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

NCT02392767 | Completed Results

• 1 other identifier: BTS815/14
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

L-Arginine; Pycnogenol; vitamin K2; vitamin B; endothelial function; hypertension; Homocystein >10

Outcome Measures

Primary Outcomes (1)

• 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")

  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

  Intervention period of 4 weeks

Secondary Outcomes (4)

• Mean of Blood Pressure Measured Daily at the Last 7 Days of the 4 Week Intervention Period.

  Intervention period of 4 weeks

• Homocystein Level Determined on the Final Day of the 4 Week Intervention Period.

  After intervention period of 4 weeks

• Asymmetric Dimethyl Arginine (ADMA) Level Determined on the Final Day of the 4 Week Intervention Period.

  After intervention period of 4 weeks

• Glycated Hemoglobin (HbA1c) Determined on the Final Day of the 4 Week Intervention Period.

  After intervention period of 4 weeks

Other Outcomes (1)

• 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

  Intervention period of 4 weeks

Study Arms (2)

Verum

ACTIVE COMPARATOR

2 times 2 tablets a day for 4 weeks.

Dietary Supplement: Verum

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Verum 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.

Verum

Placebo DIETARY_SUPPLEMENT

corn starch

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Loges & Co. GmbH: lead
• BioTeSys GmbH: collaborator

Study Sites (1)

BioTeSys

Esslingen am Neckar, 73728, Germany

Location

Related Publications (1)

• 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.

  PMID: 28153005 DERIVED

MeSH Terms

Conditions

Hyperhomocysteinemia; Hypertension

Interventions

calcium D-pantothenate, L-cysteine drug combination

Condition Hierarchy (Ancestors)

Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Malabsorption Syndromes; Metabolic Diseases; Nutritional and Metabolic Diseases; Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Birgit Goyvaerts
• Organization: Dr. Loges + Co. GmbH

goyvaerts@loges.de

0049-4171-707182

Study Officials

• Birgit Goyvaerts, Dr.

  medical advisor

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2014
• First Posted: March 19, 2015
• Study Start: October 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: May 2, 2016
• Results First Posted: May 2, 2016

Record last verified: 2016-03

Locations

DE (1)