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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-04

Study Completion Date

2022-09-28

Brief Summary

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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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Detailed Description

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Conditions

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Optimal Gastrointestinal Absorption of Omega-3

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Product 1 - AquaCelle Fish Oil Triglyceride

Intervention Type 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

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.

Group Type EXPERIMENTAL

Product 2 - AquaCelle Fish Oil Ethyl Ester

Intervention Type 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

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.

Group Type EXPERIMENTAL

Product 3 - Standard Fish Oil Triglyceride

Intervention Type 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)).

Interventions

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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.

Intervention Type 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

Intervention Type 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)).

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes