Lifestyle-related ConditionSTOPP-8 OM3NCT01323283
Study of Omega-3 Fatty Acids Regarding Ergogenic, Anti-inflammatory and Obesity Inhibitory Effects in 8 Year Old Children
A study testing Omega-3 in people with Lifestyle-related Condition and Overweight and Obesity, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Lifestyle-related Condition, Overweight and Obesity, Essential Fatty Acid Deficiency
- What is being tested?
- Omega-3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 423 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2011to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children in second grade of Swedish primary school willing to participate
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Universitetssjukhuset
Huddinge, Södermanland County, 14186
About this study
Official title: 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.
- Being tested
- Omega-3, Placebo
- Keywords
- Omega-3, physical activity, children, obesity, sedentary, accelerometry, BMI, fatty acids, inflammatory markers, intervention, randomized, double blind
- Medical subject headings
- Mental Disorders, Overweight, Obesity, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3Dietary supplement
Also called OM3
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.
PlaceboDietary supplement
This group will receive capsules containing rape seed oil. Participants will be instructed to eat three capsules each morning and evening.
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 supplementation | Active comparator | 50 % of all included children will be randomized to this arm and administered capsules containing an omega-3 fatty acid composition. Receives: Dietary Supplement: Omega-3 |
| Placebo | Placebo comparator | 50 % of included children will be randomized to this arm and will be administered placebo capsules for the 15 week intervention. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total physical activity
The childrens' physical activity will be monitored during 7 consequtive days at 0 and 15 weeks with tri-axial accelerometer.
Measured: 15 weeks
Body mass
The childrens' body mass will be measured with standardized scales at 0 and 15 weeks.
Measured: 15 weeks
Secondary outcomes (5)
BMI
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.
Measured: 15 weeks
Cardiovascular risk markers
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.
Measured: 15 weeks
Childrens reported quality of life
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).
Measured: 15 weeks
Perceived motor skill
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).
Measured: 15 weeks
Self reported physical activity
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.
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study startSep 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lifestyle-related ConditionStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 423 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Midsona AB, Forskningsrådet för arbetsliv och socialvetenskap, FAS
- Responsible party
- Principal investigator, Claude Marcus, Karolinska Institutet
- Investigators
- Claude Marcus, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01323283
- Sponsor's protocol ID
- STOPP-8 OM3
- Acronym
- STOPP-8 OM3
- Status last verified
- Oct 2018
- First submitted
- 24 Mar 2011
- Last updated
- 5 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Study of the Ergogenic, Anti-inflammatory and Obesity Inhibitory Effects of Omega-3 Fatty Acids in 8 Year Old Children
- ClinicalTrials.gov ID
- NCT01323283
- Acronym / sponsor ID
- STOPP-8 OM3 / STOPP-8 OM3
- Keywords
- Omega-3, physical activity, children, obesity, sedentary, accelerometry, BMI, fatty acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 423 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Midsona AB, Forskningsrådet för arbetsliv och socialvetenskap, FAS
- Study start
- Sep 2011 (actual)
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 25 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 supplementation | Active comparator | Dietary Supplement: Omega-350 % of all included children will be randomized to this arm and administered capsules containing an omega-3 fatty acid composition. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo50 % of included children will be randomized to this arm and will be administered placebo capsules for the 15 week intervention. |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children in second grade of Swedish primary school willing to participate
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3Also: OM3This 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. | Dietary supplement | Omega-3 supplementation |
| PlaceboThis group will receive capsules containing rape seed oil. Participants will be instructed to eat three capsules each morning and evening. | Dietary supplement | Placebo |
Primary outcome
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.
5 secondary outcomes
BMI
Time frame: 15 weeks
Cardiovascular risk markers
Time frame: 15 weeks
Childrens reported quality of life
Time frame: 15 weeks
Perceived motor skill
Time frame: 15 weeks
Self reported physical activity
Time frame: 15 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claude Marcus, Professor principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 in people with Lifestyle-related Condition and Overweight and Obesity, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total physical activity (time frame: 15 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2018.