Omega-3 Fatty Acid Dietary Intervention (O3DI)

Nemours Children's Clinic19 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertriglyceridemia

Interventions

Diet interventionOTHER

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.

Control groupOTHER

The control group will receive diet counseling and information to implement a standard lifestyle intervention Diet assessment and counseling provided throughout study.

Eligibility

Sex: ALLMin age: 10 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female patients who are 10 -17 years of age 2. BMI greater than or equal to the 85th percentile 3. Clinical serum triglyceride level \>150 mg/dl and \< 500 mg/dl performed between 3 months and 1 week prior to study visit 1 4. Ability to follow the study procedures and adhere to the diet counseling recommendations 5. Written parental permission and assent are obtained prior to any research procedures Exclusion Criteria: 1. Type 2 DM (hemoglobin A1C \>6.6%) 2. Isotretinoin use 3. Chronic kidney disease (CKD) 4. Uncontrolled hypothyroidism 5. Warfarin use 6. Liver disease (NAFLD is allowed) 7. Renal disease 8. Corticosteroid use 9. Omega-3 fatty acid use (prescription or supplement) 10. Allergy to fish and/or nuts 11. Currently pregnant or planning to become pregnant during the course of this trial - confirmed by date of LMP/querying family 12. Any significant medical condition which the investigator believes would interfere with participation in this study

Locations (1)

Nemours Cardiac Center, Nemours Children's Hospital Delaware

Wilmington, Delaware, United States

Outcomes

Primary Outcomes

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.

Time frame: 8 weeks

Secondary Outcomes

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.

Time frame: 8 weeks

Data from ClinicalTrials.gov

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