Trial Outcomes & Findings for Whole Body Protein Metabolism of a Whey/EAA Supplement Using Continuous Oral Stable Isotopes (NCT NCT04612400)
NCT ID: NCT04612400
Last Updated: 2023-08-28
Results Overview
grams of protein per 240 minutes as determined using stable isotope ingestion and blood analysis for said isotopes' concentrations.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
240 minutes
Results posted on
2023-08-28
Participant Flow
Participant milestones
| Measure |
Low Dose Then High Dose
Low dose (6.3g) EAA/whey protein supplement
Oral amino acid tracer: Whole body protein metabolism response to a dose of the supplement will be measured using a continuous oral sip-feeding (every 10 minutes) method of stable isotope tracer.
|
High Dose Then Low Dose
High dose (12.6g) EAA/whey protein supplement
Oral amino acid tracer: Whole body protein metabolism response to a dose of the supplement will be measured using a continuous oral sip-feeding (every 10 minutes) method of stable isotope tracer.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Whole Body Protein Metabolism of a Whey/EAA Supplement Using Continuous Oral Stable Isotopes
Baseline characteristics by cohort
| Measure |
Low Dose Then High
n=4 Participants
Low dose (6.3g) EAA/whey protein supplement
Oral amino acid tracer: Whole body protein metabolism response to a dose of the supplement will be measured using a continuous oral sip-feeding (every 10 minutes) method of stable isotope tracer.
|
High Dose Then Low
n=4 Participants
High dose (12.6g) EAA/whey protein supplement
Oral amino acid tracer: Whole body protein metabolism response to a dose of the supplement will be measured using a continuous oral sip-feeding (every 10 minutes) method of stable isotope tracer.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
30 years
STANDARD_DEVIATION 5.3 • n=99 Participants
|
29 years
STANDARD_DEVIATION 7 • n=107 Participants
|
29 years
STANDARD_DEVIATION 5.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
4 participants
n=107 Participants
|
8 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 240 minutesgrams of protein per 240 minutes as determined using stable isotope ingestion and blood analysis for said isotopes' concentrations.
Outcome measures
| Measure |
Low Dose
n=8 Participants
Low dose (6.3g) EAA/whey protein supplement
Oral amino acid tracer: Whole body protein metabolism response to a dose of the supplement will be measured using a continuous oral sip-feeding (every 10 minutes) method of stable isotope tracer.
|
High Dose
n=8 Participants
High dose (12.6g) EAA/whey protein supplement
Oral amino acid tracer: Whole body protein metabolism response to a dose of the supplement will be measured using a continuous oral sip-feeding (every 10 minutes) method of stable isotope tracer.
|
|---|---|---|
|
Whole-body Protein Net Balance
|
6.2 grams
Standard Deviation 5.1
|
11.8 grams
Standard Deviation 3.9
|
Adverse Events
Low Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Dose
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
Katie Rose Hisrch, Ph.D.
The University of Arkansas for Medical Sciences
Phone: 5015265708
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place