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Trial registered on ANZCTR


Registration number
ACTRN12619000916145
Ethics application status
Approved
Date submitted
14/06/2019
Date registered
1/07/2019
Date last updated
1/07/2019
Date data sharing statement initially provided
1/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of prebiotics and their effect on blood pressure.
Scientific title
The use of dietary supplements on gut metabolites and their effect on blood pressure in hypertensive patients: a phase IIa clinical trial.
Secondary ID [1] 298462 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hypertension
313239 0
high blood pressure
313357 0
Condition category
Condition code
Cardiovascular 311679 311679 0 0
Hypertension
Metabolic and Endocrine 311797 311797 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This cross-over trial will test if a modified high fibre food supplement could be used to lower blood pressure. The total study period is 9 weeks, including a 3 week wash-out period between the two arms.

-Dose: 40g/day of placebo or fibre supplement (modified high-amylose maize starch) eaten in two meals (breakfast/dinner). Examples include muffins, frittata, burgers and arancini balls
-Duration: 3 weeks each arm
-Mode of administration: oral intake as cooked food, all cooked by a chef and provided to participants
-A dietitian will be administering the intervention
-Adherence will be monitored using a food diary

Intervention code [1] 314713 0
Treatment: Other
Intervention code [2] 314714 0
Lifestyle
Intervention code [3] 314715 0
Prevention
Comparator / control treatment
placebo (normal flour or waxy maize)
Control group
Placebo

Outcomes
Primary outcome [1] 320379 0
Blood pressure measured by a sphygmomanometer

Timepoint [1] 320379 0
Baseline, weeks 3 (primary endpoint), 6 and 9 (primary endpoint) post-enrolment.
Primary outcome [2] 320380 0
Effect on arterial stiffness measured as pulse wave velocity by a SphygmoCor Instrument
Timepoint [2] 320380 0
Baseline, weeks 3 (primary endpoint), 6 and 9 (primary endpoint) post-enrolment.
Secondary outcome [1] 371406 0
Plasma level of short-chain fatty acids as assessed by blood test
Timepoint [1] 371406 0
Baseline, weeks 3 (primary endpoint), 6 and 9 (primary endpoint) post-enrolment.

Eligibility
Key inclusion criteria
18 to 70 years of age
Have body mass index between 18.5 and 30
Have blood pressure higher than 140/90 mmHg and not be taking medication to lower blood pressure
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Have normal blood pressure (equal or greater than 140/90) and blood pressure equal or lower than 165/100 mmHg
Have used antibiotics in the past 3 months or probiotics in the past 4 weeks
Have type 1 or type 2 diabetes
Are pregnant
Have gastrointestinal diseases (including inflammatory bowel disease, lactose intolerance, celiac disease, chronic pancreatitis or other malabsorption disorder).

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)
Central randomization by computer using RedCap
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software. Stratified allocation will include age, gender and BMI.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 26745 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 303005 0
Charities/Societies/Foundations
Name [1] 303005 0
National Heart Foundation
Address [1] 303005 0
2/850 Collins St, Melbourne VIC 3008
Country [1] 303005 0
Australia
Funding source category [2] 303015 0
University
Name [2] 303015 0
Monash University
Address [2] 303015 0
Wellington Rd, Clayton VIC 3800
Country [2] 303015 0
Australia
Primary sponsor type
Individual
Name
Dr Francine Marques
Address
25 Rainforest Walk, Clayton VIC 3800, Monash University
Country
Australia
Secondary sponsor category [1] 302989 0
None
Name [1] 302989 0
Address [1] 302989 0
Country [1] 302989 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303556 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 303556 0
Room 111, Chancellery Building D,
26 Sports Walk, Clayton Campus
Research Office
Monash University VIC 3800
Ethics committee country [1] 303556 0
Australia
Date submitted for ethics approval [1] 303556 0
Approval date [1] 303556 0
10/06/2019
Ethics approval number [1] 303556 0
19203

Summary
Brief summary
High blood pressure, or hypertension, is a highly prevalent chronic disease, affecting 1 in 3 people in Australia. Our diet has been long known to influence the levels of blood pressure. New evidence from our laboratory has emerged that this may be due to the tiny microorganisms that live in our gut, called gut microbes. While our bodies are incapable of digesting some types of fibre, they are fermented in gut, where they feed the community of ‘good’ microbes (especially bacteria), resulting in the release of substances that can be detected in our blood and might be beneficial in lowering our blood pressure.

The present study will test if a modified high fibre food supplement that copies the release of gut substances that could be used to lower blood pressure,
Trial website
www.marqueslab.com/gut
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94070 0
Dr Francine Marques
Address 94070 0
25 Rainforest Walk, Clayton VIC 3800, Monash University
Country 94070 0
Australia
Phone 94070 0
+610399056958
Fax 94070 0
Email 94070 0
francine.marques@monash.edu
Contact person for public queries
Name 94071 0
Dr Francine Marques
Address 94071 0
25 Rainforest Walk, Clayton VIC 3800, Monash University
Country 94071 0
Australia
Phone 94071 0
+610399056958
Fax 94071 0
Email 94071 0
francine.marques@monash.edu
Contact person for scientific queries
Name 94072 0
Dr Francine Marques
Address 94072 0
25 Rainforest Walk, Clayton VIC 3800, Monash University
Country 94072 0
Australia
Phone 94072 0
+610399056958
Fax 94072 0
Email 94072 0
francine.marques@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
This is a small trial, so data will not be shared at this instance.
What supporting documents are/will be available?
No other documents available
Summary results
No Results