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

Last updated: March 29, 2016
Sponsor: Dr. Loges & Co. GmbH
Overall Status: Completed

Phase

N/A

Condition

Atherosclerosis

Williams Syndrome

Stress

Treatment

N/A

Clinical Study ID

NCT02392767
BTS815/14
  • Ages 40-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • borderline blood pressure (systolic 130-149)

  • homocystein level >10µmol/l

Exclusion

Exclusion Criteria: e.g.

  • BMI <20kg/m2 and >32kg/m2

  • use of antihypertensives, anticoagulants, and statins

  • cardiovascular diseases e.g. stroke, myocardial infarction

  • use of L-arginine and other dietary supplements

Study Design

Total Participants: 25
Study Start date:
October 01, 2014
Estimated Completion Date:
August 31, 2015

Study Description

25 patients were included in the trial. Intervention period was 4 weeks with 2 months wash out phase. The screening visit of all volunteers before study start included volunteer information, signature of informed consent, anamnesis, medical history, ECG and blood routine analysis.

Efficacy parameters were measured at visit 1, 2, 3, and 4. Endothelial function and postprandial endothelial Reaction was tested using EndoPAT (validated diagnosis tool). Blood pressure was measured by volunteers over a period of 7 days before each visit. As additional parameters homocysteine and ADMA (assymmetric dimethyl arginine) were determed. For safety evaluation AEs (Adverse Events), CC (compliance control), tolerability, blood routine parameters and vital signs were assessed.

Connect with a study center

  • BioTeSys

    Esslingen, 73728
    Germany

    Site Not Available

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