Trial Outcomes & Findings for Dietary Nitrate and Muscle Power With Aging (NCT NCT03513302)

Results Overview

\*Maximal\* knee extension velocity was determined by having participants perform knee extensions at velocities of 0, 1.57, 3.14, 4.57, and 6.14 radians per second on an isokinetic dynamometer (device that controls velocity while measuring torque). Peak power at each velocity was calculated by multiplying the measured torque by that velocity, then a parabolic function was fit to these calculated data to predict \*maximal\* knee extensor velocity. Higher values are better.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

47 participants

Primary outcome timeframe

1 day

Results posted on

2025-02-19

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Then Nitrate Placebo (2 x 70 mL concentrated beet root juice depleted of nitrate per day) for 14 days, 14 day washout, Nitrate (2 x 70 mL concentrated beet root juice containing nitrate per day) for 14 days	Nitrate Then Placebo Nitrate (2 x 70 mL concentrated beet root juice containing nitrate per day) for 14 days, 14 day washout, placebo (2 x 70 mL concentrated beet root juice depleted of nitrate per day) for 14 days
First Intervention (14 Days) STARTED	23	24
First Intervention (14 Days) COMPLETED	8	8
First Intervention (14 Days) NOT COMPLETED	15	16
Washout (14 Days) STARTED	8	8
Washout (14 Days) COMPLETED	8	8
Washout (14 Days) NOT COMPLETED	0	0
Second Intervention (14 Days) STARTED	8	8
Second Intervention (14 Days) COMPLETED	8	8
Second Intervention (14 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Then Nitrate Placebo (2 x 70 mL concentrated beet root juice depleted of nitrate per day) for 14 days, 14 day washout, Nitrate (2 x 70 mL concentrated beet root juice containing nitrate per day) for 14 days	Nitrate Then Placebo Nitrate (2 x 70 mL concentrated beet root juice containing nitrate per day) for 14 days, 14 day washout, placebo (2 x 70 mL concentrated beet root juice depleted of nitrate per day) for 14 days
First Intervention (14 Days) Screen failure	15	16

Baseline Characteristics

Dietary Nitrate and Muscle Power With Aging

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=16 Participants All study participants
Age, Continuous	71 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

\*Maximal\* knee extension velocity was determined by having participants perform knee extensions at velocities of 0, 1.57, 3.14, 4.57, and 6.14 radians per second on an isokinetic dynamometer (device that controls velocity while measuring torque). Peak power at each velocity was calculated by multiplying the measured torque by that velocity, then a parabolic function was fit to these calculated data to predict \*maximal\* knee extensor velocity. Higher values are better.

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants placebo: 2 x 70 mL concentrated beet root juice depleted of nitrate per day for 14 days.	Nitrate n=16 Participants nitrate: 2 x 70 mL concentrated beet root juice per day for 14 days.
Maximal Knee Extension Velocity	12.2 radians per second Standard Deviation 1.9	12.7 radians per second Standard Deviation 2.1

PRIMARY outcome

Timeframe: 1 day

This outcome was determined by having participants perform knee extensions at velocities of 0, 1.57, 3.14, 4.57, and 6.14 radians per second on an isokinetic dynamometer (device that controls velocity while measuring torque). \*Peak\* power at each velocity was calculated by multiplying the measured torque by that velocity, then a parabolic function was fit to these calculated data to predict \*maximal\* knee extensor power. Higher values are better.

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants placebo: 2 x 70 mL concentrated beet root juice depleted of nitrate per day for 14 days.	Nitrate n=16 Participants nitrate: 2 x 70 mL concentrated beet root juice per day for 14 days.
Muscle Knee Extensor Power	3.98 Watts per kilogram body mass Standard Deviation 1.18	4.26 Watts per kilogram body mass Standard Deviation 1.37

PRIMARY outcome

Timeframe: 14 days

\*Maximal\* knee extension velocity was determined by having participants perform knee extensions at velocities of 0, 1.57, 3.14, 4.57, and 6.14 rad/s on an isokinetic dynamometer (device that controls velocity while measuring torque). Peak power at each velocity was calculated by multiplying the measured torque by that velocity, then \*maximal\* knee extensor velocity was determined by fitting a parabolic function to these data (\*maximal\* knee extension velocity = 2 x fitted velocity at which \*maximal\* power is developed). Higher values are better.

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants placebo: 2 x 70 mL concentrated beet root juice depleted of nitrate per day for 14 days.	Nitrate n=16 Participants nitrate: 2 x 70 mL concentrated beet root juice per day for 14 days.
Maximal Knee Extension Velocity	12.2 rad/s Standard Deviation 1.8	12.7 rad/s Standard Deviation 1.8

PRIMARY outcome

Timeframe: 14 days

\*Maximal\* knee extension power was determined by having participants perform knee extensions at velocities of 0, 1.57, 3.14, 4.57, and 6.14 rad/s on an isokinetic dynamometer (device that controls velocity while measuring torque). \*Peak\* power at each velocity was calculated by multiplying the measured torque by that velocity, then \*maximal\* power was determined by fitting a parabolic function to these data. Higher values are better.

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants placebo: 2 x 70 mL concentrated beet root juice depleted of nitrate per day for 14 days.	Nitrate n=16 Participants nitrate: 2 x 70 mL concentrated beet root juice per day for 14 days.
Maximal Knee Extension Power	4.23 W/kg Standard Deviation 1.21	4.31 W/kg Standard Deviation 1.26

OTHER_PRE_SPECIFIED outcome

Timeframe: 0,1,2,3 hours after treatment at 1 day

Plasma nitrate concentrations were measured using high performance liquid chromatography.

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants placebo: 2 x 70 mL concentrated beet root juice depleted of nitrate per day for 14 days.	Nitrate n=16 Participants nitrate: 2 x 70 mL concentrated beet root juice per day for 14 days.
Plasma Nitrate 0 h	35 umol/L Standard Deviation 24	39 umol/L Standard Deviation 19
Plasma Nitrate 1 h	35 umol/L Standard Deviation 22	601 umol/L Standard Deviation 258
Plasma Nitrate 2 h	33 umol/L Standard Deviation 20	698 umol/L Standard Deviation 214
Plasma Nitrate 3 h	33 umol/L Standard Deviation 16	661 umol/L Standard Deviation 247

OTHER_PRE_SPECIFIED outcome

Timeframe: 0,1,2,3 hours after treatment at 14 days

Plasma nitrate concentrations

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants placebo: 2 x 70 mL concentrated beet root juice depleted of nitrate per day for 14 days.	Nitrate n=16 Participants nitrate: 2 x 70 mL concentrated beet root juice per day for 14 days.
Plasma Nitrate 0 h	37 umol/L Standard Deviation 20	190 umol/L Standard Deviation 153
Plasma Nitrate 1 h	35 umol/L Standard Deviation 13	740 umol/L Standard Deviation 241
Plasma Nitrate 2 h	35 umol/L Standard Deviation 11	815 umol/L Standard Deviation 281
Plasma Nitrate 3 h	35 umol/L Standard Deviation 14	780 umol/L Standard Deviation 292

OTHER_PRE_SPECIFIED outcome

Timeframe: 0,1,2,3 hours after treatment at 1 day

Plasma nitrite concentrations were measured using high performance liquid chromatography.

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants placebo: 2 x 70 mL concentrated beet root juice depleted of nitrate per day for 14 days.	Nitrate n=16 Participants nitrate: 2 x 70 mL concentrated beet root juice per day for 14 days.
Plasma Nitrite 0 h	0.364 umol/L Standard Deviation 0.283	0.400 umol/L Standard Deviation 0.356
Plasma Nitrite 1 h	0.382 umol/L Standard Deviation 0.338	0.904 umol/L Standard Deviation 0.826
Plasma Nitrite 2 h	0.379 umol/L Standard Deviation 0.401	1.104 umol/L Standard Deviation 0.847
Plasma Nitrite 3 h	0.374 umol/L Standard Deviation 0.376	1.243 umol/L Standard Deviation 1.078

OTHER_PRE_SPECIFIED outcome

Timeframe: 0,1,2,3 hours after treatment at 14 days

Plasma nitrite concentrations were measured using high performance liquid chromatography.

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants placebo: 2 x 70 mL concentrated beet root juice depleted of nitrate per day for 14 days.	Nitrate n=16 Participants nitrate: 2 x 70 mL concentrated beet root juice per day for 14 days.
Plasma Nitrite 3 h	0.275 umol/L Standard Deviation 0.286	0.989 umol/L Standard Deviation 1.039
Plasma Nitrite 0 h	0.307 umol/L Standard Deviation 0.294	0.615 umol/L Standard Deviation 0.671
Plasma Nitrite 1 h	0.308 umol/L Standard Deviation 0.247	0.972 umol/L Standard Deviation 1.039
Plasma Nitrite 2 h	0.353 umol/L Standard Deviation 0.344	1.053 umol/L Standard Deviation 1.144

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 and 14 days of treatment

Patient-Reported Outcomes Measurement Information System perceived fatigue questionnaire (PROMIS 8a). Results given as T-score with mean of 50 and standard deviation of 10. Lower is better.

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants placebo: 2 x 70 mL concentrated beet root juice depleted of nitrate per day for 14 days.	Nitrate n=16 Participants nitrate: 2 x 70 mL concentrated beet root juice per day for 14 days.
Perceived Fatigue 1 d	42.3 T-score Standard Deviation 9.1	43.2 T-score Standard Deviation 8.9
Perceived Fatigue 14 d	39.3 T-score Standard Deviation 7.1	40.8 T-score Standard Deviation 6.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 1,14 days of treatment

Patient-Reported Outcomes Measurement Information System physical function questionnaire (PROMIS 20a). Results given as T-score with mean of 50 and standard deviation of 10. Higher is better.

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants placebo: 2 x 70 mL concentrated beet root juice depleted of nitrate per day for 14 days.	Nitrate n=16 Participants nitrate: 2 x 70 mL concentrated beet root juice per day for 14 days.
Physical Function 1 day	53.0 T-score Standard Deviation 6.8	52.2 T-score Standard Deviation 7.4
Physical Function 14 days	54.7 T-score Standard Deviation 6.8	57.0 T-score Standard Deviation 6.3

POST_HOC outcome

Timeframe: 1 and 14 days of treatment

Plasma 8-hydroxydeoxyguanosine is an indicator of oxidative damage to DNA/RNA. It was measured using a commercial enzyme-linked immunosuppressant assay kit. Lower is better.

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants placebo: 2 x 70 mL concentrated beet root juice depleted of nitrate per day for 14 days.	Nitrate n=16 Participants nitrate: 2 x 70 mL concentrated beet root juice per day for 14 days.
Plasma 8-hydroxydeoxyguanosine Pre-treatment	11.4 mg/mL Standard Deviation 4.0	11.5 mg/mL Standard Deviation 4.5
Plasma 8-hydroxydeoxyguanosine Post-treatment	11.6 mg/mL Standard Deviation 3.9	11.7 mg/mL Standard Deviation 4.5

POST_HOC outcome

Timeframe: 1 and 14 days of treatment

Protein carbonyls are an indicator of oxidative damage to proteins. It was measured using a commercial enzyme-linked immunosuppressant assay kit. Lower is better.

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants placebo: 2 x 70 mL concentrated beet root juice depleted of nitrate per day for 14 days.	Nitrate n=16 Participants nitrate: 2 x 70 mL concentrated beet root juice per day for 14 days.
Plasma Protein Carbonyls Post-treatment	3.79 nmol/mg Standard Deviation 1.67	4.46 nmol/mg Standard Deviation 2.17
Plasma Protein Carbonyls Pre-treatment	3.71 nmol/mg Standard Deviation 1.40	4.00 nmol/mg Standard Deviation 1.67

POST_HOC outcome

Timeframe: 1 and 14 days of treatment

4-hydroxynonenal is an indicator of oxidative damage to lipids (fats). It was measured using a commercial enzyme-linked immunosuppressant assay kit. Lower is better.

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants placebo: 2 x 70 mL concentrated beet root juice depleted of nitrate per day for 14 days.	Nitrate n=16 Participants nitrate: 2 x 70 mL concentrated beet root juice per day for 14 days.
Plasma 4-hydroxynonenal Post-treatment	38.4 ug/mL Standard Deviation 26.6	35.7 ug/mL Standard Deviation 24.0
Plasma 4-hydroxynonenal Pre-treatment	43.9 ug/mL Standard Deviation 25.0	38.1 ug/mL Standard Deviation 24.6

Adverse Events

Screening Period

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Nitrate

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Screening Period n=47 participants at risk Adverse events during screening, prior to arm/group assignment	Placebo n=16 participants at risk Placebo (2 x 70 mL concentrated beet root juice depleted of nitrate per day) for 14 days	Nitrate n=16 participants at risk Nitrate (2 x 70 mL concentrated beet root juice containing nitrate per day) for 14 days
Metabolism and nutrition disorders Abnormal laboratory finding	19.1% 9/47 • Number of events 18 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	0.00% 0/16 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	0.00% 0/16 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\
Endocrine disorders Abnormal laboratory finding	17.0% 8/47 • Number of events 10 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	0.00% 0/16 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	0.00% 0/16 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\
Blood and lymphatic system disorders Abnormal laboratory finding	34.0% 16/47 • Number of events 33 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	0.00% 0/16 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	0.00% 0/16 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\
Renal and urinary disorders Abnormal laboratory finding	14.9% 7/47 • Number of events 7 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	0.00% 0/16 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	0.00% 0/16 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\
Hepatobiliary disorders Abnormal laboratory finding	10.6% 5/47 • Number of events 5 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	0.00% 0/16 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	0.00% 0/16 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\
General disorders Toothache	0.00% 0/47 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	6.2% 1/16 • Number of events 1 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	0.00% 0/16 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\
Musculoskeletal and connective tissue disorders Muscle soreness	0.00% 0/47 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	12.5% 2/16 • Number of events 2 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	0.00% 0/16 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\
Cardiac disorders Syncope	0.00% 0/47 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	6.2% 1/16 • Number of events 1 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	0.00% 0/16 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\
Gastrointestinal disorders Nausea/diarrhea	0.00% 0/47 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	0.00% 0/16 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	12.5% 2/16 • Number of events 2 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\
Nervous system disorders Migraine	0.00% 0/47 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	6.2% 1/16 • Number of events 1 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	0.00% 0/16 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\
Skin and subcutaneous tissue disorders Epidermal cyst	0.00% 0/47 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	0.00% 0/16 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	6.2% 1/16 • Number of events 1 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\
Cardiac disorders High blood pressure	29.8% 14/47 • Number of events 14 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	18.8% 3/16 • Number of events 4 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	18.8% 3/16 • Number of events 4 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\

Additional Information

Dr. Andrew Coggan

Indiana University Indianapolis

Phone: 3172740656

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Screening Period n=47 participants at risk Adverse events during screening, prior to arm/group assignment	Placebo n=16 participants at risk Placebo (2 x 70 mL concentrated beet root juice depleted of nitrate per day) for 14 days	Nitrate n=16 participants at risk Nitrate (2 x 70 mL concentrated beet root juice containing nitrate per day) for 14 days
Metabolism and nutrition disorders Abnormal laboratory finding	19.1% 9/47 • Number of events 18 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	0.00% 0/16 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	0.00% 0/16 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\
Endocrine disorders Abnormal laboratory finding	17.0% 8/47 • Number of events 10 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	0.00% 0/16 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	0.00% 0/16 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\
Blood and lymphatic system disorders Abnormal laboratory finding	34.0% 16/47 • Number of events 33 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	0.00% 0/16 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	0.00% 0/16 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\
Renal and urinary disorders Abnormal laboratory finding	14.9% 7/47 • Number of events 7 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	0.00% 0/16 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	0.00% 0/16 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\
Hepatobiliary disorders Abnormal laboratory finding	10.6% 5/47 • Number of events 5 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	0.00% 0/16 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	0.00% 0/16 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\
General disorders Toothache	0.00% 0/47 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	6.2% 1/16 • Number of events 1 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	0.00% 0/16 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\
Musculoskeletal and connective tissue disorders Muscle soreness	0.00% 0/47 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	12.5% 2/16 • Number of events 2 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	0.00% 0/16 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\
Cardiac disorders Syncope	0.00% 0/47 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	6.2% 1/16 • Number of events 1 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	0.00% 0/16 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\
Gastrointestinal disorders Nausea/diarrhea	0.00% 0/47 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	0.00% 0/16 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	12.5% 2/16 • Number of events 2 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\
Nervous system disorders Migraine	0.00% 0/47 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	6.2% 1/16 • Number of events 1 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	0.00% 0/16 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\
Skin and subcutaneous tissue disorders Epidermal cyst	0.00% 0/47 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	0.00% 0/16 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	6.2% 1/16 • Number of events 1 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\
Cardiac disorders High blood pressure	29.8% 14/47 • Number of events 14 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	18.8% 3/16 • Number of events 4 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\	18.8% 3/16 • Number of events 4 • 14 days of first intervention + 14 days of washout + 14 days of second intervention \IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\