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

Primary Purpose

Overweight, Obesity

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Supplement: Omega-3 Fish Oil
Multi-Disciplinary Nutrition & Exercise program
Sponsored by
Children's Heart Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Overweight focused on measuring Overweight, Obesity, Fish Oil

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Heart Center

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 12, 2007
Last Updated
January 26, 2011
Sponsor
Children's Heart Center
Collaborators
Zone Laboratories, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00447291
Brief Title
Safety & Efficacy of Omega-3 Fish Oil in Overweight Children & Adolescents
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 Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Terminated
Why Stopped
Zone Labs, Inc discontinue utilizing their fish oil supplement and frozen foods
Study Start Date
December 2006 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Children's Heart Center
Collaborators
Zone Laboratories, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Overweight, Obesity, Fish Oil

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Supplement: Omega-3 Fish Oil
Intervention Type
Behavioral
Intervention Name(s)
Multi-Disciplinary Nutrition & Exercise program
Primary Outcome Measure Information:
Title
To compare effects between Omega 3 fish oil and placebo
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
To compare effects between Omega 3 fish oil and placebo
Description
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
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary A. Mayman, MD
Organizational Affiliation
Children's Heart Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Heart Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States

12. IPD Sharing Statement

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

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