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

Last updated: October 29, 2020
Sponsor: Commonwealth Scientific and Industrial Research Organisation, Australia
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04610983
OBP001
  • Ages 21-50
  • Male
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

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) forAustralian arm of study
  • Identify as Chinese Singaporean in ethnicity (Singaporean with Chinese heritage) forSingaporean arm of study

Exclusion

Exclusion Criteria:

  • History of chronic disease - cancer, type 2 diabetes, cardiovascular disease, liverdisease 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 infat malabsorption - chronic pancreatitis, cystic fibrosis, coeliac disease, Crohnsdisease, 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 anticoagulantswithin 28 days of Day 1 of the trial, with the exception of low dose aspirin up to150mg 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 studyfoods
  • Taking medications/supplements known to influence lipid metabolism and gastricemptying
  • 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 tocomprehend 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 thisstudy

Study Design

Total Participants: 24
Study Start date:
November 16, 2020
Estimated Completion Date:
February 28, 2021

Study 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).

Connect with a study center

  • CSIRO, Health and Biosecurity

    Adelaide, South Australia 5000
    Australia

    Active - Recruiting

  • A*STAR

    Singapore, 117599
    Singapore

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.