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Trial Outcomes & Findings for Dietary Nitrates and Vascular Function in Patients With Peripheral Artery Disease (NCT NCT01983826)

NCT ID: NCT01983826

Last Updated: 2019-06-03

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

Pre and post 8 weeks of dietary nitrate supplementation

Results posted on

2019-06-03

Participant Flow

Participant milestones

Participant milestones
Measure
Sodium Nitrate (NaNO3)
Subjects randomized to this group took Sodium Nitrate capsules (1g/day) for 8 weeks
Placebo
Subjects randomized to this group took a daily Placebo capsule (Microcrystalline cellulose) for 8 weeks
Overall Study
STARTED
13
8
Overall Study
COMPLETED
13
8
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dietary Nitrates and Vascular Function in Patients With Peripheral Artery Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Sodium Nitrate (NaNO3)
n=13 Participants
Subjects randomized to this group took Sodium Nitrate capsules (1g/day) for 8 weeks
Placebo
n=8 Participants
Subjects randomized to this group took a daily Placebo capsule (Microcrystalline cellulose) for 8 weeks
Total
n=21 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
2 Participants
n=5 Participants
3 Participants
n=7 Participants
5 Participants
n=5 Participants
Age, Categorical
>=65 years
11 Participants
n=5 Participants
5 Participants
n=7 Participants
16 Participants
n=5 Participants
Age, Continuous
73 years
STANDARD_DEVIATION 9 • n=5 Participants
69 years
STANDARD_DEVIATION 10 • n=7 Participants
72 years
STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male
Female
6 Participants
n=5 Participants
6 Participants
n=7 Participants
12 Participants
n=5 Participants
Sex: Female, Male
Male
7 Participants
n=5 Participants
2 Participants
n=7 Participants
9 Participants
n=5 Participants
Region of Enrollment
United States
13 Participants
n=5 Participants
8 Participants
n=7 Participants
21 Participants
n=5 Participants
Body Mass Index
29.2 kg/m^2
STANDARD_DEVIATION 5.9 • n=5 Participants
28.1 kg/m^2
STANDARD_DEVIATION 3.6 • n=7 Participants
28.8 kg/m^2
STANDARD_DEVIATION 5.1 • n=5 Participants
Ankle-brachial index (ABI)
0.76 ratio
STANDARD_DEVIATION 0.21 • n=5 Participants
0.81 ratio
STANDARD_DEVIATION 0.14 • n=7 Participants
0.78 ratio
STANDARD_DEVIATION 0.18 • n=5 Participants
Systolic Blood Pressure
136 mmHg
STANDARD_DEVIATION 15 • n=5 Participants
132 mmHg
STANDARD_DEVIATION 13 • n=7 Participants
135 mmHg
STANDARD_DEVIATION 14 • n=5 Participants
Diastolic Blood Pressure
72 mmHg
STANDARD_DEVIATION 9 • n=5 Participants
77 mmHg
STANDARD_DEVIATION 10 • n=7 Participants
74 mmHg
STANDARD_DEVIATION 10 • n=5 Participants

PRIMARY outcome

Timeframe: Pre and post 8 weeks of dietary nitrate supplementation

Population: 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.

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).

Outcome measures

Outcome measures
Measure
Sodium Nitrate (NaNO3) Pre
n=13 Participants
Subjects randomized to this group took Sodium Nitrate capsules (1g/day) for 8 weeks Values reflect pre intervention measures
Sodium Nitrate (NaNO3) Post
n=13 Participants
Subjects randomized to this group took Sodium Nitrate capsules (1g/day) for 8 weeks Values reflect post intervention measures
Placebo - Pre
n=8 Participants
Subjects randomized to this group took a daily Placebo capsule (Microcrystalline cellulose) for 8 weeks Values reflect pre intervention measures
Placebo - Post
n=8 Participants
Subjects randomized to this group took a daily Placebo capsule (Microcrystalline cellulose) for 8 weeks Values reflect post intervention measures
Change in Vasodilator Capacity
Peak forearm Blood Flow
16.2 ml/100ml tissue/min
Standard Deviation 6.6
16.4 ml/100ml tissue/min
Standard Deviation 4.2
16.5 ml/100ml tissue/min
Standard Deviation 5.2
14.2 ml/100ml tissue/min
Standard Deviation 7.2
Change in Vasodilator Capacity
Peak calf Blood Flow
11.6 ml/100ml tissue/min
Standard Deviation 4.9
14.1 ml/100ml tissue/min
Standard Deviation 5.1
13.1 ml/100ml tissue/min
Standard Deviation 3.5
11.9 ml/100ml tissue/min
Standard Deviation 3.7

PRIMARY outcome

Timeframe: Pre and post 8 weeks of dietary nitrate supplementation

Population: We were only able to obtain quality PWV measures in 11 subjects in the sodium nitrate group and 6 in the placebo group.

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).

Outcome measures

Outcome measures
Measure
Sodium Nitrate (NaNO3) Pre
n=11 Participants
Subjects randomized to this group took Sodium Nitrate capsules (1g/day) for 8 weeks Values reflect pre intervention measures
Sodium Nitrate (NaNO3) Post
n=11 Participants
Subjects randomized to this group took Sodium Nitrate capsules (1g/day) for 8 weeks Values reflect post intervention measures
Placebo - Pre
n=6 Participants
Subjects randomized to this group took a daily Placebo capsule (Microcrystalline cellulose) for 8 weeks Values reflect pre intervention measures
Placebo - Post
n=6 Participants
Subjects randomized to this group took a daily Placebo capsule (Microcrystalline cellulose) for 8 weeks Values reflect post intervention measures
Change in Arterial Stiffness
13.8 m/sec
Standard Deviation 3.4
12.8 m/sec
Standard Deviation 2.9
10.5 m/sec
Standard Deviation 3.1
11.0 m/sec
Standard Deviation 3.7

PRIMARY outcome

Timeframe: Pre and post 8 weeks of dietary nitrate supplementation

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.

Outcome measures

Outcome measures
Measure
Sodium Nitrate (NaNO3) Pre
n=13 Participants
Subjects randomized to this group took Sodium Nitrate capsules (1g/day) for 8 weeks Values reflect pre intervention measures
Sodium Nitrate (NaNO3) Post
n=13 Participants
Subjects randomized to this group took Sodium Nitrate capsules (1g/day) for 8 weeks Values reflect post intervention measures
Placebo - Pre
n=8 Participants
Subjects randomized to this group took a daily Placebo capsule (Microcrystalline cellulose) for 8 weeks Values reflect pre intervention measures
Placebo - Post
n=8 Participants
Subjects randomized to this group took a daily Placebo capsule (Microcrystalline cellulose) for 8 weeks Values reflect post intervention measures
Change in Functional Capacity - Distance Walked in 6 Minutes
387 meters
Standard Deviation 90
425 meters
Standard Deviation 82
423 meters
Standard Deviation 56
427 meters
Standard Deviation 66

Adverse Events

Sodium Nitrate (NaNO3) Pre

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Sodium Nitrate (NaNO3) Post

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo - Pre

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo - Post

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Darren P. Casey

University of Iowa

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place