Trial Outcomes & Findings for Dose-response Effect of Dietary Nitrate on Muscle Function in Older Individuals (NCT NCT03595774)
NCT ID: NCT03595774
Last Updated: 2024-07-29
Results Overview
Maximal knee extensor velocity determined using isokinetic dynamometry
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
13 participants
Primary outcome timeframe
1 day
Results posted on
2024-07-29
Participant Flow
Participant milestones
| Measure |
Placebo Then Low Then High
3.3 mL/kg concentrated beet root juice \*depleted of nitrate\* (1 day), washout (7 days), 1.55 mL/kg concentrated beet root juice containing nitrate + 1.55 mL/kg concentrated beet root juice \*depleted of nitrate\* (1 day), washout (7 days), 3.3 mL/kg concentrated beet root juice containing nitrate (1 day)
|
Low Then High Then Placebo
1.55 mL/kg concentrated beet root juice containing nitrate + 1.55 mL/kg concentrated beet root juice \*depleted of nitrate\* (1 day), washout (7 days), 3.3 mL/kg concentrated beet root juice containing nitrate (1 day), washout (7 days), 3.3 mL/kg concentrated beet root juice \*depleted of nitrate\* (1 day)
|
High Then Placebo Then Low
3.3 mL/kg concentrated beet root juice containing nitrate (1 day), washout (7 days), 3.3 mL/kg concentrated beet root juice \*depleted of nitrate\* (1 day)washout (7 days),1.55 mL/kg concentrated beet root juice containing nitrate + 1.55 mL/kg concentrated beet root juice \*depleted of nitrate\* (1 day)
|
High Then Low Then Placebo
3.3 mL/kg concentrated beet root juice containing nitrate (1 day), washout (7 days), 1.55 mL/kg concentrated beet root juice containing nitrate + 1.55 mL/kg concentrated beet root juice \*depleted of nitrate\* (1 day), washout (7 days),3.3 mL/kg concentrated beet root juice \*depleted of nitrate\* (1 day)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
3
|
3
|
|
Overall Study
COMPLETED
|
2
|
3
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo Then Low Then High
3.3 mL/kg concentrated beet root juice \*depleted of nitrate\* (1 day), washout (7 days), 1.55 mL/kg concentrated beet root juice containing nitrate + 1.55 mL/kg concentrated beet root juice \*depleted of nitrate\* (1 day), washout (7 days), 3.3 mL/kg concentrated beet root juice containing nitrate (1 day)
|
Low Then High Then Placebo
1.55 mL/kg concentrated beet root juice containing nitrate + 1.55 mL/kg concentrated beet root juice \*depleted of nitrate\* (1 day), washout (7 days), 3.3 mL/kg concentrated beet root juice containing nitrate (1 day), washout (7 days), 3.3 mL/kg concentrated beet root juice \*depleted of nitrate\* (1 day)
|
High Then Placebo Then Low
3.3 mL/kg concentrated beet root juice containing nitrate (1 day), washout (7 days), 3.3 mL/kg concentrated beet root juice \*depleted of nitrate\* (1 day)washout (7 days),1.55 mL/kg concentrated beet root juice containing nitrate + 1.55 mL/kg concentrated beet root juice \*depleted of nitrate\* (1 day)
|
High Then Low Then Placebo
3.3 mL/kg concentrated beet root juice containing nitrate (1 day), washout (7 days), 1.55 mL/kg concentrated beet root juice containing nitrate + 1.55 mL/kg concentrated beet root juice \*depleted of nitrate\* (1 day), washout (7 days),3.3 mL/kg concentrated beet root juice \*depleted of nitrate\* (1 day)
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
0
|
|
Overall Study
screen failure
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Dose-response Effect of Dietary Nitrate on Muscle Function in Older Individuals
Baseline characteristics by cohort
| Measure |
Placebo Then Low Then High
n=2 Participants
3.3 mL/kg concentrated beet root juice \*depleted of nitrate\* (1 day), washout (7 days), 1.55 mL/kg concentrated beet root juice containing nitrate + 1.55 mL/kg concentrated beet root juice \*depleted of nitrate\* (1 day), washout (7 days), 3.3 mL/kg concentrated beet root juice containing nitrate (1 day)
|
Low Then High Then Placebo
n=3 Participants
1.55 mL/kg concentrated beet root juice containing nitrate + 1.55 mL/kg concentrated beet root juice \*depleted of nitrate\* (1 day), washout (7 days), 3.3 mL/kg concentrated beet root juice containing nitrate (1 day), washout (7 days), 3.3 mL/kg concentrated beet root juice \*depleted of nitrate\* (1 day)
|
High Then Placebo Then Low
n=2 Participants
3.3 mL/kg concentrated beet root juice containing nitrate (1 day), washout (7 days), 3.3 mL/kg concentrated beet root juice \*depleted of nitrate\* (1 day), washout (7 days), 1.55 mL/kg concentrated beet root juice containing nitrate + 1.55 mL/kg concentrated beet root juice \*depleted of nitrate\* (1 day)
|
High Then Low Then Placebo
n=2 Participants
3.3 mL/kg concentrated beet root juice containing nitrate (1 day)washout (7 days), 1.55 mL/kg concentrated beet root juice containing nitrate + 1.55 mL/kg concentrated beet root juice \*depleted of nitrate\* (1 day), washout (7 days), 3.3 mL/kg concentrated beet root juice \*depleted of nitrate\* (1 day)
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
69 years
STANDARD_DEVIATION 4 • n=5 Participants
|
72 years
STANDARD_DEVIATION 1 • n=7 Participants
|
70 years
STANDARD_DEVIATION 4 • n=5 Participants
|
70 years
STANDARD_DEVIATION 4 • n=4 Participants
|
70 years
STANDARD_DEVIATION 3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
9 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 dayMaximal knee extensor velocity determined using isokinetic dynamometry
Outcome measures
| Measure |
Placebo
n=9 Participants
1.55 mL/kg concentrated beet root juice containing nitrate + 1.55 mL/kg concentrated beet root juice \*depleted of nitrate\* (1 day)
Other names: Beet It Sport Nitrate 400
Beet root juice: Beet root juice
|
Low Nitrate
n=9 Participants
1.55 mL/kg concentrated beet root juice containing nitrate + 1.55 mL/kg concentrated beet root juice \*depleted of nitrate\* (1 day)
Other names: Beet It Sport Nitrate 400
Beet root juice: Beet root juice
|
High Nitrate
n=9 Participants
3.3 mL/kg concentrated beet root juice containing nitrate (1 day)
Other names: Beet It Sport Nitrate 400
Beet root juice: Beet root juice
|
|---|---|---|---|
|
Maximal Knee Extensor Velocity
|
10.83 rad/s
Standard Deviation 2.41
|
11.91 rad/s
Standard Deviation 2.01
|
11.24 rad/s
Standard Deviation 2.32
|
PRIMARY outcome
Timeframe: 1 dayMaximal knee extensor power determined using isokinetic dynamometry
Outcome measures
| Measure |
Placebo
n=9 Participants
1.55 mL/kg concentrated beet root juice containing nitrate + 1.55 mL/kg concentrated beet root juice \*depleted of nitrate\* (1 day)
Other names: Beet It Sport Nitrate 400
Beet root juice: Beet root juice
|
Low Nitrate
n=9 Participants
1.55 mL/kg concentrated beet root juice containing nitrate + 1.55 mL/kg concentrated beet root juice \*depleted of nitrate\* (1 day)
Other names: Beet It Sport Nitrate 400
Beet root juice: Beet root juice
|
High Nitrate
n=9 Participants
3.3 mL/kg concentrated beet root juice containing nitrate (1 day)
Other names: Beet It Sport Nitrate 400
Beet root juice: Beet root juice
|
|---|---|---|---|
|
Maximal Knee Extensor Power
|
3.74 W/kg
Standard Deviation 1.19
|
3.92 W/kg
Standard Deviation 1.10
|
3.69 W/kg
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: 0, 1, 2, 3 h after ingestionOutcome measures
| Measure |
Placebo
n=9 Participants
1.55 mL/kg concentrated beet root juice containing nitrate + 1.55 mL/kg concentrated beet root juice \*depleted of nitrate\* (1 day)
Other names: Beet It Sport Nitrate 400
Beet root juice: Beet root juice
|
Low Nitrate
n=9 Participants
1.55 mL/kg concentrated beet root juice containing nitrate + 1.55 mL/kg concentrated beet root juice \*depleted of nitrate\* (1 day)
Other names: Beet It Sport Nitrate 400
Beet root juice: Beet root juice
|
High Nitrate
n=9 Participants
3.3 mL/kg concentrated beet root juice containing nitrate (1 day)
Other names: Beet It Sport Nitrate 400
Beet root juice: Beet root juice
|
|---|---|---|---|
|
Plasma Nitrite
0 h
|
.306 umol/L
Standard Deviation .138
|
40 umol/L
Standard Deviation 16
|
.341 umol/L
Standard Deviation .165
|
|
Plasma Nitrite
1 h
|
.299 umol/L
Standard Deviation .067
|
.459 umol/L
Standard Deviation .203
|
.478 umol/L
Standard Deviation .219
|
|
Plasma Nitrite
2 h
|
.326 umol/L
Standard Deviation .113
|
.528 umol/L
Standard Deviation .219
|
.949 umol/L
Standard Deviation .535
|
|
Plasma Nitrite
3 h
|
.347 umol/L
Standard Deviation .140
|
.820 umol/L
Standard Deviation .543
|
1.216 umol/L
Standard Deviation .458
|
SECONDARY outcome
Timeframe: 0, 1, 2, 3 h after ingestionOutcome measures
| Measure |
Placebo
n=9 Participants
1.55 mL/kg concentrated beet root juice containing nitrate + 1.55 mL/kg concentrated beet root juice \*depleted of nitrate\* (1 day)
Other names: Beet It Sport Nitrate 400
Beet root juice: Beet root juice
|
Low Nitrate
n=9 Participants
1.55 mL/kg concentrated beet root juice containing nitrate + 1.55 mL/kg concentrated beet root juice \*depleted of nitrate\* (1 day)
Other names: Beet It Sport Nitrate 400
Beet root juice: Beet root juice
|
High Nitrate
n=9 Participants
3.3 mL/kg concentrated beet root juice containing nitrate (1 day)
Other names: Beet It Sport Nitrate 400
Beet root juice: Beet root juice
|
|---|---|---|---|
|
Plasma Nitrate
0 h
|
55 umol/L
Standard Deviation 31
|
40 umol/L
Standard Deviation 16
|
34 umol/L
Standard Deviation 14
|
|
Plasma Nitrate
1 h
|
57 umol/L
Standard Deviation 14
|
523 umol/L
Standard Deviation 155
|
793 umol/L
Standard Deviation 218
|
|
Plasma Nitrate
2 h
|
67 umol/L
Standard Deviation 17
|
624 umol/L
Standard Deviation 158
|
1184 umol/L
Standard Deviation 266
|
|
Plasma Nitrate
3 h
|
66 umol/L
Standard Deviation 16
|
628 umol/L
Standard Deviation 142
|
1296 umol/L
Standard Deviation 282
|
SECONDARY outcome
Timeframe: 0, 1, 2, 3 h after ingestionOutcome measures
| Measure |
Placebo
n=9 Participants
1.55 mL/kg concentrated beet root juice containing nitrate + 1.55 mL/kg concentrated beet root juice \*depleted of nitrate\* (1 day)
Other names: Beet It Sport Nitrate 400
Beet root juice: Beet root juice
|
Low Nitrate
n=9 Participants
1.55 mL/kg concentrated beet root juice containing nitrate + 1.55 mL/kg concentrated beet root juice \*depleted of nitrate\* (1 day)
Other names: Beet It Sport Nitrate 400
Beet root juice: Beet root juice
|
High Nitrate
n=9 Participants
3.3 mL/kg concentrated beet root juice containing nitrate (1 day)
Other names: Beet It Sport Nitrate 400
Beet root juice: Beet root juice
|
|---|---|---|---|
|
Breath Nitric Oxide
2 h
|
25 ppm
Standard Deviation 10
|
43 ppm
Standard Deviation 21
|
36 ppm
Standard Deviation 12
|
|
Breath Nitric Oxide
0 h
|
19 ppm
Standard Deviation 10
|
18 ppm
Standard Deviation 9
|
18 ppm
Standard Deviation 8
|
|
Breath Nitric Oxide
1 h
|
22 ppm
Standard Deviation 10
|
39 ppm
Standard Deviation 18
|
31 ppm
Standard Deviation 12
|
|
Breath Nitric Oxide
3 h
|
21 ppm
Standard Deviation 11
|
50 ppm
Standard Deviation 31
|
36 ppm
Standard Deviation 17
|
Adverse Events
All Study Participants/Arms
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. Andrew R. Coggan
Indiana University Purdue University Indianapolis
Phone: 3172740656
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place