ANZCTR - Registration

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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]

U1111-1244-9426

Secondary ID [2]

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

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

Andrea J Braakhuis, PhD

Address

The University of Auckland

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

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.

Results not provided in https://clinicaltrials.gov/study/NCT04545398

Trial Review

Registering a new trial?

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04545398