Trial Outcomes & Findings for Dietary Nitrate Supplements and Ischemic Stroke Recovery (NCT NCT02838901)
NCT ID: NCT02838901
Last Updated: 2018-04-10
Results Overview
The primary outcome for this trial is feasibility, which will be measured by how well the participants followed instructions on taking Beet It organic beetroot juice or placebo once a day for 30 days.
COMPLETED
PHASE2
18 participants
30 days
2018-04-10
Participant Flow
The study enrolled adults who have suffered an ischemic stroke with minimum impairments defined by NIHSS scores and physical function measurements.
From June 2012 to June 2016, patients who are admitted to the Stroke Unit and who are within 96 hours of symptom onset, were screened for eligibility by reviewing their admitting history and physicals and imaging results.
Participant milestones
| Measure |
Beet It Beetroot Juice
70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.
Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle.
Nine participants were randomized to the Beet It Beetroot Juice arm. Participants had blood drawn on study day 1 and day 30 for nitrate and nitrite levels before and one hour after drinking 70 cc (3.8 mM nitrate) plus vitamin C 500 mg daily. On day 30, gait speed (using the 4 m walk) was assessed.
Eighteen participants were consented, 15 completed treatment (1 terminated treatment because of nausea), 16 followed for 30 days and 13 for 90 days.
Participants selected for the MRI portion of the study had a brain MRI performed on study day 30 to measure cerebral blood flow.
|
Beet It Beetroot Juice Placebo
70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.
Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.
Nine participants were randomized to the Beet It Beetroot Juice Placebo arm. Participants had blood drawn on study day 1 and day 30 for nitrate and nitrite levels before and one hour after drinking 70 cc (3.8 mM nitrate) plus vitamin C 500 mg daily. On day 30, gait speed (using the 4 m walk) was assessed.
Eighteen participants were consented, 15 completed treatment (1 terminated treatment because of nausea), 16 followed for 30 days and 13 for 90 days.
Participants selected for the MRI portion of the study had a brain MRI performed on study day 30 to measure cerebral b
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Beet It Beetroot Juice
70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.
Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle.
Nine participants were randomized to the Beet It Beetroot Juice arm. Participants had blood drawn on study day 1 and day 30 for nitrate and nitrite levels before and one hour after drinking 70 cc (3.8 mM nitrate) plus vitamin C 500 mg daily. On day 30, gait speed (using the 4 m walk) was assessed.
Eighteen participants were consented, 15 completed treatment (1 terminated treatment because of nausea), 16 followed for 30 days and 13 for 90 days.
Participants selected for the MRI portion of the study had a brain MRI performed on study day 30 to measure cerebral blood flow.
|
Beet It Beetroot Juice Placebo
70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.
Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.
Nine participants were randomized to the Beet It Beetroot Juice Placebo arm. Participants had blood drawn on study day 1 and day 30 for nitrate and nitrite levels before and one hour after drinking 70 cc (3.8 mM nitrate) plus vitamin C 500 mg daily. On day 30, gait speed (using the 4 m walk) was assessed.
Eighteen participants were consented, 15 completed treatment (1 terminated treatment because of nausea), 16 followed for 30 days and 13 for 90 days.
Participants selected for the MRI portion of the study had a brain MRI performed on study day 30 to measure cerebral b
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
A total of 17 participants had baseline gait speed data available
Baseline characteristics by cohort
| Measure |
Beet It Beetroot Juice
n=9 Participants
70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.
Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle
|
Beet It Beetroot Juice Placebo
n=9 Participants
70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.
Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=9 Participants
|
4 Participants
n=9 Participants
|
8 Participants
n=18 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=9 Participants
|
5 Participants
n=9 Participants
|
10 Participants
n=18 Participants
|
|
Age, Continuous
|
63.5 Age (yrs)
STANDARD_DEVIATION 8.6 • n=9 Participants
|
66.3 Age (yrs)
STANDARD_DEVIATION 9.2 • n=9 Participants
|
64.9 Age (yrs)
STANDARD_DEVIATION 8.8 • n=18 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=9 Participants
|
2 Participants
n=9 Participants
|
6 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=9 Participants
|
7 Participants
n=9 Participants
|
12 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
4 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=9 Participants
|
7 Participants
n=9 Participants
|
12 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
NA Participants
n=9 Participants
|
NA Participants
n=9 Participants
|
NA Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
2 Participants
n=18 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=9 Participants
|
9 Participants
n=9 Participants
|
18 Participants
n=18 Participants
|
|
nitrate and nitrite levels
Baseline Nitrate
|
63.9 micromoles/L
STANDARD_DEVIATION 77.2 • n=9 Participants
|
27.0 micromoles/L
STANDARD_DEVIATION 16.0 • n=9 Participants
|
45.5 micromoles/L
STANDARD_DEVIATION 57.3 • n=18 Participants
|
|
nitrate and nitrite levels
Baseline Nitrite
|
0.17 micromoles/L
STANDARD_DEVIATION 0.14 • n=9 Participants
|
0.13 micromoles/L
STANDARD_DEVIATION 0.08 • n=9 Participants
|
0.15 micromoles/L
STANDARD_DEVIATION 0.11 • n=18 Participants
|
|
gait speed
|
0.23 m/s
n=8 Participants • A total of 17 participants had baseline gait speed data available
|
0.22 m/s
n=9 Participants • A total of 17 participants had baseline gait speed data available
|
0.22 m/s
n=17 Participants • A total of 17 participants had baseline gait speed data available
|
PRIMARY outcome
Timeframe: 30 daysPopulation: Two participants were lost to follow-up by 30 days, therefore the analysis included 8 participants in each group.
The primary outcome for this trial is feasibility, which will be measured by how well the participants followed instructions on taking Beet It organic beetroot juice or placebo once a day for 30 days.
Outcome measures
| Measure |
Beet It Beetroot Juice
n=8 Participants
70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.
Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle
|
Beet It Beetroot Juice Placebo
n=8 Participants
70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.
Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.
|
|---|---|---|
|
Adherence With Intervention
|
93.5 percentage of participants
Interval 80.0 to 100.0
|
100 percentage of participants
Interval 100.0 to 100.0
|
PRIMARY outcome
Timeframe: 30 daysAdverse events that lead to treatment discontinuation
Outcome measures
| Measure |
Beet It Beetroot Juice
n=9 Participants
70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.
Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle
|
Beet It Beetroot Juice Placebo
n=9 Participants
70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.
Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.
|
|---|---|---|
|
Number of Participants With Adverse Treatment-altering Events
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: after 30 days of treatmentPopulation: The median treatment-specific changes in nitrate were analyzed using comparison of pre to post-dosing plasma on day 1. Beetroot It Beetroot juice (Active) was associated with an increase in plasma nitrate and a trend towards increased nitrite levels. The analysis included 8 participants per group since 2 did not come back for follow-up at 30 days.
This is the proof-of-concept to see if plasma levels change in those randomized to the active beet juice compared to placebo. Comparing baseline values against values at 30 days.
Outcome measures
| Measure |
Beet It Beetroot Juice
n=8 Participants
70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.
Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle
|
Beet It Beetroot Juice Placebo
n=7 Participants
70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.
Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.
|
|---|---|---|
|
Change in Plasma Nitrate Levels, Micromoles/Liter
|
174.76 micromoles/L
Interval 149.68 to 241.09
|
0.678 micromoles/L
Interval -1.678 to 2.06
|
PRIMARY outcome
Timeframe: after 30 days of treatmentPopulation: The median treatment-specific changes in nitrate were analyzed using comparison of pre to post-dosing plasma on day 1. Beetroot It Beetroot juice (Active) was associated with an increase in plasma nitrate and a trend towards increased nitrite levels. The analysis included 8 participants in active and 7 in placebo based on follow-up at 30 d.
This is the proof-of-concept to see if plasma levels change in those randomized to the active beet juice compared to placebo. Comparing baseline values against values at 30 days.
Outcome measures
| Measure |
Beet It Beetroot Juice
n=8 Participants
70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.
Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle
|
Beet It Beetroot Juice Placebo
n=7 Participants
70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.
Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.
|
|---|---|---|
|
Change in Plasma Nitrite Levels, Micromoles/Liter
|
0.114 micromoles/L
Interval 0.044 to 0.158
|
0.014 micromoles/L
Interval 0.002 to 0.028
|
SECONDARY outcome
Timeframe: baseline, 30, and 90 daysPopulation: There were 8 participants in the Active and 8 in the placebo because they did not follow-up at 30 days. BL ambulatory refers to only those participants were able to walk at baseline immediately after enrollment. For this analysis, there were only 6 participants in the active and 7 in the placebo at 30 days and 4 and 5 at 90 days, respectively.
Gait speed is measured by the time it takes to walk 10 meters. Baseline was reported.Change in gait speed from baseline was assessed at 30 and 90 days. Non-ambulatory at baseline is defined as gait speed less than 0.1 m/s.
Outcome measures
| Measure |
Beet It Beetroot Juice
n=8 Participants
70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.
Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle
|
Beet It Beetroot Juice Placebo
n=8 Participants
70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.
Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.
|
|---|---|---|
|
Gait Speed Change From Baseline
Baseline
|
.22 m/s
Interval 0.08 to 0.32
|
.23 m/s
Interval 0.07 to 0.36
|
|
Gait Speed Change From Baseline
Gait speed change 30 days
|
0.330 m/s
Interval 0.049 to 0.498
|
0.193 m/s
Interval 0.0 to 0.59
|
|
Gait Speed Change From Baseline
Gait speed change 90 days
|
0.385 m/s
Interval 0.03 to 0.635
|
0.165 m/s
Interval 0.0 to 0.76
|
|
Gait Speed Change From Baseline
BL Ambulatory: Gait Speed 30 days
|
0.591 m/s
Interval 0.18 to 0.91
|
0.575 m/s
Interval 0.326 to 1.06
|
|
Gait Speed Change From Baseline
BL Ambulatory: Gait Speed 90 days
|
0.572 m/s
Interval 0.275 to 0.942
|
0.406 m/s
Interval 0.24 to 1.22
|
SECONDARY outcome
Timeframe: 30 daysPopulation: MRI cerebral perfusion data could not be analyzed because of a change in the measurement of perfusion after the first participant was enrolled.
Participants from each group who had an MRI at baseline will be randomly selected to have a repeat MRI perfusion scan at 30 days. Cerebral blood flow will be measured by MRI perfusion scanning (arterial spin labeling) in the region of the stroke.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 daysPopulation: Only 6 participants in each group had grip strength measured at 30 days. Affected refers to the upper extremity that was affected by the stroke, and unaffected refers to the upper extremity not affected by the stroke.
The hand grip strength test is designed to replicate the grip strength required to undertake officer survival and firearms training. The test is completed using a dynamometer which measures grip strength in kilograms (kg). The score ranges from 0-90kg, higher score denotes better outcomes.
Outcome measures
| Measure |
Beet It Beetroot Juice
n=6 Participants
70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.
Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle
|
Beet It Beetroot Juice Placebo
n=6 Participants
70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.
Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.
|
|---|---|---|
|
Upper Extremity Grip Strength
Affected
|
17.4 kg
Interval 11.5 to 32.5
|
20 kg
Interval 11.0 to 35.0
|
|
Upper Extremity Grip Strength
Unaffected
|
28.75 kg
Interval 22.0 to 49.4
|
34.75 kg
Interval 21.5 to 38.7
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Only 6 in the active and 7 in the placebo had grip strength measured at 90 days. Affected refers to the upper extremity that was affected by the stroke, and unaffected refers to the upper extremity not affected by the stroke.
The hand grip strength test is designed to replicate the grip strength required to undertake officer survival and firearms training. The test is completed using a dynamometer which measures grip strength in kilograms. The score ranges from 0-90kg, higher score denotes better outcomes.
Outcome measures
| Measure |
Beet It Beetroot Juice
n=6 Participants
70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.
Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle
|
Beet It Beetroot Juice Placebo
n=7 Participants
70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.
Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.
|
|---|---|---|
|
Upper Extremity Grip Strength
Affected
|
17.5 kg
Interval 8.0 to 22.7
|
11 kg
Interval 3.0 to 27.0
|
|
Upper Extremity Grip Strength
Unaffected
|
26.75 kg
Interval 19.5 to 31.3
|
33 kg
Interval 23.0 to 85.0
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Only 5 participants in the active and 8 in the placebo were able to complete the MoCA at 30 days.
Cognition is measured with the Montreal Cognitive Assessment. MoCA is a 30 question test that assesses different types of cognitive abilities, including orientation, short-term memory, executive function, language abilities, attention and visuospatial ability. Scores on the MoCA range from zero to 30, higher scores denotes better outcomes.
Outcome measures
| Measure |
Beet It Beetroot Juice
n=5 Participants
70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.
Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle
|
Beet It Beetroot Juice Placebo
n=8 Participants
70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.
Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.
|
|---|---|---|
|
Montreal Cognitive Assessment (MoCA) Score
|
23.5 units on a scale
Interval 19.0 to 27.0
|
23 units on a scale
Interval 20.0 to 25.0
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Only 5 participants in the active and 8 in the placebo were able to complete the MoCA at 90 days.
Cognition is measured with the Montreal Cognitive Assessment. Cognition is measured with the Montreal Cognitive Assessment. MoCA is a 30 question test that assesses different types of cognitive abilities, including orientation, short-term memory, executive function, language abilities, attention and visuospatial ability. Scores on the MoCA range from zero to 30, higher scores denotes better outcomes.
Outcome measures
| Measure |
Beet It Beetroot Juice
n=5 Participants
70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.
Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle
|
Beet It Beetroot Juice Placebo
n=8 Participants
70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.
Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.
|
|---|---|---|
|
Montreal Cognitive Assessment (MoCA) Score
|
27 units on a scale
Interval 24.0 to 29.0
|
23.5 units on a scale
Interval 19.5 to 26.5
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Only 8 participants in the active and 8 in the placebo returned for the 30 day visit in order to measure the modified Rankin score.
Modified Rankin Scale is a measure of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scores range from 0 (no symptoms) to 5 (bedridden in a nursing home). Lower scores denotes better outcomes.
Outcome measures
| Measure |
Beet It Beetroot Juice
n=8 Participants
70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.
Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle
|
Beet It Beetroot Juice Placebo
n=8 Participants
70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.
Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.
|
|---|---|---|
|
Modified Rankin Score
|
3 units on a scale
Interval 1.0 to 3.0
|
3 units on a scale
Interval 2.0 to 5.0
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Only 6 participants in the active and 8 in the placebo returned for the 90 day visit and therefore modified Rankin could not be ascertained.
Modified Rankin Scale is a measure of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scores range from 0 (no symptoms) to 5 (bedridden in a nursing home). Lower scores denotes better outcomes.
Outcome measures
| Measure |
Beet It Beetroot Juice
n=6 Participants
70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.
Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle
|
Beet It Beetroot Juice Placebo
n=8 Participants
70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.
Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.
|
|---|---|---|
|
Modified Rankin Score
|
2.5 units on a scale
Interval 1.0 to 3.0
|
3 units on a scale
Interval 2.5 to 5.0
|
Adverse Events
Beet It Beetroot Juice
Beet It Beetroot Juice Placebo
Serious adverse events
| Measure |
Beet It Beetroot Juice
n=9 participants at risk
70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.
Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle
|
Beet It Beetroot Juice Placebo
n=9 participants at risk
70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.
Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.
|
|---|---|---|
|
Endocrine disorders
Hypoglycemia
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
Other adverse events
| Measure |
Beet It Beetroot Juice
n=9 participants at risk
70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.
Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle
|
Beet It Beetroot Juice Placebo
n=9 participants at risk
70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.
Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.
|
|---|---|---|
|
Nervous system disorders
Stroke
|
11.1%
1/9 • Number of events 1
|
100.0%
1/1 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
22.2%
2/9 • Number of events 3
|
0.00%
0/9
|
|
Gastrointestinal disorders
Gastroesophageal refluix
|
22.2%
2/9 • Number of events 2
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
22.2%
2/9 • Number of events 2
|
0.00%
0/9
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Number of events 1
|
22.2%
2/9 • Number of events 3
|
|
Blood and lymphatic system disorders
Easy bruising
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Nervous system disorders
Seizure
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Nervous system disorders
Mental alteration
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Endocrine disorders
Hypothermia
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Cardiac disorders
Hypotension
|
22.2%
2/9 • Number of events 3
|
0.00%
0/9
|
|
Infections and infestations
Urinary tract infection
|
11.1%
1/9 • Number of events 2
|
0.00%
0/9
|
|
Endocrine disorders
Hyperkalemia
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
22.2%
2/9 • Number of events 2
|
0.00%
0/9
|
|
Reproductive system and breast disorders
Chest Pain
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Gastrointestinal disorders
Emesis
|
22.2%
2/9 • Number of events 2
|
0.00%
0/9
|
|
Cardiac disorders
Non-specific SA nodal disease
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
22.2%
2/9 • Number of events 3
|
0.00%
0/9
|
|
Nervous system disorders
Headache
|
0.00%
0/9
|
11.1%
1/9 • Number of events 2
|
|
Gastrointestinal disorders
Blood in stool
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Dysphagia
|
0.00%
0/9
|
11.1%
1/9 • Number of events 2
|
|
Eye disorders
Eye floater
|
0.00%
0/9
|
11.1%
1/9 • Number of events 2
|
|
General disorders
Fall
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place