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

Dr. Loges

Status: Completed

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

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Verum

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02392767

BTS815/14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

25 participants in 2 patient groups, including a placebo group

Verum

Active Comparator group

Description:

2 times 2 tablets a day for 4 weeks.

Treatment:

Dietary Supplement: Verum

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo