Endothelial FunctionNCT03287518
Evaluation of the Benefit and Tolerability of WAK2017 on Endothelial Function, Blood Pressure and Lipid Profile
A study testing WAK2017 in people with Endothelial Function and Blood Pressure, run by Analyze & Realize at 2 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Endothelial Function, Blood Pressure, Lipid Metabolism
- What is being tested?
- WAK2017
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesGermany
- Study dates
- 28 Jul 2017to 15 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Consumption of the IP as instructed during the treatment period
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- Adhering to former diet (except consumption of max. 2 garlic cloves per week) and physical activity
- Requirements for blood pressure / EndoPAT measurements
- Accepting blood draws
- 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:
- Negative pregnancy testing (beta HCG-test in urine) at V1
- Commitment to use reliable contraception methods during the study Participation is based upon written informed consent by the participant following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study.
Who cannot join
- 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
Show all 38Show fewer
- Untreated or non-stabilized thyroid disorder
- History and/or presence of clinically significant cardiovascular disease as per investigator's judgement:
- Known congenital heart defects
- Myocardial infarction, heart failure, angina pectoris, life-threatening arrhythmia or stroke within the last 6 months prior to V1
- Existing thrombosis or disposition to thrombosis
- Any other known significant or serious condition / disease that renders subjects ineligible, e.g.:
- History of malignancy within the past 5 years prior to V1
- Bleeding disorder and/or need for anticoagulants
- Current psychiatric care and/or use of neuroleptics
- Bariatric surgery in the last 12 months prior to V1
- 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:
- clinically significant or
- 2x ULN (upper limit of normal), unless the deviation is justified by a previously known not clinically relevant condition, e.g. Gilbert's syndrome)
- Dietary habits that may interfere with the study objectives:
- Eating disorder
- Subjects with dietary restriction that may affect the study outcome
- Participation in a weight loss program
- Use of following medication/supplementation within the last 4 weeks prior to V1 and during the study, according to investigator's jugdement:
- Drugs or supplements that can influence SBP or DBP (e.g. ACE inhibitors, diuretics, calcium channel or ß-blockers, grape seed extract, coenzyme Q10 etc.)
- Lipid lowering drugs (affecting lipid metabolism, platelet function or antioxidant status, etc.) or dietary or health supplements (e.g. omega-3 fatty acids, green tea extract, calcium, red yeast rice, phytosterols (incl. enriched products such as e.g. Becel), oat fiber, niacin, soy protein, psyllium seed husk, glucomannan, chitosan or probiotics/prebiotics)
- Drugs that can significantly influence cholesterol levels (e.g. corticosteroids, amiodarone, anabolic steroids)
- Medications (e.g. statins, renin angiotensin system inhibitors, nebivolol, carvedilol, calcium channel blockers) or supplements (e.g. cocoa) that can influence vascular endothelial function and/or blood flow within the last 4 weeks prior to V1 and during the study
- Antiplatelet agents and / or anticoagulants (e.g. warfarin, acetylsalicylic acid)
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
analyze & realize GmbH
Berlin, 10369
Ralf Uebelhack, MD, 0049 3040 00 8 ext. 1 23, ruebelhack@analyze-realize.com
Udo Bongartz, MD, 0049 3040 00 8 ext. 543, UBongartz@a-r.com
- Not yet recruiting
BioTeSys GmbH
Esslingen am Neckar, Baden Würtemberg, 73728
Daniel Menzel, MD, 0049 71135138 ext. 36, m.studie@biotesys.de
Jasmin Steudle, 004971135138 ext. 36, m.studie@biotesys.de
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Benefit and Tolerability of WAK2017 on Endothelial Function, Blood Pressure and Lipid Profile
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.
Read the detailed description
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:
- EndoPAT AI at V4 vs. V2
- SBP at V3, V4 vs. V2, respectively
- DBP at V3, V4 vs. V2, respectively
- Fasting LDL-C concentrations and non-HDL-C at V3, V4 vs. V2, respectively
- Fasting TC concentrations at V3, V4 vs. V2, respec-tively
- Fasting HDL-C concentrations at V3, V4 vs. V2, respectively
- Fasting TG concentrations at V3, V4 vs. V2, respectively
- Fasting LDL-C/HDL-C and TC/HDL-C ratio at V3, V4 vs. V2, respectively
- SCORE value at V3, V4 vs. V2, respectively
- Global evaluation of benefit by the subjects/ investigator at V4
- Conditions
- Endothelial Function, Blood Pressure, Lipid Metabolism
- Being tested
- WAK2017, Placebo
- Keywords
- Endothelial function, Blood pressure, Lipid metabolism, EndoPAT score RHI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WAK2017Dietary 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
PlaceboDietary supplement
Also called Placebo for WAK2017
One (1) ml IP should be taken with breakfast and one (1) ml with supper every day
| Study group | Role | What they receive |
|---|---|---|
| Verum | Active comparator | WAK2017 One (1) ml IP should be taken with breakfast and one (1) ml with supper every day. Receives: Dietary Supplement: WAK2017 |
| 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Visit 2 and Visit 4 after 84 days ± 6 days after Visit 2
Secondary outcomes (22)
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
Measured: Visit 2 and Visit 4 after 84 days ± 6 days after Visit 2
Systolic Blood Pressure
Change in Systolic Blood Pressure after 6 weeks ± 3 Visit 2 versus Visit 3
Measured: 42 days ± 3
Diastolic Blood Pressure
Change in Diastolic Blood Pressure after 6 weeks ± 3 Visit 2 versus Visit 3
Measured: 42 days ± 3
Systolic Blood Pressure
Change in Systolic Blood Pressure after 12 weeks ± 6 Visit 2 versus Visit 4
Measured: 84 weeks ± 6
Diastolic Blood Pressure
Change in Diastolic Blood Pressure after 12 weeks ± 6 Visit 2 versus Visit 4
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 84 days ± 6
LDL-C/HDL-C ratio
Change in LDL-C/HDL-C ratio after 6 weeks ± 3 Visit 2 versus Visit 3.
Measured: 42 days ± 3
LDL-C/HDL-C ratio
Change in LDL-C/HDL-C ratio after 12 weeks ± 6 Visit 2 versus Visit 4.
Measured: 84 days ± 6
TC/HDL-C ratio
Change in TC/HDL-C ratio after 6 weeks ± 3 Visit 2 versus Visit 3.
Measured: 42 days ± 3
TC/HDL-C ratio
Change in TC/HDL-C ratio after 12 weeks ± 6 Visit 2 versus Visit 4.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 84 days ± 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start28 Jul 2017
- Primary completion1 Apr 2018 (estimated)
- Study completion15 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, parallel-group study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Analyze & Realize
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Ralf Uebelhack, MD, Principal investigator, analyze & realize GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287518
- Sponsor's protocol ID
- WOA/002017
- Status last verified
- Oct 2017
- First submitted
- 8 Sep 2017
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Benefit and Tolerability of WAK2017 on Endothelial Function, Blood Pressure and Lipid Profile
- ClinicalTrials.gov ID
- NCT03287518
- Acronym / sponsor ID
- WOA/002017
- Conditions
- Endothelial Function, Blood Pressure, Lipid Metabolism
- Keywords
- Endothelial function, Blood pressure, Lipid metabolism, EndoPAT score RHI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Analyze & RealizeResearch network
- Study start
- 28 Jul 2017 (actual)
- Primary completion
- 1 Apr 2018 (estimated)
- Study completion
- 15 Sep 2018 (estimated)
- First posted
- 19 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- EndoPAT AI at V4 vs. V2
- SBP at V3, V4 vs. V2, respectively
- DBP at V3, V4 vs. V2, respectively
- Fasting LDL-C concentrations and non-HDL-C at V3, V4 vs. V2, respectively
- Fasting TC concentrations at V3, V4 vs. V2, respec-tively
- Fasting HDL-C concentrations at V3, V4 vs. V2, respectively
- Fasting TG concentrations at V3, V4 vs. V2, respectively
- Fasting LDL-C/HDL-C and TC/HDL-C ratio at V3, V4 vs. V2, respectively
- SCORE value at V3, V4 vs. V2, respectively
- Global evaluation of benefit by the subjects/ investigator at V4
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, parallel-group study
| Arm | Type | Receives |
|---|---|---|
| Verum | Active comparator | Dietary Supplement: WAK2017WAK2017 One (1) ml IP should be taken with breakfast and one (1) ml with supper every day. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
Key exclusion criteria (38 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WAK2017WAK2017 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 | Dietary supplement | Verum |
| PlaceboAlso: Placebo for WAK2017One (1) ml IP should be taken with breakfast and one (1) ml with supper every day | Dietary supplement | Placebo |
Primary outcome
Endo-PAT RHI value
Time frame: Visit 2 and Visit 4 after 84 days ± 6 days after Visit 2
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
22 secondary outcomes
EndoPAT Augmentation Index (AI)
Time frame: Visit 2 and Visit 4 after 84 days ± 6 days after Visit 2
Systolic Blood Pressure
Time frame: 42 days ± 3
Diastolic Blood Pressure
Time frame: 42 days ± 3
Systolic Blood Pressure
Time frame: 84 weeks ± 6
Diastolic Blood Pressure
Time frame: 84 days ± 6
Low Density Lipoprotein cholestorol (LDL-C)
Time frame: 42 days ± 3
Low Density Lipoprotein cholestorol (LDL-C)
Time frame: 84 days ± 6
non-High Density Lipoprotein cholestorol (non-HDL-C)
Time frame: 42 days ± 3
non-High Density Lipoprotein cholestorol (non-HDL-C)
Time frame: 84 days ± 6
Total Cholestorol (TC)
Time frame: 42 days ± 3
Total Cholestorol (TC)
Time frame: 84 days ± 6
High Density Lipoprotein cholestorol (HDL-C)
Time frame: 42 days ± 3
High Density Lipoprotein cholestorol (HDL-C)
Time frame: 84 days ± 6
Triglycerides (TG)
Time frame: 42 days ± 3
Triglycerides (TG)
Time frame: 84 days ± 6
LDL-C/HDL-C ratio
Time frame: 42 days ± 3
LDL-C/HDL-C ratio
Time frame: 84 days ± 6
TC/HDL-C ratio
Time frame: 42 days ± 3
TC/HDL-C ratio
Time frame: 84 days ± 6
SCORE Value
Time frame: 42 days ± 3
SCORE Value
Time frame: 84 days ± 6
Global Evaluation of benefit
Time frame: 84 days ± 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
- Homepage for study site in BerlinLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralf Uebelhack, MD principal investigator
analyze & realize GmbH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WAK2017 in people with Endothelial Function and Blood Pressure, run by Analyze & Realize at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maya Ulbricht (0049 3040 00 8 ext. 1 62, mulbricht@a-r.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endo-PAT RHI value (time frame: Visit 2 and Visit 4 after 84 days ± 6 days after Visit 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2017.