Trial Outcomes & Findings for Nitrate Supplementation and Exercise Tolerance in Patients With Type 2 Diabetes (NCT NCT02804932)
NCT ID: NCT02804932
Last Updated: 2024-05-28
Results Overview
A 12-lead ECG, symptom limited cardiopulmonary exercise testing with gas exchange measurements will be performed on a cycle ergometer using a ramp protocol to determine maximal aerobic capacity (VO2max) and exercise efficiency.
COMPLETED
NA
54 participants
Pre and post 8 weeks of dietary nitrate supplementation
2024-05-28
Participant Flow
Participant milestones
| Measure |
Beetroot Crystals (Nitrate)
Participants will receive a nitrate rich beetroot powder (10g/day) for 8 weeks.
Super Beets: Nitrate rich beetroot powder (10g/day) for 8 weeks
|
Placebo (Beetroot Powder, no Nitrate)
Participants will receive a beetroot powder placebo (no nitrate) for 8 weeks.
Super Beets Placebo: Nitrate deficient beetroot powder (10g/day) for 8 weeks
|
Nondiabetic Control Subjects
All pre supplementation measures and study visits will be performed in a group of 15 nondiabetic control subjects to allow us to 1) quantify the degree of impairment in T2D prior to intervention and 2) assess the effectiveness of the nitrate therapy in restoring the primary outcome measures back to 'normal'. Nondiabetic controls will not receive an 8-week beetroot supplementation.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
19
|
15
|
|
Overall Study
COMPLETED
|
19
|
18
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Beetroot Crystals (Nitrate)
n=20 Participants
Participants will receive a nitrate rich beetroot powder (10g/day) for 8 weeks.
Super Beets: Nitrate rich beetroot powder (10g/day) for 8 weeks
|
Placebo (Beetroot Powder, no Nitrate)
n=19 Participants
Participants will receive a beetroot powder placebo (no nitrate) for 8 weeks.
Super Beets Placebo: Nitrate deficient beetroot powder (10g/day) for 8 weeks
|
Nondiabetic Control Subjects
n=15 Participants
All pre supplementation measures and study visits will be performed in a group of 15 nondiabetic control subjects to allow us to 1) quantify the degree of impairment in T2D prior to intervention and 2) assess the effectiveness of the nitrate therapy in restoring the primary outcome measures back to 'normal'. Nondiabetic controls will not receive an 8-week beetroot supplementation.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
>=65 years
|
8 Participants
n=20 Participants
|
5 Participants
n=19 Participants
|
4 Participants
n=15 Participants
|
17 Participants
n=54 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=54 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=20 Participants
|
14 Participants
n=19 Participants
|
11 Participants
n=15 Participants
|
37 Participants
n=54 Participants
|
|
Age, Continuous
|
58.4 years
STANDARD_DEVIATION 9.7 • n=20 Participants
|
58.7 years
STANDARD_DEVIATION 8.8 • n=19 Participants
|
60.2 years
STANDARD_DEVIATION 9.2 • n=15 Participants
|
59.2 years
STANDARD_DEVIATION 9.1 • n=54 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=20 Participants
|
5 Participants
n=19 Participants
|
5 Participants
n=15 Participants
|
15 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=20 Participants
|
14 Participants
n=19 Participants
|
10 Participants
n=15 Participants
|
39 Participants
n=54 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
20 participants
n=20 Participants
|
19 participants
n=19 Participants
|
15 participants
n=15 Participants
|
54 participants
n=54 Participants
|
PRIMARY outcome
Timeframe: Pre and post 8 weeks of dietary nitrate supplementationPopulation: One subject in the nitrate group did not reach maximal criteria during testing. Therefore, VO2max data was analyzed only in 18 participants in the nitrate group. Nondiabetic control subjects only completed VO2max testing once (same time point as pre measurements for T2D subjects).
A 12-lead ECG, symptom limited cardiopulmonary exercise testing with gas exchange measurements will be performed on a cycle ergometer using a ramp protocol to determine maximal aerobic capacity (VO2max) and exercise efficiency.
Outcome measures
| Measure |
Beetroot Crystals (Nitrate)
n=18 Participants
Participants will receive a nitrate rich beetroot powder (10g/day) for 8 weeks.
Super Beets: Nitrate rich beetroot powder (10g/day) for 8 weeks
|
Placebo (Beetroot Powder, no Nitrate)
n=18 Participants
Participants will receive a beetroot powder placebo (no nitrate) for 8 weeks.
Super Beets Placebo: Nitrate deficient beetroot powder (10g/day) for 8 weeks
|
Nondiabetic Control Subjects
n=15 Participants
All pre supplementation measures and study visits will be performed in a group of 15 nondiabetic control subjects to allow us to 1) quantify the degree of impairment in T2D prior to intervention and 2) assess the effectiveness of the nitrate therapy in restoring the primary outcome measures back to 'normal'. Nondiabetic controls will not receive an 8-week beetroot supplementation.
|
|---|---|---|---|
|
Maximal Exercise Capacity (VO2max)
VO2max - Pre supplementation
|
20.7 mL/kg/min
Standard Deviation 7.0
|
20.0 mL/kg/min
Standard Deviation 4.2
|
27.6 mL/kg/min
Standard Deviation 8.7
|
|
Maximal Exercise Capacity (VO2max)
VO2max - Post supplementation
|
21.9 mL/kg/min
Standard Deviation 7.4
|
19.7 mL/kg/min
Standard Deviation 4.6
|
—
|
PRIMARY outcome
Timeframe: Pre and post 8 weeks of dietary nitrate supplementationPopulation: Nondiabetic control subjects only completed rhythmic forearm exercise and forearm blood flow measurements at one study visit (same time point as pre measurements for T2D subjects).
Forearm blood flow will be determined using Doppler ultrasound during rhythmic forearm exercise.
Outcome measures
| Measure |
Beetroot Crystals (Nitrate)
n=19 Participants
Participants will receive a nitrate rich beetroot powder (10g/day) for 8 weeks.
Super Beets: Nitrate rich beetroot powder (10g/day) for 8 weeks
|
Placebo (Beetroot Powder, no Nitrate)
n=18 Participants
Participants will receive a beetroot powder placebo (no nitrate) for 8 weeks.
Super Beets Placebo: Nitrate deficient beetroot powder (10g/day) for 8 weeks
|
Nondiabetic Control Subjects
n=15 Participants
All pre supplementation measures and study visits will be performed in a group of 15 nondiabetic control subjects to allow us to 1) quantify the degree of impairment in T2D prior to intervention and 2) assess the effectiveness of the nitrate therapy in restoring the primary outcome measures back to 'normal'. Nondiabetic controls will not receive an 8-week beetroot supplementation.
|
|---|---|---|---|
|
Change in Skeletal Muscle Perfusion During Exercise
Forearm Blood Flow - pre supplementation
|
156 ml/min
Standard Deviation 69
|
143 ml/min
Standard Deviation 69
|
200 ml/min
Standard Deviation 64
|
|
Change in Skeletal Muscle Perfusion During Exercise
Forearm Blood Flow - post supplementation
|
175 ml/min
Standard Deviation 73
|
143 ml/min
Standard Deviation 66
|
—
|
PRIMARY outcome
Timeframe: Pre and post 8 weeks of dietary nitrate supplementationPopulation: Final number of participants studied with muscle biopsies was smaller than the total number of subjects enrolled in the study. The lower number was influenced by: (i) subjects not consenting to the muscle biopsy procedure; or (ii) technical problems (ex: not enough muscle tissue and/or extensive proportion of intramuscular fat obtained). Nondiabetic control subjects only had muscle biopsies performed at one time point (same time point as pre measurements for T2D subjects).
Muscle biopsies were obtained from the vastus lateralis using a Bergstrom needle with suction under local anesthesia, which will yield \~200-250mg of tissue. Mitochondrial function was assessed as follows: Fiber bundles were chemically permeabilized with saponin and mitochondrial respiration was analyzed by in situ high-resolution respirometry at 37°.
Outcome measures
| Measure |
Beetroot Crystals (Nitrate)
n=12 Participants
Participants will receive a nitrate rich beetroot powder (10g/day) for 8 weeks.
Super Beets: Nitrate rich beetroot powder (10g/day) for 8 weeks
|
Placebo (Beetroot Powder, no Nitrate)
n=6 Participants
Participants will receive a beetroot powder placebo (no nitrate) for 8 weeks.
Super Beets Placebo: Nitrate deficient beetroot powder (10g/day) for 8 weeks
|
Nondiabetic Control Subjects
n=10 Participants
All pre supplementation measures and study visits will be performed in a group of 15 nondiabetic control subjects to allow us to 1) quantify the degree of impairment in T2D prior to intervention and 2) assess the effectiveness of the nitrate therapy in restoring the primary outcome measures back to 'normal'. Nondiabetic controls will not receive an 8-week beetroot supplementation.
|
|---|---|---|---|
|
Change in Skeletal Muscle Mitochondrial Function
CHO-supported respiration - Pre
|
64.6 Oxygen Flux, JO2 (pmol/(s*mg))
Standard Deviation 22.2
|
71.0 Oxygen Flux, JO2 (pmol/(s*mg))
Standard Deviation 20.5
|
87.5 Oxygen Flux, JO2 (pmol/(s*mg))
Standard Deviation 21.5
|
|
Change in Skeletal Muscle Mitochondrial Function
CHO-supported respiration - Post
|
75.4 Oxygen Flux, JO2 (pmol/(s*mg))
Standard Deviation 16.4
|
59.8 Oxygen Flux, JO2 (pmol/(s*mg))
Standard Deviation 11.1
|
—
|
Adverse Events
Beetroot Crystals (Nitrate)
Placebo (Beetroot Powder, no Nitrate)
Nondiabetic Control Subjects
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