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| Name | Class |
|---|---|
| BioTeSys GmbH | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum | Active Comparator | 2 times 2 tablets a day for 4 weeks. |
|
| Placebo | Placebo Comparator | 2 times 2 tablets a day which cornstarch. Tablets look identical like verum tablets. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 EndoPATâ„¢ 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean of Blood Pressure Measured Daily at the Last 7 Days of the 4 Week Intervention Period. | 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. | Intervention period of 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
Inclusion Criteria:
Exclusion Criteria:
e.g.
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| Name | Affiliation | Role |
|---|---|---|
| Birgit Goyvaerts, Dr. | medical advisor | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioTeSys | Esslingen am Neckar | 73728 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28153005 | Derived | 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. |
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Cross-over study
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| ID | Title | Description |
|---|---|---|
| FG000 | First Verum, Then Placebo | 2 times a day 2 verum tablets for 4 weeks. 8 weeks wash out. Then 2 times a day 2 placebo tablets for 4 weeks. |
| FG001 | First Placebo, Then Verum | 2 times a day 2 placebo tablets for 4 weeks. 8 weeks wash out. Then 2 times a day 2 verum tablets for 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | First Verum, Then Placebo | 2 times a day 2 verum tablets for 4 weeks. 8 weeks wash out. Then 2 times a day 2 placebo tablets for 4 weeks. |
| BG001 | First Placebo, Then Verum | 2 times a day 2 placebo tablets for 4 weeks. 8 weeks wash out. Then 2 times a day 2 verum tablets for 4 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 EndoPATâ„¢ 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 | Posted | Mean | 95% Confidence Interval | Delta lnRHI [Index] | Intervention period of 4 weeks |
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Verum | 2 times 2 tablets a day for 4 weeks. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Birgit Goyvaerts | Dr. Loges + Co. GmbH | 0049-4171-707182 | goyvaerts@loges.de |
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| ID | Term |
|---|---|
| D020138 | Hyperhomocysteinemia |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D000592 | Amino Acid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| C068637 | calcium D-pantothenate, L-cysteine drug combination |
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| Placebo | Dietary Supplement | corn starch |
|
| Homocystein Level Determined on the Final Day of the 4 Week Intervention Period. | 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) | After intervention period of 4 weeks |
| Asymmetric Dimethyl Arginine (ADMA) Level Determined on the Final Day of the 4 Week Intervention Period. | 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 | After intervention period of 4 weeks |
| Glycated Hemoglobin (HbA1c) Determined on the Final Day of the 4 Week Intervention Period. | Glycated hemoglobin (HbA1c) as percentage of total hemoglobin was determined on the final day of the 4 week intervention period. | After intervention period of 4 weeks |
| Intervention period of 4 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
2 times 2 tablets a day for 4 weeks.
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.
| OG001 | Placebo | 2 times 2 tablets a day for 4 weeks. Placebo: corn starch |
|
|
| Secondary | Mean of Blood Pressure Measured Daily at the Last 7 Days of the 4 Week Intervention Period. | 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. | Posted | Mean | 95% Confidence Interval | mmHg | Intervention period of 4 weeks |
|
|
|
| Secondary | Homocystein Level Determined on the Final Day of the 4 Week Intervention Period. | 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) | Posted | Mean | 95% Confidence Interval | μmol/l | After intervention period of 4 weeks |
|
|
|
| Secondary | Asymmetric Dimethyl Arginine (ADMA) Level Determined on the Final Day of the 4 Week Intervention Period. | 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 | Posted | Mean | 95% Confidence Interval | µmol/l | After intervention period of 4 weeks |
|
|
|
| Secondary | Glycated Hemoglobin (HbA1c) Determined on the Final Day of the 4 Week Intervention Period. | Glycated hemoglobin (HbA1c) as percentage of total hemoglobin was determined on the final day of the 4 week intervention period. | Posted | Mean | 95% Confidence Interval | percentage of total hemoglobin | After intervention period of 4 weeks |
|
|
|
| Other Pre-specified | 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 | 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 | Posted | Mean | 95% Confidence Interval | Percentage of the standard Quick value | Intervention period of 4 weeks |
|
|
|
| 0 |
| 25 |
| 9 |
| 25 |
| EG001 | Placebo | 2 times 2 tablets a day for 4 weeks. Placebo: corn starch | 0 | 25 | 12 | 25 |
| cold | Infections and infestations | MedDRA | Systematic Assessment | common cold |
|
| headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| malaise | Gastrointestinal disorders | MedDRA | Systematic Assessment | stomach upset with diarrhoea |
|
| nasal mucosa disorder | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| loose stools | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| herpes NOS | Infections and infestations | MedDRA | Systematic Assessment |
|
| febrile infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| gastrointestinal infection | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| lumbago | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| generalized aching | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | after gardening |
|
| skin rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| bladder infection | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| cycling accident | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
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| D008286 | Malabsorption Syndromes |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014804 | Vitamin B Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |