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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

RDC Clinical Pty Ltd

Investigators

  • 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)

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

August 19, 2026

First Submitted That Met QC Criteria

August 24, 2026

First Posted (Actual)

August 28, 2026

Study Record Updates

Last Update Posted (Actual)

August 28, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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