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

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).

Study Overview

• Status: Unknown
• Conditions: Lifestyle
• Intervention / Treatment: Dietary supplement: Experimental: Control; Dietary supplement: Experimental: Treatment 1 - Semi-Solid food matrix; Dietary supplement: Treatment 2 - Solid food matrix

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).

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Bradley L Klingner, BSc; Phone Number: +61 8 83038818; Email: Bradley.Klingner@csiro.au

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Recruiting
      • CSIRO, Health and Biosecurity
      • Contact: Bradley L Klingner, BSc; Phone Number: +61 8 83038818; Email: Bradley.Klingner@csiro.au
      • Contact: Bianca Benassi Evans, PhD; Phone Number: +61 8 83038982; Email: Bianca.Benassi-Evans@csiro.au
      • Principal Investigator: Welma Stonehouse, PhD
• Singapore
  • Singapore, Singapore, 117599
    • Not yet recruiting
    • A*STAR
    • Contact: Ciaran G Forde, PhD; Email: Ciaran_Forde@sifbi.a-star.edu.sg
    • Contact: Pey Sze Teo, PhD; Phone Number: +65 6407 0497; Email: Teo_Pey_Sze@sifbi.a-star.edu.sg
    • Principal Investigator: Ciaran G Forde, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control; Control 2 * Gel Encapsulated Algal Oil Capsules (each containing 200mg DHA) Total dose of 400mg DHA.	Dietary supplement: Experimental: Control; 2 x algal oil gel capsules delivering 400mg DHA in total
Experimental: Treatment 1 - Semi-Solid food matrix; Vegetable encapsulated algal oil integrated with a semi-solid food product (soup) to deliver 400 mg DHA.	Dietary supplement: Experimental: Treatment 1 - Semi-Solid food matrix; Test Food 1: 200g serve soup + "ingredient"
Experimental: Treatment 2 - Solid food matrix; Vegetable encapsulated algal oil integrated with a solid food product (extruded snack) to deliver 400 mg DHA.	Dietary supplement: Treatment 2 - Solid food matrix; Test Food 2: 50g serve extruded snack (savoury snack) + "ingredient"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Commonwealth Scientific and Industrial Research Organisation, Australia
• Collaborators: Agency for Science, Technology and Research

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 16, 2020
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: October 26, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (Actual): November 2, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2020
• Last Update Submitted That Met QC Criteria: October 29, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: OBP001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No