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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Verum

2 times 2 tablets a day for 4 weeks.

Group Type ACTIVE_COMPARATOR

Verum

Intervention Type DIETARY_SUPPLEMENT

2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid.

Placebo

2 times 2 tablets a day which cornstarch. Tablets look identical like verum tablets.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

corn starch

Interventions

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Verum

2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid.

Intervention Type DIETARY_SUPPLEMENT

Placebo

corn starch

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* borderline blood pressure (systolic 130-149)
* homocystein level \>10µmol/l

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes