N/A
Completed N=25
Effect of L-Arginine and Pycnogenol on Light to Moderate Hypertension and Endothelial Function
Endothelial Dysfunction · Hyperhomocysteinemia · Hypertension Grade I, Subgroup "Borderline" (WHO)
Source: ClinicalTrials.gov NCT02392767 ↗
Enrolled (actual)
25
Serious AEs
0.0%
Results posted
May 2016
Primary outcomePrimary: Change in Endothelial Function Between the Visit at Start of Supplementation Phase and the Visit on the Final Day of the 4 Week Supplementation Phase (Delta "lnRHI") — 0.070; -0.052 Delta lnRHI [Index]
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Endothelial Function Between the Visit at Start of Supplementation Phase and the Visit on the Final Day of the 4 Week Supplementation Phase (Delta "lnRHI") |
0.070; -0.052 | — |
| SECONDARY Mean of Blood Pressure Measured Daily at the Last 7 Days of the 4 Week Intervention Period. |
132.8; 133.2; 82.2; 83.5 | — |
| SECONDARY Homocystein Level Determined on the Final Day of the 4 Week Intervention Period. |
9.10; 11.95 | — |
| SECONDARY Asymmetric Dimethyl Arginine (ADMA) Level Determined on the Final Day of the 4 Week Intervention Period. |
0.638; 0.632 | — |
| SECONDARY Glycated Hemoglobin (HbA1c) Determined on the Final Day of the 4 Week Intervention Period. |
5.37; 5.34 | — |
Eligibility Criteria
Inclusion Criteria
- borderline blood pressure (systolic 130-149)
- homocystein level >10µmol/l
Exclusion Criteria
e.g.
- BMI 32kg/m2
- use of antihypertensives, anticoagulants, and statins
- cardiovascular diseases e.g. stroke, myocardial infarction
- use of L-arginine and other dietary supplements
Data sourced from ClinicalTrials.gov (NCT02392767). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.