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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)
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Scientific title
Sustained Wellbeing Benefits of Red Meat Consumption in a Modern Flexitarian Diet: A Study Protocol for a 10 Week Randomised Clinical Trial
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Secondary ID [1]
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5000927-4
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Well-being
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Polyunsaturated fatty acids
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Assessment method [1]
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Concentrations of polyunsaturated fatty acids (18:2 n-6, 18:3 n-3, 20:4 n-6, 20:5 n-3, 22:5 n-3, 22:6 n-3) in erythrocyte membranes
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Timepoint [1]
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Baseline to 10 week comparison
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Secondary outcome [1]
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Psychological and mental wellbeing
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Assessment method [1]
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Multidimensional Fatigue Symptom Inventory Short Form (MSFI-SF). The Total MFSI-SF score ranges from -24 to 96, with higher values indicating greater fatigue.
The five subscales of the MFSI each ranges from 0 to 24:
1. General subscale = ranges from 0 to 24, with higher values indicating greater fatigue (worse outcomes)
2. Physical subscale = ranges from 0 to 24, with higher values indicating greater fatigue (worse outcomes)
3. Emotional subscale = ranges from 0 to 24, with higher values indicating greater fatigue (worse outcomes)
4. Mental subscale = ranges from 0 to 24, with higher values indicating greater fatigue (worse outcomes)
5. Vigor subscale = ranges from 0 to 24, with higher values indicating greater vigor (better outcomes) Total MFSI-SF score = (General + Physical + Emotional + Mental) - Vigor = Total Score ranges from -24 to 96 with higher values indicating greater fatigue (worse outcomes).
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Timepoint [1]
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Change from baseline to 10 week comparison
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Secondary outcome [2]
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Psychological and mental wellbeing
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Assessment method [2]
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Depression Anxiety Stress Scales-Short form (DASS-21) Depression score ranges from 0 to 42 (raw scores 0 to 21, which are then multiplied by 2 to be equivalent to the DASS-42), with higher numbers indicating greater depression (worse outcome).
Anxiety score ranges from 0 to 42 (raw scores 0 to 21, which are then multiplied by 2 to be equivalent to the DASS-42), with higher numbers indicating greater anxiety (worse outcome).
Stress score ranges from 0 to 42 (raw scores 0 to 21, which are then multiplied by 2 to be equivalent to the DASS-42), with higher numbers indicating greater stress (worse outcome).
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Timepoint [2]
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Change from baseline to 10 week comparison
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Secondary outcome [3]
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Psychological and mental wellbeing
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Assessment method [3]
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WHO-Five Well-Being Index (WHO 5). The raw score ranges from 0 to 25, with 0 representing the worst and 100 representing the best possible quality of life The percentage score ranges from 0 to 100, with 0 representing the worst and 100 representing the best possible quality of life
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Timepoint [3]
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Change from baseline to 10 week comparison
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Secondary outcome [4]
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Psychological and mental wellbeing
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Assessment method [4]
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Positive Eating Scale (PES) Total Positive Eating score (PES-Tot) = ranges from 1 to 4, with higher values indicating better experiences with eating Satisfaction with Eating subscale (PES-Sat) = ranges from 1 to 4, with higher values indicating more satisfaction with eating Pleasure when Eating subscale (PES-Pl) = ranges from 1 to 4, with higher values indicating more pleasure when eating
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Timepoint [4]
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Change from baseline to 10 week comparison
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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.
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Minimum age
20
Years
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Maximum age
35
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/05/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/09/2022
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Sample size
Target
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Accrual to date
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Final
80
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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[other]
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Auckland, New Zealand
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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AgResearch
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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University of Otago
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
Introduction The trend of flexitarian eating patterns is on the rise, with young adults amongst the biggest adopters claiming health and environmental reasons to reduce red meat intake. Nutrient dense meat and animal products are often the lynchpin of these diets, even when consumed only occasionally and in moderate amounts. Red meat provides forms and concentrations of essential proteins, lipids, and micronutrients that are scarce in exclusively vegetarian regimens. The aim of this investigation is to consider the effects of moderate consumption of lean red meat as part of an otherwise vegetarian balanced diet and its impact on biomarkers of sustained health and wellbeing. Methods and analyses A cohort of healthy, young (20-34 years) male and female participants will take part in two-arm parallel, randomised-controlled trial for a duration of 12 weeks, with a 3-month post follow-up. The trial will commence with a two-week assessment period followed by allocation to the intervention arms. The intervention will include the consumption of red meat or meat-alternatives three times per week for 10 weeks. Blood samples of the participants will be measured for changes in erythrocyte fatty acid distribution, circulating amino acids, neurotransmitters, markers of mineral status and inflammatory markers. Questionnaires to assess wellbeing and mental health will be undertaken every two weeks. Body composition, physical function test, blood measurements will be assessed at allocation (t0), week five into the intervention (t5) and post intervention (t10). Discussion To our knowledge this is the first randomised controlled trial (RCT) investigating the overarching health consequences of consuming NZ pasture fed red meat or no meat, as part of a healthy diet. Ethics and dissemination The trial was approved by the New Zealand Ministry of Health's Health and Disability Ethics Committees (20/STH/157).
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Trial website
https://clinicaltrials.gov/study/NCT04869163
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Trial related presentations / publications
Braakhuis A, Gillies N, Worthington A, Knowles S, Conner T, Roy R, Pham T, Bermingham E, Cameron-Smith D. A Modern Flexitarian Dietary Intervention Incorporating Web-Based Nutrition Education in Healthy Young Adults: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Dec 21;10(12):e30909. doi: 10.2196/30909.
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Public notes
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Contacts
Principal investigator
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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)
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When will data be available (start and end dates)?
Data will be made available when he study is complete (July 2022)
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
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