Study of Omega-3 Fatty Acids Regarding Ergogenic, Anti-inflammatory and Obesity Inhibitory Effects in 8 Year Old Children (STOPP-8 OM3)

Karolinska Institute

Status: Completed

Conditions: Essential Fatty Acid Deficiency; Overweight and Obesity; Lifestyle-related Condition

Treatments: Dietary Supplement: Omega-3; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01323283

STOPP-8 OM3

Details and patient eligibility

About

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.

Enrollment: 423 patients

Sex: All

Ages: 7 to 9 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Children in second grade of Swedish primary school willing to participate

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

423 participants in 2 patient groups, including a placebo group

Omega-3 supplementation

Active Comparator group

Description:

50 % of all included children will be randomized to this arm and administered capsules containing an omega-3 fatty acid composition.

Treatment:

Dietary Supplement: Omega-3

Placebo

Placebo Comparator group

Description:

50 % of included children will be randomized to this arm and will be administered placebo capsules for the 15 week intervention.

Treatment:

Dietary Supplement: Placebo