Trial Outcomes & Findings for High Altitude and Exogenous Carbohydrate Oxidation (NCT NCT03851744)
NCT ID: NCT03851744
Last Updated: 2021-09-02
Results Overview
Use indirect calorimetry and stable isotope methodologies to measure if acute HA exposure changes the rate of exogenous carbohydrate oxidation during steady-state aerobic exercise compared to SL
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
7 hours
Results posted on
2021-09-02
Participant Flow
No significant events happen prior to assignment of participants to a study arm.
Participant milestones
| Measure |
Sea Level First, Then High Altitude
Carbohydrate metabolism measured at SL first then HA
Sea Level: Carbohydrate consumed at 1.8 g/min during treadmill exercise at SL
7 day washout
High Altitude: Carbohydrate consumed at 1.8 g/min during treadmill exercise at HA
|
High Altitude First, Then Sea Level
Carbohydrate metabolism measured at HA first then SL
High Altitude: Carbohydrate consumed at 1.8 g/min during treadmill exercise at HA
7 day washout
Sea Level: Carbohydrate consumed at 1.8 g/min during treadmill exercise at SL
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
High Altitude and Exogenous Carbohydrate Oxidation
Baseline characteristics by cohort
| Measure |
Sea Level First, Then High Altitude
n=4 Participants
Carbohydrate metabolism measured at SL, then HA
Sea Level: Carbohydrate consumed at 1.8 g/min during treadmill exercise at SL
7 day washout
High Altitude: Carbohydrate consumed at 1.8 g/min during treadmill exercise at HA
|
High Altitude, Then Sea Level
n=6 Participants
Carbohydrate metabolism measured at HA, then SL
High Altitude: Carbohydrate consumed at 1.8 g/min during treadmill exercise at HA
7 day washout
Sea Level: Carbohydrate consumed at 1.8 g/min during treadmill exercise at SL
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=93 Participants
|
6 participants
n=4 Participants
|
10 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 7 hoursUse indirect calorimetry and stable isotope methodologies to measure if acute HA exposure changes the rate of exogenous carbohydrate oxidation during steady-state aerobic exercise compared to SL
Outcome measures
| Measure |
Sea Level
n=8 Participants
Carbohydrate metabolism measured at SL
Sea Level: Carbohydrate consumed at 1.8 g/min during treadmill exercise at SL
|
High Altitude
n=8 Participants
Carbohydrate metabolism measured at HA
High Altitude: Carbohydrate consumed at 1.8 g/min during treadmill exercise at HA
|
|---|---|---|
|
Rate of Exogenous Carbohydrate Oxidation
|
0.44 g/min
Standard Deviation 0.05
|
0.35 g/min
Standard Deviation 0.07
|
PRIMARY outcome
Timeframe: 7 hoursUse stable isotope methodologies to measure if acute HA exposure changes the rate of glucose turnover during steady-state aerobic exercise compared to SL
Outcome measures
| Measure |
Sea Level
n=8 Participants
Carbohydrate metabolism measured at SL
Sea Level: Carbohydrate consumed at 1.8 g/min during treadmill exercise at SL
|
High Altitude
n=8 Participants
Carbohydrate metabolism measured at HA
High Altitude: Carbohydrate consumed at 1.8 g/min during treadmill exercise at HA
|
|---|---|---|
|
Rate of Glucose Turnover
Glucose Rate of Disappearance
|
14.3 mg/kg/min
Standard Deviation 2.0
|
12.7 mg/kg/min
Standard Deviation 1.7
|
|
Rate of Glucose Turnover
Metabolic Clearance Rate
|
12.1 mg/kg/min
Standard Deviation 2.3
|
8.9 mg/kg/min
Standard Deviation 1.8
|
Adverse Events
Sea Level
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Altitude
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