A Study to Determine Optimal Absorption of Single Dose Omega-3

A Randomised Three-way Cross Over Study to Determine the Optimal Absorption of an Omega-3 Supplement Administered as a Single Oral Dose to Healthy Volunteers

This is a randomised three-way cross over study comparing the optimal absorption of a single dose of fish oil using 3 different forms to one another on increasing blood concentrations of fatty acids in 24 healthy adult participants aged 19 years and over.

Study Overview

• Status: Completed
• Conditions: Optimal Gastrointestinal Absorption of Omega-3
• Intervention / Treatment: Drug: Product 1 - AquaCelle Fish Oil Triglyceride; Drug: Product 2 - AquaCelle Fish Oil Ethyl Ester; Drug: Product 3 - Standard Fish Oil Triglyceride

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4006
      • RDC Global Pty Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male and females over 19 years and otherwise healthy
• Healthy BMI >18.0 and <30.0
• Able to provide informed consent
• Agree to arrive fasted on the day of the trial
• Agree to participate in all arms of the study

Exclusion Criteria:

• Unstable or serious illness [e.g. kidney, liver (including NAFLD), GIT, heart conditions, diabetes, thyroid gland function malignancy]*
• Any treatment that included radiation or chemotherapy within the previous 2 years
• Receiving/prescribed coumandin (Warfarin), heparin, daltaparin, enoxaparin or other anticoagulation therapy.
• Regular use of supplements containing the investigational material (e.g. Omega-3 fatty acids), in the last 3 months, regular consumption of foods containing the investigational material (e.g. fish for omega-3) #
• Active smokers, nicotine, alcohol, drug abuse
• Chronic past and/or current alcohol use (>14 alcoholic drinks week)
• Allergic to any of the ingredients (i.e., fish oil)
• Pregnant or lactating women

• Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion

  • An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.

    • Regular use or consumption is considered if participants are consuming omega containing supplements or foods on 3 or more days per week.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Product 1 - AquaCelle Fish Oil Triglyceride; 1 dose of 2 capsules equivalent to 1.6g Fish Oil Triglyceride (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)) and 0.4g AquaCelle The dose will be consumed orally with 250 mL water.	Drug: Product 1 - AquaCelle Fish Oil Triglyceride; 1 dose of 2 capsules equivalent to 1.6g Fish Oil Triglyceride (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)) and 0.4g AquaCelle.
Experimental: Product 2 - AquaCelle Fish Oil Ethyl Ester; 1 dose of 2 capsules equivalent to 1.6g Fish Oil Ethyl Ester (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)) and 0.28g AquaCelle The dose will be consumed orally with 250 mL water.	Drug: Product 2 - AquaCelle Fish Oil Ethyl Ester; 1 dose of 2 capsules equivalent to 1.6g Fish Oil Ethyl Ester (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)) and 0.28g AquaCelle
Experimental: Product 3 - Standard Fish Oil Triglyceride; 1 dose of 2 capsules equivalent to 1.6g Fish Oil Triglyceride (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)). The dose will be consumed orally with 250 mL water.	Drug: Product 3 - Standard Fish Oil Triglyceride; 1 dose of 2 capsules equivalent to 1.6g Fish Oil Triglyceride (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma EPA+DHA as measured by AUC0-24	Change in plasma EPA+DHA from baseline as measured by AUC0-24	0, 2, 4, 6, 8, 10, 12 and 24 hours post ingestion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Peak plasma concentration	24 hours post ingestion
Tmax	Time to peak plasma concentration	24 hours post ingestion

Collaborators and Investigators

• Sponsor: RDC Clinical Pty Ltd
• Investigators: Principal Investigator: David Briskey, PhD, The University of Queensland

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2022
• Primary Completion (Actual): September 28, 2022
• Study Completion (Actual): September 28, 2022

Study Registration Dates

• First Submitted: August 4, 2022
• First Submitted That Met QC Criteria: August 4, 2022
• First Posted (Actual): August 8, 2022

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 22, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: BTFISH-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No