Clinical trial NCT04610983: Omega-3 Bioavailability From Vegetable-omega-3 Enriched Products
Official title: Bioavailability of Omega-3 Long-chain Polyunsaturated Fatty Acids (LCPUFA) From Foods Enriched With Vegetable-encapsulated Omega-3 Oils
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lifestyle
Lead sponsor: Commonwealth Scientific and Industrial Research Organisation, Australia
Sponsor class: OTHER_GOV
Collaborators: name: Agency for Science, Technology and Research
First posted: 2020-11-02
Enrollment: 24
Sex: MALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A randomised, controlled, acute, 3-way cross-over study design will be used
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: Blood Plasma Omega-3 Concentration
timeFrame: 0 Minutes (T0), 120 Minutes (T1), 240 Minutes (T2), 360 Minutes (T3), 480 Minutes (T4) and 1440 Minutes (T5)
Secondary outcomes:
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CSIRO, Health and Biosecurity
state: South Australia
city: Singapore
country: Singapore
facility: A*STAR
Study officials:
References:
citation: 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.