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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)
Scientific title
Acute Evidence of Digestive, Metabolic and Nutritional Differences in Beef and Meat- Analogue Meals
Secondary ID [1] 0 0
U1111-1244-9426
Secondary ID [2] 0 0
5000927
Universal Trial Number (UTN)
Trial acronym
PREDITION
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diet, Healthy 0 0
Protein; Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

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
Timepoint [1] 0 0
Change from baseline to 240-minutes post meal ingestion
Secondary outcome [1] 0 0
Fatty acids (14:0, 16:0, 16:1 n-7, 18:0, 18:1 n-9, others)
Timepoint [1] 0 0
Change from baseline to 240-minutes post meal ingestion
Secondary outcome [2] 0 0
Amino acids/ Neurotransmitters
Timepoint [2] 0 0
Change from baseline to 240-minutes post meal ingestion
Secondary outcome [3] 0 0
Glucose/ Insulin
Timepoint [3] 0 0
Change from baseline to 240-minutes post meal ingestion
Secondary outcome [4] 0 0
Minerals/ Iron
Timepoint [4] 0 0
Change from baseline to 240-minutes post meal ingestions
Secondary outcome [5] 0 0
Fullness
Timepoint [5] 0 0
Change from baseline to 240-minutes post meal ingestion
Secondary outcome [6] 0 0
Digestive Symptoms
Timepoint [6] 0 0
Change from baseline to 240-minutes post meal ingestion
Secondary outcome [7] 0 0
Meal Palatability
Timepoint [7] 0 0
Difference between intervention meals, 30 minutes post meal

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.
Minimum age
20 Years
Maximum age
34 Years
Sex
Males
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Basic Science
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/12/2021
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
[other]

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Singapore Institute for Clinical Sciences
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Massey University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
AgResearch
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
The Riddet Institute
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04545398
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.
Public notes

Contacts
Principal investigator
Name 0 0
Andrea J Braakhuis, PhD
Address 0 0
The University of Auckland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries