Trial Outcomes & Findings for Effect of an EAA/Whey Composition on Protein Metabolism (NCT NCT03502941)
NCT ID: NCT03502941
Last Updated: 2021-11-02
Results Overview
Changes in net protein balance at whole body (grams)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
Change from 4.5 to 8.5 hours.
Results posted on
2021-11-02
Participant Flow
Of the 16 subjects enrolled, 8 were randomized into an arm that has a crossover component of two study interventions. The other 8 subjects were randomized into a control arm that had only one intervention.
Participant milestones
| Measure |
EAAs/Whey (6.3 g Dose First, Then 12.6g)
Subjects will consume 6.3 g of EAAs/whey in \~12 oz water at their first intervention visit, then 12.6 g of the same product at their second intervention visit.
|
EAAs/Whey (12.6g First, Then 6.3g)
Subjects will consume 12.6 g of EAAs/whey in \~12 oz water at their first intervention visit, then 6.3 g of the same product at their second intervention visit.
|
Whey Protein Alone
Subjects will consume 12.6 g of whey protein isolate which is an equal amount to the double dose of EAAs/whey.
12.6 g of whey protein isolate: Whey protein isolate alone, which is an equal amount to the double dose of the mixture of EAAs/whey
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
5
|
8
|
|
Overall Study
COMPLETED
|
3
|
5
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of an EAA/Whey Composition on Protein Metabolism
Baseline characteristics by cohort
| Measure |
EAAs/Whey: 6.3g First, Then 12.6g
n=3 Participants
Subjects will consume 6.3 g of EAAs/whey in \~12 oz water on 1 day. Then washout at least 5 days. Then consume 12.6 g of study product at another visit.
|
EAAs/Whey: 12.6g First, Then 6.3g
n=5 Participants
Subjects will consume 12.6 g of EAAs/whey in \~12 oz water on 1 day. Then washout at least 5 days. Then consume 6.3 g of study product at another visit.
|
Whey Protein Alone
n=8 Participants
Subjects will consume 12.6 g of whey protein isolate which is an equal amount to the double dose of EAAs/whey.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
13 Participants
n=4 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
|
|
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
|
PRIMARY outcome
Timeframe: Change from 4.5 to 8.5 hours.Changes in net protein balance at whole body (grams)
Outcome measures
| Measure |
A Single Dose of EAAs/Whey
n=8 Participants
Subjects will consume 6.3 g of EAAs/whey in \~12 oz water.
6.3 g of EAAs mixture and whey protein isolate: A single dose of the mixture of EAAs/whey
|
A Double Dose of EAAs/Whey
n=8 Participants
Subjects will consume 12.6 g of EAAs/whey in \~12 oz water
12.6 g of EAAs mixture and whey protein isolate: A double dose of the mixture of EAAs/whey
|
Whey Protein Alone
n=8 Participants
Subjects will consume 12.6 g of whey protein isolate which is an equal amount to the double dose of EAAs/whey.
12.6 g of whey protein isolate: Whey protein isolate alone, which is an equal amount to the double dose of the mixture of EAAs/whey
|
|---|---|---|---|
|
Protein Anabolism
|
3.56 grams
Standard Deviation 1.89
|
11.8 grams
Standard Deviation 1.79
|
3.02 grams
Standard Deviation 0.91
|
PRIMARY outcome
Timeframe: From 4.5 to 8.5 hours.Changes in protein synthesis in muscle (percent)
Outcome measures
| Measure |
A Single Dose of EAAs/Whey
n=8 Participants
Subjects will consume 6.3 g of EAAs/whey in \~12 oz water.
6.3 g of EAAs mixture and whey protein isolate: A single dose of the mixture of EAAs/whey
|
A Double Dose of EAAs/Whey
n=8 Participants
Subjects will consume 12.6 g of EAAs/whey in \~12 oz water
12.6 g of EAAs mixture and whey protein isolate: A double dose of the mixture of EAAs/whey
|
Whey Protein Alone
n=8 Participants
Subjects will consume 12.6 g of whey protein isolate which is an equal amount to the double dose of EAAs/whey.
12.6 g of whey protein isolate: Whey protein isolate alone, which is an equal amount to the double dose of the mixture of EAAs/whey
|
|---|---|---|---|
|
Protein Synthesis
|
0.024 percent change
Standard Deviation 0.048
|
0.044 percent change
Standard Deviation 0.038
|
0.022 percent change
Standard Deviation 0.041
|
Adverse Events
A Single Dose of EAAs/Whey
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
A Double Dose of EAAs/Whey
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Whey Protein Alone
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
David D.Church, Ph.D.
University of Arkansas for Medical Sciences
Phone: 5015265709
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place