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

Bioavailability of Omega-3 Long-chain Polyunsaturated Fatty Acids (LCPUFA) From Foods Enriched With Vegetable-encapsulated Omega-3 Oils

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04610983
Enrollment
24
Registered
2020-11-02
Start date
2020-11-16
Completion date
2021-02-28
Last updated
2020-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lifestyle

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).

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).

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

Sponsors

Agency for Science, Technology and Research
CollaboratorOTHER
Commonwealth Scientific and Industrial Research Organisation, Australia
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender
MALE
Age
21 Years to 50 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Blood Plasma Omega-3 Concentration0 Minutes (T0), 120 Minutes (T1), 240 Minutes (T2), 360 Minutes (T3), 480 Minutes (T4) and 1440 Minutes (T5)Blood Plasma Omega-3 Concentration

Countries

Australia, Singapore

Contacts

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026