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The use of prebiotics and their effect on blood pressure.

The use of dietary supplements on gut metabolites and their effect on blood pressure in hypertensive patients: a phase IIa clinical trial.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000916145
Enrollment
20
Registered
2019-07-01
Start date
2019-07-09
Completion date
2021-05-24
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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,

Interventions

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 pro

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

Sponsors

Dr Francine Marques
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

18 to 70 years of age Have body mass index between 18.5 and 35 Have blood pressure higher than 140/90 mmHg and not be taking medication to lower blood pressure

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).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 22, 2026