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

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

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity; Lifestyle-related Condition; Essential Fatty Acid Deficiency
• Intervention / Treatment: Dietary supplement: Omega-3; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 423
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Södermanland
    • Huddinge, Södermanland, Sweden, 14186
      • Karolinska Universitetssjukhuset

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 9 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Omega-3 supplementation; 50 % of all included children will be randomized to this arm and administered capsules containing an omega-3 fatty acid composition.	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.; Other Names: OM3
PLACEBO_COMPARATOR: Placebo; 50 % of included children will be randomized to this arm and will be administered placebo capsules for the 15 week intervention.	Dietary supplement: Placebo; This group will receive capsules containing rape seed oil. Participants will be instructed to eat three capsules each morning and evening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Body mass	The childrens' body mass will be measured with standardized scales at 0 and 15 weeks.	15 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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-α, IL-6, IL-1, PAI-1, Glucose, Insulin, fatty acids and FTO-gene expression.	15 weeks
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
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
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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Midsona AB; Forskningsrådet för arbetsliv och socialvetenskap, FAS

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2011
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): June 1, 2012

Study Registration Dates

• First Submitted: March 24, 2011
• First Submitted That Met QC Criteria: March 24, 2011
• First Posted (ESTIMATE): March 25, 2011

Study Record Updates

• Last Update Posted (ACTUAL): October 5, 2018
• Last Update Submitted That Met QC Criteria: October 3, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: physical activity; obesity; children; intervention; sedentary; Omega-3; BMI; randomized; inflammatory markers; double blind; fatty acids; accelerometry
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: STOPP-8 OM3