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

Hyperhomocysteinemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02392767
• Other study ID #: BTS815/14
• Status: Completed
• Phase: N/A
• First received: November 14, 2014
• Last updated: August 31, 2015
• Start date: October 2014
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Dr. Loges & Co. GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The effect of a combination product (Verum ) with L-arginine, Pycnogenol, vitamin K2, R8+) 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.

Description:

25 patients are tested. Intervention period is 4 weeks with 2 months wash out phase. Before study start there well be a screening visit of all volunteers including volunteer information, signature of informed consent, anamnesis, medical history, ECG and Blood routine analysis. Efficacy parameters will be checked at visit 1, 2, 3, and 4. Endothelial function and postprandial endothelial Reaction is tested using EndoPAT. Blood pressure will be measures by volunteers during the 7 days before each visit. As Biomarker, homocysteine, an ADMA will be analysed. For Safety AEs CCs, tolerability, blood routine parameters and vital signs will be checked.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperhomocysteinemia
• Hypertension
• Hypertension Grade I

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
Germany	BioTeSys	Esslingen

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Loges & Co. GmbH	BioTeSys GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Prothrombin time		4 weeks	Yes
Primary	Endothelial function (EndoPAT)	EndoPAT	4 weeks	No
Secondary	blood pressure		4 weeks	No
Secondary	homocystein level		4 weeks	No
Secondary	ADMA		4 weeks	No
Secondary	HBA1c		4 weeks	No