An interventional study of Verum and Placebo in Endothelial Dysfunction, Hyperhomocysteinemia and Hypertension Grade I, Subgroup "Borderline" (WHO), sponsored by Dr. Loges & Co. GmbH. Completed at 1 site in Germany. Open to participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-02.
Sponsored by Dr. Loges & Co. GmbH · Not applicable, Interventional, and Treatment
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.
34 studies on the registry are indexed under Hyperhomocysteinemia; 4 are open to participants now.
This study's enrollment of 25 is below the median of 84 across 21 interventional studies indexed under Hyperhomocysteinemia.
Browse Hyperhomocysteinemia studies →This is the only study on the registry with Dr. Loges & Co. GmbH as lead sponsor.
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Exclusion Criteria:
e.g.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
2 times 2 tablets a day for 4 weeks.
Dietary Supplement: Verum
2 times 2 tablets a day which cornstarch. Tablets look identical like verum tablets.
Dietary Supplement: Placebo
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.
corn starch
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
Time frame: Intervention period of 4 weeks
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.
Time frame: Intervention period of 4 weeks
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)
Time frame: 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
Time frame: 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.
Time frame: After intervention period of 4 weeks
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
Time frame: Intervention period of 4 weeks
Cross-over study
| Milestone | First Verum, Then Placebo | First Placebo, Then Verum |
|---|---|---|
| Started | 12 | 13 |
| Completed | 12 | 13 |
| Not completed | 0 | 0 |
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
| Delta lnRHI [Index] | Verum | Placebo |
|---|---|---|
| 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") | 0.070 (-0.065 to 0.205) | -0.052 (-0.163 to 0.060) |
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.
| mmHg | Verum | Placebo |
|---|---|---|
| systolic reading | 132.8 (129.1 to 136.6) | 133.2 (130.4 to 136.1) |
| diastolic reading | 82.2 (79.8 to 84.6) | 83.5 (81.7 to 85.3) |
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)
| μmol/l | Verum | Placebo |
|---|---|---|
| Homocystein Level Determined on the Final Day of the 4 Week Intervention Period. | 9.10 (8.30 to 9.90) | 11.95 (11.19 to 12.72) |
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
| µmol/l | Verum | Placebo |
|---|---|---|
| Asymmetric Dimethyl Arginine (ADMA) Level Determined on the Final Day of the 4 Week Intervention Period. | 0.638 (0.594 to 0.682) | 0.632 (0.596 to 0.668) |
Glycated hemoglobin (HbA1c) as percentage of total hemoglobin was determined on the final day of the 4 week intervention period.
| percentage of total hemoglobin | Verum | Placebo |
|---|---|---|
| Glycated Hemoglobin (HbA1c) Determined on the Final Day of the 4 Week Intervention Period. | 5.37 (5.20 to 5.54) | 5.34 (5.19 to 5.50) |
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
| Percentage of the standard Quick value | Verum | Placebo |
|---|---|---|
| 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 | 2.00 (-0.54 to 4.54) | 1.50 (-1.31 to 4.31) |
Collected over 4 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Verum | — | 0/25 (0%) | 9/25 (36%) |
| Placebo | — | 0/25 (0%) | 12/25 (48%) |
| Event | Verum | Placebo |
|---|---|---|
| febrile infectionInfections and infestations | 0/25 | 3/25 |
| coldInfections and infestations | 2/25 | 1/25 |
| headacheNervous system disorders | 2/25 | 2/25 |
| diarrhoeaGastrointestinal disorders | 0/25 | 1/25 |
| malaiseGastrointestinal disorders | 0/25 | 1/25 |
| nasal mucosa disorderSurgical and medical procedures | 0/25 | 1/25 |
| loose stoolsGastrointestinal disorders | 0/25 | 1/25 |
| herpes NOSInfections and infestations | 0/25 | 1/25 |
| gastrointestinal infectionGastrointestinal disorders | 0/25 | 1/25 |
| lumbagoMusculoskeletal and connective tissue disorders | 1/25 | 0/25 |
| Age, Categorical(Participants) | First Verum, Then Placebo | First Placebo, Then Verum | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 12 | 13 | 25 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | First Verum, Then Placebo | First Placebo, Then Verum | Total |
|---|---|---|---|
| Female | 3 | 4 | 7 |
| Male | 9 | 9 | 18 |
| Region of Enrollment(participants) | First Verum, Then Placebo | First Placebo, Then Verum | Total |
|---|---|---|---|
| Germany | 12 | 13 | 25 |
Plan to share: Undecided — Undecided
The record gives a start of Oct 2014, a primary completion of Aug 2015 and a completion of Aug 2015. It does not say whether these dates are actual or estimated.
Results were first posted in May 2016, 9 months after primary completion.
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This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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