Omega-3 Fatty Acid Dietary Intervention (O3DI)

Study Overview
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Brief Summary
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Elevated cholesterol, including triglyceride levels, can lead to the development of cardiovascular disease in adulthood. A diet that is rich in omega-3 fatty acids (O3FA) can improve triglyceride levels in a way that is safe and does not require medication. This is a single-center, prospective, unblinded, randomized-controlled dietary intervention study to assess the impact of an omega-3 fatty acid diet compared to a standard lifestyle intervention on serum triglyceride in patients with hypertriglyceridemia. The study consists of an 8-week dietary treatment period followed by an 8-week observation period.

Official Title
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Omega-3 Fatty Acid Dietary Intervention for Dyslipidemia of Obesity in Children 10 to <18 Years of Age: O3DI Study

Conditions
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Hypertriglyceridemia

Intervention / Treatment
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* Other: Diet intervention
* Other: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients who are 10 -17 years of age BMI greater than or equal to the 85th percentile Clinical serum triglyceride level >150 mg/dl and < 500 mg/dl performed between 3 months and 1 week prior to study visit 1 Ability to follow the study procedures and adhere to the diet counseling recommendations Written parental permission and assent are obtained prior to any research procedures Exclusion Criteria: Type 2 DM (hemoglobin A1C >6.6%) Isotretinoin use Chronic kidney disease (CKD) Uncontrolled hypothyroidism Warfarin use Liver disease (NAFLD is allowed) Renal disease Corticosteroid use Omega-3 fatty acid use (prescription or supplement) Allergy to fish and/or nuts Currently pregnant or planning to become pregnant during the course of this trial - confirmed by date of LMP/querying family Any significant medical condition which the investigator believes would interfere with participation in this study

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard lifestyle intervention + omega-3 fatty acid enriched diet<br>American Heart Association Target Diet/Standard Lifestyle Intervention (SLI) + omega-3 fatty acid enriched foods | Other: Diet intervention<br>* The intervention group will receive diet counseling and information to implement a standard lifestyle intervention plus omega-3 fatty acid enriched foods Diet assessment and counseling provided throughout study.<br>* Other names: Standard lifestyle intervention + omega-3 fatty acid enriched diet;|
| Active Comparator: Standard lifestyle intervention<br>American Heart Association Target Diet/Standard Lifestyle Intervention (SLI) | Other: Control group<br>* The control group will receive diet counseling and information to implement a standard lifestyle intervention Diet assessment and counseling provided throughout study.<br>* Other names: Standard lifestyle intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in serum triglyceride level after an 8-week diet intervention compared to baseline | The study will test whether omega-3 fatty acid enriched diet is associated with a 20% or greater reduction in serum triglyceride levels. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change red blood cell omega-3 fatty acid content / index after an 8-week diet intervention compared to baseline | Total levels of omega-3 fatty acids in red blood cell membrane phospholipids are measured. Percentages are reported as an index. The study will identify the index/total omega-3 fatty acid in red blood cells following initiation of an omega-3 fatty acid enriched diet. | 8 weeks |