Trial Outcomes & Findings for Trial of Oral Glutamine on Mitochondrial Function in CKD (NCT NCT02838979)
NCT ID: NCT02838979
Last Updated: 2022-07-14
Results Overview
31P MRS/OS was used to measure mitochondrial phosphorylation capacity (ATPmax).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
2 weeks
Results posted on
2022-07-14
Participant Flow
Participant milestones
| Measure |
Oral L-Glutamine First, Then Maltodestrin
Subjects will receive 0.4 g/kg/day of L-glutamine (Nutrestore, EMMAUS Life Sciences, Inc Torrance, CA) in three divided daily doses. Duration 2 weeks
L-glutamine: Oral Glutamine for 2 weeks at dose of 0.4mg/kg/day in three divided daily doses
|
Maltodextrin First, Then L-glutamine
Identical appearing maltodextrin powder.
Maltodextrin: Oral maltodextrin as described for the active agent: 2 weeks at dose of 0.4mg/kg/day in three divided daily doses.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
|
Overall Study
COMPLETED
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Oral Glutamine on Mitochondrial Function in CKD
Baseline characteristics by cohort
| Measure |
L-Glutamine First, Then Maltodextrin
n=6 Participants
Subjects will first receive 0.4 g/kg/day of L-glutamine (Nutrestore, EMMAUS Life Sciences, Inc Torrance, CA) first, then crossover taking Maltodextrin.
|
Maltodextrin First, Then L-glutamine
n=5 Participants
Subjects will first receive Identical appearing maltodextrin powder first, then crossover to taking L-glutamine.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 16.6 • n=5 Participants
|
58 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
58 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeks31P MRS/OS was used to measure mitochondrial phosphorylation capacity (ATPmax).
Outcome measures
| Measure |
L-Glutamine
n=11 Participants
L-glutamine: Oral Glutamine for 2 weeks at dose of 0.4mg/kg/day in three divided daily doses
|
Maltodextrin
n=11 Participants
Identical appearing maltodextrin powder.
Maltodextrin: Oral maltodextrin as described for the active agent: 2 weeks at dose of 0.4mg/kg/day in three divided daily doses.
|
|---|---|---|
|
Muscle Mitochondrial Function
|
0.88 mM ATP/s
Standard Deviation 0.30
|
0.90 mM ATP/s
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: 2 weeksTo test if glutamine improves objective isometric muscle fatigue by comparing the measurement of FTI from each arm. Muscle fatigability was tested by calculating FTI as the area under the force-time curve during isometric force generated at 70 % of maximal voluntary contraction (MVC),
Outcome measures
| Measure |
L-Glutamine
n=11 Participants
L-glutamine: Oral Glutamine for 2 weeks at dose of 0.4mg/kg/day in three divided daily doses
|
Maltodextrin
n=11 Participants
Identical appearing maltodextrin powder.
Maltodextrin: Oral maltodextrin as described for the active agent: 2 weeks at dose of 0.4mg/kg/day in three divided daily doses.
|
|---|---|---|
|
Change in Force-time Integral Area Under the Curve in Active Agent vs. Placebo
|
58.87 N*s
Standard Deviation 24.07
|
52.36 N*s
Standard Deviation 21.22
|
SECONDARY outcome
Timeframe: 2 weeksTo test the effect of glutamine supplementation on muscle endurance, sum of the muscle force (force-time integral, FTI, N\*s) normalized to maximum voluntary contraction (MVC, N) generated during voluntary contraction.
Outcome measures
| Measure |
L-Glutamine
n=11 Participants
L-glutamine: Oral Glutamine for 2 weeks at dose of 0.4mg/kg/day in three divided daily doses
|
Maltodextrin
n=11 Participants
Identical appearing maltodextrin powder.
Maltodextrin: Oral maltodextrin as described for the active agent: 2 weeks at dose of 0.4mg/kg/day in three divided daily doses.
|
|---|---|---|
|
Muscle Fatigue
|
2.52 s-1
Standard Deviation 1.09
|
2.41 s-1
Standard Deviation 1.03
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 weeksTo test if glutamine improves plasma NAD+ compared to placebo. Plasma NAD+ concentrations were quantified in mM using 31p MRS based in vivo assay.
Outcome measures
| Measure |
L-Glutamine
n=11 Participants
L-glutamine: Oral Glutamine for 2 weeks at dose of 0.4mg/kg/day in three divided daily doses
|
Maltodextrin
n=11 Participants
Identical appearing maltodextrin powder.
Maltodextrin: Oral maltodextrin as described for the active agent: 2 weeks at dose of 0.4mg/kg/day in three divided daily doses.
|
|---|---|---|
|
Plasma NAD+ Levels
|
0.95 mM
Standard Deviation 0.25
|
0.98 mM
Standard Deviation 0.19
|
POST_HOC outcome
Timeframe: 2 weeksTo test if glutamine improves maximal voluntary contraction compared to placebo. Maximum voluntary contraction (MVC) was determined by the isometric force generated using first dorsal interosseous (FDI) muscle against a force transducer.
Outcome measures
| Measure |
L-Glutamine
n=11 Participants
L-glutamine: Oral Glutamine for 2 weeks at dose of 0.4mg/kg/day in three divided daily doses
|
Maltodextrin
n=11 Participants
Identical appearing maltodextrin powder.
Maltodextrin: Oral maltodextrin as described for the active agent: 2 weeks at dose of 0.4mg/kg/day in three divided daily doses.
|
|---|---|---|
|
Maximal Voluntary Contraction
|
23.6 N/m
Standard Deviation 6.834
|
23.22 N/m
Standard Deviation 8.967
|
Adverse Events
L-Glutamine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Maltodextrin
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