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

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ClinicalTrials.gov Identifier: NCT00447291
Recruitment Status : Terminated (Zone Labs, Inc discontinue utilizing their fish oil supplement and frozen foods)
First Posted : March 14, 2007
Last Update Posted : January 27, 2011
Sponsor:
Collaborator:
Zone Laboratories, Inc.
Information provided by:
Children's Heart Center

Brief 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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : December 2006
Actual Primary Completion Date : March 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. To compare effects between Omega 3 fish oil and placebo [ Time Frame: 3 months ]
    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 :
  1. To compare effects between Omega 3 fish oil and placebo [ Time Frame: 3 months ]
    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



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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 14, 2007    Key Record Dates
Last Update Posted: January 27, 2011
Last Verified: September 2006

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

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms