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

Not Applicable

Completed

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

Brief 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.

Detailed 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

e.g.

Arm && Interventions

Group	Intervention	Description
Verum	Verum	2 times 2 tablets a day for 4 weeks.
Placebo	Placebo	2 times 2 tablets a day which cornstarch. Tablets look identical like verum tablets.

Primary Outcome Measures

Name	Time	Method
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")	Intervention period of 4 weeks	Endothelial function was determined with the EndoPAT™ method (non-invasive Peripheral Aterial Tonometry) using a reactive hyperemia procedure. The outcome measure is the change in endothelial function between the visit at start of the supplementation phase and the visit on the final day of the 4 week supplementation phase. The endothelial function is determined as the natural log of the Reactive Hyperemia Index ("lnRHI") which is the post-to-pre occlusion peripheral arterial tonometry signal ratio in the occluded side, relative to the same ratio in the control side, corrected for baseline vascular tone of the occluded side. Normal lnRHI \> 0.51, Abnormal lnRHI \< 0.51

Secondary Outcome Measures

Name	Time	Method
Asymmetric Dimethyl Arginine (ADMA) Level Determined on the Final Day of the 4 Week Intervention Period.	After intervention period of 4 weeks	ADMA (asymmetric dimethyl arginine) was determined on the final day of the 4 week intervention period. Samples were analyzed batch wise using an enzymatic test
Homocystein Level Determined on the Final Day of the 4 Week Intervention Period.	After intervention period of 4 weeks	Homocystein level in µmol/l was determined on the final day of the 4 week intervention period. The first supplementation period started at visit one and lasted for 4 weeks. It was followed by a wash out phase of 8 weeks and subsequently by a second supplementation phase of 4 weeks (cross-over design)
Mean of Blood Pressure Measured Daily at the Last 7 Days of the 4 Week Intervention Period.	Intervention period of 4 weeks	The mean of daily systolic and diastolic blood pressure measured daily at the last 7 days of the 4 week intervention period. Measurements were performed by subjects at home and were taken on the left arm, after at least 10 minutes of rest, in a sitting position.
Glycated Hemoglobin (HbA1c) Determined on the Final Day of the 4 Week Intervention Period.	After intervention period of 4 weeks	Glycated hemoglobin (HbA1c) as percentage of total hemoglobin was determined on the final day of the 4 week intervention period.