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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00447291
• Other study ID #: 06.02.001
• Status: Terminated
• Phase: Phase 3
• First received: March 12, 2007
• Last updated: January 26, 2011
• Start date: December 2006
• Est. completion date: July 2010

Study information

• Verified date: September 2006
• Source: Children's Heart Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: July 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• Supplement: Omega-3 Fish Oil

Behavioral:
• Multi-Disciplinary Nutrition & Exercise program

Locations

Country	Name	City	State
United States	Children's Heart Center	Las Vegas	Nevada

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	3 months	No