Study of Omega-3 Fatty Acids Regarding Ergogenic, Anti-inflammatory and Obesity Inhibitory Effects in 8 Year Old Children
- Conditions
- Overweight and ObesityEssential Fatty Acid DeficiencyLifestyle-related Condition
- Interventions
- Dietary Supplement: Omega-3Dietary Supplement: Placebo
- Registration Number
- NCT01323283
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 423
- Children in second grade of Swedish primary school willing to participate
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Omega-3 supplementation Omega-3 50 % of all included children will be randomized to this arm and administered capsules containing an omega-3 fatty acid composition. Placebo Placebo 50 % of included children will be randomized to this arm and will be administered placebo capsules for the 15 week intervention.
- Primary Outcome Measures
Name Time Method Total physical activity 15 weeks The childrens' physical activity will be monitored during 7 consequtive days at 0 and 15 weeks with tri-axial accelerometer.
Body mass 15 weeks The childrens' body mass will be measured with standardized scales at 0 and 15 weeks.
- Secondary Outcome Measures
Name Time Method Cardiovascular risk markers 15 weeks Blood samples is collected from all participants at 0 and 15 weeks. This will not be decisive for inclusion in the study. Local anaesthesia will be used and the children can choose not to leave blood. Fasting blood samples will be analyzed for LDL-C, HDL-C, tot-C, TG, hsCRP, TNF-α, IL-6, IL-1, PAI-1, Glucose, Insulin, fatty acids and FTO-gene expression.
BMI 15 weeks The childrens' height will be measured using standardised stadiometer at 0 and 15 weeks. Along with the bosy mass data individual BMI (kilograms/meters squared) will be calculated for each time point.
Childrens reported quality of life 15 weeks A validated questionnaire for self-report of subjective perception of quality of life are filled out by each child at 0 and 15 weeks with assistance of an adult (parent or caregiver).
Self reported physical activity 15 weeks A validated questionnaire for subjective self-report of physical activity will be filled out by each child at 0 and 15 weeks with assistance by parent or caregiver.
Perceived motor skill 15 weeks A validated questionnaire for subjective self-report of motor skills are filled out by each child at 0 and 15 weeks with assistance of an adult (parent or caregiver).
Trial Locations
- Locations (1)
Karolinska Universitetssjukhuset
🇸🇪Huddinge, Södermanland, Sweden