Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000896178p
Ethics application status
Submitted, not yet approved
Date submitted
13/02/2019
Date registered
26/06/2019
Date last updated
26/06/2019
Date data sharing statement initially provided
26/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of red meat consumption on human metabolic and gut health in free living adults.
Scientific title
Investigation of the metabolic impact and gut response to regular (18% total fat) and premium (5% total fat) quality beef mince intake as part of the normal diet in healthy adults: A Pilot Study
Secondary ID [1] 297377 0
WBS: RE-02737
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Health 311519 0
Gut microbiome community profiling 313178 0
Condition category
Condition code
Metabolic and Endocrine 310161 310161 0 0
Normal metabolism and endocrine development and function
Oral and Gastrointestinal 311643 311643 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This pilot study will use a two arm randomized controlled trial design. The twenty-four (n=24) participants will be randomly split into two groups of twelve (n=12).

Treatment for group 1: regular grade (18% fat) beef mince
Treatment for group 2: premium grade (5% fat) beef mince

All of the following study protocols are common to both groups:

For the duration of the trial, free-living participants will be required to refrain from consuming any red or processed red meat, except for the red meat (raw beef mince) provided to them. Red meat includes beef, veal, lamb, mutton, pork, and kangaroo. Red meat does not include poultry (e.g. chicken, turkey) or fish. Participants will be provided with an in-depth table outlining what constitutes processed red meat foods. Participants may consume processed white meat foods.

To monitor adherence to the intervention, participants will be advised to record their daily food and beverage intake in food diaries for the duration of the study. The food diaries will be collected weekly.

Participants will be provided with either regular grade (18% fat) or premium grade (5% fat) raw beef mince. The raw beef will be pre-portioned and provided to participants during the study along with food safety handout, however the cooking style is up to the participant. Participants will be required to cook and consume 65g of cooked mince a day in week 2, and 130g a day of cooked mince in week 3. As this is a study of habitual diet, participants can cook the meat in any way they choose. No mince is consumed in weeks 1 and 4.

Week 1: Normal diet with omission of all red and processed red meat
Week 2: Normal diet with 65g/day of cooked beef mince.
Week 3: Normal diet with 130g/day cooked beef mince.
Week 4: Normal diet with omission of al red and processed meat
Intervention code [1] 313634 0
Lifestyle
Comparator / control treatment
Each individual will function as their own control, as data will be collected prior to and following each weekly treatment. This is particularly important as many gut microbes are specific to the individual, thus each individual functioning as their own control ensure no confounding bias to gut response.
Data from the end of week 1 and week 4 will function as 'control' periods.
Control group
Active

Outcomes
Primary outcome [1] 319053 0
Changes in the gut microbiome composition (this is an exploratory outcome)

Characterisation of the changes to the gut microbial population dynamics in response to regulated red meat intake using metagenomics. Abundances of gut microbiota taxa, communities and microbiome diversity will be determined by 16S rRNA gene sequencing from stool samples.
Timepoint [1] 319053 0
Day 1, 8, 15, 22, 29
Primary outcome [2] 319054 0
Changes in indicators of metabolic health (exploratory outcome)

Characterisation of the inter- and intra-individual changes to indicators of metabolic health in response to red meat intake using untargeted metabolomics


Timepoint [2] 319054 0
Days 1, 8, 15, 22, 29
Primary outcome [3] 319055 0
Changes in indicators of gut health (exploratory outcome)

Characterisation of the inter- and intra-individual changes to indicators of gut health in response to red meat intake using untargeted metabolomics
Timepoint [3] 319055 0
Days 1, 8, 15, 22, 29
Secondary outcome [1] 371317 0
Changes in stool metabolite profile (exploratory outcome)

Characterisation of the inter- and intra-individual changes to stool metabolites in response to red meat intake using untargeted metabolomics


Timepoint [1] 371317 0
Days 1, 8, 15, 22, 29
Secondary outcome [2] 372001 0
Changes in urine metabolite profile (exploratory outcome)

Characterisation of the inter- and intra-individual changes to urine metabolites in response to red meat intake using untargeted metabolomics
Timepoint [2] 372001 0
Days 1, 8, 15, 22, 29

Eligibility
Key inclusion criteria
Healthy weight (body mass index 18.5 - 25kg/m2) males and females adults (aged 18 to 50) who are deemed eligible to participate as indicated by not meeting one or more of the exclusion criterion.

Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded from participating within the project for the following reasons: Individuals with presence of chronic diseases related to the metabolism of energy and nutrients (i.e. hyperthyroidism, diagnosed diabetes), pathologic eating disorders, individuals with the presence of gastrointestinal disorders and diseases (i.e. inflammatory bowel disease, irritable bowel syndrome, coeliac disease, gastroenteritis), pregnant, menopausal/post-menopausal, taking contraindicated medication (i.e. psychotropic drugs, antibiotics, immunosuppressive drugs, or appetite suppressants), the use of any dietary/nutritional supplement that might interfere with the results of the study, weight unstable in the past 3 months, or irregular bowel patterns.

Study design
Purpose of the study
Prevention
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/07/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 25620 0
3083 - Bundoora

Funding & Sponsors
Funding source category [1] 301945 0
Commercial sector/Industry
Name [1] 301945 0
Australian Meat Processor Corporation
Country [1] 301945 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
64 Plenty Rd, Bundoora VIC 3083
Country
Australia
Secondary sponsor category [1] 301702 0
None
Name [1] 301702 0
Address [1] 301702 0
Country [1] 301702 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 302627 0
RMIT University Human Research Ethics Committee
Ethics committee address [1] 302627 0
Ethics committee country [1] 302627 0
Australia
Date submitted for ethics approval [1] 302627 0
30/08/2018
Approval date [1] 302627 0
Ethics approval number [1] 302627 0
2177

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

Contacts
Principal investigator
Name 90870 0
Prof Harsharn Gill
Address 90870 0
RMIT University
Bundoora West Campus
264 Plenty Rd, Bundoora VIC 3083
Country 90870 0
Australia
Phone 90870 0
+61, 03, 9926 2600
Fax 90870 0
Email 90870 0
[email protected]
Contact person for public queries
Name 90871 0
Elena Zafiris
Address 90871 0
RMIT University
Bundoora West Campus
264 Plenty Rd, Bundoora VIC 3083
Country 90871 0
Australia
Phone 90871 0
+61413239671
Fax 90871 0
Email 90871 0
[email protected]
Contact person for scientific queries
Name 90872 0
Elena Zafiris
Address 90872 0
RMIT University
Bundoora West Campus
264 Plenty Rd, Bundoora VIC 3083
Country 90872 0
Australia
Phone 90872 0
+61413239671
Fax 90872 0
Email 90872 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.