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

Overweight and Obesity Clinical Trial

— STOPP-8 OM3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01323283
• Other study ID #: STOPP-8 OM3
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Essential Fatty Acid Deficiency
• Lifestyle-related Condition
• Mental Disorders
• Obesity
• Overweight
• Overweight and Obesity

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