The proposed research will determine the effectiveness of nitrite, a naturally occurring compound in the body, for improving the health and function of arteries in middle-aged and older adults. The study also will provide insight into how sodium nitrite therapy improves artery health by determining the physiological mechanisms (biological reasons) involved. Overall, the proposed research will provide important new scientific evidence on the effectiveness of sodium nitrite for decreasing the risk of developing cardiovascular diseases with aging.
The improvement in blood vessel function and stiffness will be determined over a 10 week period. Subjects will be randomly assigned to either placebo (0 mg/day), low dose (80 mg/day) or high dose (160 mg/day) sodium nitrite. Main outcome measures will be performed at baseline and week 10.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
33
Sugar pill manufactured to mimic sodium nitrite capsules
80 mg/d or 160 mg/d
Clinical Translational Research Center
Boulder, Colorado, United States
Baseline and Week 10 Flow-Mediated Dilation
Brachial artery flow mediated dilation (FMD) is assessed prior to entering the study. If subjects pass the inclusion requirements, FMD is analyzed at baseline and week 10. Flow-Mediated Dilation is calculated as the percent change in artery diameter in response to 5 minutes of cuff occlusion at Baseline and Week 10 timepoints; i.e. (Peak Diameter-Baseline Diameter)/Baseline Diameter x 100.
Time frame: Baseline (Week 0), Week 10
Baseline and Week 10 Plasma Nitrite Concentrations
Time frame: Baseline (Week 0), Week 10
Baseline and Week 10 Aortic Pulse Wave Velocity
Time frame: Baseline (Week 0), Week 10
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