Optimal Gastrointestinal Absorption of Omega-3Phase 4NCT05491759
A Study to Determine Optimal Absorption of Single Dose Omega-3
A Phase 4 study testing Product 1 - AquaCelle Fish Oil Triglyceride, Product 2 - AquaCelle Fish Oil Ethyl Ester and Product 3 - Standard Fish Oil Triglyceride in people with Optimal Gastrointestinal Absorption of Omega-3, run by RDC Clinical Pty Ltd at 1 site in Australia.
Trial summary
This is a randomised three-way cross over study comparing the optimal absorption of a single dose of fish oil using 3 different forms to one another on increasing blood concentrations of fatty acids in 24 healthy adult participants aged 19 years and over. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Optimal Gastrointestinal Absorption of Omega-3
- What is being tested?
- Product 1 - AquaCelle Fish Oil Triglyceride, Product 2 - AquaCelle Fish Oil Ethyl Ester and Product 3 - Standard Fish Oil Triglyceride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteAustralia
- Study dates
- 4 Aug 2022to 28 Sep 2022
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and females over 19 years and otherwise healthy
- Healthy BMI \>18.0 and \<30.0
- Able to provide informed consent
- Agree to arrive fasted on the day of the trial
- Agree to participate in all arms of the study
Who cannot join
- Unstable or serious illness [e.g. kidney, liver (including NAFLD), GIT, heart conditions, diabetes, thyroid gland function malignancy]*
- Any treatment that included radiation or chemotherapy within the previous 2 years
- Receiving/prescribed coumandin (Warfarin), heparin, daltaparin, enoxaparin or other anticoagulation therapy.
- Regular use of supplements containing the investigational material (e.g. Omega-3 fatty acids), in the last 3 months, regular consumption of foods containing the investigational material (e.g. fish for omega-3) #
- Active smokers, nicotine, alcohol, drug abuse
- Chronic past and/or current alcohol use (\>14 alcoholic drinks week)
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- Allergic to any of the ingredients (i.e., fish oil)
- Pregnant or lactating women
- Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
- An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
- Regular use or consumption is considered if participants are consuming omega containing supplements or foods on 3 or more days per week.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Three-way Cross Over Study to Determine the Optimal Absorption of an Omega-3 Supplement Administered as a Single Oral Dose to Healthy Volunteers
This is a randomised three-way cross over study comparing the optimal absorption of a single dose of fish oil using 3 different forms to one another on increasing blood concentrations of fatty acids in 24 healthy adult participants aged 19 years and over.
- Being tested
- Product 1 - AquaCelle Fish Oil Triglyceride, Product 2 - AquaCelle Fish Oil Ethyl Ester, Product 3 - Standard Fish Oil Triglyceride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Product 1 - AquaCelle Fish Oil TriglycerideDrug
1 dose of 2 capsules equivalent to 1.6g Fish Oil Triglyceride (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)) and 0.4g AquaCelle.
Product 2 - AquaCelle Fish Oil Ethyl EsterDrug
1 dose of 2 capsules equivalent to 1.6g Fish Oil Ethyl Ester (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)) and 0.28g AquaCelle
Product 3 - Standard Fish Oil TriglycerideDrug
1 dose of 2 capsules equivalent to 1.6g Fish Oil Triglyceride (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)).
| Study group | Role | What they receive |
|---|---|---|
| Product 1 - AquaCelle Fish Oil Triglyceride | Experimental | 1 dose of 2 capsules equivalent to 1.6g Fish Oil Triglyceride (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)) and 0.4g AquaCelle The dose will be consumed orally with 250 mL water. Receives: Drug: Product 1 - AquaCelle Fish Oil Triglyceride |
| Product 2 - AquaCelle Fish Oil Ethyl Ester | Experimental | 1 dose of 2 capsules equivalent to 1.6g Fish Oil Ethyl Ester (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)) and 0.28g AquaCelle The dose will be consumed orally with 250 mL water. Receives: Drug: Product 2 - AquaCelle Fish Oil Ethyl Ester |
| Product 3 - Standard Fish Oil Triglyceride | Experimental | 1 dose of 2 capsules equivalent to 1.6g Fish Oil Triglyceride (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)).
The dose will be consumed orally with 250 mL water. Receives: Drug: Product 3 - Standard Fish Oil Triglyceride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma EPA+DHA as measured by AUC0-24
Change in plasma EPA+DHA from baseline as measured by AUC0-24
Measured: 0, 2, 4, 6, 8, 10, 12 and 24 hours post ingestion
Secondary outcomes (2)
Cmax
Peak plasma concentration
Measured: 24 hours post ingestion
Tmax
Time to peak plasma concentration
Measured: 24 hours post ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start4 Aug 2022
- Primary completion28 Sep 2022
- Study completion28 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optimal Gastrointestinal Absorption of Omega-3Studies of the same condition, open and under way.
- More trials run by RDC Clinical Pty LtdThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- RDC Clinical Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Briskey, PhD, Principal investigator, The University of Queensland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491759
- Sponsor's protocol ID
- BTFISH-22
- Status last verified
- Dec 2022
- First submitted
- 4 Aug 2022
- Last updated
- 24 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Three-way Cross Over Study to Determine the Optimal Absorption of an Omega-3 Supplement Administered as a Single Oral Dose to Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05491759
- Acronym / sponsor ID
- BTFISH-22
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- RDC Clinical Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2022 (actual)
- Primary completion
- 28 Sep 2022 (actual)
- Study completion
- 28 Sep 2022 (actual)
- First posted
- 8 Aug 2022 (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.
This is a randomised three-way cross over study comparing the optimal absorption of a single dose of fish oil using 3 different forms to one another on increasing blood concentrations of fatty acids in 24 healthy adult participants aged 19 years and over.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Product 1 - AquaCelle Fish Oil Triglyceride | Experimental | Drug: Product 1 - AquaCelle Fish Oil Triglyceride1 dose of 2 capsules equivalent to 1.6g Fish Oil Triglyceride (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)) and 0.4g AquaCelle The dose will be consumed orally with 250 mL water. |
| Product 2 - AquaCelle Fish Oil Ethyl Ester | Experimental | Drug: Product 2 - AquaCelle Fish Oil Ethyl Ester1 dose of 2 capsules equivalent to 1.6g Fish Oil Ethyl Ester (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)) and 0.28g AquaCelle The dose will be consumed orally with 250 mL water. |
| Product 3 - Standard Fish Oil Triglyceride | Experimental | Drug: Product 3 - Standard Fish Oil Triglyceride1 dose of 2 capsules equivalent to 1.6g Fish Oil Triglyceride (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)). The dose will be consumed orally with 250 mL water. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and females over 19 years and otherwise healthy
- Healthy BMI \>18.0 and \<30.0
- Able to provide informed consent
- Agree to arrive fasted on the day of the trial
- Agree to participate in all arms of the study
Key exclusion criteria (11 listed)
- Unstable or serious illness [e.g. kidney, liver (including NAFLD), GIT, heart conditions, diabetes, thyroid gland function malignancy]*
- Any treatment that included radiation or chemotherapy within the previous 2 years
- Receiving/prescribed coumandin (Warfarin), heparin, daltaparin, enoxaparin or other anticoagulation therapy.
- Regular use of supplements containing the investigational material (e.g. Omega-3 fatty acids), in the last 3 months, regular consumption of foods containing the investigational material (e.g. fish for omega-3) #
- Active smokers, nicotine, alcohol, drug abuse
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 |
|---|---|---|
| Product 1 - AquaCelle Fish Oil Triglyceride1 dose of 2 capsules equivalent to 1.6g Fish Oil Triglyceride (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)) and 0.4g AquaCelle. | Drug | Product 1 - AquaCelle Fish Oil Triglyceride |
| Product 2 - AquaCelle Fish Oil Ethyl Ester1 dose of 2 capsules equivalent to 1.6g Fish Oil Ethyl Ester (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)) and 0.28g AquaCelle | Drug | Product 2 - AquaCelle Fish Oil Ethyl Ester |
| Product 3 - Standard Fish Oil Triglyceride1 dose of 2 capsules equivalent to 1.6g Fish Oil Triglyceride (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)). | Drug | Product 3 - Standard Fish Oil Triglyceride |
Primary outcome
Plasma EPA+DHA as measured by AUC0-24
Time frame: 0, 2, 4, 6, 8, 10, 12 and 24 hours post ingestion
Change in plasma EPA+DHA from baseline as measured by AUC0-24
2 secondary outcomes
Cmax
Time frame: 24 hours post ingestion
Tmax
Time frame: 24 hours post ingestion
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 24 Oct 2023.
- Individual participant dataSharing planned: No. No IPD will be shared
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.
David Briskey, PhD principal investigator
The University of Queensland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Product 1 - AquaCelle Fish Oil Triglyceride, Product 2 - AquaCelle Fish Oil Ethyl Ester and Product 3 - Standard Fish Oil Triglyceride in people with Optimal Gastrointestinal Absorption of Omega-3, run by RDC Clinical Pty Ltd at 1 site in Australia.
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 11 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 24 Oct 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 Australia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Plasma EPA+DHA as measured by AUC0-24 (time frame: 0, 2, 4, 6, 8, 10, 12 and 24 hours post ingestion). 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 24 Oct 2023.