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Omega-3 Fatty Acid Dietary Intervention (O3DI)

Primary Purpose

Hypertriglyceridemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diet intervention
Control group
Sponsored by
Nemours Children's Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertriglyceridemia

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nemours Cardiac Center, Nemours Children's Hospital Delaware

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Standard lifestyle intervention + omega-3 fatty acid enriched diet

Standard lifestyle intervention

Arm Description

American Heart Association Target Diet/Standard Lifestyle Intervention (SLI) + omega-3 fatty acid enriched foods

American Heart Association Target Diet/Standard Lifestyle Intervention (SLI)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 16, 2021
Last Updated
March 20, 2023
Sponsor
Nemours Children's Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05025943
Brief Title
Omega-3 Fatty Acid Dietary Intervention (O3DI)
Official Title
Omega-3 Fatty Acid Dietary Intervention for Dyslipidemia of Obesity in Children 10 to <18 Years of Age: O3DI Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 16, 2021 (Actual)
Primary Completion Date
September 7, 2022 (Actual)
Study Completion Date
March 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nemours Children's Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard lifestyle intervention + omega-3 fatty acid enriched diet
Arm Type
Experimental
Arm Description
American Heart Association Target Diet/Standard Lifestyle Intervention (SLI) + omega-3 fatty acid enriched foods
Arm Title
Standard lifestyle intervention
Arm Type
Active Comparator
Arm Description
American Heart Association Target Diet/Standard Lifestyle Intervention (SLI)
Intervention Type
Other
Intervention Name(s)
Diet intervention
Other Intervention Name(s)
Standard lifestyle intervention + omega-3 fatty acid enriched diet
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Other Intervention Name(s)
Standard lifestyle intervention
Intervention Description
The control group will receive diet counseling and information to implement a standard lifestyle intervention Diet assessment and counseling provided throughout study.
Primary Outcome Measure Information:
Title
change in serum triglyceride level after an 8-week diet intervention compared to baseline
Description
The study will test whether omega-3 fatty acid enriched diet is associated with a 20% or greater reduction in serum triglyceride levels.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
change red blood cell omega-3 fatty acid content / index after an 8-week diet intervention compared to baseline
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carissa Baker-Smith, MD, MPH, MS
Organizational Affiliation
Nemours Cardiac Center, Nemours Children's Hospital Delaware
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nemours Cardiac Center, Nemours Children's Hospital Delaware
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Omega-3 Fatty Acid Dietary Intervention (O3DI)

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