Effect of L-Arginine and Pycnogenol on Light to Moderate Hypertension and Endothelial Function

NCT02392767 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2016-05-02

Study results available
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Summary

The effect of a combination product (Verum ) with L-arginine, Pycnogenol, vitamin K2, R-(+)-alpha-lipoic acid and vitamins B6, B12 and folic acid is investigated in a double blind placebo-controlled cross-over study. Volunteers with hypertension and hyperhomocysteinemia are randomly assigned to the dietary supplement or placebo.

Conditions

  • Endothelial Dysfunction
  • Hyperhomocysteinemia
  • Hypertension Grade I, Subgroup "Borderline" (WHO)

Interventions

DIETARY_SUPPLEMENT

Verum

2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid.

DIETARY_SUPPLEMENT

Placebo

corn starch

Sponsors & Collaborators

  • BioTeSys GmbH

    collaborator OTHER
  • Dr. Loges & Co. GmbH

    lead INDUSTRY

Principal Investigators

  • Birgit Goyvaerts, Dr. · medical advisor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02392767 on ClinicalTrials.gov