Butyrate: effect of oral administration in patients with mild hypertensio

Completed

Conditions: hypertension
high blood pressure
10057166

Registration Number: NL-OMON49499

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

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

- 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is average daytime systolic blood pressure as measured by<br /><br>24-hour ambulatory blood pressure. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are other blood pressure measurements, including:<br /><br>- Average diastolic daytime ambulatory blood pressure, average systolic and<br /><br>diastolic night-time blood pressure and average systolic and diastolic 24-hour<br /><br>ambulatory blood pressure;<br /><br>- Office blood pressure (two-weekly);<br /><br>- Home blood pressure measurement (weekly).<br /><br><br /><br>Other study parameters include:<br /><br>- Faecal and plasma SCFA levels, including butyrate;<br /><br>- Gut microbiome composition;<br /><br>- Parameters of renal fluid and electrolyte balance regulation, including:<br /><br>weight and total body fluid as measured with body impedance analysis (BIA);<br /><br>plasma renin activity and aldosterone levels; sodium excretion in 24 hour<br /><br>urine;<br /><br>- Baroreceptor activity and pulse wave velocity as measured with Nexfin.<br /><br>- Dietary intake (mijn.voedingscentrum.nl/nl/eetmeter)<br /><br>- Change in immunophenotype</p><br>