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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04610983
Other study ID # OBP001
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date November 16, 2020
Est. completion date February 2021

Study information

Verified date October 2020
Source Commonwealth Scientific and Industrial Research Organisation, Australia
Contact Bradley L Klingner, BSc
Phone +61 8 83038818
Email Bradley.Klingner@csiro.au
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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).


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date February 2021
Est. primary completion date February 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 21 Years to 50 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Experimental: Control
2 x algal oil gel capsules delivering 400mg DHA in total
Experimental: Treatment 1 - Semi-Solid food matrix
Test Food 1: 200g serve soup + "ingredient"
Treatment 2 - Solid food matrix
Test Food 2: 50g serve extruded snack (savoury snack) + "ingredient"

Locations

Country Name City State
Australia CSIRO, Health and Biosecurity Adelaide South Australia
Singapore A*STAR Singapore

Sponsors (2)

Lead Sponsor Collaborator
Commonwealth Scientific and Industrial Research Organisation, Australia Agency for Science, Technology and Research

Countries where clinical trial is conducted

Australia,  Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood Plasma Omega-3 Concentration Blood Plasma Omega-3 Concentration 0 Minutes (T0), 120 Minutes (T1), 240 Minutes (T2), 360 Minutes (T3), 480 Minutes (T4) and 1440 Minutes (T5)
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