Omega-3 Fatty Acid Dietary Intervention (O3DI)
Completed · Not applicable
Conditions studied: Hypertriglyceridemia
In brief
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.
Key facts
- Study ID
- NCT05025943
- Run by
- Nemours Children's Clinic
- People needed
- 19
- Starts
- 2021-08-16
- Expected to finish
- 2023-03-15
- Last updated by the study team
- 2023-03-21
Who can join
Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female patients who are 10 -17 years of age
- BMI greater than or equal to the 85th percentile
- Clinical serum triglyceride level >150 mg/dl and < 500 mg/dl performed between 3 months and 1 week prior to study visit 1
- Ability to follow the study procedures and adhere to the diet counseling recommendations
- Written parental permission and assent are obtained prior to any research procedures
You may not qualify if…
- Type 2 DM (hemoglobin A1C >6.6%)
- Isotretinoin use
- Chronic kidney disease (CKD)
- Uncontrolled hypothyroidism
- Warfarin use
- Liver disease (NAFLD is allowed)
- Renal disease
- Corticosteroid use
- Omega-3 fatty acid use (prescription or supplement)
- Allergy to fish and/or nuts
- Currently pregnant or planning to become pregnant during the course of this trial - confirmed by date of LMP/querying family
- Any significant medical condition which the investigator believes would interfere with participation in this study
Where it is running
- Nemours Cardiac Center, Nemours Children's Hospital Delaware — Wilmington, Delaware, United States
Full record on ClinicalTrials.gov
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