Clinical Trial: Effect of NWT-03 on Blood Pressure
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Study of Two Parts to Determine the Effect of NWT-03 on Blood Pressure in Healthy Subjects
Brief Summary: Part 2 of the study will assess the effect of 2g of NWT-03 (an egg-white protein hydrolysate) on systolic and diastolic blood pressure and flow-mediated dilation in a crossover designed study in healthy adults with mild hypertension.
Detailed Summary:
Sponsor: Newtricious R&D BV
Current Primary Outcome: Change from baseline in daytime systolic blood pressure at 4 and 8 weeks [ Time Frame: For both intervention periods: 48h ABPM before baseline visit, 4 and 8 weeks after baseline visit ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change from baseline in daytime diastolic blood pressure at 4 and 8 weeks [ Time Frame: For both intervention periods: 48h ABPM before baseline visit, 4 and 8 weeks after baseline visit ]
- Change from baseline in flow-mediated dilation (only for n=10 subgroup) at 8 weeks [ Time Frame: Both periods: at baseline and after 8 weeks ]
- Change from 48 before baseline in albuminuria at 8 weeks [ Time Frame: For each period: 48h before baseline and 8 weeks after baseline ]
Original Secondary Outcome: Same as current
Information By: Newtricious R&D BV
Dates:
Date Received: November 6, 2013
Date Started: October 2013
Date Completion:
Last Updated: May 22, 2014
Last Verified: May 2014
