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Effect of NWT-03 on Blood Pressure - Part 1

NCT02148198 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2014-05-28

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Newtricious R&D BV

    lead INDUSTRY

Principal Investigators

  • Joseph Eustace, PhD · University College Cork

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2013-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02148198 on ClinicalTrials.gov