NCT03287518

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

Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Benefit and Tolerability of WAK2017 on Endothelial Function, Blood Pressure and Lipid Profile

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Analyze & Realize · Network
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	WAK2017	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
DIETARY_SUPPLEMENT	Placebo	One (1) ml IP should be taken with breakfast and one (1) ml with supper every day

Timeline

• Start date: 2017-07-28
• Primary completion: 2018-04-01
• Completion: 2018-09-15
• First posted: 2017-09-19
• Last updated: 2017-11-09

Locations

2 sites across 1 country: Germany