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

Lifestyle Clinical Trial

Official title:

Bioavailability of Omega-3 Long-chain Polyunsaturated Fatty Acids (LCPUFA) From Foods Enriched With Vegetable-encapsulated Omega-3 Oils

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04610983
• Other study ID #: OBP001
• Status: Recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Lifestyle

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)