Effect of NWT-03 on Blood Pressure - Part 1 | NCT02148198

NCT02148198

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1g NWT-03, then placebo	Active Comparator	7 days 1g NWT-03, followed by 7 days placebo, separated by a 5-day wash-out period	Dietary Supplement: NWT-03, an egg-white protein hydrolysate Dietary Supplement: Placebo
placebo, then 1g NWT-03	Placebo Comparator	7 days placebo, followed by 7days 1g NWT-03, separated by a 5-day wash-out period	Dietary Supplement: NWT-03, an egg-white protein hydrolysate Dietary Supplement: Placebo
2g NWT-03, then placebo	Active Comparator	7 days 2g NWT-03, followed by 7 days placebo, separated by a 5-day wash-out period	Dietary Supplement: NWT-03, an egg-white protein hydrolysate Dietary Supplement: Placebo
placebo, then 2g NWT-03	Placebo Comparator	7 days placebo, followed by 7days 2g NWT-03, separated by a 5-day wash-out period	Dietary Supplement: NWT-03, an egg-white protein hydrolysate Dietary Supplement: Placebo
5g NWT-03, then placebo	Active Comparator	7 days 5g NWT-03, followed by 7 days placebo, separated by a 5-day wash-out period

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NWT-03, an egg-white protein hydrolysate	Dietary Supplement	For placebo comparator, a combination of sweetener + aroma, which was equal to the combination used in the intervention period, was given

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	For both intervention periods: 48h ABPM before baseline visit and 5 days after baseline visit

Secondary Outcomes

Measure	Description	Time Frame
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.	48h ABPM before baseline visit and 5 days after baseline visit
Change from baseline in 48h systolic blood pressure at 5 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Be able to give written informed consent,
Be between 35 and 75 years of age,
Be in generally good health as determined by the investigator,
Smokers and non-smokers are eligible,
Have a stable body weight (< 5% change) over the past 3-months,
Have a Body Mass Index (BMI) between 25 and 35 kg/m2,
Be: (a) Normotensive (Systolic Blood Pressure <130 mmHg & Diastolic Blood Pressure <85 mmHg), (b) High normotensive (Systolic Blood Pressure 130-139 mmHg & Diastolic Blood Pressure 85-89 mmHg) or (c) Mild hypertensive (Systolic Blood Pressure 140-159 mmHg & Diastolic Blood Pressure 90-99 mmHg).

Exclusion Criteria:

Are less than 35 and greater than 75 years of age,
Females are pregnant, lactating or wish to become pregnant during the study.
Are hypersensitive to any of the components of the test product,
Have a significant acute or chronic coexisting illness such as cardiovascular disease, Chronic kidney disease (CKD), gastrointestinal disorder, endocrinological disorder, immunological disorder, metabolic disease or any condition which contraindicates, in the investigators judgement, entry to the study,
Having a condition or have taken a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results; to include diuretics, blood pressure medication and medication interfering with renin-angiotensin-aldosterone system (RAAS), such as ACE-inhibitors, angiotensin receptor blockers, direct renin inhibitors or aldosterone receptor inhibitor,
Are taking non-steroidal anti-inflammatory drugs (NSAIDs) within 2 weeks of baseline visit or for the duration of the trial,
Suffer from diabetes mellitus, either type I and type II,
Consume more than the recommended alcohol guidelines i.e. >21 alcohol units/week for males and >14 units/week for females,
History of illicit drug use,
Use of nasal decongestants and other over-the counter or herbal preparation within 2 weeks of baseline visit and for the duration of the trial,
Heavy intake of coffee (i.e. more that 4 cups daily) within 2 weeks of baseline visit and for the duration of the trial,
Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial,
Subjects may not be receiving treatment involving experimental drugs,
If the subject has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study. An exception will be made where subjects have participated in part 1 of the study,
Have a malignant disease or any concomitant end-stage organ disease,