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
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- To compare effects between Omega 3 fish oil and placebo
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 8 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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 Outcomes
- To compare effects between Omega 3 fish oil and placebo(3 months)