A Study to Determine Optimal Absorption of Single Dose Omega-3
- Conditions
- Optimal Gastrointestinal Absorption of Omega-3
- Interventions
- Drug: Product 1 - AquaCelle Fish Oil TriglycerideDrug: Product 2 - AquaCelle Fish Oil Ethyl EsterDrug: Product 3 - Standard Fish Oil Triglyceride
- Registration Number
- NCT05491759
- Lead Sponsor
- RDC Clinical Pty Ltd
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- 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
-
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Product 1 - AquaCelle Fish Oil Triglyceride 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. Product 2 - AquaCelle Fish Oil Ethyl Ester 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. Product 3 - Standard Fish Oil Triglyceride 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.
- Primary Outcome Measures
Name Time Method Plasma EPA+DHA as measured by AUC0-24 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 Outcome Measures
Name Time Method Tmax 24 hours post ingestion Time to peak plasma concentration
Cmax 24 hours post ingestion Peak plasma concentration
Trial Locations
- Locations (1)
RDC Global Pty Ltd
🇦🇺Brisbane, Queensland, Australia