Omega-3 Fatty Acid Dietary Intervention (O3DI)

Hypertriglyceridemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05025943
• Other study ID #: O3DI
• Status: Completed
• Phase: N/A
• Start date: August 16, 2021
• Est. completion date: March 15, 2023

Study information

• Verified date: March 2023
• Source: Nemours Children's Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 15, 2023
• Est. primary completion date: September 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

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

Locations

Country	Name	City	State
United States	Nemours Cardiac Center, Nemours Children's Hospital Delaware	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Nemours Children's Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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