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
Recruitment status was Not yet recruiting
Sponsor:
Karolinska Institutet
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01323283
First received: March 24, 2011
Last updated: May 12, 2011
Last verified: March 2011
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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:
MedlinePlus related topics:
Obesity
Drug Information available for:
Omega-3 Fatty Acids
U.S. FDA Resources
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
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 May 23, 2013