An acute, randomised, crossover study investigating the absorption and bioavailability of fish oil with novel self-emulsifying delivery system in healthy adults

This will be an acute, double-blind, placebo-controlled, randomised, crossover study. It will be a double-blinded study where no participant nor researcher on the trial will know what intervention is given at each study visit. There will be four intervention arms: Arm 1: fish oil with NovaVita® + ethyl easter (EE) Arm 2: fish oil with NovaVita® + re-esterified triglycerides (rTG) Arm 3: standard fish oil made with EE only, as placebo Arm 4: standard fish oil made with rTG only, as a commercial product The NovaVita® is a novel, proprietary liquid-based, self-emulsifying delivery system formulation. Each treatment will contain equivalent amounts of fish oil (1500 mg). For the treatments containing the NovaVita® solution, it will be 1500 mg of fish oil (either in EE or rTG chemical form) with 643 mg of NovaVita® solution. The treatments and their dosages have been tested to be safe for human consumption. At each study visit, all eligible participants will be checked for dietary and lifestyle compliance, such as having fasted at least 10-12 hours prior to the visit, keeping their diet constant, no strenuous physical activity, no alcohol, no caffeinated tea or coffee formulations and no health supplements 24 hours to visit, and no consumption of fish nor seafood 48 h to visit, as well as no consumption of fish oil supplement or similar product e.g. krill oil and algae oil, throughout the duration of the study. A baseline sample will be taken at -0.5 and 0 h prior to consuming the treatment. The participants will then consume the treatment (provided in oral liquids dose) within two minutes with 240 mL of water. Subsequent blood collection would be at 0.5, 1, 1.5, 2, 3, 4, 5, and 6 h, where participants will remain at the clinical research facility. Participants will be asked to refrain from consuming water an hour before the treatment and 2 h after the treatment. A controlled amount of water (500 mL) will be provided to participants and the amount left unconsumed after each study visit will be recorded for quality control. The timepoints selected were based on previous studies demonstrating the typical duration required for postprandial digestion and absorption of fish oil interventions in humans to clearly quantify for the maximum peaks in concentration and time of fatty acids (EPA and DHA), as well as their total absorption in the blood stream. Blood samples are obtained via the finger prick test using a single use disposable lancet (Accu-Chek Safe T-Pro Plus) and 500 uL blood collected per timepoints into chilled microvette capillary blood collection tubes treated with EDTA for plasma EPA and DHA analysis. Samples are centrifuged to obtain 250 uL supernatant and stored in aliquots and kept in -80degC freezer until plasma insulin analysis. The collected blood samples will be sent to a certified laboratory in the College of Health, Medicine and Wellbeing, University of Newcastle for the EPA and DHA analysis. The participants will be advised to refrain from consuming other foods or snacks apart from the low-fat meal (500 kcal, 15 g protein (12% energy), 100 g carbohydrate (80% energy), 4.5 g fat (8% energy), that is provided for them to be consumed the night before their study visit the next morning. They will also be asked to refrain from strenuous physical activity during the duration of the study (0 to 6 h). There is a washout period of at least a week between study visits. Each study visit will take approximately 6 h and a total of 24 h for the whole study involving four study visits.