Supplementation Absorption Comparison (PHAABS)

August 24, 2026 updated by: RDC Clinical Pty Ltd

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • Queensland
      • Fortitude Valley, Queensland, Australia, 4006
        • RDC Clinical
        • Principal Investigator:
          • David Briskey, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Part A:

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Aquacelle® Omega 3
Participants will have a single dose containing 315mg EPA and DHA.
Dietary supplement: Aquacelle® Omega 3
Participants will consume 1 capsule containing 315mg EPA and DHA
Other Names:
  • Omega-3
Active Comparator: Comparator Omega 3
Participants will have a single dose containing 315mg EPA and DHA
Dietary supplement: Comparator Omega 3
Participants will consume 1 capsule containing 315mg EPA and DHA
Other Names:
  • Omega-3
Experimental: Plexosome® Vitamin D3
Participants will have 1000IU vitamin D3 each day for 7 days.
Dietary supplement: Plexosome® Vitamin D3
Participants will have 1000IU vitamin D3 each day for 7 days
Other Names:
  • Cholecalciferol
  • Vitamin D3
Active Comparator: Comparator Vitamin D3
Participants will have 1000IU vitamin D3 each day for 7 days.
Dietary supplement: Comparator Vitamin D3
Participants will have 1000IU vitamin D3 each day for 7 days
Other Names:
  • Cholecalciferol
  • Vitamin D3
Experimental: Plexosome® Vitamin D3 6 weeks
Participants will have 1000IU vitamin D3 each day for 6 weeks.
Dietary supplement: Plexosome® Vitamin D3 6 weeks
Participants will have 1000IU vitamin D3 each day for 6 weeks
Other Names:
  • Cholecalciferol
  • Vitamin D3
Active Comparator: Comparator Vitamin D3 6 weeks
Participants will have 1000IU vitamin D3 each day for 6 weeks.
Combination product: Comparator Vitamin D3 6 weeks
Participants will have 1000IU vitamin D3 each day for 6 weeks
Other Names:
  • Cholecalciferol
  • Vitamin D3

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part A: serum/plasma absorption (AUC) of the trial product t0-t168 (vitamin D3)
Time Frame: Baseline to day 7
Baseline-corrected values in serum/plasma absorption (AUC) of the trial product t0-t168 (vitamin D3)
Baseline to day 7
Part A: serum/plasma absorption (AUC) of the trial product t0-t24 (omega-3)
Time Frame: Baseline to day 2
Baseline-corrected values in serum/plasma absorption (AUC) of the trial product t0-t24 (omega-3)
Baseline to day 2
Part B: Baseline-corrected serum 25(OH)D AUC (0-6 weeks)
Time Frame: Baseline to 6 weeks
Baseline-corrected serum 25(OH)D AUC (0-6 weeks)
Baseline to 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Part A: Serum/plasma absorption (AUC) of the trial product t0-t8 (vitamin D3)
Time Frame: Baseline to 8 hours
Serum/plasma absorption (AUC) of the trial product t0-t8 (vitamin D3)
Baseline to 8 hours
Part A: serum/plasma absorption (AUC) of the trial product t0-t24 (vitamin D3)
Time Frame: Baseline to day 2
serum/plasma absorption (AUC) of the trial product t0-t24 (vitamin D3)
Baseline to day 2
Part A: Serum/plasma absorption (AUC) of the trial product t0-t48 (vitamin D3)
Time Frame: Baseline to day 3
Serum/plasma absorption (AUC) of the trial product t0-t48 (vitamin D3)
Baseline to day 3
Part A: Serum/plasma absorption (AUC) of the trial product t0-t10 (omega-3)
Time Frame: Baseline to 10hours
Serum/plasma absorption (AUC) of the trial product t0-t10 (omega-3)
Baseline to 10hours
Part A: Change and absolute Tmax (vitamin D)
Time Frame: Baseline to day 7
Change and absolute Tmax
Baseline to day 7
Part A: Change and absolute Cmax (vitamin D)
Time Frame: Baseline to day 7
Change and absolute Cmax
Baseline to day 7
Part A: Change and absolute Tmax (omega-3)
Time Frame: Baseline to day 2
Change and absolute Tmax
Baseline to day 2
Part A: Change and absolute Cmax (omega-3)
Time Frame: Baseline to day 2
Change and absolute Cmax
Baseline to day 2
Part A: Participant demographics
Time Frame: Baseline
Participant demographics
Baseline
Part A: Tolerability
Time Frame: Baseline to day 7
Tolerability
Baseline to day 7
Part A: Safety via AE monitoring
Time Frame: Baseline to day 7
Safety via AE monitoring
Baseline to day 7
Part B: Change from baseline at week 6, standard vs enhanced formulation
Time Frame: Baseline to week 6
Change from baseline at week 6, standard vs enhanced formulation
Baseline to week 6
Part B: Weekly 25(OH)D change
Time Frame: Baseline to week 6
Weekly 25(OH)D change
Baseline to week 6
Part B: Weekly cholecalciferol change
Time Frame: Baseline to week 6
Weekly cholecalciferol change
Baseline to week 6
Part B: Demographics
Time Frame: Baseline
Demographics
Baseline
Part B: Tolerability
Time Frame: Baseline to week 6
Tolerability
Baseline to week 6
Part B: Safety (E/LFT)
Time Frame: Baseline to week 6
Safety (E/LFT)
Baseline to week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RDC Clinical Pty Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Briskey, RDC Clinical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PHAABS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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