Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04610983




Registration number
NCT04610983
Ethics application status
Date submitted
26/10/2020
Date registered
2/11/2020
Date last updated
2/11/2020

Titles & IDs
Public title
Omega-3 Bioavailability From Vegetable-omega-3 Enriched Products
Scientific title
Bioavailability of Omega-3 Long-chain Polyunsaturated Fatty Acids (LCPUFA) From Foods Enriched With Vegetable-encapsulated Omega-3 Oils
Secondary ID [1] 0 0
OBP001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lifestyle 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Experimental: Control
Treatment: Other - Experimental: Treatment 1 - Semi-Solid food matrix
Treatment: Other - Treatment 2 - Solid food matrix

Experimental: Control - Control 2 \* Gel Encapsulated Algal Oil Capsules (each containing 200mg DHA) Total dose of 400mg DHA.

Experimental: Treatment 1 - Semi-Solid food matrix - Vegetable encapsulated algal oil integrated with a semi-solid food product (soup) to deliver 400 mg DHA.

Experimental: Treatment 2 - Solid food matrix - Vegetable encapsulated algal oil integrated with a solid food product (extruded snack) to deliver 400 mg DHA.


Treatment: Other: Experimental: Control
2 x algal oil gel capsules delivering 400mg DHA in total

Treatment: Other: Experimental: Treatment 1 - Semi-Solid food matrix
Test Food 1: 200g serve soup + "ingredient"

Treatment: Other: Treatment 2 - Solid food matrix
Test Food 2: 50g serve extruded snack (savoury snack) + "ingredient"
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Blood Plasma Omega-3 Concentration
Timepoint [1] 0 0
0 Minutes (T0), 120 Minutes (T1), 240 Minutes (T2), 360 Minutes (T3), 480 Minutes (T4) and 1440 Minutes (T5)

Eligibility
Key inclusion criteria
* Healthy men
* Age: 21-50 years old
* BMI 18-27.5 kg/m2
* Consume less than 2 meals of fatty fish/week
* Not consume fish oil supplements over the past 3 months
* Identify as Australian European in ethnicity (Australian with European heritage) for Australian arm of study
* Identify as Chinese Singaporean in ethnicity (Singaporean with Chinese heritage) for Singaporean arm of study
Minimum age
21 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
* History of chronic disease - cancer, type 2 diabetes, cardiovascular disease, liver disease or any condition that may, in the opinion of the principle investigator, influence the study outcomes (Self reported, no clinical testing will be performed)
* History of gastrointestinal disease, pancreatic insufficiency, conditions resulting in fat malabsorption - chronic pancreatitis, cystic fibrosis, coeliac disease, Crohns disease, gastric bypass surgery, small bowel resection, abnormal thyroid function (Self reported, no clinical testing will be performed)
* Bleeding disorders, currently taking anticoagulants or has received anticoagulants within 28 days of Day 1 of the trial, with the exception of low dose aspirin up to150 mg daily (Self reported)
* Any medical procedures deemed by the principal investigator to affect study outcomes
* Known food allergies, hypersensitivity, dietary avoidance or intolerance to the study foods
* Taking medications/supplements known to influence lipid metabolism and gastric emptying
* On any weight-loss program
* History of smoking during the 6 months prior to the study (Self reported)
* Persons considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol
* History of drug abuse or alcoholism (Self reported)
* Participation in another research study within 30 days preceding the start of this study

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
16/11/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2021
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CSIRO, Health and Biosecurity - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
Singapore
State/province [1] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Government body
Name
Commonwealth Scientific and Industrial Research Organisation, Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Agency for Science, Technology and Research
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
CSIRO's Food Program has developed a novel vegetable-based Omega-3 long-chain polyunsaturated fatty acid (Omega 3)encapsulant to be used as ingredient in various food products, however, it is unknown whether the vegetable-based carrier matrix will affect omega-3 bioavailability. This project aims to compare the bioavailability of omega-3 from two test foods containing vegetable (cauliflower)-encapsulated algal oil (the "ingredient") against a control test product (algal oil gel capsules) across two ethnicities (Australian European vs. Chinese Singaporean).
Trial website
https://clinicaltrials.gov/study/NCT04610983
Trial related presentations / publications
Stonehouse W, Klingner B, Tso R, Teo PS, Terefe NS, Forde CG. Bioequivalence of long-chain omega-3 polyunsaturated fatty acids from foods enriched with a novel vegetable-based omega-3 delivery system compared to gel capsules: a randomized controlled cross-over acute trial. Eur J Nutr. 2022 Jun;61(4):2129-2141. doi: 10.1007/s00394-021-02795-7. Epub 2022 Jan 18.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Bradley L Klingner, BSc
Address 0 0
Country 0 0
Phone 0 0
+61 8 83038818
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04610983