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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] 298170 0
‘Nil known
Universal Trial Number (UTN)
U1111-12329784
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gastrointestinal function 312732 0
Condition category
Condition code
Oral and Gastrointestinal 311233 311233 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: 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] 314397 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. Baseline (control) is before starting the intervention (before week 1)
Control group
Active

Outcomes
Primary outcome [1] 319990 0
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] 319990 0
4 weeks
Primary outcome [2] 320005 0
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] 320005 0
4 weeks
Secondary outcome [1] 370116 0
Changes in urine metabolite profile (untargeted metabolomics not a specific metabolite)
Timepoint [1] 370116 0
4 weeks
Secondary outcome [2] 370187 0
Changes in stool metabolite profile (untargeted metabolomics not a specific metabolite)
Timepoint [2] 370187 0
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
24
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 302705 0
University
Name [1] 302705 0
RMIT university
Country [1] 302705 0
Australia
Primary sponsor type
University
Name
RMIT
Address
264 Plenty Rd, Bundoora VIC 3083
Country
Australia
Secondary sponsor category [1] 302633 0
None
Name [1] 302633 0
Address [1] 302633 0
Country [1] 302633 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303315 0
Royal Melbourne Institute of technology Human Research Ethics Committee
Ethics committee address [1] 303315 0
124 La Trobe St, Melbourne VIC 3000
Ethics committee country [1] 303315 0
Australia
Date submitted for ethics approval [1] 303315 0
12/12/2018
Approval date [1] 303315 0
06/03/2019
Ethics approval number [1] 303315 0

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 93242 0
Prof Harsharn Gill
Address 93242 0
RMIT university , 264 Plenty Rd, Bundoora VIC 3083
Country 93242 0
Australia
Phone 93242 0
+61 399252600
Fax 93242 0
Email 93242 0
[email protected]
Contact person for public queries
Name 93243 0
roya afshari
Address 93243 0
RMIT university, 264 Plenty Rd, Bundoora VIC 3083
Country 93243 0
Australia
Phone 93243 0
+61 399252600
Fax 93243 0
Email 93243 0
[email protected]
Contact person for scientific queries
Name 93244 0
roya afshari
Address 93244 0
RMIT university, 264 Plenty Rd, Bundoora VIC 3083
Country 93244 0
Australia
Phone 93244 0
+61 399252600
Fax 93244 0
Email 93244 0
[email protected]

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.TypeCitationLinkEmailOther DetailsAttachment
2026Informed 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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