hypertension
Conditions
Interventions
either 2 gram of sodium butyrate twice daily or placebo with equal amount of sodium chloride for 4 weeks.
Sponsors
Amsterdam UMC
Eligibility
Inclusion criteria
Inclusion criteria: Age between 40 and 65 years - For females: postmenopausal status - Caucasian - Mild hypertension (defined as systolic blood pressure between 140 and 159 mmHg and/or diastolic blood pressure between 90 and 99 mmHg) OR use of 1 antihypertensive drug due to hypertension and willing to temporarily stop this medication during the study - BMI lower than 27 kg/m2
Exclusion criteria
Exclusion criteria: - Use of betablockers - Known secondary causes of hypertension such as renal artery stenosis, adrenal or thyroid disease - History of cardiovascular disease: angina pectoris, myocardial infarction, cerebrovascular accident, transient ischemic attack, peripheral artery disease, heart failure. - History of diabetes mellitus - Current smoking - Antibiotics usage within three months before inclusion - Having a severe disease of the digestive tract, such as celiac disease, Crohn’s disease, active ulcerative colitis or short bowel syndrome. - Impaired renal function, defined as an estimated glomerular filtration rate (eGFR) lower than 60 ml/min/1,73m2 using the CKD-EPI formula
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is average daytime systolic blood pressure as measured by 24-hour ambulatory blood pressure measurement | — |
Secondary
| Measure | Time frame |
|---|---|
| effect of oral butyrate: - Average diastolic daytime ambulatory blood pressure, average systolic and diastolic night-time blood pressure and average systolic and diastolic 24-hour ambulatory blood pressure; Office blood pressure (two-weekly); Home blood pressure measurement (weekly) - Faecal and plasma SCFA levels, including butyrate; - Gut microbiome composition; - Parameters of renal fluid and electrolyte balance regulation, including: weight and total body fluid as measured with body composition (using bio impedance analysis, BIA), plasma renin activity and aldosterone levels and sodium excretion in 24 hour urine; - Change in immunophenotype, including levels of T-regulatory- and T-helper cells; - Baroreceptor activity and pulse wave velocity as measured with Nexfin; - Dietary intake (mijn.voedingscentrum.nl/nl/eetmeter). | — |
Contacts
Public Contactmax nieuwdorp
AMC
Outcome results
None listed