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

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 Overview

• Status: Completed
• Conditions: Hypertriglyceridemia
• Intervention / Treatment: Other: Diet intervention; Other: Control group

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Wilmington, Delaware, United States, 19803
      • Nemours Cardiac Center, Nemours Children's Hospital Delaware

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard lifestyle intervention + omega-3 fatty acid enriched diet; American Heart Association Target Diet/Standard Lifestyle Intervention (SLI) + omega-3 fatty acid enriched foods	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 Names: Standard lifestyle intervention + omega-3 fatty acid enriched diet
Active Comparator: Standard lifestyle intervention; American Heart Association Target Diet/Standard Lifestyle Intervention (SLI)	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.; Other Names: Standard lifestyle intervention

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nemours Children's Clinic
• Investigators: Principal Investigator: Carissa Baker-Smith, MD, MPH, MS, Nemours Cardiac Center, Nemours Children's Hospital Delaware

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2021
• Primary Completion (Actual): September 7, 2022
• Study Completion (Actual): March 15, 2023

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: August 24, 2021
• First Posted (Actual): August 30, 2021

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 20, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypertriglyceridemia
• Other Study ID Numbers: O3DI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No