HypertriglyceridemiaNCT05025943
Omega-3 Fatty Acid Dietary Intervention (O3DI)
A study testing Diet intervention in people with Hypertriglyceridemia, run by Nemours Children's Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- Diet intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2021to 15 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Type 2 DM (hemoglobin A1C >6.6%)
- Isotretinoin use
- Chronic kidney disease (CKD)
- Uncontrolled hypothyroidism
- Warfarin use
- Liver disease (NAFLD is allowed)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Nemours Cardiac Center, Nemours Children's Hospital Delaware
Wilmington, Delaware, 19803
About this study
Official title: Omega-3 Fatty Acid Dietary Intervention for Dyslipidemia of Obesity in Children 10 to <18 Years of Age: O3DI Study
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.
- Conditions
- Hypertriglyceridemia
- Being tested
- Diet intervention, Control group
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet interventionOther
Also called Standard lifestyle intervention + omega-3 fatty acid enriched diet
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.
Control groupOther
Also called Standard lifestyle intervention
The control group will receive diet counseling and information to implement a standard lifestyle intervention Diet assessment and counseling provided throughout study.
| Study group | Role | What they receive |
|---|---|---|
| Standard lifestyle intervention + omega-3 fatty acid enriched diet | Experimental | American Heart Association Target Diet/Standard Lifestyle Intervention (SLI) + omega-3 fatty acid enriched foods Receives: Other: Diet intervention |
| Standard lifestyle intervention | Active comparator | American Heart Association Target Diet/Standard Lifestyle Intervention (SLI) Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (1)
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start16 Aug 2021
- Primary completion7 Sep 2022
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carissa Baker-Smith, MD, MPH, MS, Principal investigator, Nemours Cardiac Center, Nemours Children's Hospital Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025943
- Sponsor's protocol ID
- O3DI
- Status last verified
- Mar 2023
- First submitted
- 16 Aug 2021
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Fatty Acid Dietary Intervention for Dyslipidemia of Obesity in Children 10 to <18 Years of Age: O3DI Study
- ClinicalTrials.gov ID
- NCT05025943
- Acronym / sponsor ID
- O3DI
- Conditions
- Hypertriglyceridemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 7 Sep 2022 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard lifestyle intervention + omega-3 fatty acid enriched diet | Experimental | Other: Diet interventionAmerican Heart Association Target Diet/Standard Lifestyle Intervention (SLI) + omega-3 fatty acid enriched foods |
| Standard lifestyle intervention | Active comparator | Other: Control groupAmerican Heart Association Target Diet/Standard Lifestyle Intervention (SLI) |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- Type 2 DM (hemoglobin A1C >6.6%)
- Isotretinoin use
- Chronic kidney disease (CKD)
- Uncontrolled hypothyroidism
- Warfarin use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet interventionAlso: Standard lifestyle intervention + omega-3 fatty acid enriched dietThe 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 | Standard lifestyle intervention + omega-3 fatty acid enriched diet |
| Control groupAlso: Standard lifestyle interventionThe control group will receive diet counseling and information to implement a standard lifestyle intervention Diet assessment and counseling provided throughout study. | Other | Standard lifestyle intervention |
Primary outcome
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.
1 secondary outcome
change red blood cell omega-3 fatty acid content / index after an 8-week diet intervention compared to baseline
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carissa Baker-Smith, MD, MPH, MS principal investigator
Nemours Cardiac Center, Nemours Children's Hospital Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet intervention in people with Hypertriglyceridemia, run by Nemours Children's Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in serum triglyceride level after an 8-week diet intervention compared to baseline (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.