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
The primary purpose of this project is to assess the efficacy (effectiveness) of plant-based nitrate tablets to elevate nitric oxide in your system as measured by saliva and effect on lowering blood pressure (BP), supporting blood vessel function in men and women with hypertension.
This clinical trial is to assess the efficacy of plant-based bioequivalent Nitric Oxide supplement for improving blood pressure and endothelial reactivity over a 12 weeks intervention period in individuals with metabolic syndrome. The study also examines the effect of plant-based bioequivalent Nitric Oxide supplement on other markers of cardiovascular function and cardiovascular disease risk including Total, LDL and HDL-Cholesterol, Triglycerides, and a multitude of inflammatory markers.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| plant based bioequivalent dietary nitrate supplement | Active Comparator | The nitrate supplement consists of nitrate-rich beetroot extract 20mg, thiamine mononitrate 90mg, potassium nitrate 480mg, ascorbic acid 150mg, folic acid 200mcg, methylcobalamin 200mcg, calcium 115mg, pomegranate fruit extract 5mg and green coffee bean extract 115mg. |
|
| placebo | Placebo Comparator | The Placebo does not contain any nitric oxide supplement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plant based bioequivalent Nitrate supplementation | Dietary Supplement | The nitrate supplement consists of nitrate-rich beetroot extract 20mg, thiamine mononitrate 90mg, potassium nitrate 480mg, ascorbic acid 150mg, folic acid 200mcg, methylcobalamin 200mcg, calcium 115mg, pomegranate fruit extract 5mg and green coffee bean extract 115mg. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of change in blood pressure | change in blood pressure (in millimeters of mercury) over twelve weeks under effect of active treatment and placebo | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| changes in serum, plasma and salivary Nitrite and Nitrate | change in serum nitrate and nitrate levels (in mcg) over 12 weeks comparing active treatment to placebo | 12 weeks |
| cardiometabolic relevant biomarkers (as compared to placebo) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center | Torrance | California | 90502 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33183558 | Derived | Cherukuri L, Birudaraju D, Kinninger A, Chaganti BT, Shekar C, Hamal S, Shaikh K, Flores F, Roy SK, Sotka W, Green SJ, Budoff MJ. Effect of a plant-based bioequivalent inorganic nitrate (NO3-) complex with vitamins, antioxidants and phytophenol rich food extracts in hypertensive individuals - A randomized, double-blind, placebo-controlled study. Clin Nutr ESPEN. 2020 Dec;40:327-335. doi: 10.1016/j.clnesp.2020.08.007. Epub 2020 Sep 7. |
Not provided
Not provided
Not provided
Double Blind Placebo Controlled
Not provided
Not provided
Not provided
|
| Placebo | Dietary Supplement | Placebo |
|
measures of serum markers of inflammation (Crp) and glucose over 12 weeks in active vs placebo arms
| 12 weeks |