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Completed

NCT Number: NCT05025943

Omega-3 Fatty Acid Dietary Intervention (O3DI)

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.

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Key information

Conditions

Hypertriglyceridemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nemours Cardiac Center, Nemours Children's Hospital Delaware

Wilmington, Delaware, 19803, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet intervention

Other

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

Control Group

Other

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

Primary outcomes

  1. change in serum triglyceride level after an 8-week diet intervention compared to baseline

    Time frame: 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 outcomes

  1. change red blood cell omega-3 fatty acid content / index after an 8-week diet intervention compared to baseline

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Aug 30, 2021
Registry last updated
Mar 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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