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

This study has been terminated.
(Zone Labs, Inc discontinue utilizing their fish oil supplement and frozen foods)
Sponsor:
Collaborator:
Zone Laboratories, Inc.
Information provided by:
Children's Heart Center
ClinicalTrials.gov Identifier:
NCT00447291
First received: March 12, 2007
Last updated: January 26, 2011
Last verified: September 2006
History of Changes
  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 3

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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • To compare effects between Omega 3 fish oil and placebo [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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:
  • To compare effects between Omega 3 fish oil and placebo [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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


Enrollment: 60
Study Start Date: December 2006
Study Completion Date: July 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
  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
Las Vegas, Nevada, United States, 89109
Sponsors and Collaborators
Children's Heart Center
Zone Laboratories, Inc.
Investigators
Principal Investigator: Gary A. Mayman, MD Children's Heart Center
  More Information

No publications provided

Responsible Party: Gary A. Mayman/ Principal investigator, Children's Heart Center
ClinicalTrials.gov Identifier: NCT00447291     History of Changes
Other Study ID Numbers: 06.02.001
Study First Received: March 12, 2007
Last Updated: January 26, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Heart Center:
Overweight
Obesity
Fish Oil

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
 Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013