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Butyrate: Effect of Oral Administration in patients with Mild Hypertensio

Recruiting
Conditions
hypertension
Registration Number
NL-OMON22936
Lead Sponsor
Amsterdam UMC
Brief Summary

follow

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
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 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

- 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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary outcome is average daytime systolic blood pressure as measured by 24-hour ambulatory blood pressure measurement
Secondary Outcome Measures
NameTimeMethod
effect of oral butyrate: <br>- 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) <br>- Faecal and plasma SCFA levels, including butyrate;<br>- Gut microbiome composition;<br>- Parameters of renal fluid and electrolyte balance regulation, including: weight and<br>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;<br>- Change in immunophenotype, including levels of T-regulatory- and T-helper cells;<br>- Baroreceptor activity and pulse wave velocity as measured with Nexfin;<br>- Dietary intake (mijn.voedingscentrum.nl/nl/eetmeter).
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