Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624000112561
Ethics application status
Approved
Date submitted
4/01/2024
Date registered
8/02/2024
Date last updated
4/08/2024
Date data sharing statement initially provided
8/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating high blood pressure and gut leakiness
Scientific title
Investigating the relationship between blood pressure and gut permeability in normotensive and hypertensive patients
Secondary ID [1] 311263 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High Blood Pressure 332488 0
Hypertension 332489 0
Gastrointestinal permeability 332659 0
Condition category
Condition code
Cardiovascular 329179 329179 0 0
Hypertension
Oral and Gastrointestinal 329364 329364 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants will have blood pressure measured in the office (over 3 times, after being seated for 5 minutes) and over 24 hours with an ambulatory blood pressure device (every 15 minutes during the day and every 30 minutes during the night),
Participants will have gastrointestinal permeability assessed using the multisugar test. In this test participants consume a solution of sugars (sucrose, lactulose, L-rhamnose, erythritol and sucralose) and collect urine for 24 hours. This test will be administered by a research officer.
Participants will have gastrointestinal transit time assessed using the blue muffin test. In this test participants consume a regular muffin made using blue food colouring, and record the time taken until blue/green colour is observed in the faeces. This test will be administered by a research officer.
Participants will have plasma collected (once) and fecal samples self-collected (once). There are an additional, optional three fecal self collections occurring weekly post-enrolment.
Participants will record their dietary intake for 3 days.
Participants will complete a quality of life survey, several cognitive tests (from NIH Toolbox), a sleep survey, a depression/anxiety survey and a gastrointestinal symptoms survey.
Intervention code [1] 327717 0
Diagnosis / Prognosis
Comparator / control treatment
Participants with 24 hour ambulatory systolic blood pressure <130 mmHg and diastolic blood pressure <98 mmHg not taking antihypertensive medication.
Control group
Active

Outcomes
Primary outcome [1] 337020 0
Degree of gut permeability
Timepoint [1] 337020 0
24 urine will be collected following administration of the multisugar test drink at study visit 2. This will be approximately 3-7 days post study enrolment, depending on when participant schedules this appointment.
Secondary outcome [1] 430372 0
Associations between gut permeability and anti-hypertensive medication intake
Timepoint [1] 430372 0
24 urine will be collected following administration of the multisugar test drink at study visit 2. This will be approximately 3-7 days post study enrolment, depending on when participant schedules this appointment
Secondary outcome [2] 430373 0
Associations between gut permeability and gut microbiota
Timepoint [2] 430373 0
Once, faecal samples will be collected at the first bowel motion following visit 1 (enrolment).
Secondary outcome [3] 430993 0
Associations between gut permeability and gut microbial metabolites in plasma and fecal samples
Timepoint [3] 430993 0
Once, faecal samples will be collected at the first bowel motion following visit 1 (enrolment)
Secondary outcome [4] 431484 0
Associations between gut permeability and dietary intake
Timepoint [4] 431484 0
Gut permeability: Assessed once. 24 urine will be collected following administration of the multisugar test drink at study visit 2. This will be approximately 3-7 days post study enrolment, depending on when participant schedules this appointment Dietary Intake: Assessed once. Approximately 2-5 days following study visit 2. This will be approximately 5-12 days post study enrolment, depending on when participant schedules this appointment
Secondary outcome [5] 431485 0
Associations between gut permeability and cognition
Timepoint [5] 431485 0
Gut permeability: Assessed once. 24 urine will be collected following administration of the multisugar test drink at study visit 2. This will be approximately 3-7 days post study enrolment, depending on when participant schedules this appointment Cognition: Assessed once, at visit 2.
Secondary outcome [6] 431486 0
Associations between gut permeability and quality of life
Timepoint [6] 431486 0
Gut permeability: Assessed once. 24 urine will be collected following administration of the multisugar test drink at study visit 2. This will be approximately 3-7 days post study enrolment, depending on when participant schedules this appointment Quality of life: Assessed once, at visit 2.
Secondary outcome [7] 431487 0
Associations between gut permeability and depression/anxiety
Timepoint [7] 431487 0
Gut permeability: Assessed once. 24 urine will be collected following administration of the multisugar test drink at study visit 2. This will be approximately 3-7 days post study enrolment, depending on when participant schedules this appointment Depression/anxiety: Assessed once, at visit 2.
Secondary outcome [8] 431488 0
Associations between gut permeability and sleep quality
Timepoint [8] 431488 0
Gut permeability: Assessed once. 24 urine will be collected following administration of the multisugar test drink at study visit 2. This will be approximately 3-7 days post study enrolment, depending on when participant schedules this appointment Sleep Quality: Assessed once, at visit 2.
Secondary outcome [9] 431491 0
Associations between gut permeability and gastrointestinal symptoms
Timepoint [9] 431491 0
Gut permeability: Assessed once. 24 urine will be collected following administration of the multisugar test drink at study visit 2. This will be approximately 3-7 days post study enrolment, depending on when participant schedules this appointment Gastrointestinal symptoms: Assessed once, at visit 2.

Eligibility
Key inclusion criteria
Inclusion criteria:
• Ability to give informed consent.
• 18-75 years of age
• BMI 18.5-40 kg/m2
• Either sex

For normotensive participants:
- Not taking antihypertensive medications AND
- 24 hour ambulatory blood pressure monitoring results of Systolic blood pressure <130 mmHg and diastolic blood pressure <80 mmHg

For untreated hypertensive participants:
- Not taking antihypertensive medications AND
- 24 hour ambulatory blood pressure monitoring results of Systolic blood pressure >130 mmHg and diastolic blood pressure >80 mmHg

For treated hypertensive participants:
- Taking 1-2 antihypertensive medications, regardless of blood pressure results
OR
- Taking 3 or more antihypertensive medications including a diuretic AND
-24 hour ambulatory blood pressure monitoring results of Systolic blood pressure <130 mmHg and diastolic blood pressure <80 mmHg

For resistant hypertensive participants:
- Taking 3 or more antihypertensive medications including a diuretic AND
- 24 hour ambulatory blood pressure monitoring results of Systolic blood pressure >130 mmHg and diastolic blood pressure >80 mmHg
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Alzheimers, dementia or other unsoundness of mind
• Recent use of antibiotics (<3 months) or probiotics (< 6 weeks)
• Pregnant or lactating women
• Presence of gastrointestinal diseases (including ulcerative colitis, crohn’s disease, inflammatory bowel disease, lactose intolerance, celiac disease, chronic pancreatitis or other malabsorption disorder).
• Previous gastrointestinal surgery.
• Renal dysfunction with an eGFR < 45.
• ADHD stimulant medications (as this may affect blood pressure)
• Office blood pressure over/equal to 165/100 mmHg – these participants will be advised to see their GPs as guidelines suggest antihypertensive therapy should be started soon.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/02/2024
Actual
26/02/2024
Date of last participant enrolment
Anticipated
16/12/2024
Actual
Date of last data collection
Anticipated
18/12/2024
Actual
Sample size
Target
96
Accrual to date
29
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315518 0
Charities/Societies/Foundations
Name [1] 315518 0
Viertel Charitable Foundation
Country [1] 315518 0
Australia
Funding source category [2] 315519 0
Charities/Societies/Foundations
Name [2] 315519 0
National Heart Foundation
Country [2] 315519 0
Australia
Primary sponsor type
Individual
Name
A/Prof Francine Marques
Address
25 Rainforest Walk, Clayton VIC 3800, Monash University
Country
Australia
Secondary sponsor category [1] 317602 0
None
Name [1] 317602 0
Address [1] 317602 0
Country [1] 317602 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314421 0
Monash Health Human Research Ethics Commitee
Ethics committee address [1] 314421 0
Ethics committee country [1] 314421 0
Australia
Date submitted for ethics approval [1] 314421 0
15/06/2023
Approval date [1] 314421 0
04/09/2023
Ethics approval number [1] 314421 0
97737

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

Contacts
Principal investigator
Name 131518 0
A/Prof Francine Marques
Address 131518 0
Monash University, 25 Rainforest Walk, Clayton 3800 VIC
Country 131518 0
Australia
Phone 131518 0
+61425075884
Fax 131518 0
Email 131518 0
[email protected]
Contact person for public queries
Name 131519 0
Francine Marques
Address 131519 0
Monash University, 25 Rainforest Walk, Clayton 3800 VIC
Country 131519 0
Australia
Phone 131519 0
+61425075884
Fax 131519 0
Email 131519 0
[email protected]
Contact person for scientific queries
Name 131520 0
Francine Marques
Address 131520 0
Monash University, 25 Rainforest Walk, Clayton 3800 VIC
Country 131520 0
Australia
Phone 131520 0
+61425075884
Fax 131520 0
Email 131520 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Anyone who wishes to access it

Conditions for requesting access:
• -

What individual participant data might be shared?
• Microbiome sequence data only, deidentified with the only meta-data as group (normotensive, untreated hypertensive, treated hypertensive OR resistant hypertensive)

What types of analyses could be done with individual participant data?
• Any purpose

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication, with no end date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approvals by Principal Investigator (A/Prof Francine Marques, [email protected], P: +61-03-85321916)

Are there extra considerations when requesting access to individual participant data?
No


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.