Optimal Gastrointestinal Absorption of Omega-3
Conditions
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.
Interventions
DRUGProduct 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.
DRUGProduct 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
DRUGProduct 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)).
Sponsors
RDC Clinical Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 24 hours post ingestion | Peak plasma concentration |
| Tmax | 24 hours post ingestion | Time to peak plasma concentration |
Countries
Australia
Outcome results
None listed