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Completed

NCT Number: NCT05491759

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

RDC Global Pty Ltd

Brisbane, Queensland, 4006, Australia

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Product 1 - AquaCelle Fish Oil Triglyceride

Drug

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.

Product 2 - AquaCelle Fish Oil Ethyl Ester

Drug

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

Product 3 - Standard Fish Oil Triglyceride

Drug

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)).

Primary outcomes

  1. Plasma EPA+DHA as measured by AUC0-24

    Time frame: 0, 2, 4, 6, 8, 10, 12 and 24 hours post ingestion

    Change in plasma EPA+DHA from baseline as measured by AUC0-24

Secondary outcomes

  1. Cmax

    Time frame: 24 hours post ingestion

    Peak plasma concentration

  2. Tmax

    Time frame: 24 hours post ingestion

    Time to peak plasma concentration

Sponsors and collaborators

Lead sponsor

RDC Clinical Pty Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 8, 2022
Registry last updated
Oct 24, 2023

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.