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

This study is currently recruiting participants.

Verified by Children's Heart Center, March 2007

Sponsors and Collaborators:	Children's Heart Center Zone Laboratories, Inc.
Information provided by:	Children's Heart Center
ClinicalTrials.gov Identifier:	NCT00447291

Purpose

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.

Condition	Intervention	Phase
Overweight Obesity	Drug: Supplement: Omega-3 Fish Oil Behavioral: Multi-Disciplinary Nutrition & Exercise program	Phase III

MedlinePlus related topics: Exercise and Physical Fitness Obesity Obesity in Children

Drug Information available for: Insulin Fish oil Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy 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

Further study details as provided by Children's Heart Center:

Estimated Enrollment:

100

Eligibility

Ages Eligible for Study:	8 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447291

Locations

United States, Nevada
Children's Heart Center	Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Humberto Restrepo, MD, MPH 702-732-1290 hurescan@yahoo.com
Principal Investigator: Gary A Mayman, MD

Sponsors and Collaborators

Children's Heart Center

Zone Laboratories, Inc.

Investigators

Principal Investigator:

Gary A. Mayman, MD

Children's Heart Center

More Information

Study ID Numbers:	06.02.001
Study First Received:	March 12, 2007
Last Updated:	March 12, 2007
ClinicalTrials.gov Identifier:	NCT00447291
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Heart Center:

Overweight
Obesity
Fish Oil

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders
Overnutrition

Overweight
Insulin Resistance
Insulin
Inflammation

ClinicalTrials.gov processed this record on January 16, 2009