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

January 26, 2011 updated by: Children's Heart Center

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Children's Heart Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Gary A. Mayman, MD, Children's Heart Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

March 12, 2007

First Submitted That Met QC Criteria

March 12, 2007

First Posted (Estimate)

March 14, 2007

Study Record Updates

Last Update Posted (Estimate)

January 27, 2011

Last Update Submitted That Met QC Criteria

January 26, 2011

Last Verified

September 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06.02.001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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