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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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00010276
Enrollment
81
Registered
2016-04-07
Start date
2012-05-07
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mild to moderate elevated blood pressure I10

Interventions

Group 1: Treatment (dietary management): 2x daily 2 tablets (per day: 2.4 g L-arginine, 3 mg vitamin B6, 0.4 mg folic acid, 2 µg vitamin B12) Study phase I: randomized, placebo-controlled, double-

Sponsors

QUIRIS Healthcare GmbH & Co. KG
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
blood pressure homocysteine level baseline and after 3 and 6 months—

Countries

Germany

Contacts

Public ContactClaudia Reule

BioTeSys GmbH

info@biotesys.de+49 (0) 711/31 05 71-45

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026