Omega-3 Bioavailability From Vegetable-omega-3 Enriched Products
NCT ID: NCT04610983
Last Updated: 2020-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
24 participants
INTERVENTIONAL
2020-11-16
2021-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
SINGLE
Study Groups
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Control
Control 2 \* Gel Encapsulated Algal Oil Capsules (each containing 200mg DHA) Total dose of 400mg DHA.
Experimental: Control
2 x algal oil gel capsules delivering 400mg DHA in total
Treatment 1 - Semi-Solid food matrix
Vegetable encapsulated algal oil integrated with a semi-solid food product (soup) to deliver 400 mg DHA.
Experimental: Treatment 1 - Semi-Solid food matrix
Test Food 1: 200g serve soup + "ingredient"
Treatment 2 - Solid food matrix
Vegetable encapsulated algal oil integrated with a solid food product (extruded snack) to deliver 400 mg DHA.
Treatment 2 - Solid food matrix
Test Food 2: 50g serve extruded snack (savoury snack) + "ingredient"
Interventions
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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"
Eligibility Criteria
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Inclusion Criteria
* 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 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
21 Years
50 Years
MALE
Yes
Sponsors
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Agency for Science, Technology and Research
OTHER
Commonwealth Scientific and Industrial Research Organisation, Australia
OTHER_GOV
Responsible Party
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Bradley Klingner
Project Manager and Principal Investigator delegate
Locations
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CSIRO, Health and Biosecurity
Adelaide, South Australia, Australia
A*STAR
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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OBP001
Identifier Type: -
Identifier Source: org_study_id