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

NCT01323283 | Completed

• 1 other identifier: STOPP-8 OM3
• Study Type: interventional
• Target: 423
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

Omega-3; physical activity; children; obesity; sedentary; accelerometry; BMI; fatty acids; inflammatory markers; intervention; randomized; double blind

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• BMI

  15 weeks

• Cardiovascular risk markers

  15 weeks

• Childrens reported quality of life

  15 weeks

• Perceived motor skill

  15 weeks

• Self reported physical activity

  15 weeks

Study Arms (2)

Omega-3 supplementation

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Omega-3 DIETARY_SUPPLEMENT

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.

Also known as: OM3

Omega-3 supplementation

Placebo DIETARY_SUPPLEMENT

This group will receive capsules containing rape seed oil. Participants will be instructed to eat three capsules each morning and evening.

Placebo

Eligibility Criteria

• Age: 7 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Midsona AB: collaborator
• Forskningsrådet för arbetsliv och socialvetenskap, FAS: collaborator

Study Sites (1)

Karolinska Universitetssjukhuset

Huddinge, Södermanland County, 14186, Sweden

Location

MeSH Terms

Conditions

Mental Disorders; Overweight; Obesity; Motor Activity; Sedentary Behavior

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Claude Marcus, Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 24, 2011
• First Posted: March 25, 2011
• Study Start: September 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: October 5, 2018

Record last verified: 2018-10

Locations

SE (1)