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

RDC Clinical

Status and phase: Completed; Phase 4

Conditions: Optimal Gastrointestinal Absorption of Omega-3

Treatments: Drug: Product 2 - AquaCelle Fish Oil Ethyl Ester; Drug: Product 1 - AquaCelle Fish Oil Triglyceride; Drug: Product 3 - Standard Fish Oil Triglyceride

Study type: Interventional

Funder types: Industry

Identifiers

NCT05491759

BTFISH-22

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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22 participants in 3 patient groups

Product 1 - AquaCelle Fish Oil Triglyceride

Experimental group

Description:

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.

Treatment:

Drug: Product 1 - AquaCelle Fish Oil Triglyceride

Product 2 - AquaCelle Fish Oil Ethyl Ester

Experimental group

Description:

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.

Treatment:

Drug: Product 2 - AquaCelle Fish Oil Ethyl Ester

Product 3 - Standard Fish Oil Triglyceride

Experimental group

Description:

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.

Treatment:

Drug: Product 3 - Standard Fish Oil Triglyceride