Safety & Efficacy of Omega-3 Fish Oil in Overweight Children & Adolescents

Phase 3

Terminated

• Conditions: Overweight; Obesity

• Registration Number: NCT00447291
• Lead Sponsor: Children's Heart Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2006-09
• Study Start: 2006-12
• Study First Submitted: 2007-03-12
• Study First Submitted QC: 2007-03-12
• Study First Posted: 2007-03-14
• Primary Completion: 2010-03
• Study Completion: 2010-07
• Last Update Submitted: 2011-01-26
• Last Update Posted: 2011-01-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Between 8-18 years old
• BMI ≥95th percentile
• Patient & parent/guardian consent to participate
• Attendance of Risk Factor Reduction lifestyle modification program

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To compare effects between Omega 3 fish oil and placebo	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.

Secondary Outcome Measures

Name	Time	Method
To compare effects between Omega 3 fish oil and placebo	3 months	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

Trial Locations

Locations (1)

Children's Heart Center; 🇺🇸 Las Vegas, Nevada, United States