Clinical trial NCT02392767: Effect of L-Arginine and Pycnogenol on Light to Moderate Hypertension and Endothelial Function
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Dysfunction
Hyperhomocysteinemia
Hypertension Grade I, Subgroup "Borderline" (WHO)
Keywords: L-Arginine
Pycnogenol
vitamin K2
vitamin B
endothelial function
hypertension
Homocystein >10
Lead sponsor: Dr. Loges & Co. GmbH
Sponsor class: INDUSTRY
Collaborators: name: BioTeSys GmbH
First posted: 2015-03-19
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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")
timeFrame: Intervention period of 4 weeks
Secondary outcomes:
measure: Mean of Blood Pressure Measured Daily at the Last 7 Days of the 4 Week Intervention Period.
timeFrame: Intervention period of 4 weeks
measure: Homocystein Level Determined on the Final Day of the 4 Week Intervention Period.
timeFrame: After intervention period of 4 weeks
measure: Asymmetric Dimethyl Arginine (ADMA) Level Determined on the Final Day of the 4 Week Intervention Period.
timeFrame: After intervention period of 4 weeks
measure: Glycated Hemoglobin (HbA1c) Determined on the Final Day of the 4 Week Intervention Period.
timeFrame: After intervention period of 4 weeks
Other outcomes:
measure: Change in Prothrombin Time Between the Visit at Start of Supplementation Phase and the Visit on the Final Day of the 4 Week Supplementation Phase
timeFrame: Intervention period of 4 weeks
Locations:
city: Esslingen
country: Germany
facility: BioTeSys
Study officials:
affiliation: medical advisor
name: Birgit Goyvaerts, Dr.
role: STUDY_CHAIR
References:
citation: Reule CA, Goyvaerts B, Schoen C. Effects of an L-arginine-based multi ingredient product on endothelial function in subjects with mild to moderate hypertension and hyperhomocysteinemia - a randomized, double-blind, placebo-controlled, cross-over trial. BMC Complement Altern Med. 2017 Feb 2;17(1):92. doi: 10.1186/s12906-017-1603-9.