ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619000787189

Ethics application status

Approved

Date submitted

8/05/2019

Date registered

28/05/2019

Date last updated

15/09/2020

Date data sharing statement initially provided

28/05/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

An investigation of the effect of cheese consumption, as part of the normal diet, on oral and gut microbiome, and metabolic responses in healthy adults [A Pilot Study]

Scientific title

An investigation of the effect of cheese consumption, as part of the normal diet, on oral and gut microbiome, and metabolic responses in healthy adults [A Pilot Study]

Secondary ID [1]

‘Nil known

Universal Trial Number (UTN)

U1111-12329784

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

gastrointestinal function

Condition category

Condition code

Oral and Gastrointestinal

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: commercial cheddar cheese
Treatment for group 2: Artisanal cheddar cheese

All of the following study protocols are common to both groups:
For the duration of the study period, participants will be required to not consume any fermented dairy products - excluding the cheese provided to them. To monitor adherence to the intervention, participants will be asked to record the food diary three times a week (one weekend and two week days). Also the researcher will call them every week to determine whether or not they follow up the intervention.

Week 1(days 1-7): For the duration of one week, at the start, all participants will be asked to consume their normal diet with the omission of fermented dairy products (wash out period) .

Week 2 (days 8-14): participants will be supplied with 350g of cheese (one week's supply; one-year-old commercially produced cheddar cheese or one-year-old artisanal cheddar cheese , dependent on their randomized allocation). Participants will be instructed to consume 50 g cheese/day (25 g twice daily) for the duration of one week.

Week 3 (days 15-21): Participants will be supplied with another week's supply of cheese (350g) ( one-year-old commercially produced cheddar cheese or one-year-old artisanal cheddar cheese , dependent on their randomized allocation) and will be advised to consume 50g of cheese/day as during week 2.

Week 4 (days 22-28: Participants will be asked to return to their normal diet (post-intervention period).

Intervention code [1]

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. Baseline (control) is before starting the intervention (before week 1)

Control group

Active

Outcomes

Primary outcome [1]

Changes in the gut microbiome composition.
Abundances of gut microbiota taxa, communities and microbiome diversity will be determined by 16S rRNA gene sequencing from stool samples

Timepoint [1]

4 weeks

Primary outcome [2]

Changes in the oral microbiome composition.
Abundances of oral microbiota taxa, communities and microbiome diversity will be determined by 16S rRNA gene sequencing from saliva samples

Timepoint [2]

4 weeks

Secondary outcome [1]

Changes in urine metabolite profile (untargeted metabolomics not a specific metabolite)

Timepoint [1]

4 weeks

Secondary outcome [2]

Changes in stool metabolite profile (untargeted metabolomics not a specific metabolite)

Timepoint [2]

4 weeks

Eligibility

Key inclusion criteria

Healthy weight (body mass index 18.5 - 25kg/m2) males and females adults (aged between 18 and 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 and lactose intolerance and allergy to dairy products. Additional exclusion criteria include: individuals with the presence of gastrointestinal disorders and diseases (i.e. inflammatory bowel disease, irritable bowel syndrome, coeliac disease, gastroenteritis), pregnant, post-menopausal, taking contraindicated mediation (i.e. psychotropic drugs, antibiotics or appetite suppressants), the use of any dietary 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

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

numbered containers

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Twenty-four (n=24) healthy weight (body mass index (BMI) 18.5- 25kg/m2) males and females adults (aged 18 and 50) will be recruited for this study.
In metabolic phenotyping studies, there is no currently accepted approach for the estimation of statistical power and sample size, due in large part to the unknown nature of the expected effect. In this hypothesis generating science, the number of important analytes and the effect size are not known a priori. Several metabolomics based studies that have investigated the effects of dietary interventions, utilizing specific foods, on the human metabolome, typically comprise of 20 (n=20) participants [1-4]. These studies share similarities in design, duration and methodology with the current proposed study, and yield statistically significant data. The number of participants will be increased to 24 to compensate for drop outs.
1. Martin F-PJ, Montoliu I, Nagy Kl, Moco S, Collino S, Guy P, Redeuil K, Scherer M, Rezzi S, Kochhar S: Specific dietary preferences are linked to differing gut microbial metabolic activity in response to dark chocolate intake. Journal of proteome research 2012, 11:6252-6263.
2. Bondia-Pons I, Barri T, Hanhineva K, Juntunen K, Dragsted LO, Mykkänen H, Poutanen K: UPLC-QTOF/MS metabolic profiling unveils urinary changes in humans after a whole grain rye versus refined wheat bread intervention. Molecular nutrition & food research 2013, 57:412-422.
3. Hjerpsted JB, Ritz C, Schou SS, Tholstrup T, Dragsted LO: Effect of cheese and butter intake on metabolites in urine using an untargeted metabolomics approach. Metabolomics 2014, 10:1176-1185.
4. Edmands WM, Beckonert OP, Stella C, Campbell A, Lake BG, Lindon JC, Holmes E, Gooderham NJ: Identification of human urinary biomarkers of cruciferous vegetable consumption by metabonomic profiling. Journal of proteome research 2011, 10:4513-4521.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

3/06/2019

Actual

10/07/2019

Date of last participant enrolment

Anticipated

13/06/2019

Actual

26/07/2019

Date of last data collection

Anticipated

30/06/2019

Actual

31/08/2019

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

RMIT university

Address [1]

264 Plenty Rd, Bundoora VIC 3083

Country [1]

Australia

Primary sponsor type

University

Name

RMIT

Address

264 Plenty Rd, Bundoora VIC 3083

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Melbourne Institute of technology Human Research Ethics Committee

Ethics committee address [1]

124 La Trobe St, Melbourne VIC 3000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/12/2018

Approval date [1]

06/03/2019

Ethics approval number [1]

Summary

Brief summary

This study will investigate the effects of cheese consumption on metabolic and gut health in healthy human subjects.  Individuals participating in this study will be required to follow their usual diet (habitual diet) with minor adjustments regarding the consumption of cheese and dairy fermented products. Investigating the effects of cheese in the habitual diet under free living conditions will generate clinically relevant results and knowledge.  The primary aim of this project is to characterise the response of the saliva, urine and stool microbiome and metabolome to habitual diets that differ in their type of production (quality)

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Harsharn Gill

Address

RMIT university , 264 Plenty Rd, Bundoora VIC 3083

Country

Australia

Phone

+61 399252600

Fax

harsharn.gill@rmit.edu.au

Contact person for public queries

Name

roya afshari

Address

RMIT university, 264 Plenty Rd, Bundoora VIC 3083

Country

Australia

Phone

+61 399252600

Fax

roya.afshari@rmit.edu.au

Contact person for scientific queries

Name

roya afshari

Address

RMIT university, 264 Plenty Rd, Bundoora VIC 3083

Country

Australia

Phone

+61 399252600

Fax

roya.afshari@rmit.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

The privacy of participants will be protected in all medium used throughout this study with the use of coding. After de-identification; individual participant data underlying published results only will be made publicly available.

When will data be available (start and end dates)?

after publication
no end date determined

Available to whom?

To anyone who wishes to access it.

Available for what types of analyses?

Data will be available only to achieve the aims in the approved proposal

How or where can data be obtained?

access subject to approvals by Principal Investigator

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
2026	Informed consent form					377546-(Uploaded-08-05-2019-09-53-40)-Study-related document.doc

Results publications and other study-related documents

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