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NCT Number: NCT07791797

Supplementation Absorption Comparison

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.

Recruiting

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Key information

Conditions

Healthy Volunteer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

RDC Clinical

Fortitude Valley, Queensland, 4006, Australia

Location status: Recruiting

Location contact

David Briskey

CONTACT

[email protected]

+61 (0) 731024486

David Briskey, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Aquacelle® Omega 3

Dietary Supplement

Participants will consume 1 capsule containing 315mg EPA and DHA

Other names: Omega-3

Comparator Omega 3

Dietary Supplement

Participants will consume 1 capsule containing 315mg EPA and DHA

Other names: Omega-3

Plexosome® Vitamin D3

Dietary Supplement

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

Other names: Cholecalciferol, Vitamin D3

Comparator Vitamin D3

Dietary Supplement

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

Other names: Cholecalciferol, Vitamin D3

Plexosome® Vitamin D3 6 weeks

Dietary Supplement

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

Other names: Cholecalciferol, Vitamin D3

Comparator Vitamin D3 6 weeks

Combination Product

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

Other names: Cholecalciferol, Vitamin D3

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

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

    Time frame: Baseline to day 7

    Change and absolute Tmax

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

    Time frame: Baseline to day 7

    Change and absolute Cmax

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

    Time frame: Baseline to day 2

    Change and absolute Tmax

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

    Time frame: Baseline to day 2

    Change and absolute Cmax

  9. Part A: Participant demographics

    Time frame: Baseline

    Participant demographics

  10. Part A: Tolerability

    Time frame: Baseline to day 7

    Tolerability

  11. Part A: Safety via AE monitoring

    Time frame: Baseline to day 7

    Safety via AE monitoring

  12. 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

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

    Time frame: Baseline to week 6

    Weekly 25(OH)D change

  14. Part B: Weekly cholecalciferol change

    Time frame: Baseline to week 6

    Weekly cholecalciferol change

  15. Part B: Demographics

    Time frame: Baseline

    Demographics

  16. Part B: Tolerability

    Time frame: Baseline to week 6

    Tolerability

  17. Part B: Safety (E/LFT)

    Time frame: Baseline to week 6

    Safety (E/LFT)

Other outcomes

  1. Part B (exploratory): parathyroid hormone

    Time frame: Baseline to week 6

    Change from baseline to week 6 in parathyroid hormone (PTH)

  2. Part B (exploratory): calcium

    Time frame: Baseline to week 6

    Change from baseline to week 6 in calcium

  3. Part B (exploratory): high-sensitivity C-reactive protein

    Time frame: Baseline to week 6

    Change from baseline to week 6 in high-sensitivity C-reactive protein (hs-CRP)

  4. Part B (exploratory): interleukin-6 (IL-6)

    Time frame: Baseline to week 6

    Change from baseline to week 6 in interleukin-6 (IL-6)

  5. Part B (exploratory): interleukin-1b (IL-1b)

    Time frame: Baseline to week 6

    Change from baseline to week 6 in interleukin-1b (IL-1b)

  6. Part B (exploratory): MCP-1 (Monocyte Chemoattractant Protein-1)

    Time frame: Baseline to week 6

    Change from baseline to week 6 in MCP-1 (Monocyte Chemoattractant Protein-1) also known as CCL2 (Chemokine (C-C motif) ligand 2)

  7. Part B (exploratory): tumour necrosis factor-alpha (TNF-α)

    Time frame: Baseline to week 6

    Change from baseline to week 6 in tumour necrosis factor-alpha (TNF-α)].

Study contacts

Contact information is provided by the study sponsor or research team.

David Briskey

CONTACT

[email protected]

+61(0)731024486

Sponsors and collaborators

Lead sponsor

RDC Clinical Pty Ltd

Industry

Registry information

Official study 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

Acronym: PHAABS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 28, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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