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

NCT ID: NCT04610983

Last Updated: 2020-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-16

Study Completion Date

2021-02-28

Brief Summary

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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

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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

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Lifestyle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

A randomised, controlled, acute, 3-way cross-over study design will be used
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control

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

Group Type EXPERIMENTAL

Experimental: Control

Intervention Type DIETARY_SUPPLEMENT

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

Treatment 1 - Semi-Solid food matrix

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

Group Type EXPERIMENTAL

Experimental: Treatment 1 - Semi-Solid food matrix

Intervention Type DIETARY_SUPPLEMENT

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

Treatment 2 - Solid food matrix

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

Group Type EXPERIMENTAL

Treatment 2 - Solid food matrix

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Experimental: Control

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

Intervention Type DIETARY_SUPPLEMENT

Experimental: Treatment 1 - Semi-Solid food matrix

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

Intervention Type DIETARY_SUPPLEMENT

Treatment 2 - Solid food matrix

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

* 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
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Agency for Science, Technology and Research

OTHER

Sponsor Role collaborator

Commonwealth Scientific and Industrial Research Organisation, Australia

OTHER_GOV

Sponsor Role lead

Responsible Party

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Bradley Klingner

Project Manager and Principal Investigator delegate

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CSIRO, Health and Biosecurity

Adelaide, South Australia, Australia

Site Status RECRUITING

A*STAR

Singapore, , Singapore

Site Status NOT_YET_RECRUITING

Countries

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Australia Singapore

Central Contacts

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Bradley L Klingner, BSc

Role: CONTACT

+61 8 83038818

Facility Contacts

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Bradley L Klingner, BSc

Role: primary

+61 8 83038818

Bianca Benassi Evans, PhD

Role: backup

+61 8 83038982

Ciaran G Forde, PhD

Role: primary

Pey Sze Teo, PhD

Role: backup

+65 6407 0497

References

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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.

Reference Type DERIVED
PMID: 35041046 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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OBP001

Identifier Type: -

Identifier Source: org_study_id