Trial Outcomes & Findings for Essential Amino Acids and Protein Kinetics During Caloric Deprivation (NCT NCT03372928)
NCT ID: NCT03372928
Last Updated: 2020-11-20
Results Overview
Assessed using stable isotope infusions of phenylalanine.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
3 hour measure of muscle protein synthesis
Results posted on
2020-11-20
Participant Flow
This was a cross-over design study. 19 volunteers completed both the standard and high EAA testing phases.
Participant milestones
| Measure |
Low EAA First, Then High EAA
Participants received EAA provided relative to body mass at a standard dose (0.10 g/kg; LOW)) during energy deprivation first, then received EAA provided relative to body mass at a high dose (0.3 g/kg; HIGH) during energy deprivation.
|
High EAA First, Then Low EAA
Participants received EAA provided relative to body mass at a high dose (0.30 g/kg; HIGH) during energy deprivation first, then received EAA provided relative to body mass at a low dose (0.1 g/kg; LOW) during energy deprivation.
|
|---|---|---|
|
First Intervention (5 d Energy Deficit)
STARTED
|
10
|
10
|
|
First Intervention (5 d Energy Deficit)
COMPLETED
|
10
|
10
|
|
First Intervention (5 d Energy Deficit)
NOT COMPLETED
|
0
|
0
|
|
Washout (14 d)
STARTED
|
10
|
10
|
|
Washout (14 d)
COMPLETED
|
10
|
9
|
|
Washout (14 d)
NOT COMPLETED
|
0
|
1
|
|
Second Intervention (5 d Energy Deficit)
STARTED
|
10
|
9
|
|
Second Intervention (5 d Energy Deficit)
COMPLETED
|
10
|
9
|
|
Second Intervention (5 d Energy Deficit)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Essential Amino Acids and Protein Kinetics During Caloric Deprivation
Baseline characteristics by cohort
| Measure |
All Study Participants
n=19 Participants
All participants were randomized to receive all interventions.
|
|---|---|
|
Age, Continuous
|
23 years
STANDARD_DEVIATION 5 • n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Body Mass Index
|
25.4 kilograms per meter squared
STANDARD_DEVIATION 2.7 • n=93 Participants
|
PRIMARY outcome
Timeframe: 3 hour measure of muscle protein synthesisAssessed using stable isotope infusions of phenylalanine.
Outcome measures
| Measure |
Standard EAA Dose
n=19 Participants
EAA dose provided at 0.10 g/kg body mass
Standard EAA: EAA provided relative to body mass at a standard dose (0.10 g/kg) during energy deprivation
|
High EAA Dose
n=19 Participants
EAA dose provided at 0.30 g/kg body mass
High EAA: EAA provided relative to body mass at a high dose (0.30 g/kg) during energy deprivation
|
|---|---|---|
|
Postprandial, Resting Muscle Protein Synthesis Rates
|
0.055 percent per hour
Standard Deviation 0.01
|
0.061 percent per hour
Standard Deviation 0.02
|
PRIMARY outcome
Timeframe: 3 hour measure of muscle protein synthesisAssess using stable isotope infusions of phenylalanine.
Outcome measures
| Measure |
Standard EAA Dose
n=19 Participants
EAA dose provided at 0.10 g/kg body mass
Standard EAA: EAA provided relative to body mass at a standard dose (0.10 g/kg) during energy deprivation
|
High EAA Dose
n=19 Participants
EAA dose provided at 0.30 g/kg body mass
High EAA: EAA provided relative to body mass at a high dose (0.30 g/kg) during energy deprivation
|
|---|---|---|
|
Postprandial, Post-exercise Muscle Protein Synthesis Rates
|
0.055 percent per hour
Standard Deviation 0.01
|
0.065 percent per hour
Standard Deviation 0.02
|
PRIMARY outcome
Timeframe: 3 hour measure of whole-body protein balanceAssessed using stable isotope infusions of tyrosine. Net Whole-body Protein Balance is defined as whole-body protein synthesis - whole-body protein breakdown)
Outcome measures
| Measure |
Standard EAA Dose
n=19 Participants
EAA dose provided at 0.10 g/kg body mass
Standard EAA: EAA provided relative to body mass at a standard dose (0.10 g/kg) during energy deprivation
|
High EAA Dose
n=19 Participants
EAA dose provided at 0.30 g/kg body mass
High EAA: EAA provided relative to body mass at a high dose (0.30 g/kg) during energy deprivation
|
|---|---|---|
|
How Well Participants Suppress the Degradation of Body Proteins While Stimulating the Growth of New Proteins After Ingesting Varying Doses of EAA at Rest and After Exercise. Net Whole-body Protein Balance
|
2.7 grams of protein per 180min
Standard Deviation 1.7
|
21.3 grams of protein per 180min
Standard Deviation 3.4
|
Adverse Events
Low EAA First, Then High EAA: Low EAA Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High EAA First, Then Low EAA: Low EAA Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low EAA First, Then High EAA: High EAA Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High EAA First, Then Low EAA: High EAA Treatment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low EAA First, Then High EAA: Low EAA Treatment
n=10 participants at risk
EAA dose provided at 0.10 g/kg body mass during first intervention, then EAA dose provided at 0.30 g/kg body mass during second intervention.
Low EAA Treatment Period
|
High EAA First, Then Low EAA: Low EAA Treatment
n=10 participants at risk
EAA dose provided at 0.30 g/kg body mass during first intervention, then EAA dose provided at 0.10 g/kg body mass during second intervention.
Low EAA Treatment Period
|
Low EAA First, Then High EAA: High EAA Treatment
n=10 participants at risk
EAA dose provided at 0.10 g/kg body mass during first intervention, then EAA dose provided at 0.30 g/kg body mass during second intervention.
High EAA Treatment Period
|
High EAA First, Then Low EAA: High EAA Treatment
n=10 participants at risk
EAA dose provided at 0.30 g/kg body mass during first intervention, then EAA dose provided at 0.10 g/kg body mass during second intervention.
High EAA Treatment Period
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
mild erythema
|
0.00%
0/10 • 1 day
non-serious adverse event
|
0.00%
0/10 • 1 day
non-serious adverse event
|
0.00%
0/10 • 1 day
non-serious adverse event
|
10.0%
1/10 • Number of events 1 • 1 day
non-serious adverse event
|
Additional Information
Jess Gwin
US Army Research Institute of Environmental Medicine
Phone: 508-206-2300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place