Randomized, placebo-controlled, double-blind study to evaluate the influence of a combination product with L-arginine, folic acid, vitamin b6 and vitamin b12 on endothelial function in people with mild to moderate blood pressure elevation.
Not Applicable
- Conditions
- mild to moderate elevated blood pressureI10Essential (primary) hypertension
- Registration Number
- DRKS00010276
- Lead Sponsor
- QUIRIS Healthcare GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 81
Inclusion Criteria
Slightly to moderatly elevated blood pressure (high-normal and subgroup „borderline grade 1: 130 to
=149 mmHg SBP), which is under assessment of other risk factors (end organ damage, diabetes,
clinically relevant cardiovascular diseases) not under need for mecial therapy (defined by the german
„Leitlinie zur Behandlung der arteriellen Hypertonie)
Nonsmoker
Exclusion Criteria
-BMI >30 kg/m2
-Sleep-Apnoe
-Use of Antihypertensives or Statins
-Cardiovascular Diseases
- Use of drugs biasing the study outcome (Sildenafil, Vardenafil, Tadalafil, Nitrate), Estrogenes, etc.
- use of L-arginine or other supplements
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fat-induced change of endothelial function (??RHI (Reactive Hyperemia Index)) assessed with EndoPAT, Itamar Medical Ltd., Israel, baseline and after 3 and 6 months of intervention
- Secondary Outcome Measures
Name Time Method blood pressure<br>homocysteine level<br><br>baseline and after 3 and 6 months