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Trial registered on ANZCTR
Registration number
ACTRN12626000737336
Ethics application status
Approved
Date submitted
3/06/2026
Date registered
19/06/2026
Date last updated
7/10/2026
Date data sharing statement initially provided
19/06/2026
Type of registration
Prospectively registered
Titles & IDs
Public title
An acute, randomised, crossover study investigating the absorption and bioavailability of fish oil with novel self-emulsifying delivery system in healthy adults
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Scientific title
An acute, randomised, crossover study investigating the absorption and bioavailability of fish oil with novel self-emulsifying delivery system in healthy adults
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Additional trial identifiers [1]
317472
0
NA
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Universal Trial Number (UTN)
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Trial acronym
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Related trial records
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Health condition
Health condition(s) studied:
Cardiovascular disease
342305
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Inflammation
342306
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Condition category
Condition code
Cardiovascular
338300
338300
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0
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Normal development and function of the cardiovascular system
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Inflammatory and Immune System
338421
338421
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0
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Normal development and function of the immune system
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Intervention/exposure
Study type
Interventional
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Description of the intervention or exposure
This will be an acute, double-blind, controlled, randomised, crossover study. It will be a double-blind 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 control
Arm 4: standard fish oil made with rTG only, as a commercial product (comparator)
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 omega 3 fatty acids (EPA and DHA) 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 (554 kcal, 34.8 g protein (26% energy), 90.6 g carbohydrate (70% energy), 2.2 g fat (4% 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.
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Intervention code [1]
334268
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Prevention
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Intervention code [2]
334454
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Treatment: Other
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Description of the comparator or control
The control, which will be in a form of standard fish oil with ethyl ester (EE), and without the NovaVita® (novel self-emulsifying delivery system formulation), will act as a negative control for the study. The control will contain equivalent amounts of fish oil (1500 mg). The control formulation has 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 control 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 (-0.5 to 6 h). There is a washout period of at least a week between study visits.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Baseline-adjusted incremental area under the curve (iAUC) of plasma eicosapentaenoic acid (EPA)
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Assessment method [1]
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Gold standard gas chromatography and mass spectrometry used to analyse for plasma eicosapentaenoic acid (EPA) concentrations at each respective timepoint. iAUC calculated based on the trapezoidal rule.
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Timepoint [1]
345639
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Blood samples taken at timepoints -0.5 and 0 as baseline samples and further blood samples obtained postprandially at 0.5, 1, 1.5, 2, 3, 4, 5 and 6 h after fish oil consumption at each study visit.
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Primary outcome [2]
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Cmax, the maximum or highest concentration of plasma eicosapentaenoic acid (EPA) reached in the bloodstream (as shown in plasma) during blood collection from baseline to 6 h.
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Assessment method [2]
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Gold standard gas chromatography and mass spectrometry used to analyse for plasma eicosapentaenoic acid (EPA) concentrations at each respective timepoint, and determining the highest concentration reached within the timeframe of blood collection.
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Timepoint [2]
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Blood samples taken at timepoints -0.5 and 0 as baseline samples and further blood samples obtained postprandially at 0.5, 1, 1.5, 2, 3, 4, 5 and 6 h after fish oil consumption at each study visit.
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Primary outcome [3]
345641
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tmax, the time where maximum or highest concentration (Cmax) of plasma eicosapentaenoic acid (EPA) is reached in the bloodstream (as shown in plasma) during blood collection from baseline to 6 h.
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Assessment method [3]
345641
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Gold standard gas chromatography and mass spectrometry used to analyse for plasma eicosapentaenoic acid (EPA) concentrations at each respective timepoint, and determining the timepoint where the Cmax is achieved.
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Timepoint [3]
345641
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Blood samples taken at timepoints -0.5 and 0 as baseline samples and further blood samples obtained postprandially at 0.5, 1, 1.5, 2, 3, 4, 5 and 6 h after fish oil consumption at each study visit.
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Secondary outcome [1]
462652
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Baseline-adjusted incremental area under the curve (iAUC) of plasma docosahexaenoic acid (DHA) (primary outcome).
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Assessment method [1]
462652
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Gold standard gas chromatography and mass spectrometry used to analyse for plasma docosahexaenoic acid (DHA) concentrations each respective timepoint. iAUC calculated based on the trapezoidal rule.
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Timepoint [1]
462652
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Blood samples taken at timepoints -0.5 and 0 as baseline samples and further blood samples obtained postprandially at 0.5, 1, 1.5, 2, 3, 4, 5 and 6 h after fish oil consumption at each study visit.
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Secondary outcome [2]
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Cmax (primary outcome), the maximum or highest concentration of plasma docosahexaenoic acid (DHA) reached in the bloodstream (as shown in plasma) during blood collection from baseline to 6 h.
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Assessment method [2]
463073
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Gold standard gas chromatography and mass spectrometry used to analyse for plasma docosahexaenoic acid (DHA) concentrations at each respective timepoint, and determining the highest concentration reached within the timeframe of blood collection.
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Timepoint [2]
463073
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Blood samples taken at timepoints -0.5 and 0 as baseline samples and further blood samples obtained postprandially at 0.5, 1, 1.5, 2, 3, 4, 5 and 6 h after fish oil consumption at each study visit.
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Secondary outcome [3]
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tmax (primary outcome), the time where maximum or highest concentration (Cmax) of plasma docosahexaenoic acid (DHA) is reached in the bloodstream (as shown in plasma) during blood collection from baseline to 6 h.
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Assessment method [3]
463074
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Gold standard gas chromatography and mass spectrometry used to analyse for plasma docosahexaenoic acid (DHA) concentrations at each respective timepoint, and determining the timepoint where the Cmax is achieved.
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Timepoint [3]
463074
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Blood samples taken at timepoints -0.5 and 0 as baseline samples and further blood samples obtained postprandially at 0.5, 1, 1.5, 2, 3, 4, 5 and 6 h after fish oil consumption at each study visit.
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Eligibility
Key inclusion criteria
• Healthy participants (males and females)
• Aged between 18-60 years old
• Body Mass Index (BMI) of 18.5-29.9kg/m2 (Healthy and overweight)
• Glycated haemoglobin A1c (HbA1c) <39 mmol/mol (According to American Diabetes Association (ADA) guidelines)
• Fasting blood glucose (FBG) <5.6 mmol/L (ADA guidelines)
• Healthy blood pressure (systolic < /=120, diastolic < /=80)
• Healthy lipid profile (total cholesterol (TC) <4.0 mmol/L, fasting triglyceride (FTG) <1.7 mmol/L, low-density lipoprotein (LDL) <2.0 mmol/L)
• No consumption of supplements or products containing omega-3 prior to enrollment (e.g. fish oil, krill oil, or algae oil)
• Able to communicate well in English
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Minimum age
18
Years
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Maximum age
60
Years
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Sex
Both males and females
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Healthy volunteers
Yes
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Key exclusion criteria
• Body Mass Index (BMI) >29.9kg/m2 (obese)
• Glycated haemoglobin A1c (HbA1c) >39 mmol/mol (ADA guidelines)
• Fasting blood glucose (FBG) >5.6 mmol/L (ADA guidelines)
• High fasting glycerides (TFG) >1.7 mmol/L, high low-density lipoprotein (LDL) >2.0 mmol/L and high total cholesterol (TC) >5.0 mmol/L
• Known food allergies or intolerance to marine (fish/shellfish) or fish oil products
• Regular consumption of supplements or products containing omega-3 prior to enrollment (e.g. fish oil, krill oil, or algae oil)
• Pre-existing medical conditions, gastrointestinal disorders, or taking medications known to affect fat metabolism or regulation, or that impede lipid absorption
• Anaemic or other known blood disorders
• Use of steroids, protease inhibitors or antipsychotics medicines known to influence fat metabolism and body fat distribution
• Pregnant or breastfeeding
• Smoking
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be applied to the study. Each of the treatment arm will be allocated a random number and sequence generated by the computer (www.randomizer.org), and concealed in an opaque envelope till the day of assignment for each participant. Each participant will not know in which order or what type of treatment they will be given at each visit.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of participants to each of the treatment will be performed using a randomisation table created by computer software (www.randomizer.org).
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Pharmacokinetics
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
28/09/2026
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Actual
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Date of last participant enrolment
Anticipated
1/12/2026
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Actual
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Date of last data collection
Anticipated
31/12/2026
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Actual
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Sample size
Target
25
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
28170
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New Zealand
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State/province [1]
28170
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Auckland
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Pharma New Zealand PNZ Limited
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Address [1]
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Country [1]
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New Zealand
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Primary sponsor type
Commercial sector/Industry
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Name
Pharma New Zealand PNZ Limited
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Address
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
324921
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Country [1]
324921
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
320571
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Massey University Human Ethics Committee: Ohu Matatika 1 (formerly Southern A Committee)
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Ethics committee address [1]
320571
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https://www.massey.ac.nz/research/ethics/human-ethics/
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Ethics committee country [1]
320571
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New Zealand
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Date submitted for ethics approval [1]
320571
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29/06/2026
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Approval date [1]
320571
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31/08/2026
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Ethics approval number [1]
320571
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OM1 26/45
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Summary
Brief summary
Current research has recommended to consume 1-2 g/d of fish or fish oil supplements for the intake of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) for cellular growth and inflammation mediation. However, the optimal absorption of fish oil products and supplements is highly dependent on the type and form of supplement. The self-emulsifying drug delivery system such as the N-SERDS+® as an improved version from existing delivery formats, may potentially increase the surface area available for the fish oil to be digested, thus improving lipid digestion and absorption of the omega-3 fatty acids. Therefore, the aim of the study is to investigate the acute pharmacokinetics (Cmax, tmax, and total absorption, iAUC) of the fish oil formulated with N-SERDS+® self-emulsifying delivery system and its impact on the absorption rate and total concentration of omega-3 fatty acids (EPA and DHA) compared to the other conventional and current methods of fish oil delivery in healthy humans.
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Trial website
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Trial related presentations / publications
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Public notes
References to support the time points chosen for blood collection at each study visit:: 1. West, A. L., Burdge, G. C., & Calder, P. C. (2016). Lipid structure does not modify incorporation of EPA and DHA into blood lipids in healthy adults: a randomised-controlled trial. British Journal of Nutrition, 116(5), 788-797. 2. Sung, H., Sinclair, A. J., Lewandowski, P. A., & Su, X. Q. (2018). Postprandial long-chain n-3 polyunsaturated fatty acid response to krill oil and fish oil consumption in healthy women: a randomised controlled, single-dose, crossover study. Asia Pacific journal of clinical nutrition, 27(1), 148-157. 3. Ottestad, I., Nordvi, B., Vogt, G., Holck, M., Halvorsen, B., Brønner, K. W., ... & Ulven, S. M. (2016). Bioavailability of n-3 fatty acids from n-3-enriched foods and fish oil with different oxidative quality in healthy human subjects: a randomised single-meal cross-over study. Journal of nutritional science, 5, e43.
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Contacts
Principal investigator
Name
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Dr Wen Xin Janice
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Address
150922
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Riddet Institute Massey University Private Bag 11 222 Palmerston North 4442
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Country
150922
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New Zealand
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Phone
150922
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+64 2108903957
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Fax
150922
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Email
150922
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[email protected]
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Contact person for public queries
Name
150923
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Wen Xin Janice
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Address
150923
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Riddet Institute Massey University Private Bag 11 222 Palmerston North 4442
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Country
150923
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New Zealand
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Phone
150923
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+64 2108903957
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Fax
150923
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Email
150923
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[email protected]
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Contact person for scientific queries
Name
150924
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Wen Xin Janice
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Address
150924
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Riddet Institute Massey University Private Bag 11 222 Palmerston North 4442
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Country
150924
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New Zealand
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Phone
150924
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+64 2108903957
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Fax
150924
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Email
150924
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment:
Participant data will not be shared. A de-identified code will be used for collected data in scientific journal publication.
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF