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

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00447291

Enrollment

Registered

2007-03-14

Start date

2006-12-31

Completion date

2010-07-31

Last updated

2011-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

Keywords

Overweight, Obesity, Fish Oil

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.

Interventions

DRUGSupplement: Omega-3 Fish Oil

BEHAVIORALMulti-Disciplinary Nutrition & Exercise program

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

8 Years to 18 Years

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

Design outcomes

Primary

Measure	Time frame	Description
To compare effects between Omega 3 fish oil and placebo	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

Measure	Time frame	Description
To compare effects between Omega 3 fish oil and placebo	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026