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

• Status: Terminated
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Heart Center
• Collaborator: Zone Laboratories, Inc.

Criteria

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