NCT05025943

Omega-3 Fatty Acid Dietary Intervention (O3DI)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Nemours Children's Clinic · Academic / Other
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hypertriglyceridemia

Interventions

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

Timeline

• Start date: 2021-08-16
• Primary completion: 2022-09-07
• Completion: 2023-03-15
• First posted: 2021-08-30
• Last updated: 2023-03-21

Locations

1 site across 1 country: United States