OverweightPhase 3NCT00447291
Safety & Efficacy of Omega-3 Fish Oil in Overweight Children & Adolescents
A Phase 3 study testing Supplement: Omega-3 Fish Oil and Multi-Disciplinary Nutrition & Exercise program in people with Overweight and Obesity, run by Children's Heart Center at 1 site in United States.
Trial summary
Children with an excess in body weight, increase the risk of obesity-related co-morbidities and cardiovascular diseases. Childhood obesity may be due to diets laden with fat and lack of physical activity. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Supplement: Omega-3 Fish Oil and Multi-Disciplinary Nutrition & Exercise program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Jul 2010
- Phase
- Phase 3
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Between 8-18 years old
- BMI ≥95th percentile
- Patient \& parent/guardian consent to participate
- Attendance of Risk Factor Reduction lifestyle modification program
Who cannot join
- Major surgical Procedure within 1 year
- Significant cardiovascular disease or other morbidity that preclude patients from following dietary regimen or exercising.
- Mentally Challenged
- Currently taking fish oil supplements, unless 1 month wash-out period is achieved.
- Diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Safety and Efficacy of Omega-3 Fish Oil Dietary Supplementation in Biometric Measurement, Lipid Profile, Serum Markers for Inflammation, and Insulin Resistance in Overweight Children and Adolescents
Children with an excess in body weight, increase the risk of obesity-related co-morbidities and cardiovascular diseases. Childhood obesity may be due to diets laden with fat and lack of physical activity. Omega-3 fish oil is a supplementation that may promote a greater reduction of pro-inflammatory mediators; combined with exercise and nutritional regimens it may also help improve glycemic, lipid markers, and body composition in overweight children and adolescents.
- Conditions
- Overweight, Obesity
- Being tested
- Supplement: Omega-3 Fish Oil, Multi-Disciplinary Nutrition & Exercise program
- Keywords
- Overweight, Obesity, Fish Oil
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplement: Omega-3 Fish OilDrug
Multi-Disciplinary Nutrition & Exercise programBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare effects between Omega 3 fish oil and placebo
To compare the effect of Omega 3 fish oil dietary supplementation versus placebo on biometric measurement, lipid profile, serum markers for inflammation and insulin resistance in overweight children and adolescents undergoing treatment with a low-glycemic load diet and exercise.
Measured: 3 months
Secondary outcomes (1)
To compare effects between Omega 3 fish oil and placebo
To compare the changes in weekly physical activity, biometrics measurements and body mass index between overweight children and adolescents receiving Omega 3 fish oil supplementation versus placeb
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2007 (estimated)
- Study startDec 2006
- Primary completionMar 2010
- Study completionJul 2010
Why it stopped: Zone Labs, Inc discontinue utilizing their fish oil supplement and frozen foods
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Heart Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zone Laboratories, Inc.
- Investigators
- Gary A. Mayman, MD, Principal investigator, Children's Heart Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447291
- Sponsor's protocol ID
- 06.02.001
- Status last verified
- Sep 2006
- First submitted
- 12 Mar 2007
- Last updated
- 27 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of Omega-3 Fish Oil Dietary Supplementation in Biometric Measurement, Lipid Profile, Serum Markers for Inflammation, and Insulin Resistance in Overweight Children and Adolescents
- ClinicalTrials.gov ID
- NCT00447291
- Acronym / sponsor ID
- 06.02.001
- Conditions
- Overweight, Obesity
- Keywords
- Overweight, Obesity, Fish Oil
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Zone Labs, Inc discontinue utilizing their fish oil supplement and frozen foods
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Children's Heart CenterIndustry (pharma, biotech, devices)
- Collaborators
- Zone Laboratories, Inc.
- Study start
- Dec 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 14 Mar 2007 (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.
Children with an excess in body weight, increase the risk of obesity-related co-morbidities and cardiovascular diseases. Childhood obesity may be due to diets laden with fat and lack of physical activity. Omega-3 fish oil is a supplementation that may promote a greater reduction of pro-inflammatory mediators; combined with exercise and nutritional regimens it may also help improve glycemic, lipid markers, and body composition in overweight children and adolescents.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Between 8-18 years old
- BMI ≥95th percentile
- Patient \& parent/guardian consent to participate
- Attendance of Risk Factor Reduction lifestyle modification program
Key exclusion criteria (5 listed)
- Major surgical Procedure within 1 year
- Significant cardiovascular disease or other morbidity that preclude patients from following dietary regimen or exercising.
- Mentally Challenged
- Currently taking fish oil supplements, unless 1 month wash-out period is achieved.
- Diabetes
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 |
|---|---|---|
| Supplement: Omega-3 Fish Oil | Drug | – |
| Multi-Disciplinary Nutrition & Exercise program | Behavioural | – |
Primary outcome
To compare effects between Omega 3 fish oil and placebo
Time frame: 3 months
To compare the effect of Omega 3 fish oil dietary supplementation versus placebo on biometric measurement, lipid profile, serum markers for inflammation and insulin resistance in overweight children and adolescents undergoing treatment with a low-glycemic load diet and exercise.
1 secondary outcome
To compare effects between Omega 3 fish oil and placebo
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Zone Labs, Inc discontinue utilizing their fish oil supplement and frozen foods). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2011.
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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.
Gary A. Mayman, MD principal investigator
Children's Heart Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Supplement: Omega-3 Fish Oil and Multi-Disciplinary Nutrition & Exercise program in people with Overweight and Obesity, run by Children's Heart Center at 1 site in United States.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 27 Jan 2011. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Zone Labs, Inc discontinue utilizing their fish oil supplement and frozen foods). Results are not available in the source record.
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?
To compare effects between Omega 3 fish oil and placebo (time frame: 3 months). 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 27 Jan 2011.