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Oral supplementation of Neo40(TM), a nitrate lozenge, will reduce blood pressure in healthy adults with clinical prehypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitric Oxide supplement | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitric Oxide supplement | Dietary Supplement | Lozenge consisting of beetroot and 75 mg caffeine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Systolic and Diastolic Blood Pressure Readings | Two blood pressure readings at rest will be taken at baseline and again after thirty days during the follow-up appointment. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Functional Capacity | Participant will take a six minute walk test at baseline and again after thirty days during the follow-up appointment. Achieved distances will be measured and recorded. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Quality of Life | Participants will fill out a standardized quality of life questionnaire at baseline and again after thirty days during the follow-up appointment. Summary component scores will be recorded and compared. | 30 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ernst Schwarz, MD, PhD | California Medical Institute, Cedars Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Medical Institute | Beverly Hills | California | 90211 | United States |
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| ID | Term |
|---|---|
| D058246 | Prehypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Placebo | Dietary Supplement | Same form factor and flavor as test lozenge but contains no active ingredients |
|