Clinical Trials Directory

Trials / Completed

CompletedNCT01323283

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

Intervention Study of the Ergogenic, Anti-inflammatory and Obesity Inhibitory Effects of Omega-3 Fatty Acids in 8 Year Old Children

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
423 (actual)
Sponsor
Karolinska Institutet · Academic / Other
Sex
All
Age
7 Years – 9 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTOmega-3This group will receive capsules containing omega-3, omega-6 and vitamin E. The dosage is six capsules per day containing a total of 558 mg of eico-pentaenoic acid (EPA), 174 mg of docosahexaeonic acid (DHA), 60 mg of gamma-linolenic acid (GLA) and 9,6 mg vitamin E in natural form (alfa-tocopherol), gelatine, glycerol. Participants will be instructed to eat three capsules each morning and evening.
DIETARY_SUPPLEMENTPlaceboThis group will receive capsules containing rape seed oil. Participants will be instructed to eat three capsules each morning and evening.

Timeline

Start date
2011-09-01
Primary completion
2012-06-01
Completion
2012-06-01
First posted
2011-03-25
Last updated
2018-10-05

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT01323283. Inclusion in this directory is not an endorsement.