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

NCT04610983 | Unknown Phase 2

• 1 other identifier: OBP001
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 2

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).

Conditions

Lifestyle

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (3)

Control

EXPERIMENTAL

Control 2 \* Gel Encapsulated Algal Oil Capsules (each containing 200mg DHA) Total dose of 400mg DHA.

Dietary Supplement: Experimental: Control

Treatment 1 - Semi-Solid food matrix

EXPERIMENTAL

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

Treatment 2 - Solid food matrix

EXPERIMENTAL

Vegetable encapsulated algal oil integrated with a solid food product (extruded snack) to deliver 400 mg DHA.

Dietary Supplement: Treatment 2 - Solid food matrix

Interventions

Experimental: Control DIETARY_SUPPLEMENT

2 x algal oil gel capsules delivering 400mg DHA in total

Control

Experimental: Treatment 1 - Semi-Solid food matrix DIETARY_SUPPLEMENT

Test Food 1: 200g serve soup + "ingredient"

Treatment 1 - Semi-Solid food matrix

Treatment 2 - Solid food matrix DIETARY_SUPPLEMENT

Test Food 2: 50g serve extruded snack (savoury snack) + "ingredient"

Treatment 2 - Solid food matrix

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Commonwealth Scientific and Industrial Research Organisation, Australia: lead
• Agency for Science, Technology and Research: collaborator

Study Sites (2)

CSIRO, Health and Biosecurity

Adelaide, South Australia, 5000, Australia

RECRUITING

A*STAR

Singapore, 117599, Singapore

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 35041046 DERIVED

Central Study Contacts

Bradley L Klingner, BSc

CONTACT

+61 8 83038818; Bradley.Klingner@csiro.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Manager and Principal Investigator delegate

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

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 2, 2020
• Study Start: November 16, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: November 2, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); SG (1)