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
  Purpose

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.


Condition Intervention
Lifestyle-related Condition
Overweight and Obesity
Essential Fatty Acid Deficiency
Dietary Supplement: Omega-3
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Intervention Study of the Ergogenic, Anti-inflammatory and Obesity Inhibitory Effects of Omega-3 Fatty Acids in 8 Year Old Children

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 480
Study Start Date: September 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  Eligibility

Ages Eligible for Study:   7 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01323283

Contacts
Contact: Claude Marcus, Professor +46707486159 claude.marcus@ki.se
Contact: Gustav Olsson, B Sc +46763188236 gustav.olsson@ki.se

Locations
Sweden
Karolinska Universitetssjukhuset Not yet recruiting
Huddinge, Södermanland, Sweden, 14186
Contact: Gustav Olsson    +46763188236    gustav.olsson@ki.se   
Principal Investigator: Claude Marcus, Professor         
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Claude Marcus, Professor Karolinska Institutet
  More Information

No publications provided

Responsible Party: Claude Marcus, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01323283     History of Changes
Other Study ID Numbers: STOPP-8 OM3
Study First Received: March 24, 2011
Last Updated: May 12, 2011
Health Authority: Sweden: Regional Ethical Review Board
Sweden: Swedish Research Council

Keywords provided by Karolinska Institutet:
Omega-3
physical activity
children
obesity
sedentary
accelerometry
BMI
fatty acids
inflammatory markers
intervention
randomized
double blind

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Central Nervous System Stimulants
Anti-Inflammatory Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014