Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Mean Percentage Change in Methemoglobin Over 12 Weeks |
A blood sample was drawn for each participant to measure the levels of methemoglobin. The mean percentage change between baseline, 6 weeks and 12 weeks in methemoglobin with 95% CI was calculated using linear mixed effects model. |
Baseline, 6 weeks, 12 weeks |
|
Other |
Mean Change in Isoquercetin Over 12 Weeks |
A blood sample was drawn for each participant to measure the levels of isoquercetin. The mean changes between baseline, 6 weeks and 12 weeks in isoquercetin with 95% CI were calculated using linear mixed effects model. |
Baseline, 6 weeks, 12 weeks |
|
Other |
Mean Change in Plasma Nitrite Over 12 Weeks |
A blood sample was drawn for each participant to measure the levels of plasma nitrite. The mean changes between baseline, 6 weeks and 12 weeks in plasma nitrite with 95% CI were calculated using linear mixed effects model. |
Baseline, 6 weeks, 12 weeks |
|
Other |
Mean Change in Estimated-Glomerular Filtration Rate (eGFR) Over 12 Weeks |
Estimated-Glomerular Filtration Rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation. The equation is GFR = 141 * min(Scr/?,1)a * max(Scr/?, 1)-1.209 * 0.993Age * 1.018 [if female] * 1.159 [if black]. Scr is serum creatinine (mg/dL), ? is 0.7 for females and 0.9 for males, a is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/? or 1, and max indicates the maximum of Scr/? or 1. The mean changes between baseline, 6 weeks and 12 weeks in eGFR with 95% CI were calculated using linear mixed effects model. |
Baseline, 6 weeks, 12 weeks |
|
Other |
Mean Change in Lipid Profile Biomarkers Total Cholesterol, Low Density Lipoprotein (LDL)-Cholesterol and High Density Lipoprotein (HDL)-Cholesterol Over 12 Weeks |
A blood sample was drawn for each participant to measure the levels of total cholesterol, Low Density Lipoprotein (LDL)-cholesterol and High Density Lipoprotein (HDL)-cholesterol. The mean changes between baseline and 12 weeks in total cholesterol, Low Density Lipoprotein (LDL)-cholesterol and High Density Lipoprotein (HDL)-cholesterol with 95% CI were calculated using linear mixed effects model. |
Baseline,12 weeks |
|
Other |
Mean Change in Lipid Profile Biomarker Triglycerides Over 12 Weeks |
A blood sample was drawn for each participant to measure the levels of triglycerides. The mean changes between baseline and 12 weeks in triglycerides with 95% CI were calculated using linear mixed effects model, and the log transformed triglyceride was calculated. |
Baseline,12 weeks |
|
Other |
Mean Change in Hemoglobin Over 12 Weeks |
A blood sample was drawn for each participant to measure the levels of hemoglobin. The mean changes between baseline, 6 weeks and 12 weeks in hemoglobin with 95% CI were calculated using linear mixed effects model. |
baseline, 6 weeks, 12 weeks |
|
Other |
Mean Change in Plasma Nitrate Over 12 Weeks |
A blood sample was drawn for each participant to measure the levels of plasma nitrate. The mean changes between baseline, 6 weeks and 12 weeks in plasma nitrate with 95% CI were calculated using linear mixed effects model. |
Baseline, 6 weeks, 12 weeks |
|
Other |
Mean Change in Urinary Albumin-to-creatinine Ratios Over 12 Weeks |
A urine sample was taken for each participant to measure the levels of urinary albumin-to-creatinine ratios. The mean changes between baseline, 6 weeks and 12 weeks in urinary albumin-to-creatinine ratios with 95% CI were calculated using linear mixed effects model, and the log transformed urinary albumin-to-creatinine ratios was calculated. |
Baseline, 6 weeks, 12 weeks |
|
Other |
Mean Change in Blood Pressure Over 12 Weeks |
Blood pressure was measured using the OMRON HEM-907 XL BP Monitor per standard protocol by trained and certified research staff. The mean changes between baseline, 6 weeks and 12 weeks in blood pressure with 95% CI were calculated using linear mixed effects model. |
Baseline, 6 weeks, 12 weeks |
|
Other |
Mean Change in Pulse Over 12 Weeks |
Pulse was measured at the brachial artery per standard protocol by trained and certified research staff. The mean changes between baseline, 6 weeks and 12 weeks in pulse with 95% CI were calculated using linear mixed effects model. |
Baseline, 6 weeks, 12 weeks |
|
Primary |
Mean Percentage Change in Endothelium-dependent Flow-mediated Vasodilation (FMD) Over 12 Weeks |
FMD was measured using high resolution ultrasound on the brachial artery. FMD was calculated as the maximal percentage change in vessel size during hyperemia . The mean changes between baseline, 6 weeks and 12 weeks in FMD with 95% CI were calculated using linear mixed effects model. |
Baseline, 6 weeks, 12 weeks |
|
Secondary |
Mean Change in Endothelial Function Biomarkers VCAM-1, ICAM-1, E-selectin and vWF Over 12 Weeks |
A blood sample was drawn for each participant to measure the levels of Vascular Adhesion Molecule-1(VCAM-1), Intercellular Adhesion Molecule-1 (ICAM-1), E-selectin, and von Willebrand Factor (vWF). The mean changes between baseline, 6 weeks and 12 weeks in VCAM-1, ICAM-1, E-selectin and vWF with 95% CI were calculated using linear mixed effects model. |
Baseline, 6 weeks, 12 weeks |
|
Secondary |
Mean Change in Endothelial Function Biomarker Asymmetrical DiMethylArginine (ADMA) Over 12 Weeks |
A blood sample was drawn for each participant to measure the levels of Asymmetrical DiMethylArginine (ADMA). The mean changes between baseline, 6 weeks and 12 weeks in ADMA with 95% CI were calculated using linear mixed effects model. |
Baseline, 6 weeks, 12 weeks |
|
Secondary |
Mean Change in Endothelial Function Biomarker Endostatin Over 12 Weeks |
A blood sample was drawn for each participant to measure the levels of endostatin. The mean changes between baseline, 6 weeks and 12 weeks in endostatin with 95% CI were calculated using linear mixed effects model, and the log transformed endostatin was calculated. |
Baseline, 6 weeks, 12 weeks |
|
Secondary |
Mean Change in Endothelial Function Biomarker Urine Epidermal Growth Factor (UEGF) Over 12 Weeks |
A urine sample was taken for each participant to measure the levels of Urine Epidermal Growth Factor (UEGF). The mean changes between baseline, 6 weeks and 12 weeks in UEGF with 95% CI were calculated using linear mixed effects model, and the log transformed Urine EGF/creatinine ratio was calculated. |
Baseline, 6 weeks, 12 weeks |
|
Secondary |
Mean Change in Inflammatory Biomarker C-Reactive Protein (CRP) Over 12 Weeks |
A blood sample was drawn for each participant to measure the levels of C-Reactive Protein (CRP). The mean changes between baseline, 6 weeks and 12 weeks in CRP with 95% CI were calculated using linear mixed effects model. |
Baseline, 6 weeks, 12 weeks |
|
Secondary |
Mean Change in Inflammatory Biomarkers Tumor Necrosis Factor-a (TNF-a), Interleukin-17 (IL-17), Interleukin-1ß (IL-1beta), and Monocyte Chemoattractant Protein-1 (MCP-1) Over 12 Weeks |
A blood sample was drawn for each participant to measure the levels of Tumor Necrosis Factor-a (TNF-a), interleukin-17 (IL-17), interleukin-1ß (IL-1beta), and Monocyte Chemoattractant Protein-1 (MCP-1). The mean changes between baseline, 6 weeks and 12 weeks in TNF-a, IL-17, IL-1beta, MCP-1 with 95% CI were calculated using linear mixed effects model. |
Baseline, 6 weeks, 12 weeks |
|
Secondary |
Mean Change in Inflammatory Biomarker Interleukin-6 (IL-6) Over 12 Weeks |
A blood sample was drawn for each participant to measure the levels of interleukin-6 (IL-6). The mean changes between baseline, 6 weeks and 12 weeks in interleukin-6 (IL-6) with 95% CI were calculated using linear mixed effects model, and the log transformed IL-6 was calculated. |
Baseline, 6 weeks, 12 weeks |
|
Secondary |
Mean Change in Oxidative Stress Biomarker Low-density Lipoprotein (LDL) Over 12 Weeks |
A blood sample was drawn for each participant to measure the levels of low-density lipoprotein (LDL). The mean changes between baseline, 6 weeks and 12 weeks in LDL with 95% CI were calculated using linear mixed effects model. |
Baseline, 6 weeks, 12 weeks |
|
Secondary |
Mean Change in Oxidative Stress Biomarker Nitrotyrosine Over 12 Weeks |
A blood sample was drawn for each participant to measure the levels of nitrotyrosine. The mean changes between baseline, 6 weeks and 12 weeks in nitrotyrosine with 95% CI were calculated using linear mixed effects model. |
Baseline, 6 weeks, 12 weeks |
|