Omega-3 Fatty AcidsNCT07480707
Can People Achieve a Target Omega-3 Index by Following a Personalized Omega-3 Dosing Regimen?
A study testing Fish Oil Supplementation in people with Omega-3 Fatty Acids, run by Fatty Acid Research Institute.
Trial summary
The goal of this project is to evaluate the efficacy of personalized dosage recommendations of Parasol Omega-3 Fish Oil on achieving an Omega-3 Index of >8% in individuals with a baseline Omega-3 Index <8% over a 90-day period. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Omega-3 Fatty Acids
- What is being tested?
- Fish Oil Supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Baseline omega-3 index less than 8%
Who cannot join
- Currently taking a fish oil or other omega-3 supplement
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Using Personalized Dosage Recommendations of Parasol Omega-3 Fish Oil Based on Omega-3 Index Values: A Pilot Study
The goal of this project is to evaluate the efficacy of personalized dosage recommendations of Parasol Omega-3 Fish Oil on achieving an Omega-3 Index of >8% in individuals with a baseline Omega-3 Index <8% over a 90-day period.
- Conditions
- Omega-3 Fatty Acids
- Being tested
- Fish Oil Supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish Oil SupplementationDietary supplement
Enrolled participants will be instructed to start taking 2 capsules per day on the day they take their baseline O3I and once O3I results are available to adjust to a personalized dose of Fish Oil, based on their baseline Omega-3 Index, and instructed to continue their current omega-3 dietary intake. Recommendations will be:
- O3I > 6.8% but ≤ 8% - 1 capsule
- O3I > 5.5% but ≤ 6.8% - 2 capsules
- O3I > 4.4% but ≤ 5.5% - 3 capsules
- O3I ≤ 4.4% - 4 capsules
| Study group | Role | What they receive |
|---|---|---|
| Fish oil supplementation arm | Experimental | Participants will receive Fish Oil Receives: Dietary Supplement: Fish Oil Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Omega-3 index
RBC omega-3 index value
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Omega-3 Fatty AcidsStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatty Acid Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Omegaquant Analytics, LLC
- Responsible party
- Principal investigator, William S Harris, Fatty Acid Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480707
- Sponsor's protocol ID
- FARI-001
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Proprietary study
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Using Personalized Dosage Recommendations of Parasol Omega-3 Fish Oil Based on Omega-3 Index Values: A Pilot Study
- ClinicalTrials.gov ID
- NCT07480707
- Acronym / sponsor ID
- FARI-001
- Conditions
- Omega-3 Fatty Acids
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Fatty Acid Research InstituteUniversity, hospital or other
- Collaborators
- Omegaquant Analytics, LLC
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 18 Mar 2026 (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.
The goal of this project is to evaluate the efficacy of personalized dosage recommendations of Parasol Omega-3 Fish Oil on achieving an Omega-3 Index of >8% in individuals with a baseline Omega-3 Index <8% over a 90-day period.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fish oil supplementation arm | Experimental | Dietary Supplement: Fish Oil SupplementationParticipants will receive Fish Oil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Baseline omega-3 index less than 8%
Key exclusion criteria (1 listed)
- Currently taking a fish oil or other omega-3 supplement
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 |
|---|---|---|
| Fish Oil SupplementationEnrolled participants will be instructed to start taking 2 capsules per day on the day they take their baseline O3I and once O3I results are available to adjust to a personalized dose of Fish Oil, based on their baseline Omega-3 Index, and instructed to continue their current omega-3 dietary intake. Recommendations will be: * O3I > 6.8% but ≤ 8% - 1 capsule * O3I > 5.5% but ≤ 6.8% - 2 capsules * O3I > 4.4% but ≤ 5.5% - 3 capsules * O3I ≤ 4.4% - 4 capsules | Dietary supplement | Fish oil supplementation arm |
Primary outcome
Omega-3 index
Time frame: 90 days
RBC omega-3 index value
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No. Proprietary study
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Fish Oil Supplementation in people with Omega-3 Fatty Acids, run by Fatty Acid Research Institute.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William Harris, Ph.D. (913-302-9433, wsh@faresinst.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Omega-3 index (time frame: 90 days). 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 18 Mar 2026.