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Status unknownNCT04610983Updated Nov 2, 2020

Omega-3 Bioavailability From Vegetable-omega-3 Enriched Products

A Phase 2 interventional study of Experimental: Control and Experimental: Treatment 1 - Semi-Solid food matrix in Lifestyle, sponsored by Commonwealth Scientific and Industrial Research Organisation, Australia. Status unknown at 2 sites in 2 countries. Open to male participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-02.

Sponsored by Commonwealth Scientific and Industrial Research Organisation, Australia · Phase 2, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Oct 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
21 Years to 50 Years
Sex
Male
01

Study 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).

Read the detailed description

Omega-3 long-chain polyunsaturated fatty acids (omega-3) (eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA]) is associated with many health benefits including improved brain, heart, joint and eye health. However, \<20% of the world's population consume adequate amounts of these fatty acids. Individuals who don't consume fish (major dietary omega-3 source) and particularly vegans/vegetarians are at greatest risk of omega-3 deficiency. Convenient strategies empowering consumers to increase their omega-3 intake have potential to significantly impact health outcomes. CSIRO's Food Program has developed a novel vegetable-based omega-3 encapsulant to be used as ingredient in various food products. Using algal oil as omega-3 source provides vegan/vegetarian options. However, it is unknown whether the vegetable-based carrier matrix will affect omega-3 bioavailability. As these products are intended for global markets, it is also unknown whether ethnic differences may affect omega-3 bioavailability. This project forms part of a larger project aiming to develop sensorially and culturally acceptable food products that incorporate vegetable-encapsulated omega-3 oils to assist Australian and Singaporean consumers to achieve their omega-3 LCPUFA intake. This component of the 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). To achieve this, two clinical trials, following the same protocol, will be executed in both Australia (Australian European) and Singapore (Chinese Singaporean).

02

Conditions studied

  • Lifestyle
03

In context

Lead sponsor

Commonwealth Scientific and Industrial Research Organisation, Australia is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Control

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

    Dietary Supplement: Experimental: Control

  • Experimental
    Treatment 1 - Semi-Solid food matrix

    Vegetable encapsulated algal oil integrated with a semi-solid food product (soup) to deliver 400 mg DHA.

    Dietary Supplement: Experimental: Treatment 1 - Semi-Solid food matrix

  • Experimental
    Treatment 2 - Solid food matrix

    Vegetable encapsulated algal oil integrated with a solid food product (extruded snack) to deliver 400 mg DHA.

    Dietary Supplement: Treatment 2 - Solid food matrix

Interventions

  • Dietary supplementExperimental: Control

    2 x algal oil gel capsules delivering 400mg DHA in total

  • Dietary supplementExperimental: Treatment 1 - Semi-Solid food matrix

    Test Food 1: 200g serve soup + "ingredient"

  • Dietary supplementTreatment 2 - Solid food matrix

    Test Food 2: 50g serve extruded snack (savoury snack) + "ingredient"

06

What researchers measure

Primary outcomes

  1. Blood Plasma Omega-3 Concentration

    Blood Plasma Omega-3 Concentration

    Time frame: 0 Minutes (T0), 120 Minutes (T1), 240 Minutes (T2), 360 Minutes (T3), 480 Minutes (T4) and 1440 Minutes (T5)

07

Study locations

1 of 2 sites recruiting
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References and documents

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. PubMed 35041046 ↗

Study documents

  • Protocol and statistical analysis plan · Oct 20, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04610983
Lead sponsor
Commonwealth Scientific and Industrial Research Organisation, Australia
Collaborators
Agency for Science, Technology and Research
Responsible party
Bradley Klingner (Project Manager and Principal Investigator delegate, Commonwealth Scientific and Industrial Research Organisation, Australia) — Principal investigator
First posted
Nov 2, 2020
Start date
Nov 16, 2020 (estimated)
Primary completion
Feb 2021 (estimated)
Completion
Feb 2021 (estimated)
Last update
Nov 2, 2020

Study contacts

Bradley L Klingner, BSc
Contact
Bradley.Klingner@csiro.au
+61 8 83038818

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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