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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01323283
Other study ID # STOPP-8 OM3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2011
Est. completion date June 2012

Study information

Verified date October 2018
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 423
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 9 Years
Eligibility Inclusion Criteria:

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

Study Design


Intervention

Dietary Supplement:
Omega-3
This 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.
Placebo
This group will receive capsules containing rape seed oil. Participants will be instructed to eat three capsules each morning and evening.

Locations

Country Name City State
Sweden Karolinska Universitetssjukhuset Huddinge Södermanland

Sponsors (3)

Lead Sponsor Collaborator
Karolinska Institutet Forskningsrådet för arbetsliv och socialvetenskap, FAS, Midsona AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total physical activity The childrens' physical activity will be monitored during 7 consequtive days at 0 and 15 weeks with tri-axial accelerometer. 15 weeks
Primary Body mass The childrens' body mass will be measured with standardized scales at 0 and 15 weeks. 15 weeks
Secondary BMI 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. 15 weeks
Secondary Cardiovascular risk markers 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-a, IL-6, IL-1, PAI-1, Glucose, Insulin, fatty acids and FTO-gene expression. 15 weeks
Secondary Childrens reported quality of life 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). 15 weeks
Secondary Perceived motor skill 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). 15 weeks
Secondary Self reported physical activity 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. 15 weeks
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