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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04869163




Registration number
NCT04869163
Ethics application status
Date submitted
18/04/2021
Date registered
3/05/2021

Titles & IDs
Public title
Sustained Meat and Alternative Intake (PRotEin DIet SatisfacTION Trial 4) (PREDITION)
Scientific title
Sustained Wellbeing Benefits of Red Meat Consumption in a Modern Flexitarian Diet: A Study Protocol for a 10 Week Randomised Clinical Trial
Secondary ID [1] 0 0
5000927-4
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Well-being 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Non-red meat

Active comparator: red meat consumers - Consumes red meat 3 times a week

Experimental: non-red meat consumers - Consumes a non-red meat comparison product 3 times a week


Other interventions: Non-red meat
Red meat analogues and alternatives
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Polyunsaturated fatty acids
Timepoint [1] 0 0
Baseline to 10 week comparison
Secondary outcome [1] 0 0
Psychological and mental wellbeing
Timepoint [1] 0 0
Change from baseline to 10 week comparison
Secondary outcome [2] 0 0
Psychological and mental wellbeing
Timepoint [2] 0 0
Change from baseline to 10 week comparison
Secondary outcome [3] 0 0
Psychological and mental wellbeing
Timepoint [3] 0 0
Change from baseline to 10 week comparison
Secondary outcome [4] 0 0
Psychological and mental wellbeing
Timepoint [4] 0 0
Change from baseline to 10 week comparison

Eligibility
Key inclusion criteria
Inclusion criteria:

* All participants are required to be omnivores who in the last 2 months consumed at least 2-3 meals per week containing meat of any description (red or white fleshed meat, including fish).
* All participants must be willing to consume both red meat and meat-analogues for the purposes of the trial.
Minimum age
20 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria:

* Obesity (BMI = 30 kg/m2),
* Hyperlipidaemia
* Anosmia and ageusia (issues with smell and taste),
* Use of medications (except for occasional NSAIDs and antihistamines) or recreational drugs, or who smoke tobacco
* Disordered eating

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
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
17/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2022
Sample size
Target
Accrual to date
Final
80
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
AgResearch
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Otago
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Access to data will be granted to appropriate members of the research team and to authorised representatives from the host institution to monitor or audit the study and ensure compliance with regulations. Data will be made available to external academics on reasonable request.

Supporting document/s available: Study protocol, Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Data will be made available when he study is complete (July 2022)
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

TypeOther DetailsAttachment
Informed consent form https://cdn.clinicaltrials.gov/large-docs/63/NCT04869163/ICF_000.pdf



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04869163