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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Karolinska Institutet.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01323283
First received: March 24, 2011
Last updated: May 12, 2011
Last verified: March 2011

March 24, 2011
May 12, 2011
September 2011
June 2012   (final data collection date for primary outcome measure)
  • Total physical activity [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
    The childrens' physical activity will be monitored during 7 consequtive days at 0 and 15 weeks with tri-axial accelerometer.
  • Body mass [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
    The childrens' body mass will be measured with standardized scales at 0 and 15 weeks.
Same as current
Complete list of historical versions of study NCT01323283 on ClinicalTrials.gov Archive Site
  • BMI [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
    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.
  • Cardiovascular risk markers [ Time Frame: 15 weeks ] [ Designated as safety issue: Yes ]
    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.
  • Quality of life [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
    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).
  • Perceived motor skill [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
    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).
  • Self reported physical activity [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Study of Omega-3 Fatty Acids Regarding Ergogenic, Anti-inflammatory and Obesity Inhibitory Effects in 8 Year Old Children
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Lifestyle-related Condition
  • Overweight and Obesity
  • Essential Fatty Acid Deficiency
  • 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 Name: OM3
  • Dietary Supplement: Placebo
    This group will receive capsules containing rape seed oil. Participants will be instructed to eat three capsules each morning and evening.
  • 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.
    Intervention: Dietary Supplement: Omega-3
  • Placebo Comparator: Placebo
    50 % of included children will be randomized to this arm and will be administered placebo capsules for the 15 week intervention.
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
480
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Any morbidity affecting ambulatory physical activity, studied blood parameters and self-report parameters (i.e. perceived motor skill, quality of life and physical activity)
  • Knowing beforehand participant will not be able to complete the intervention and/or the 0 - and 15 week assessments/clinics.
Both
7 Years to 9 Years
Yes
Contact: Claude Marcus, Professor +46707486159 claude.marcus@ki.se
Contact: Gustav Olsson, B Sc +46763188236 gustav.olsson@ki.se
Sweden
 
NCT01323283
STOPP-8 OM3
No
Claude Marcus, Professor, Karolinska Institutet
Karolinska Institutet
Not Provided
Principal Investigator: Claude Marcus, Professor Karolinska Institutet
Karolinska Institutet
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP