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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014