hypertension
Conditions
Interventions
The investigational products are sodium butyrate (Sensilab) and placebo.
Patients will be randomised over the intervention and control group. In the
intervention group, patients will receive 13 caps
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age between 40 and 65 years - For females: postmenopausal status - Caucasian - Mild hypertension (defined as systolic blood pressure range 140-159 mmHg and/or diastolic blood pressure range 90-100 mmHg) without antihypertensive medication OR use of 1 antihypertensive drug due to hypertension and willing to temporarily stop this medication - Body mass index (BMI) lower than 27 kg/m2
Exclusion criteria
Exclusion criteria: - Insufficient knowledge of the Dutch language - 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 within a period of two years before the screening visit. Participants without an available lab result on renal function will not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is average daytime systolic blood pressure as measured by 24-hour ambulatory blood pressure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are other blood pressure measurements, including: - 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). Other study parameters include: - 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 impedance analysis (BIA); plasma renin activity and aldosterone levels; sodium excretion in 24 hour urine; - Baroreceptor activity and pulse wave velocity as measured with Nexfin. - Dietary intake (mijn.voedingscentrum.nl/nl/eetmeter) - Change in immunophenotype | — |
Countries
Netherlands
Outcome results
None listed