Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000730707
Ethics application status
Approved
Date submitted
5/04/2022
Date registered
20/05/2022
Date last updated
20/05/2022
Date data sharing statement initially provided
20/05/2022
Date results information initially provided
20/05/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intestinal barrier function in response to physiological stress
Scientific title
Intestinal barrier function in response to a high fat, high carbohydrate meal and corticotropin releasing hormone in healthy adults - a single blinded randomised control trial
Secondary ID [1] 306846 0
Nil known
Universal Trial Number (UTN)
Trial acronym
McFeed study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
intestinal permeability 325938 0
Condition category
Condition code
Oral and Gastrointestinal 323250 323250 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The interventions for the participants will include:
- Intravenous injection of 100 micrograms of corticotropin releasing hormone
- High fat, high carbohydrate meal which contains 56-60 g total fat, 82 g carbohydrate and 28-30 g protein.
Each of the above 2 interventions will be separated by at least a 2 week time period
The study doctor will administer all of the interventions
Each intervention will only be given once over the course of the 3 visits. The shortest interval will be 6 weeks and there is no upper limit on time between the interventions.
All interventions will occur at the Alfred Hospital, in the gastroenterology department study room. All interventions will be administered under clinical monitoring. The washout period is 2 weeks between interventions
Intervention code [1] 323308 0
Treatment: Other
Comparator / control treatment
Intravenous injection of normal saline as placebo
Control group
Placebo

Outcomes
Primary outcome [1] 330991 0
Change in plasma markers of intestinal permeability - I-FABP, syndecan-1, LBP and sCD14 in response to CRH and high fat, high carbohydrate meal intake
Timepoint [1] 330991 0
Change in the aforementioned markers of intestinal permeability from baseline (time = 0 hours) at 2 hours, 6 hours and 24 hours after each of the corticotropin releasing hormone, high fat, high carbohydrate meal and placebo injection.
Secondary outcome [1] 408409 0
nil
Timepoint [1] 408409 0
Nil

Eligibility
Key inclusion criteria
• Healthy males and females between the ages of 18 – 65
• Participants who are able to give informed consent
• Volunteers should be able to attend Monash University, Alfred Campus on 7 occasions
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Inclusion criteria not met
• Past medical history of diabetes (type 1 or 2)
• Past medical history of inflammatory bowel disease, coeliac disease, a diagnosis of irritable bowel syndrome or significant gastrointestinal symptoms not otherwise medically diagnosed
• Patients actively taking non-steroidal anti-inflammatory medications (NSAIDs) or corticosteroids
• Probiotic or antibiotic intake over the past 2 months
• Pregnant or breast feeding participants
• Allergy or intolerance to the components of the proposed meals

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomization.com platform
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis
Given that this is the first study investigating the timeline of intestinal permeability change in response to the described stimuli, a sample size of 10 participants has been chosen to initially explore these effects. The median values of the quantitative results of the ELISA will be compared between the 3 different conditions. Non parametric paired analyses will be performed and a statistical criterion of p<0.05 as significant will be adopted.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
11/11/2020
Date of last participant enrolment
Anticipated
Actual
20/10/2021
Date of last data collection
Anticipated
Actual
15/12/2021
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 311171 0
University
Name [1] 311171 0
Monash University
Country [1] 311171 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Central clinical school
55 Commercial road, Prahran
Victoria
3181
Country
Australia
Secondary sponsor category [1] 312531 0
None
Name [1] 312531 0
None
Address [1] 312531 0
None
Country [1] 312531 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310702 0
Monash University Research Ethics committee
Ethics committee address [1] 310702 0
55 Commercial road
Prahran
Victoria
3181
Ethics committee country [1] 310702 0
Australia
Date submitted for ethics approval [1] 310702 0
Approval date [1] 310702 0
25/11/2019
Ethics approval number [1] 310702 0
22637

Summary
Brief summary
Intestinal barrier perturbation is a central mechanism to a multitude of diseases but its function has proven elusive to measure. Clearer experimental models of barrier dysfunction induction and reliable non-invasive markers are required.

Currently we do not have a good way to intestinal permeability or 'leaky gut'
The aim of this study is to help develop blood tests which will help with this measurement.
We hypothesise that both the high fat, high carbohydrate meal as well as the injection of corticotropin releasing hormone will cause a significant disruption to the intestinal barrier function that will be measurable with the blood tests that we are testing.
Trial website
nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118566 0
Dr Tamara Mogilevski
Address 118566 0
Monash University, Central Clinical School
55 Commercial road
Prahran
Victoria
3181
Country 118566 0
Australia
Phone 118566 0
+61 3 9076 6000
Fax 118566 0
Email 118566 0
tamara.mogilevski@monash.edu
Contact person for public queries
Name 118567 0
Dr Tamara Mogilevski
Address 118567 0
Monash University, Central Clinical School
55 Commercial road
Prahran
Victoria
3181
Country 118567 0
Australia
Phone 118567 0
+61 03 9076 6000
Fax 118567 0
Email 118567 0
tamara.mogilevski@monash.edu
Contact person for scientific queries
Name 118568 0
Dr Tamara Mogilevski
Address 118568 0
Monash University, Central Clinical School
55 Commercial road
Prahran
Victoria
3181
Country 118568 0
Australia
Phone 118568 0
+61 03 9076 6000
Fax 118568 0
Email 118568 0
tamara.mogilevski@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants not consented for this


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.