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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
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
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:
313239 0
high blood pressure
313357 0
Condition category
Condition code
Cardiovascular 311679 311679 0 0
Metabolic and Endocrine 311797 311797 0 0
Other metabolic disorders

Study type
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
Intervention code [3] 314715 0
Comparator / control treatment
placebo (normal flour or waxy maize)
Control group

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.

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 26745 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 303005 0
Name [1] 303005 0
National Heart Foundation
Address [1] 303005 0
2/850 Collins St, Melbourne VIC 3008
Country [1] 303005 0
Funding source category [2] 303015 0
Name [2] 303015 0
Monash University
Address [2] 303015 0
Wellington Rd, Clayton VIC 3800
Country [2] 303015 0
Primary sponsor type
Dr Francine Marques
25 Rainforest Walk, Clayton VIC 3800, Monash University
Secondary sponsor category [1] 302989 0
Name [1] 302989 0
Address [1] 302989 0
Country [1] 302989 0

Ethics approval
Ethics application status
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
Date submitted for ethics approval [1] 303556 0
Approval date [1] 303556 0
Ethics approval number [1] 303556 0

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
Trial related presentations / publications
Public notes

Principal investigator
Name 94070 0
Dr Francine Marques
Address 94070 0
25 Rainforest Walk, Clayton VIC 3800, Monash University
Country 94070 0
Phone 94070 0
Fax 94070 0
Email 94070 0
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
Phone 94071 0
Fax 94071 0
Email 94071 0
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
Phone 94072 0
Fax 94072 0
Email 94072 0

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