SCFA butyrate supplementation affects blood pressure
ID
Bron
Verkorte titel
Aandoening
hypertension
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome is average daytime systolic blood pressure as measured by 24-hour ambulatory blood pressure measurement
Achtergrond van het onderzoek
Intestinal SCFA (short chain fatty acids) are thought to be involved in blood pressure regulation via butyrate producing gutmicrobiota. In order to study the direct effects of SCFA butyrate, we will perform a double-blind randomized placebo-controlled trial in 50 patients with hypertension. Subjects will be treated with either 2 gram of sodium butyrate twice daily or placebo with equal amount of sodium chloride for 4 weeks. At baseline and after 4 weeks we will assess the primary endpoint which is effect of oral butyrate on 24h blood pressure; secondary objectives are to assess the effect of oral butyrate on plasma and faecal SCFA levels, gut microbiome composition, natriuresis and diuresis, renin and aldosterone levels, immunophenotype, hemodynamic parameters such as baroreceptor sensitivity and pulse wave velocity, and changes in weight and body composition.
Doel van het onderzoek
SCFA butyrate supplementation affects blood pressure
Onderzoeksopzet
Baseline, 2 (only office blood pressure and BIA) and 4 weeks (active treatment) as well as 5 weeks (washout)
Onderzoeksproduct en/of interventie
either 2 gram of sodium butyrate twice daily or placebo with equal amount of sodium chloride for 4 weeks.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8924 |
| Ander register | METC AMC : 2020_106 |