Trial Review

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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
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)

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

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/study/NCT04545398
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04545398