Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 13GRNT16490002 | Other Grant/Funding Number | American Heart Association |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| American Heart Association | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The overarching question addressed in the current project is: Does dietary nitrate supplementation (8 weeks) improve physiological function in patients with peripheral arterial disease (PAD)? The investigators will specifically address whether dietary nitrate supplementation enhances blood vessel function, blood pressure regulation, and exercise capacity. The proposed project uses an array of clearly defined measurements which will allow investigators to quantify blood vessel function (vasodilator responsiveness and arterial stiffness), blood pressure (variability and responsiveness to stress), and functional capacity before and after 8 weeks of dietary supplementation.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium Nitrate | Experimental | Sodium Nitrate (1g/day) for 8 weeks |
|
| Placebo capsule | Placebo Comparator | Microcrystalline cellulose (daily) for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Nitrate | Dietary Supplement | Sodium Nitrate (1g/day) for 8 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Vasodilator Capacity | Forearm and calf blood flow will be measured independently by venous occlusion plethysmography using mercury-in-silastic strain gauges. Plethysmographic measurements will be made at rest and following 5 minutes of ischemia (reactive hyperemia) of the distal limb (forearm and calf). Peak blood flow will be determined as the highest flow recorded during the post deflation period. Total blood flow will be measured as the area under the time-curve after resting flow is subtracted. Vascular conductance will be calculated using blood flow/mean arterial pressure (via finger plethysmograph). | Pre and post 8 weeks of dietary nitrate supplementation |
| Change in Arterial Stiffness | ECG gated arterial waveforms will be obtained via applanation tonometry from the carotid and femoral arteries. The pulse wave velocity (PWV; index of arterial stiffness) will be determined between the carotid and femoral measurement sites (cfPWV). The time (t) between the feet of recorded pressure waves will be determined as the mean of 10 consecutive cardiac cycles. PWV is calculated from the distance (D; meters) between measurement points and the measured time delay (t): PWV = D/Δt (m/s). | Pre and post 8 weeks of dietary nitrate supplementation |
| Change in Functional Capacity - Distance Walked in 6 Minutes | 6-minute walk tests will be performed before and after treatment to assess functional capacity. The main comparisons will be changes distance walked in 6 minutes after 8 weeks of dietary nitrate supplementation. | Pre and post 8 weeks of dietary nitrate supplementation |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Darren P Casey, Ph.D. | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35090799 | Derived | Hughes WE, Treichler DP, Ueda K, Bock JM, Casey DP. Sodium nitrate supplementation improves blood pressure reactivity in patients with peripheral artery disease. Nutr Metab Cardiovasc Dis. 2022 Mar;32(3):710-714. doi: 10.1016/j.numecd.2021.12.002. Epub 2021 Dec 8. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sodium Nitrate (NaNO3) | Subjects randomized to this group took Sodium Nitrate capsules (1g/day) for 8 weeks |
| FG001 | Placebo | Subjects randomized to this group took a daily Placebo capsule (Microcrystalline cellulose) for 8 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sodium Nitrate (NaNO3) | Subjects randomized to this group took Sodium Nitrate capsules (1g/day) for 8 weeks |
| BG001 | Placebo | Subjects randomized to this group took a daily Placebo capsule (Microcrystalline cellulose) for 8 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Vasodilator Capacity | Forearm and calf blood flow will be measured independently by venous occlusion plethysmography using mercury-in-silastic strain gauges. Plethysmographic measurements will be made at rest and following 5 minutes of ischemia (reactive hyperemia) of the distal limb (forearm and calf). Peak blood flow will be determined as the highest flow recorded during the post deflation period. Total blood flow will be measured as the area under the time-curve after resting flow is subtracted. Vascular conductance will be calculated using blood flow/mean arterial pressure (via finger plethysmograph). | Calf blood flow measures were only performed in 11 of the subjects in the NaNO3 group and 7 of the subjects in the Placebo group. | Posted | Mean | Standard Deviation | ml/100ml tissue/min | Pre and post 8 weeks of dietary nitrate supplementation |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sodium Nitrate (NaNO3) Pre | Subjects randomized to this group took Sodium Nitrate capsules (1g/day) for 8 weeks Values reflect pre intervention measures |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Darren P. Casey | University of Iowa | darren-casey@uiowa.edu |
Not provided
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C031618 | sodium nitrate |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Other |
Microcrystalline cellulose (daily) for 8 weeks |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Ankle-brachial index (ABI) | Ankle Brachial Index (ABI) is the ratio of the blood pressure in the lower legs to the blood pressure in the arms. Compared to the arm, lower blood pressure in the leg may be a symptom of peripheral artery disease (PAD) or a blockage in the leg. Ranges for ABI values are: No blockage (1.0 to 1.4) Borderline blockage (0.91 to 0.99). An ankle-brachial index number is this range indicates that you have borderline PAD. PAD (less than 0.90). An ankle-brachial index number in this range is considered abnormal and indicates a diagnosis of PAD. | Mean | Standard Deviation | ratio |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
Subjects randomized to this group took Sodium Nitrate capsules (1g/day) for 8 weeks Values reflect pre intervention measures
| OG001 | Sodium Nitrate (NaNO3) Post | Subjects randomized to this group took Sodium Nitrate capsules (1g/day) for 8 weeks Values reflect post intervention measures |
| OG002 | Placebo - Pre | Subjects randomized to this group took a daily Placebo capsule (Microcrystalline cellulose) for 8 weeks Values reflect pre intervention measures |
| OG003 | Placebo - Post | Subjects randomized to this group took a daily Placebo capsule (Microcrystalline cellulose) for 8 weeks Values reflect post intervention measures |
|
|
| Primary | Change in Arterial Stiffness | ECG gated arterial waveforms will be obtained via applanation tonometry from the carotid and femoral arteries. The pulse wave velocity (PWV; index of arterial stiffness) will be determined between the carotid and femoral measurement sites (cfPWV). The time (t) between the feet of recorded pressure waves will be determined as the mean of 10 consecutive cardiac cycles. PWV is calculated from the distance (D; meters) between measurement points and the measured time delay (t): PWV = D/Δt (m/s). | We were only able to obtain quality PWV measures in 11 subjects in the sodium nitrate group and 6 in the placebo group. | Posted | Mean | Standard Deviation | m/sec | Pre and post 8 weeks of dietary nitrate supplementation |
|
|
|
| Primary | Change in Functional Capacity - Distance Walked in 6 Minutes | 6-minute walk tests will be performed before and after treatment to assess functional capacity. The main comparisons will be changes distance walked in 6 minutes after 8 weeks of dietary nitrate supplementation. | Posted | Mean | Standard Deviation | meters | Pre and post 8 weeks of dietary nitrate supplementation |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Sodium Nitrate (NaNO3) Post | Subjects randomized to this group took Sodium Nitrate capsules (1g/day) for 8 weeks Values reflect post intervention measures | 0 | 13 | 0 | 13 | 0 | 13 |
| EG002 | Placebo - Pre | Subjects randomized to this group took a daily Placebo capsule (Microcrystalline cellulose) for 8 weeks Values reflect pre intervention measures | 0 | 8 | 0 | 8 | 0 | 8 |
| EG003 | Placebo - Post | Subjects randomized to this group took a daily Placebo capsule (Microcrystalline cellulose) for 8 weeks Values reflect post intervention measures | 0 | 8 | 0 | 8 | 0 | 8 |
Not provided
Not provided
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D001519 | Behavior |
| Title | Measurements |
|---|---|
|