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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
92
For placebo comparator, a combination of sweetener + aroma, which was equal to the combination used in the intervention period, was given
A combination of sweetener + aroma, which was equal to the combination used in the intervention period was given as placebo comparator.
Change from baseline in average daytime systolic blood pressure at 5 days
Blood pressure will be measured two times for 48h during each intervention period; 48h before the baseline measurement and 5 days after baseline measurement.
Time frame: For both intervention periods: 48h ABPM before baseline visit and 5 days after baseline visit
Change from baseline in average daytime diastolic blood pressure at 5 days
Blood pressure will be measured two times for 48h during each intervention period; 48h before the baseline measurement and 5 days after baseline measurement.
Time frame: 48h ABPM before baseline visit and 5 days after baseline visit
Change from baseline in 48h systolic blood pressure at 5 days
Blood pressure will be measured two times for 48h during each intervention period; 48h before the baseline measurement and 5 days after baseline measurement.
Time frame: 48h ABPM before baseline visit and 5 days after baseline visit
Change from baseline in 48h diastolic blood pressure at 5 days
Blood pressure will be measured two times for 48h during each intervention period; 48h before the baseline measurement and 5 days after baseline measurement.
Time frame: 48h ABPM before baseline visit and 5 days after baseline visit
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