Study of Omega-3 Fatty Acids Regarding Ergogenic, Anti-inflammatory and Obesity Inhibitory Effects in 8 Year Old Children (STOPP-8 OM3)
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|ClinicalTrials.gov Identifier: NCT01323283|
Recruitment Status : Unknown
Verified March 2011 by Karolinska Institutet.
Recruitment status was: Not yet recruiting
First Posted : March 25, 2011
Last Update Posted : May 13, 2011
|Condition or disease||Intervention/treatment||Phase|
|Lifestyle-related Condition Overweight and Obesity Essential Fatty Acid Deficiency||Dietary Supplement: Omega-3 Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||480 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Intervention Study of the Ergogenic, Anti-inflammatory and Obesity Inhibitory Effects of Omega-3 Fatty Acids in 8 Year Old Children|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||June 2012|
|Estimated Study Completion Date :||June 2012|
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.
- 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.
- Body mass [ Time Frame: 15 weeks ]The childrens' body mass will be measured with standardized scales at 0 and 15 weeks.
- 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.
- 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.
- 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).
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01323283
|Contact: Claude Marcus, Professorfirstname.lastname@example.org|
|Contact: Gustav Olsson, B Scemail@example.com|
|Karolinska Universitetssjukhuset||Not yet recruiting|
|Huddinge, Södermanland, Sweden, 14186|
|Contact: Gustav Olsson +46763188236 firstname.lastname@example.org|
|Principal Investigator: Claude Marcus, Professor|
|Principal Investigator:||Claude Marcus, Professor||Karolinska Institutet|