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NCT Number: NCT01323283

Study of Omega-3 Fatty Acids Regarding Ergogenic, Anti-inflammatory and Obesity Inhibitory Effects 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.

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Key information

Conditions

Lifestyle-related Condition Behavior Body Weight Essential Fatty Acid Deficiency Mental Disorders Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Sedentary Behavior Signs and Symptoms

Age range

7 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Universitetssjukhuset

Huddinge, Södermanland County, 14186, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

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.

Other names: OM3

Placebo

Dietary Supplement

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

Primary outcomes

  1. Total physical activity

    Time frame: 15 weeks

    The childrens' physical activity will be monitored during 7 consequtive days at 0 and 15 weeks with tri-axial accelerometer.

  2. Body mass

    Time frame: 15 weeks

    The childrens' body mass will be measured with standardized scales at 0 and 15 weeks.

Secondary outcomes

  1. BMI

    Time frame: 15 weeks

    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.

  2. Cardiovascular risk markers

    Time frame: 15 weeks

    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.

  3. Childrens reported quality of life

    Time frame: 15 weeks

    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).

  4. Perceived motor skill

    Time frame: 15 weeks

    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).

  5. Self reported physical activity

    Time frame: 15 weeks

    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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Forskningsrådet för arbetsliv och socialvetenskap, FAS
  • Midsona AB

Registry information

Official study title

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

Acronym: STOPP-8 OM3

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 25, 2011
Registry last updated
Oct 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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