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The main objective of the study is to evaluate the endothelial function of WAK2017. In addition the effects on the blood pressure and the parameters of lipid metabolism will be explored.
The main objective of the study is to evaluate the endothelial function of WAK2017. In addition the effects on the blood pressure and the parameters of lipid metabolism will be explored.
Primary endpoint is defined as the difference in change in EndoPAT score RHI pre-dose and after 12 weeks of IP intake (visit V4 vs. V2) in comparison between the verum and placebo.
To characterize the benefit of the IP the following secondary endpoints will be analysed in comparison be-tween the verum and placebo:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum | Active Comparator | WAK2017 One (1) ml IP should be taken with breakfast and one (1) ml with supper every day. |
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| Placebo | Placebo Comparator | The placebo liquid is identical in colour and flavor to the verum. In order to maintain the blind with respect to the odour, the placebo will contain 3% Concentrated Aged Garlic Extract (DER 0.9-1.2:1), which is considered as inactive with respect to a potential beneficial effect. One (1) ml IP should be taken with breakfast and one (1) ml with supper every day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WAK2017 | Dietary Supplement | WAK2017 is a solution with following active ingredients: Aged Garlic Extract. One (1) ml IP should be taken with breakfast and one (1) ml with supper every day |
| Measure | Description | Time Frame |
|---|---|---|
| Endo-PAT RHI value | Change of EndoPAT score RHI measurement Visit 2 to Visit 4. EndoPAT parameter (Reactive Hyperemia Index (RHI) will be assessed per Endo-PAT 2000 according to standardized procedures provided by the manufacturer (Itamar Medical Ltd., Israel), at Visit 2 and Visit 4 | Visit 2 and Visit 4 after 84 days ± 6 days after Visit 2 |
| Measure | Description | Time Frame |
|---|---|---|
| EndoPAT Augmentation Index (AI) | Change of EndoPAT parameter Augmentation Index (AI) will be assessed per Endo-PAT 2000 according to standardized procedures provided by the manufacturer (Itamar Medical Ltd., Israel), at Visit 2 and Visit 4 | Visit 2 and Visit 4 after 84 days ± 6 days after Visit 2 |
| Systolic Blood Pressure |
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Inclusion Criteria:
Male and female subjects, 40-75 years
BMI 25-34.9 kg/m2
High normal or hypertension grade 1 blood pressure levels (130-159 / 85-99 mmHg) both at screening (mean of the 2nd and 3rd measurement during the assessment in triplicate at V1) and at baseline (mean of the 2nd and 3rd measurement during the assessment in triplicate at V2)
EndoPAT score (RHI): < 2.2 at V1
Readiness to comply with study procedures, in particular:
Non-smoker / smoking cessation of last ≥12 months prior to V1
Stable body weight in the last 3 months prior to V1 (<3 kg self-reported change)
If allowed concomitant medications are taken this must have been stable at least during the last month prior to V1
Women of childbearing potential:
Exclusion Criteria:
Known allergy or hypersensitivity to the components of the investigational product
Known genetic hyperlipidemia
Known secondary hypertension
Known white-coat hypertension
Known type-1-diabetes
Uncontrolled or within the last 6 months prior to V1 diagnosed type-2-diabetes
Untreated or non-stabilized thyroid disorder
History and/or presence of clinically significant cardiovascular disease as per investigator's judgement:
Any other known significant or serious condition / disease that renders subjects ineligible, e.g.:
Any known metabolic disease, gastrointestinal disorder or other clinically significant disease/disorder which in the investigator's opinion could interfere with the results of the study or the safety of the subject
Known arm lymphedema (e.g. due to mastectomy)
Other deviation of laboratory parameter(s) at V1 that is:
Dietary habits that may interfere with the study objectives:
Use of following medication/supplementation within the last 4 weeks prior to V1 and during the study, according to investigator's jugdement:
Use of weight loss treatment
Drug abuse
Alcohol abuse (men: ≥21 units/week, women: ≥14 units/ week; 1 unit equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)
Reported participation in night shift work 2 weeks prior to V1 and/or during the study
Women of child-bearing potential: pregnant or breast-feeding
Participation in another study or blood donation during the last 30 days prior to V1
Any other reason deemed suitable for exclusion as per investigator's judgment
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maya Ulbricht | Contact | 0049 3040 00 8 | 1 62 | mulbricht@a-r.com |
| Masaki Matsushita, PhD | Contact | + 1 949 855 2776 | mmatsushita@wakunaga.com |
| Name | Affiliation | Role |
|---|---|---|
| Ralf Uebelhack, MD | analyze & realize GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioTeSys GmbH | Not yet recruiting | Esslingen am Neckar | Baden Würtemberg | 73728 | Germany |
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| Label | URL |
|---|---|
| Homepage for study site in Berlin | View source |
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Randomized, double-blind, placebo-controlled, parallel-group study
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double-blind, placebo-controlled
| Placebo | Dietary Supplement | One (1) ml IP should be taken with breakfast and one (1) ml with supper every day |
|
|
Change in Systolic Blood Pressure after 6 weeks ± 3 Visit 2 versus Visit 3 |
| 42 days ± 3 |
| Diastolic Blood Pressure | Change in Diastolic Blood Pressure after 6 weeks ± 3 Visit 2 versus Visit 3 | 42 days ± 3 |
| Systolic Blood Pressure | Change in Systolic Blood Pressure after 12 weeks ± 6 Visit 2 versus Visit 4 | 84 weeks ± 6 |
| Diastolic Blood Pressure | Change in Diastolic Blood Pressure after 12 weeks ± 6 Visit 2 versus Visit 4 | 84 days ± 6 |
| Low Density Lipoprotein cholestorol (LDL-C) | Change in LDL-C concentration after 6 weeks ± 3 Visit 2 versus Visit 3. Blood samples will be obtained for the assessment of serum LDL-C concentrations. | 42 days ± 3 |
| Low Density Lipoprotein cholestorol (LDL-C) | Change in LDL-C concentration after 12 weeks ± 6 Visit 2 versus Visit 4. Blood samples will be obtained for the assessment of serum LDL-C concentrations. | 84 days ± 6 |
| non-High Density Lipoprotein cholestorol (non-HDL-C) | Change in non-HDL-C concentration after 6 weeks ± 3 Visit 2 versus Visit 3. Blood samples will be obtained for the assessment of serum non-HDL-C concentrations. The non-HDL cholesterol values are obtained by subtracting the HDL cholesterol value from the total cholesterol. | 42 days ± 3 |
| non-High Density Lipoprotein cholestorol (non-HDL-C) | Change in non-HDL-C concentration after 12 weeks ± 6 Visit 2 versus Visit 4. Blood samples will be obtained for the assessment of serum non-HDL-C concentrations. The non-HDL cholesterol values are obtained by subtracting the HDL cholesterol value from the total cholesterol | 84 days ± 6 |
| Total Cholestorol (TC) | Change in TC concentration after 6 weeks ± 3 Visit 2 versus Visit 3. Blood samples will be obtained for the assessment of serum Total Cholestorol (TC) concentrations. | 42 days ± 3 |
| Total Cholestorol (TC) | Change in TC concentration after 12 weeks ± 6 Visit 2 versus Visit 4. Blood samples will be obtained for the assessment of serum Total Cholestorol (TC) concentrations. | 84 days ± 6 |
| High Density Lipoprotein cholestorol (HDL-C) | Change in HDL-C concentration after 6 weeks ± 3 Visit 2 versus Visit 3. Blood samples will be obtained for the assessment of serum HDL-C concentrations. | 42 days ± 3 |
| High Density Lipoprotein cholestorol (HDL-C) | Change in HDL-C concentration after 12 weeks ± 6 Visit 2 versus Visit 4. Blood samples will be obtained for the assessment of serum HDL-C concentrations. | 84 days ± 6 |
| Triglycerides (TG) | Change in TG concentration after 6 weeks ± 3 Visit 2 versus Visit 3. Blood samples will be obtained for the assessment of serum TG concentrations. | 42 days ± 3 |
| Triglycerides (TG) | Change in TG concentration after 12 weeks ± 6 Visit 2 versus Visit 4. Blood samples will be obtained for the assessment of serum TG concentrations. | 84 days ± 6 |
| LDL-C/HDL-C ratio | Change in LDL-C/HDL-C ratio after 6 weeks ± 3 Visit 2 versus Visit 3. | 42 days ± 3 |
| LDL-C/HDL-C ratio | Change in LDL-C/HDL-C ratio after 12 weeks ± 6 Visit 2 versus Visit 4. | 84 days ± 6 |
| TC/HDL-C ratio | Change in TC/HDL-C ratio after 6 weeks ± 3 Visit 2 versus Visit 3. | 42 days ± 3 |
| TC/HDL-C ratio | Change in TC/HDL-C ratio after 12 weeks ± 6 Visit 2 versus Visit 4. | 84 days ± 6 |
| SCORE Value | The SCORE value will be assessed on V2 - V4 using the European Low Risk Chart by the European Society of Cardiology (Perk et al., 2012), during biometric assess-ment. | 42 days ± 3 |
| SCORE Value | The SCORE value will be assessed on V2 - V4 using the European Low Risk Chart by the European Society of Cardiology (Perk et al., 2012), during biometric assess-ment. | 84 days ± 6 |
| Global Evaluation of benefit | Both the subjects and investigator(s) will evaluate independently the benefit of the IP by means of a global scaled evaluation with "very good", "good", "moderate" and "poor". | 84 days ± 6 |
| analyze & realize GmbH | Recruiting | Berlin | 10369 | Germany |
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