Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000011987
Ethics application status
Approved
Date submitted
11/12/2019
Date registered
9/01/2020
Date last updated
23/06/2021
Date data sharing statement initially provided
9/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The acute effect of plant-based meat-alternatives on arterial endothelial function and cardiovascular risk markers
Scientific title
The acute effect of plant-based meat-alternatives on arterial endothelial function and cardiovascular risk markers
Secondary ID [1] 299617 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular risk 314913 0
Arterial endothelial function 315631 0
Condition category
Condition code
Diet and Nutrition 313268 313268 0 0
Other diet and nutrition disorders
Cardiovascular 313269 313269 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be invited to the CPC RPA clinic on four occasions. Participants will be asked to moderate their red meat intake for two days prior (no more than a serve per day) and fast for at least 10 hours prior to study visits 1 & 3. During study visits 1 & 3, participants will consume two burgers in a randomized order (one during each study) with a minimum of 4 weeks apart. The two burgers will be 1) a burger made with a beef patty, or 2) a plant-based meat-alternative burger (Beyond Burger, ingredients include peas protein, bean protein, rice protein, etc.). The size of the animal-derived meat patty will be matched with the Beyond Burger patty (1/4 lb raw weight, i.e., 113 grams). The burgers will differ only in their patty; other components will be identical (bun, sauce, salad). All intervention food will be consumed under supervision. All burgers will be prepared in the metabolic kitchen of the CPC RPA clinic, The University of Sydney, by researchers hold a Food Handling Level 1 Certificate.
The participants will return for study visits 2 & 4, undertaken the day after visits 1 & 3, respectively. Study visits 2 & 4 will consist of an additional venous blood sample (no more than 20mL, approximately 24 hours post-meal). Participants will be instructed to not consume red meat or processed meat in the 24-hour period between visits 1 & 2, and visits 3 & 4.
Intervention code [1] 315873 0
Lifestyle
Comparator / control treatment
Consumption of a burger made with a beef patty
Control group
Active

Outcomes
Primary outcome [1] 321762 0
Change in endothelial function determined by ultrasound scans of Flow-Mediated Dilation (FMD)
Timepoint [1] 321762 0
Combined 2 and 4 h post consumption
Secondary outcome [1] 377895 0
Change in blood Trimethylamine N-Oxide (TMAO) assessed using blood assay
Timepoint [1] 377895 0
Baseline and 24 h post consumption
Secondary outcome [2] 377896 0
Change in blood triglyceride assessed using blood assay
Timepoint [2] 377896 0
Baseline, 2, 4 and 24 h post consumption
Secondary outcome [3] 377897 0
Change in blood pressure assessed using a commercially available automated oscillometric device
Timepoint [3] 377897 0
Baseline, 2 and 4 h post consumption

Eligibility
Key inclusion criteria
Healthy adults with a BMI less than 30kg/m2, who currently consuming red meat within the NHMRC dietary guidelines
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Current smokers or those who have ceased smoking within the past six months; women who are pregnant or breastfeeding; individuals who have previously been diagnosed with cardiovascular disease, hypertension, pre-diabetes, type 1 diabetes, type 2 diabetes, gastrointestinal disorders or any other major illness; currently using lipid-lowering or vasoactive medications (e.g. anti-hypertensives); those who have any known food intolerances or allergies.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/01/2020
Actual
5/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 304094 0
University
Name [1] 304094 0
The University of Sydney
Country [1] 304094 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Michael Skilton
Address
Boden Collaboration for Obesity, Nutrition, Exercise & Eating Disorders, The Charles Perkins Centre, University of Sydney, Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 304303 0
University
Name [1] 304303 0
The University of Sydney
Address [1] 304303 0
Boden Collaboration for Obesity, Nutrition, Exercise & Eating Disorders, The Charles Perkins Centre, University of Sydney, Camperdown NSW 2006
Country [1] 304303 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304583 0
Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 304583 0
RESEARCH ETHICS AND GOVERNANCE OFFICE
ROYAL PRINCE ALFRED HOSPITAL
CAMPERDOWN NSW 2050
Ethics committee country [1] 304583 0
Australia
Date submitted for ethics approval [1] 304583 0
15/09/2019
Approval date [1] 304583 0
18/12/2019
Ethics approval number [1] 304583 0
2019/ETH12808

Summary
Brief summary
The consumption of red meat and processed red meat is associated with cardiovascular disease and mortality risk. There is strong evidence that plant-based sources of protein are associated with beneficial outcomes, particularly when replacing red meat in the diet. This project will be looking at the effect of a plant-based meat-alternative burger versus a traditional meat burger on post-meal biomarkers including TMAO, triglycerides, as well as endothelial function in 20 healthy human adults, aged 18-45 years. Participants will be given one of the two types of burger on each visit, after an overnight fast. A blood sample and an ultrasound will be taken at before consuming the meal, and 2 hours and 4 hours post-meal. An additional blood sample will be taken at 24 hours post-meal. Cardiovascular risk factors including LDL-cholesterol, triglycerides, IL-6, glucose, blood pressure and body weight will also be assessed at each visit.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97474 0
A/Prof Michael Skilton
Address 97474 0
Boden Collaboration for Obesity, Nutrition, Exercise & Eating Disorders, Charles Perkins Centre, D17 Johns Hopkins Drive, Camperdown, NSW 2006
Country 97474 0
Australia
Phone 97474 0
+61 02 8627 1916
Fax 97474 0
Email 97474 0
[email protected]
Contact person for public queries
Name 97475 0
A/Prof Michael Skilton
Address 97475 0
Boden Collaboration for Obesity, Nutrition, Exercise & Eating Disorders, Charles Perkins Centre, D17 Johns Hopkins Drive, Camperdown, NSW 2006
Country 97475 0
Australia
Phone 97475 0
+61 02 8627 1916
Fax 97475 0
Email 97475 0
[email protected]
Contact person for scientific queries
Name 97476 0
A/Prof Michael Skilton
Address 97476 0
Boden Collaboration for Obesity, Nutrition, Exercise & Eating Disorders, Charles Perkins Centre, D17 Johns Hopkins Drive, Camperdown, NSW 2006
Country 97476 0
Australia
Phone 97476 0
+61 02 8627 1916
Fax 97476 0
Email 97476 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.