Effect of a Dietary Supplement on Endothelial Function in Volunteers With Light to Moderate Hypertension - a Randomised, Double-blind, Placebo Controlled Cross-over Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Endothelial Dysfunction
- Sponsor
- Dr. Loges & Co. GmbH
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- 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")
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •borderline blood pressure (systolic 130-149)
- •homocystein level \>10µmol/l
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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")
Time Frame: Intervention period of 4 weeks
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
Secondary Outcomes
- 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)
- Mean of Blood Pressure Measured Daily at the Last 7 Days of the 4 Week Intervention Period.(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)