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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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:
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

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
Other
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
NA
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.