NCT02148198

Effect of NWT-03 on Blood Pressure - Part 1

A Study of Two Parts to Determine the Effect of NWT-03 on Blood Pressure in Healthy Subjects. Part 1: A Dose Ranging, Cross-over Study to Determine the Effect of 1g, 2g & 5gs of NWT-03 Versus Placebo on Blood Pressure in Healthy Subjects.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Newtricious R&D BV · Industry
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Part 1 of the study will assess the effect of 1g, 2g and 5g doses of NWT-03 on systolic and diastolic blood pressure in a cross-over designed study in healthy adults with normal, high normal and mild hypertension. Based on results from this study, one dose will be selected for a placebo controlled parallel study assessing a single dose of NWT-03 on systolic and diastolic blood pressure and endothelial function in a similar population.

Conditions

• Blood Pressure

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	NWT-03, an egg-white protein hydrolysate	For placebo comparator, a combination of sweetener + aroma, which was equal to the combination used in the intervention period, was given
DIETARY_SUPPLEMENT	Placebo	A combination of sweetener + aroma, which was equal to the combination used in the intervention period was given as placebo comparator.

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-07-01
• First posted: 2014-05-28
• Last updated: 2014-05-28