Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04545398
Registration number
NCT04545398
Ethics application status
Date submitted
12/05/2020
Date registered
11/09/2020
Date last updated
28/11/2023
Titles & IDs
Public title
Acute Meat and Alternative Intake (PRotEin DIet SatisfacTION Trial 3)
Query!
Scientific title
Acute Evidence of Digestive, Metabolic and Nutritional Differences in Beef and Meat- Analogue Meals
Query!
Secondary ID [1]
0
0
U1111-1244-9426
Query!
Secondary ID [2]
0
0
5000927
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
PREDITION
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Diet, Healthy
0
0
Query!
Protein; Disease
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Other interventions - Food. Beef, Pasture-raised
Other interventions - Food. Beef, Grain-fed
Other interventions - Food. Meat alternative
Other interventions - Food, Lamb
Experimental: Pasture-raised - The meal contains grass/pasture fed beef
Experimental: Grain-fed - The meal contains grain-fed beef
Placebo Comparator: Meat Alternative - The meal contains a meat alternative
Experimental: Lamb - The meal contains lamb
Other interventions: Food. Beef, Pasture-raised
Pasture-raised beef
Other interventions: Food. Beef, Grain-fed
Grain-fed beef
Other interventions: Food. Meat alternative
Meat alternative
Other interventions: Food, Lamb
Lamb
Query!
Intervention code [1]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
LCPUFA (18:2 n-6, 18:3 n-3, 20:4 n-6, 20:5 n-3, 22:5 n-3, 22:6 n-3
Query!
Assessment method [1]
0
0
Chylomicron fatty acids, blood test
Query!
Timepoint [1]
0
0
Change from baseline to 240-minutes post meal ingestion
Query!
Secondary outcome [1]
0
0
Fatty acids (14:0, 16:0, 16:1 n-7, 18:0, 18:1 n-9, others)
Query!
Assessment method [1]
0
0
Chylomicron fatty acids, blood test
Query!
Timepoint [1]
0
0
Change from baseline to 240-minutes post meal ingestion
Query!
Secondary outcome [2]
0
0
Amino acids/ Neurotransmitters
Query!
Assessment method [2]
0
0
blood test
Query!
Timepoint [2]
0
0
Change from baseline to 240-minutes post meal ingestion
Query!
Secondary outcome [3]
0
0
Glucose/ Insulin
Query!
Assessment method [3]
0
0
Blood test
Query!
Timepoint [3]
0
0
Change from baseline to 240-minutes post meal ingestion
Query!
Secondary outcome [4]
0
0
Minerals/ Iron
Query!
Assessment method [4]
0
0
Blood test
Query!
Timepoint [4]
0
0
Change from baseline to 240-minutes post meal ingestions
Query!
Secondary outcome [5]
0
0
Fullness
Query!
Assessment method [5]
0
0
Questionnaire (8 questions), Likert scale, non-directional answers
Query!
Timepoint [5]
0
0
Change from baseline to 240-minutes post meal ingestion
Query!
Secondary outcome [6]
0
0
Digestive Symptoms
Query!
Assessment method [6]
0
0
Questionnaire (11 questions), Likert scale, higher score indicative of greater symptoms
Query!
Timepoint [6]
0
0
Change from baseline to 240-minutes post meal ingestion
Query!
Secondary outcome [7]
0
0
Meal Palatability
Query!
Assessment method [7]
0
0
Questionnaire (5 questions), Likert scale, higher score indicative of greater palatability
Query!
Timepoint [7]
0
0
Difference between intervention meals, 30 minutes post meal
Query!
Eligibility
Key inclusion criteria
- All participants will be required to be omnivores willing to consume both red meat and
plant-base alternatives for the purposes of the trial.
Query!
Minimum age
20
Years
Query!
Query!
Maximum age
34
Years
Query!
Query!
Sex
Males
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
- Those with chronic health conditions, hyperlipidaemia, obesity (BMI = 30), use of
medications (except occasional use of NSAIDs and antihistamines), history of anosmia
and ageusia (issues with taste and smell), current dieting or disordered eating
pattern and smoking tobacco or recreational drugs will be excluded from participating.
- Participants will be asked to complete an on-line screening which will include the
Three-factor Eating Questionnaire-R18 (TFEQ) and a health survey. Participants with a
TFEQ score greater than 75% will be excluded from participating on the basis their
perception of food is potentially influenced by underlying psychological issues
Query!
Study design
Purpose of the study
Basic Science
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
Query!
Query!
Query!
Query!
Intervention assignment
Crossover
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/11/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
20/12/2021
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
30
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
New Zealand
Query!
State/province [1]
0
0
[other]
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
University of Auckland, New Zealand
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Singapore Institute for Clinical Sciences
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Other
Query!
Name [2]
0
0
Massey University
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Other collaborator category [3]
0
0
Other
Query!
Name [3]
0
0
AgResearch
Query!
Address [3]
0
0
Query!
Country [3]
0
0
Query!
Other collaborator category [4]
0
0
Other
Query!
Name [4]
0
0
The Riddet Institute
Query!
Address [4]
0
0
Query!
Country [4]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
Introduction: Protein rich foods that are alternatives to farm-grown meat have received
considerable consumer attention. Whilst meat alternatives were once niche food products aimed
at vegetarians, they are increasingly marketed to omnivores and "flexitarians", thus
contributing to a trend for reductions in red meat intakes [1]. Studies to date have
addressed the environmental benefit, plus consumer perceptions and acceptability of meat
alternatives [2, 3, 4], yet there is surprisingly a paucity of data compared the nutritional
and digestive differences to meat. The aim of this trial is to compare the digestive
consequences of pasture-fed and grain-finished, beef versus a plant-based meat analogue
blinded meal.
Methods and analyses: Healthy, young (20-34 y) participants will be asked to consume three
separate meals in a crossover, blinded investigation followed by five hours of blood testing
and questionnaires to assess the digestive consequences of meat and a plant-based meat
analogue. The three meals will include either pasture-fed, or grain-finished, or laboratory
based protein alternative as a mixed meal, in random order, separated by one week minimum.
Plasma samples will be assessed amino acid content, neurotransmitter proteins, chylomicron
fatty acid distribution and general health indices.
Ethics and dissemination: The trial has been granted ethical approval by the Ministry of
Health, Health and Disability Ethics Committee (Ref: 19/STH/226). All results originating
from this study will be submitted for publication in scientific journals and presented at
meetings.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04545398
Query!
Trial related presentations / publications
1. Thakur A. Market for Plant-Based Meat Alternatives. Environmental, Health, and Business Opportunities in the New Meat Alternatives Market. IGI Global; 2019: 218-37.
Slade P. If you build it, will they eat it? Consumer preferences for plant-based and cultured meat burgers. Appetite. 2018 Jun 1;125:428-437. doi: 10.1016/j.appet.2018.02.030. Epub 2018 Mar 5.
3. Circus VE, Robison R. Exploring perceptions of sustainable proteins and meat attachment. B Food J. 2019.
Keefe LM. #FakeMeat: How big a deal will animal meat analogs ultimately be? Anim Front. 2018 Jul 19;8(3):30-37. doi: 10.1093/af/vfy011. eCollection 2018 Jul. No abstract available.
Ekmekcioglu C, Wallner P, Kundi M, Weisz U, Haas W, Hutter HP. Red meat, diseases, and healthy alternatives: A critical review. Crit Rev Food Sci Nutr. 2018 Jan 22;58(2):247-261. doi: 10.1080/10408398.2016.1158148. Epub 2017 Jun 28.
Forouhi NG, Krauss RM, Taubes G, Willett W. Dietary fat and cardiometabolic health: evidence, controversies, and consensus for guidance. BMJ. 2018 Jun 13;361:k2139. doi: 10.1136/bmj.k2139.
Hicks TM, Knowles SO, Farouk MM. Global Provisioning of Red Meat for Flexitarian Diets. Front Nutr. 2018 Jun 14;5:50. doi: 10.3389/fnut.2018.00050. eCollection 2018.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Andrea J Braakhuis, PhD
Query!
Address
0
0
The University of Auckland
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04545398
Download to PDF