Omega-3 Fatty Acid Dietary Intervention (O3DI)
1 other identifier
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2021
CompletedStudy Start
First participant enrolled
August 16, 2021
CompletedFirst Posted
Study publicly available on registry
August 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2023
CompletedMarch 21, 2023
March 1, 2023
1.1 years
August 16, 2021
March 20, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
change red blood cell omega-3 fatty acid content / index after an 8-week diet intervention compared to baseline
8 weeks
Study Arms (2)
Standard lifestyle intervention + omega-3 fatty acid enriched diet
EXPERIMENTALAmerican Heart Association Target Diet/Standard Lifestyle Intervention (SLI) + omega-3 fatty acid enriched foods
Standard lifestyle intervention
ACTIVE COMPARATORAmerican Heart Association Target Diet/Standard Lifestyle Intervention (SLI)
Interventions
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.
The control group will receive diet counseling and information to implement a standard lifestyle intervention Diet assessment and counseling provided throughout study.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nemours Cardiac Center, Nemours Children's Hospital Delaware
Wilmington, Delaware, 19803, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carissa Baker-Smith, MD, MPH, MS
Nemours Cardiac Center, Nemours Children's Hospital Delaware
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2021
First Posted
August 30, 2021
Study Start
August 16, 2021
Primary Completion
September 7, 2022
Study Completion
March 15, 2023
Last Updated
March 21, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share