Study Stopped
Zone Labs, Inc discontinue utilizing their fish oil supplement and frozen foods
Safety & Efficacy of Omega-3 Fish Oil in Overweight Children & Adolescents
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
1 other identifier
interventional
60
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2006
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 12, 2007
CompletedFirst Posted
Study publicly available on registry
March 14, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedJanuary 27, 2011
September 1, 2006
3.2 years
March 12, 2007
January 26, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 months
Secondary Outcomes (1)
To compare effects between Omega 3 fish oil and placebo
3 months
Interventions
Eligibility Criteria
You may qualify if:
- Between 8-18 years old
- BMI ≥95th percentile
- Patient \& parent/guardian consent to participate
- Attendance of Risk Factor Reduction lifestyle modification program
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Heart Centerlead
- Zone Laboratories, Inc.collaborator
Study Sites (1)
Children's Heart Center
Las Vegas, Nevada, 89109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gary A. Mayman, MD
Children's Heart Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 12, 2007
First Posted
March 14, 2007
Study Start
December 1, 2006
Primary Completion
March 1, 2010
Study Completion
July 1, 2010
Last Updated
January 27, 2011
Record last verified: 2006-09