Evaluation of the Benefit and Tolerability of WAK2017 on Endothelial Function, Blood Pressure and Lipid Profile

NCT03287518 | Unknown

• 1 other identifier: WOA/002017
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Endothelial Function; Blood Pressure; Lipid Metabolism

Keywords

Endothelial function; Blood pressure; Lipid metabolism; EndoPAT score RHI

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (22)

• EndoPAT Augmentation Index (AI)

  Visit 2 and Visit 4 after 84 days ± 6 days after Visit 2

• Systolic Blood Pressure

  42 days ± 3

• Diastolic Blood Pressure

  42 days ± 3

• Systolic Blood Pressure

  84 weeks ± 6

• Diastolic Blood Pressure

  84 days ± 6

Study Arms (2)

Verum

ACTIVE COMPARATOR

WAK2017 One (1) ml IP should be taken with breakfast and one (1) ml with supper every day.

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.

Dietary Supplement: Placebo

Interventions

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

Verum

Placebo DIETARY_SUPPLEMENT

One (1) ml IP should be taken with breakfast and one (1) ml with supper every day

Also known as: Placebo for WAK2017

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• Analyze & Realize: lead

Study Sites (2)

BioTeSys GmbH

Esslingen am Neckar, Baden Würtemberg, 73728, Germany

NOT YET RECRUITING

analyze & realize GmbH

Berlin, 10369, Germany

RECRUITING

Related Links

• Homepage for study site in Berlin

Study Officials

• Ralf Uebelhack, MD

  analyze & realize GmbH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maya Ulbricht

CONTACT

0049 3040 00 8; mulbricht@a-r.com

Masaki Matsushita, PhD

CONTACT

+ 1 949 855 2776; mmatsushita@wakunaga.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind, placebo-controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, parallel-group study

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: September 19, 2017
• Study Start: July 28, 2017
• Primary Completion: April 1, 2018
• Study Completion: September 15, 2018
• Last Updated: November 9, 2017

Record last verified: 2017-10

Locations

DE (2)