Trial Outcomes & Findings for Effect of Beetroot Juice on Coronary Blood Flow and Walking Performance in PAD (NCT NCT02553733)
NCT ID: NCT02553733
Last Updated: 2026-08-13
Results Overview
Peak treadmill time was determined using the Gardner treadmill protocol, measured as the number of seconds the participant was able to walk until they asked to stop the test due to leg fatigue.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
4 to 6 days after initiating daily ingestion of beetroot juice
Results posted on
2026-08-13
Participant Flow
13 participants were screened for eligibility. 2 participants were excluded due to not meeting inclusion criteria. 11 participants were randomized. A total of 11 participants finished the entirety of the study (n=0 dropped out of the study once randomized).
Participant milestones
| Measure |
Beetroot Juice First, Then Placebo
Participants consumed 70 mL of beetroot juice (0.3 g inorganic nitrate) twice daily for 5-7 days during the first period, followed by a washout period, and then consumed 70 mL of nitrate-depleted placebo juice twice daily for 5-7 days during the second period.
|
Placebo First, Then Beetroot Juice
Participants consumed 70 mL of nitrate-depleted placebo juice twice daily for 5-7 days during the first period, followed by a washout period, and then consumed 70 mL of beetroot juice (0.3 g inorganic nitrate) twice daily for 5-7 days during the second period.
|
|---|---|---|
|
First intervention (5-7 days)
STARTED
|
6
|
5
|
|
First intervention (5-7 days)
COMPLETED
|
6
|
5
|
|
First intervention (5-7 days)
NOT COMPLETED
|
0
|
0
|
|
Washout period (14 days)
STARTED
|
6
|
5
|
|
Washout period (14 days)
COMPLETED
|
6
|
5
|
|
Washout period (14 days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (5-7 days)
STARTED
|
6
|
5
|
|
Second Intervention (5-7 days)
COMPLETED
|
6
|
5
|
|
Second Intervention (5-7 days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Beetroot Juice on Coronary Blood Flow and Walking Performance in PAD
Baseline characteristics by cohort
| Measure |
All Study Participants
n=11 Participants
Subjects will consume 70 ml of beetroot juice (Beet-It Organic Shot) or placebo (Beet-It Organic Placebo) twice per day (morning, afternoon) for 5 to 7 days to assess the short-term effects of this nitrate supplement on graded treadmill walking responses (day 4) and vasodilator/vasoconstrictor responses in the coronary and lower leg circulations (day 5 or 6 or 7). On both study visits, subjects will consume their morning dose 1 hour 45 min before experiments begin.
Beetroot juice placebo: This beverage is identical in look and taste to the Beet-It organic shot, but has the nitrate removed. It is also bottled and supplied by James White Drinks (UK).
Beetroot juice: This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=1 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=1 Participants
|
|
Age, Continuous
|
64.5 years
STANDARD_DEVIATION 8 • n=1 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=1 Participants
|
PRIMARY outcome
Timeframe: 4 to 6 days after initiating daily ingestion of beetroot juicePeak treadmill time was determined using the Gardner treadmill protocol, measured as the number of seconds the participant was able to walk until they asked to stop the test due to leg fatigue.
Outcome measures
| Measure |
Beetroot Juice (Beet-It Organic Shot)
n=10 Participants
Subjects will consume 70 ml of beetroot juice (Beet-It Organic Shot) twice per day (morning, afternoon) for 5 to 7 days to assess the short term effects of this nitrate supplement on graded treadmill walking responses (day 4) and vasodilator/vasoconstrictor responses in the coronary and lower leg circulations (day 5 or 6 or 7). On both study visits, subjects will consume their morning dose 1 hour 45 min before experiments begin.
Beetroot juice: This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK).
|
Beetroot Juice Placebo (Beet-It Organic Placebo)
n=10 Participants
Subjects will consume 70 ml of beetroot juice placebo (Beet-It Organic Placebo) twice per day (morning, afternoon) for 5 to 7 days to assess the short term effects of this nitrate supplement on graded treadmill walking responses (day 4) and vasodilator/vasoconstrictor responses in the coronary and lower leg circulations (day 5 or 6 or 7). On both study visits, subjects will consume their morning dose 1 hour 45 min before experiments begin.
Beetroot juice placebo: This beverage is identical in look and taste to the Beet-It organic shot, but has the nitrate removed. It is also bottled and supplied by James White Drinks (UK).
|
|---|---|---|
|
Peak Treadmill Time
|
730.5 s
Standard Deviation 604.5
|
691.3 s
Standard Deviation 547.7
|
SECONDARY outcome
Timeframe: 4 days after initiating daily ingestion of beetroot juiceChange in LAD coronary artery flow velocity, measured using transthoracic ultrasound, from baseline rest to peak plantar flexion exercise. Single leg plantar flexion exercise of the most symptomatic leg was performed at a rate of 20 contractions per minute, with increases in workload (1 kg) every minute until volitional fatigue, or until maximum exercise duration of 14 min was reached.
Outcome measures
| Measure |
Beetroot Juice (Beet-It Organic Shot)
n=11 Participants
Subjects will consume 70 ml of beetroot juice (Beet-It Organic Shot) twice per day (morning, afternoon) for 5 to 7 days to assess the short term effects of this nitrate supplement on graded treadmill walking responses (day 4) and vasodilator/vasoconstrictor responses in the coronary and lower leg circulations (day 5 or 6 or 7). On both study visits, subjects will consume their morning dose 1 hour 45 min before experiments begin.
Beetroot juice: This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK).
|
Beetroot Juice Placebo (Beet-It Organic Placebo)
n=11 Participants
Subjects will consume 70 ml of beetroot juice placebo (Beet-It Organic Placebo) twice per day (morning, afternoon) for 5 to 7 days to assess the short term effects of this nitrate supplement on graded treadmill walking responses (day 4) and vasodilator/vasoconstrictor responses in the coronary and lower leg circulations (day 5 or 6 or 7). On both study visits, subjects will consume their morning dose 1 hour 45 min before experiments begin.
Beetroot juice placebo: This beverage is identical in look and taste to the Beet-It organic shot, but has the nitrate removed. It is also bottled and supplied by James White Drinks (UK).
|
|---|---|---|
|
Coronary Flow Velocity Response to Peak Plantar Flexion Exercise
|
11.83 cm/s
Standard Deviation 10.46
|
7.06 cm/s
Standard Deviation 6.01
|
SECONDARY outcome
Timeframe: 4 to 6 days after initiating daily ingestion of beetroot juiceResting mean arterial blood pressure (mmHg) obtained prior to the exercise treadmill test obtained using an automated arm blood pressure cuff.
Outcome measures
| Measure |
Beetroot Juice (Beet-It Organic Shot)
n=11 Participants
Subjects will consume 70 ml of beetroot juice (Beet-It Organic Shot) twice per day (morning, afternoon) for 5 to 7 days to assess the short term effects of this nitrate supplement on graded treadmill walking responses (day 4) and vasodilator/vasoconstrictor responses in the coronary and lower leg circulations (day 5 or 6 or 7). On both study visits, subjects will consume their morning dose 1 hour 45 min before experiments begin.
Beetroot juice: This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK).
|
Beetroot Juice Placebo (Beet-It Organic Placebo)
n=11 Participants
Subjects will consume 70 ml of beetroot juice placebo (Beet-It Organic Placebo) twice per day (morning, afternoon) for 5 to 7 days to assess the short term effects of this nitrate supplement on graded treadmill walking responses (day 4) and vasodilator/vasoconstrictor responses in the coronary and lower leg circulations (day 5 or 6 or 7). On both study visits, subjects will consume their morning dose 1 hour 45 min before experiments begin.
Beetroot juice placebo: This beverage is identical in look and taste to the Beet-It organic shot, but has the nitrate removed. It is also bottled and supplied by James White Drinks (UK).
|
|---|---|---|
|
Resting Blood Pressure
|
85 mmHg
Standard Deviation 8
|
91 mmHg
Standard Deviation 9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 to 6 days after initiating ingestion of beetroot juiceVenous blood samples were collected via venipuncture for storage and later determination of plasma nitrate concentration at Wake Forest University.
Outcome measures
| Measure |
Beetroot Juice (Beet-It Organic Shot)
n=11 Participants
Subjects will consume 70 ml of beetroot juice (Beet-It Organic Shot) twice per day (morning, afternoon) for 5 to 7 days to assess the short term effects of this nitrate supplement on graded treadmill walking responses (day 4) and vasodilator/vasoconstrictor responses in the coronary and lower leg circulations (day 5 or 6 or 7). On both study visits, subjects will consume their morning dose 1 hour 45 min before experiments begin.
Beetroot juice: This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK).
|
Beetroot Juice Placebo (Beet-It Organic Placebo)
n=11 Participants
Subjects will consume 70 ml of beetroot juice placebo (Beet-It Organic Placebo) twice per day (morning, afternoon) for 5 to 7 days to assess the short term effects of this nitrate supplement on graded treadmill walking responses (day 4) and vasodilator/vasoconstrictor responses in the coronary and lower leg circulations (day 5 or 6 or 7). On both study visits, subjects will consume their morning dose 1 hour 45 min before experiments begin.
Beetroot juice placebo: This beverage is identical in look and taste to the Beet-It organic shot, but has the nitrate removed. It is also bottled and supplied by James White Drinks (UK).
|
|---|---|---|
|
Plasma Nitrate Concentration Prior to Plantar Flexion Test Visit.
|
763.50 uM
Standard Deviation 123.22
|
46.28 uM
Standard Deviation 28.18
|
Adverse Events
Beet-It Organic Shot
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Beetroot Juice Placebo (Beet-It Organic Placebo)
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place