LifestylePhase 2NCT04610983
Omega-3 Bioavailability From Vegetable-omega-3 Enriched Products
A Phase 2 study testing Experimental: Treatment 1 - Semi-Solid food matrix and Treatment 2 - Solid food matrix in people with Lifestyle, run by Commonwealth Scientific and Industrial Research Organisation, Australia at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Lifestyle
- What is being tested?
- Experimental: Treatment 1 - Semi-Solid food matrix and Treatment 2 - Solid food matrix
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 16 Nov 2020to Feb 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Australia1 site, 1 recruiting
- Recruiting
CSIRO, Health and Biosecurity
Adelaide, South Australia, 5000
Bradley L Klingner, BSc, +61 8 83038818, Bradley.Klingner@csiro.au
Bianca Benassi Evans, PhD, +61 8 83038982, Bianca.Benassi-Evans@csiro.au
Singapore1 site, 1 recruiting
- Not yet recruiting
A*STAR
Singapore, 117599
Ciaran G Forde, PhD, Ciaran_Forde@sifbi.a-star.edu.sg
Pey Sze Teo, PhD, +65 6407 0497, Teo_Pey_Sze@sifbi.a-star.edu.sg
About this study
Official title: Bioavailability of Omega-3 Long-chain Polyunsaturated Fatty Acids (LCPUFA) From Foods Enriched With Vegetable-encapsulated Omega-3 Oils
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).
- Conditions
- Lifestyle
- Being tested
- Experimental: Control, Experimental: Treatment 1 - Semi-Solid food matrix, Treatment 2 - Solid food matrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: ControlDietary supplement
2 x algal oil gel capsules delivering 400mg DHA in total
Experimental: Treatment 1 - Semi-Solid food matrixDietary supplement
Test Food 1: 200g serve soup + "ingredient"
Treatment 2 - Solid food matrixDietary supplement
Test Food 2: 50g serve extruded snack (savoury snack) + "ingredient"
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Control 2 * Gel Encapsulated Algal Oil Capsules (each containing 200mg DHA) Total dose of 400mg DHA. Receives: Dietary Supplement: Experimental: Control |
| Treatment 1 - Semi-Solid food matrix | Experimental | Vegetable encapsulated algal oil integrated with a semi-solid food product (soup) to deliver 400 mg DHA. Receives: Dietary Supplement: Experimental: Treatment 1 - Semi-Solid food matrix |
| Treatment 2 - Solid food matrix | Experimental | Vegetable encapsulated algal oil integrated with a solid food product (extruded snack) to deliver 400 mg DHA. Receives: Dietary Supplement: Treatment 2 - Solid food matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Plasma Omega-3 Concentration
Blood Plasma Omega-3 Concentration
Measured: 0 Minutes (T0), 120 Minutes (T1), 240 Minutes (T2), 360 Minutes (T3), 480 Minutes (T4) and 1440 Minutes (T5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start16 Nov 2020 (estimated)
- Primary completionFeb 2021 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A randomised, controlled, acute, 3-way cross-over study design will be used
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Commonwealth Scientific and Industrial Research Organisation, Australia
- Sponsor type
- Other government
- Collaborators
- Agency for Science, Technology and Research
- Responsible party
- Principal investigator, Bradley Klingner, Commonwealth Scientific and Industrial Research Organisation, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610983
- Sponsor's protocol ID
- OBP001
- Status last verified
- Oct 2020
- First submitted
- 26 Oct 2020
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Omega-3 Long-chain Polyunsaturated Fatty Acids (LCPUFA) From Foods Enriched With Vegetable-encapsulated Omega-3 Oils
- ClinicalTrials.gov ID
- NCT04610983
- Acronym / sponsor ID
- OBP001
- Conditions
- Lifestyle
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Commonwealth Scientific and Industrial Research Organisation, AustraliaOther government
- Collaborators
- Agency for Science, Technology and Research
- Study start
- 16 Nov 2020 (estimated)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 2 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A randomised, controlled, acute, 3-way cross-over study design will be used
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Dietary Supplement: Experimental: ControlControl 2 * Gel Encapsulated Algal Oil Capsules (each containing 200mg DHA) Total dose of 400mg DHA. |
| Treatment 1 - Semi-Solid food matrix | Experimental | Dietary Supplement: Experimental: Treatment 1 - Semi-Solid food matrixVegetable encapsulated algal oil integrated with a semi-solid food product (soup) to deliver 400 mg DHA. |
| Treatment 2 - Solid food matrix | Experimental | Dietary Supplement: Treatment 2 - Solid food matrixVegetable encapsulated algal oil integrated with a solid food product (extruded snack) to deliver 400 mg DHA. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Control2 x algal oil gel capsules delivering 400mg DHA in total | Dietary supplement | Control |
| Experimental: Treatment 1 - Semi-Solid food matrixTest Food 1: 200g serve soup + "ingredient" | Dietary supplement | Treatment 1 - Semi-Solid food matrix |
| Treatment 2 - Solid food matrixTest Food 2: 50g serve extruded snack (savoury snack) + "ingredient" | Dietary supplement | Treatment 2 - Solid food matrix |
Primary outcome
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)
Blood Plasma Omega-3 Concentration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Derived from this study: PubMed 35041046Stonehouse 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Experimental: Treatment 1 - Semi-Solid food matrix and Treatment 2 - Solid food matrix in people with Lifestyle, run by Commonwealth Scientific and Industrial Research Organisation, Australia at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bradley L Klingner, BSc (+61 8 83038818, Bradley.Klingner@csiro.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04610983, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020.