Omega-3 Fatty Acid Dietary Intervention (O3DI)

Not Applicable

Completed

• Conditions: Hypertriglyceridemia
• Interventions: Other: Control group; Other: Diet intervention

• Registration Number: NCT05025943
• Lead Sponsor: Nemours Children's Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-16
• Study First Submitted: 2021-08-16
• Study First Submitted QC: 2021-08-24
• Study First Posted: 2021-08-30
• Primary Completion: 2022-09-07
• Status Verified: 2023-03
• Study Completion: 2023-03-15
• Last Update Submitted: 2023-03-20
• Last Update Posted: 2023-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard lifestyle intervention	Control group	American Heart Association Target Diet/Standard Lifestyle Intervention (SLI)
Standard lifestyle intervention + omega-3 fatty acid enriched diet	Diet intervention	American Heart Association Target Diet/Standard Lifestyle Intervention (SLI) + omega-3 fatty acid enriched foods

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
change red blood cell omega-3 fatty acid content / index after an 8-week diet intervention compared to baseline	8 weeks	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.

Trial Locations

Locations (1)

Nemours Cardiac Center, Nemours Children's Hospital Delaware; 🇺🇸 Wilmington, Delaware, United States