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Healthy VolunteerPhase 4PHAABSNCT07791797

Supplementation Absorption Comparison

A Phase 4 study testing Aquacelle® Omega 3, Comparator Omega 3 and Plexosome® Vitamin D3 in people with Healthy Volunteer, run by RDC Clinical Pty Ltd at 1 site in Australia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this interventional study is to compare the absorption of supplements with and without absorption enhancing technology in healthy volunteers. We will be testing vitamin D3 and omega 3 in both males and females 18 years and older. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy Volunteer
What is being tested?
Aquacelle® Omega 3, Comparator Omega 3 and Plexosome® Vitamin D3
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteAustralia
Study dates
31 Aug 2026to Sep 2027
Phase
Phase 4
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

  • Adults 18 years and older
  • Generally healthy
  • BMI 18.5-29.9 kg/m2
  • Able to provide informed consent
  • Agree to not participate in another clinical trial while enrolled in this trial
  • Agree not to change current diet and/or exercise frequency or intensity during entire study period
  • Participant's ability to participate fully and comply with demands of the study including attendance at all scheduled blood collection time points

Who cannot join

  • Have a serious illness e.g. mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as MS, kidney disease, liver disease or heart conditions
  • Have an unstable illness e.g. diabetes and thyroid gland dysfunction
  • Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
  • Significant change in diet in the past 1-month (e.g., removal of a food group or calorie restriction)
  • Active smokers, nicotine use or drug (prescription or illegal substances) abuse
  • Chronic past and/or current alcohol use (>21 alcoholic drinks week)
Show all 13Show fewer
  • Pregnant or lactating women
  • Allergic to any of the ingredients in enhanced or standard formula
  • Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month (excluding RDC Clinical trials)
  • Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
  • Regular use within the past 4 weeks of supplements containing the trial product
  • Part B:
  • The above criteria apply, plus baseline serum 25(OH)D <20.0 ng/mL (<50.0 nm/L)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

David Briskey contact

+61(0)731024486

research@rdcglobal.com.au

Australia1 site, 1 recruiting

  • RDC Clinical

    Fortitude Valley, Queensland, 4006

    David Briskey, +61 (0) 731024486, research@rdcglobal.com.au

    David Briskey, PhD

    Recruiting

Other trials in Australia

About this study

Official title: Effect of Different Supplement Formulations on Nutrient Absorption in Otherwise Healthy Participants: a Randomised, Parallel-group Study With Double-blinded Omega-3 and Single-blinded Vitamin D3

The goal of this interventional study is to compare the absorption of supplements with and without absorption enhancing technology in healthy volunteers. We will be testing vitamin D3 and omega 3 in both males and females 18 years and older. Part A will comprise of two arms receiving a single dose of omega-3 supplement, and two arms who will receive vitamin D3 supplement daily for 7 days. Part B comprises of two arms who will receive vitamin D3 supplement daily for 6 weeks.

Being tested
Aquacelle® Omega 3, Comparator Omega 3, Plexosome® Vitamin D3, Comparator Vitamin D3, Plexosome® Vitamin D3 6 weeks
Keywords
absorption, vitamin D, omega-3

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aquacelle® Omega 3Dietary supplement

    Also called Omega-3

    Participants will consume 1 capsule containing 315mg EPA and DHA

  • Comparator Omega 3Dietary supplement

    Also called Omega-3

    Participants will consume 1 capsule containing 315mg EPA and DHA

  • Plexosome® Vitamin D3Dietary supplement

    Also called Cholecalciferol, Vitamin D3

    Participants will have 1000IU vitamin D3 each day for 7 days

  • Comparator Vitamin D3Dietary supplement

    Also called Cholecalciferol, Vitamin D3

    Participants will have 1000IU vitamin D3 each day for 7 days

  • Plexosome® Vitamin D3 6 weeksDietary supplement

    Also called Cholecalciferol, Vitamin D3

    Participants will have 1000IU vitamin D3 each day for 6 weeks

  • Comparator Vitamin D3 6 weeksCombination product

    Also called Cholecalciferol, Vitamin D3

    Participants will have 1000IU vitamin D3 each day for 6 weeks

Study groups in NCT07791797
Study groupRoleWhat they receive
Aquacelle® Omega 3ExperimentalParticipants will have a single dose containing 315mg EPA and DHA.
Receives: Dietary Supplement: Aquacelle® Omega 3
Comparator Omega 3Active comparatorParticipants will have a single dose containing 315mg EPA and DHA
Receives: Dietary Supplement: Comparator Omega 3
Plexosome® Vitamin D3ExperimentalParticipants will have 1000IU vitamin D3 each day for 7 days.
Receives: Dietary Supplement: Plexosome® Vitamin D3
Comparator Vitamin D3Active comparatorParticipants will have 1000IU vitamin D3 each day for 7 days.
Receives: Dietary Supplement: Comparator Vitamin D3
Plexosome® Vitamin D3 6 weeksExperimentalParticipants will have 1000IU vitamin D3 each day for 6 weeks.
Receives: Dietary Supplement: Plexosome® Vitamin D3 6 weeks
Comparator Vitamin D3 6 weeksActive comparatorParticipants will have 1000IU vitamin D3 each day for 6 weeks.
Receives: Combination Product: Comparator Vitamin D3 6 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: serum/plasma absorption (AUC) of the trial product t0-t168 (vitamin D3)

    Baseline-corrected values in serum/plasma absorption (AUC) of the trial product t0-t168 (vitamin D3)

    Measured: Baseline to day 7

  2. Part A: serum/plasma absorption (AUC) of the trial product t0-t24 (omega-3)

    Baseline-corrected values in serum/plasma absorption (AUC) of the trial product t0-t24 (omega-3)

    Measured: Baseline to day 2

  3. Part B: Baseline-corrected serum 25(OH)D AUC (0-6 weeks)

    Baseline-corrected serum 25(OH)D AUC (0-6 weeks)

    Measured: Baseline to 6 weeks

Secondary outcomes (17)

  1. Part A: Serum/plasma absorption (AUC) of the trial product t0-t8 (vitamin D3)

    Serum/plasma absorption (AUC) of the trial product t0-t8 (vitamin D3)

    Measured: Baseline to 8 hours

  2. Part A: serum/plasma absorption (AUC) of the trial product t0-t24 (vitamin D3)

    serum/plasma absorption (AUC) of the trial product t0-t24 (vitamin D3)

    Measured: Baseline to day 2

  3. Part A: Serum/plasma absorption (AUC) of the trial product t0-t48 (vitamin D3)

    Serum/plasma absorption (AUC) of the trial product t0-t48 (vitamin D3)

    Measured: Baseline to day 3

  4. Part A: Serum/plasma absorption (AUC) of the trial product t0-t10 (omega-3)

    Serum/plasma absorption (AUC) of the trial product t0-t10 (omega-3)

    Measured: Baseline to 10hours

  5. Part A: Change and absolute Tmax (vitamin D)

    Change and absolute Tmax

    Measured: Baseline to day 7

  6. Part A: Change and absolute Cmax (vitamin D)

    Change and absolute Cmax

    Measured: Baseline to day 7

  7. Part A: Change and absolute Tmax (omega-3)

    Change and absolute Tmax

    Measured: Baseline to day 2

  8. Part A: Change and absolute Cmax (omega-3)

    Change and absolute Cmax

    Measured: Baseline to day 2

  9. Part A: Participant demographics

    Participant demographics

    Measured: Baseline

  10. Part A: Tolerability

    Tolerability

    Measured: Baseline to day 7

  11. Part A: Safety via AE monitoring

    Safety via AE monitoring

    Measured: Baseline to day 7

  12. Part B: Change from baseline at week 6, standard vs enhanced formulation

    Change from baseline at week 6, standard vs enhanced formulation

    Measured: Baseline to week 6

  13. Part B: Weekly 25(OH)D change

    Weekly 25(OH)D change

    Measured: Baseline to week 6

  14. Part B: Weekly cholecalciferol change

    Weekly cholecalciferol change

    Measured: Baseline to week 6

  15. Part B: Demographics

    Demographics

    Measured: Baseline

  16. Part B: Tolerability

    Tolerability

    Measured: Baseline to week 6

  17. Part B: Safety (E/LFT)

    Safety (E/LFT)

    Measured: Baseline to week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2026
  2. Study start31 Aug 2026
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

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
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07791797
Sponsor's protocol ID
PHAABS
Acronym
PHAABS
Status last verified
Aug 2026
First submitted
19 Aug 2026
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aquacelle® Omega 3, Comparator Omega 3 and Plexosome® Vitamin D3 in people with Healthy Volunteer, 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 7 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 10 Sep 2026. 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?

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 David Briskey (+61(0)731024486, research@rdcglobal.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: serum/plasma absorption (AUC) of the trial product t0-t168 (vitamin D3) (time frame: Baseline to day 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07791797.

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 10 Sep 2026.

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