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

Hyperhomocysteinemia Clinical Trial

Official title: Effect of a Dietary Supplement on Endothelial Function in Volunteers With Light to Moderate Hypertension - a Randomised, Double-blind, Placebo Controlled Cross-over Study

Status Completed

Clinical Trial Summary

The effect of a combination product (Verum ) with L-arginine, Pycnogenol, vitamin K2, R8+) 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.

Clinical Trial Description

25 patients are tested. Intervention period is 4 weeks with 2 months wash out phase. Before study start there well be a screening visit of all volunteers including volunteer information, signature of informed consent, anamnesis, medical history, ECG and Blood routine analysis. Efficacy parameters will be checked at visit 1, 2, 3, and 4. Endothelial function and postprandial endothelial Reaction is tested using EndoPAT. Blood pressure will be measures by volunteers during the 7 days before each visit. As Biomarker, homocysteine, an ADMA will be analysed. For Safety AEs CCs, tolerability, blood routine parameters and vital signs will be checked. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperhomocysteinemia
• Hypertension
• Hypertension Grade I

• NCT number: NCT02392767
• Study type: Interventional
• Source: Dr. Loges & Co. GmbH
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Completion date: August 2015