RecruitingACTRN12624000112561

Investigating high blood pressure and gut leakiness

Investigating the relationship between blood pressure and gut permeability in normotensive and hypertensive patients

Sponsor

A/Prof Francine Marques

Enrollment

96 participants

Start Date

Feb 26, 2024

Study Type

Observational

Conditions

Gastrointestinal permeability Hypertension High Blood Pressure

Summary

High blood pressure, or hypertension, is a highly prevalent chronic disease, affecting 1 in 3 people in Australia. It is a disease where the blood inside the heart and blood vessels is pumped with more force than normal. This adds stress to these important organs, increasing the chance of having a heart attack or a stroke. We have shown that changes in the gut bacteria happen in hypertension. We think that these changes in the gut bacteria may disrupt intestinal permeability, also known as “leaky gut”. But we don’t know much about the relationship between blood pressure and leaky gut. This research will measure blood pressure and gut leakiness in people with normal and high blood pressure. By learning about the relationship between gut leakiness and blood pressure, we may be able to design drug and diet therapies that make the gut less leaky, to help people with high blood pressure. This research does not involve being given any treatments (e.g. drugs, special diets) for blood pressure.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

High blood pressure (hypertension) affects one in three Australians and is a major risk factor for heart attack and stroke. This study is investigating an emerging link between blood pressure and 'leaky gut' — a condition where the lining of the intestine becomes more permeable than it should be, allowing bacteria or their products to enter the bloodstream. Researchers think changes in gut bacteria may be contributing to high blood pressure through this mechanism. The study will measure blood pressure and gut permeability in people with a range of blood pressure profiles — normal, untreated high, treated high, and treatment-resistant high — to see if there is a pattern. No treatment is given; this is a measurement study only. You may be eligible if you are aged 18 to 75, have a BMI between 18.5 and 40, have not used antibiotics in the past 3 months, and fall into one of the blood pressure categories described. People with existing gut diseases, previous gut surgery, or pregnancy are not eligible. This research could lead to entirely new strategies for treating blood pressure through the gut-heart connection.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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.