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Omega-3 Fatty Acid Dietary Intervention (O3DI)

Sponsor
Nemours Children's Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05025943
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Diet intervention
  • Other: Control group
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Omega-3 Fatty Acid Dietary Intervention for Dyslipidemia of Obesity in Children 10 to <18 Years of Age: O3DI Study
Actual Study Start Date :
Aug 16, 2021
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
Aug 15, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nemours Cardiac Center, Nemours Children's Hospital Delaware Wilmington Delaware United States 19803

    Sponsors and Collaborators

    • Nemours Children's Clinic

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nemours Children's Clinic
    ClinicalTrials.gov Identifier:
    NCT05025943
    Other Study ID Numbers:
    • O3DI
    First Posted:
    Aug 30, 2021
    Last Update Posted:
    Aug 30, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypertriglyceridemia

    Study Results

    No Results Posted as of Aug 30, 2021