Supplementation Absorption Comparison

NCT07791797 | Not Yet Recruiting Phase 4

• 1 other identifier: PHAABS
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy Volunteer

Keywords

absorption; vitamin D; omega-3

Outcome Measures

Primary Outcomes (3)

• 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)

  Baseline to day 7

• 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)

  Baseline to day 2

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

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

  Baseline to 6 weeks

Secondary Outcomes (17)

• Part A: 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)

  Baseline to day 2

• Part A: 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)

  Baseline to 10hours

• Part A: Change and absolute Tmax (vitamin D)

  Baseline to day 7

Study Arms (6)

Aquacelle® Omega 3

EXPERIMENTAL

Participants will have a single dose containing 315mg EPA and DHA.

Dietary Supplement: Aquacelle® Omega 3

Comparator Omega 3

ACTIVE COMPARATOR

Participants will have a single dose containing 315mg EPA and DHA

Dietary Supplement: Comparator Omega 3

Plexosome® Vitamin D3

EXPERIMENTAL

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

Dietary Supplement: Plexosome® Vitamin D3

Comparator Vitamin D3

ACTIVE COMPARATOR

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

Dietary Supplement: Comparator Vitamin D3

Plexosome® Vitamin D3 6 weeks

EXPERIMENTAL

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

Dietary Supplement: Plexosome® Vitamin D3 6 weeks

Comparator Vitamin D3 6 weeks

ACTIVE COMPARATOR

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

Combination Product: Comparator Vitamin D3 6 weeks

Interventions

Aquacelle® Omega 3 DIETARY_SUPPLEMENT

Participants will consume 1 capsule containing 315mg EPA and DHA

Also known as: Omega-3

Aquacelle® Omega 3

Comparator Omega 3 DIETARY_SUPPLEMENT

Participants will consume 1 capsule containing 315mg EPA and DHA

Also known as: Omega-3

Comparator Omega 3

Plexosome® Vitamin D3 DIETARY_SUPPLEMENT

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

Also known as: Cholecalciferol, Vitamin D3

Plexosome® Vitamin D3

Comparator Vitamin D3 DIETARY_SUPPLEMENT

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

Also known as: Cholecalciferol, Vitamin D3

Comparator Vitamin D3

Plexosome® Vitamin D3 6 weeks DIETARY_SUPPLEMENT

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

Also known as: Cholecalciferol, Vitamin D3

Plexosome® Vitamin D3 6 weeks

Comparator Vitamin D3 6 weeks COMBINATION_PRODUCT

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

Also known as: Cholecalciferol, Vitamin D3

Comparator Vitamin D3 6 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• RDC Clinical Pty Ltd: lead

Study Sites (1)

RDC Clinical

Fortitude Valley, Queensland, 4006, Australia

Location

MeSH Terms

Interventions

Docosahexaenoic Acids; Cholecalciferol

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids

Study Officials

• David Briskey

  RDC Clinical

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Briskey

CONTACT

+61(0)731024486; research@rdcglobal.com.au

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind omega-3 sub-study and a single-blind vitamin D3 sub-study, with blinded laboratory analysis and blinded statistical analysis
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Locations

AU (1)