/week of either oily fish or poultry for 12 weeks. Measurements and biological sampling will be performed at baseline and at the end of the intervention.
The main objective of the study is to investigate the effect on cardiovascular risk markers, primarily blood pressure and plasma triacylglycerol. Moreover, the effects on cognitive function, behaviour, emotions and physiological stress response will be assessed. In addition, change in n-3 long chain polyunsaturated fatty acid status (compliance), anthropometry, body composition, vitamin D status, inflammatory markers, growth markers, physical activity and diet will be measured. Outcomes will be analysed with focus on potential gender- and genotype-specific effects.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children must:
- •Be 8 - 9 years of age at the start of the intervention
- •Be healthy
- •Like oily fish and chicken
- •Be willing to be randomized to eat fish or chicken
- •Not consume oily fish more than once per week 3 months prior to intervention start
- •Not consume fish oil 3 months prior to intervention start
- •Speak Danish in order to understand the study procedures
- •Parents must read and speak Danish, in order to be properly informed about the study procedures
- •The child must live in a household with ≤5 persons
排除标准
- •Serious chronic illnesses and diseases that may interfere with study outcomes
- •Diagnosed Attention Deficit Hyperactivity Disorder (ADHD) or other psychiatric illness
- •Intake of medication that may affect study outcomes
- •Concomitant participation in other studies involving dietary supplements or blood sampling
- •Living in a household with another participating child
结局指标
主要结局
Blood pressure
时间窗: At 12 weeks
Serum triacylglycerol concentration
时间窗: At 12 weeks
Fasting blood level
次要结局
- Fat mass index by bioimpedance(At 12 weeks)
- Cognitive function measured by the Cambridge Neuropsychological Test Automated Battery(At 12 weeks)
- Plasma glucose(At 12 weeks)
- Waist circumference(At 12 weeks)
- Selective attention capacity measured by Stroop Test(At 12 weeks)
- Hair cortisol(At 12 weeks)
- Serum insulin(At 12 weeks)
- Attention measured by the D2 Test of Attention(At 12 weeks)
- Serum HDL cholesterol(At 12 weeks)
- Heart rate(At 12 weeks)
- BMI z-score(At 12 weeks)
- Saliva cortisol after cold-pressor task(At 12 weeks)
- Serum LDL cholesterol(At 12 weeks)
- Blood glycosylated haemoglobin (HbA1c)(At 12 weeks)
- Response inhibition measured by Flanker test(At 12 weeks)
- Compliance measured by content of n-3 long-chain polyunsaturated fatty acids in red blood cells(At 12 weeks)
研究者
Camilla Trab Damsgaard
Associate Professor
University of Copenhagen