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