Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NWT-03, then placebo | Other | 4 weeks 2g NWT-03 followed by placebo , separated by a 4wk wash-out period |
|
| Placebo, then NWT-03 | Other | 4 weeks placebo followed by 2g NWT-03, separated by a 4wk wash-out period |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in daytime systolic blood pressure at 4 and 8 weeks | For both intervention periods: 48h ABPM before baseline visit, 4 and 8 weeks after baseline visit |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in daytime diastolic blood pressure at 4 and 8 weeks | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Vitals (weight, height, BMI) | During screening (up to 4 weeks before baseline) | |
| eGFR | Each period: 48h before baseline and week 8 |
Inclusion Criteria:
Exclusion Criteria:
Subjects will be excluded from the study if they meet any of the below criteria;
Are less than 35 and greater than 75 years of age,
Females are pregnant, lactating or wish to become pregnant during the study. Female subject is currently either of:
non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or any female who is surgically sterilized (via documented hysterectomy or bilateral tubal ligation). (For purposes of this study, postmenopausal is defined as one year without menses), OR
child bearing potential, the subject is eligible to enter and participate in this study if she is not lactating and has a negative urine pregnancy test at the screening visit, visit 2 and upon completion of the study at visit 7. The subject must also agree to one of the following methods of contraception:
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 than 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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlantia Food CRO | Cork | Ireland |
Not provided
| ID | Term |
|---|---|
| D000419 | Albuminuria |
| ID | Term |
|---|---|
| D011507 | Proteinuria |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C579614 | NWT-03 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Dietary Supplement | A combination of sweetener + aroma , which was equal to the combination used in the intervention period, was given. |
|
| Both periods: at baseline and after 8 weeks |
| Change from 48 before baseline in albuminuria at 8 weeks | For each period: 48h before baseline and 8 weeks after baseline |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |