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Trial record 42 of 50 for:    vitamin k2

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

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ClinicalTrials.gov Identifier: NCT02392767
Recruitment Status : Completed
First Posted : March 19, 2015
Results First Posted : May 2, 2016
Last Update Posted : May 2, 2016
Sponsor:
Collaborator:
BioTeSys GmbH
Information provided by (Responsible Party):
Dr. Loges & Co. GmbH

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.

Condition or disease Intervention/treatment Phase
Endothelial Dysfunction Hyperhomocysteinemia Hypertension Grade I, Subgroup "Borderline" (WHO) Dietary Supplement: Verum Dietary Supplement: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : October 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015


Arm Intervention/treatment
Active Comparator: Verum
2 times 2 tablets a day for 4 weeks.
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.

Placebo Comparator: Placebo
2 times 2 tablets a day which cornstarch. Tablets look identical like verum tablets.
Dietary Supplement: Placebo
corn starch




Primary Outcome Measures :
  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") [ 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 Outcome Measures :
  1. Mean of Blood Pressure Measured Daily at the Last 7 Days of the 4 Week Intervention Period. [ Time Frame: Intervention period of 4 weeks ]
    The mean of daily systolic and diastolic blood pressure measured daily at the last 7 days of the 4 week intervention period. Measurements were performed by subjects at home and were taken on the left arm, after at least 10 minutes of rest, in a sitting position.

  2. Homocystein Level Determined on the Final Day of the 4 Week Intervention Period. [ Time Frame: After intervention period of 4 weeks ]

    Homocystein level in µmol/l was determined on the final day of the 4 week intervention period.

    The first supplementation period started at visit one and lasted for 4 weeks. It was followed by a wash out phase of 8 weeks and subsequently by a second supplementation phase of 4 weeks (cross-over design)


  3. Asymmetric Dimethyl Arginine (ADMA) Level Determined on the Final Day of the 4 Week Intervention Period. [ Time Frame: After intervention period of 4 weeks ]
    ADMA (asymmetric dimethyl arginine) was determined on the final day of the 4 week intervention period. Samples were analyzed batch wise using an enzymatic test

  4. Glycated Hemoglobin (HbA1c) Determined on the Final Day of the 4 Week Intervention Period. [ Time Frame: After intervention period of 4 weeks ]
    Glycated hemoglobin (HbA1c) as percentage of total hemoglobin was determined on the final day of the 4 week intervention period.


Other Outcome Measures:
  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 [ Time Frame: Intervention period of 4 weeks ]
    Prothrombin Time was assessed at the visit at start of the supplementation phase and the visit at the end of the 4 week supplementation phase. Blood coagulability is expressed in units of Quick value. In this case, the measured prothrombin time is expressed in relation to the coagulation time of a healthy person. The value obtained is the "percentage of the standard Quick value". In a person not receiving oral anticoagulation the "normal" Quick value is between 70 and 100%. The longer the patient's coagulation time, the lower the Quick value



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02392767


Locations
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Germany
BioTeSys
Esslingen, Germany, 73728
Sponsors and Collaborators
Dr. Loges & Co. GmbH
BioTeSys GmbH
Investigators
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Study Chair: Birgit Goyvaerts, Dr. medical advisor

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Loges & Co. GmbH
ClinicalTrials.gov Identifier: NCT02392767     History of Changes
Other Study ID Numbers: BTS815/14
First Posted: March 19, 2015    Key Record Dates
Results First Posted: May 2, 2016
Last Update Posted: May 2, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided
Keywords provided by Dr. Loges & Co. GmbH:
L-Arginine
Pycnogenol
vitamin K2
vitamin B
endothelial function
hypertension
Homocystein >10
Additional relevant MeSH terms:
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Vitamins
Vitamin K 2
Hypertension
Hyperhomocysteinemia
Vascular Diseases
Cardiovascular Diseases
Amino Acid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Malabsorption Syndromes
Metabolic Diseases
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Pycnogenols
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Adjuvants, Immunologic
Immunologic Factors
Antioxidants
Protective Agents