Trial Outcomes & Findings for Nutritional Biomarkers of Sarcopenia (NCT NCT05117112)
NCT ID: NCT05117112
Last Updated: 2024-09-25
Results Overview
The amount of leucine in the plasma at rest, following an overnight fast. Then maximum concentration of plasma leucine was the higher concentration observed following ingestion of the drink. The maximum amount can be different for everyone but typically occurs 45 to 75 minutes after consumption of the amino acid drink
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
A 5-hour period.
Results posted on
2024-09-25
Participant Flow
Participant milestones
| Measure |
Healthy Young
18 to 30 years old.
|
Healthy Elderly
Greater than or equal to 70 years of age. Handgrip greater than 35.5 and 20 for men and women, respectively.
|
Sarcopenic Elderly
Greater than or equal to 70 years of age. Handgrip less than 35.5 and 20 for men and women, respectively.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
11
|
10
|
|
Overall Study
COMPLETED
|
9
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nutritional Biomarkers of Sarcopenia
Baseline characteristics by cohort
| Measure |
Healthy Young
n=9 Participants
18 to 30 years old.
|
Healthy Elderly
n=10 Participants
Greater than or equal to 70 years of age. Handgrip greater than 35.5 and 20 for men and women, respectively.
|
Sarcopenic Elderly
n=10 Participants
Greater than or equal to 70 years of age. Handgrip less than 35.5 and 20 for men and women, respectively.
|
Total
n=29 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
|
9 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Age, Continuous
|
26.8 years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
75.5 years
STANDARD_DEVIATION 5.5 • n=7 Participants
|
77.1 years
STANDARD_DEVIATION 3.9 • n=5 Participants
|
60.4 years
STANDARD_DEVIATION 23.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
28 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
|
|
Region of Enrollment
United States
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: A 5-hour period.The amount of leucine in the plasma at rest, following an overnight fast. Then maximum concentration of plasma leucine was the higher concentration observed following ingestion of the drink. The maximum amount can be different for everyone but typically occurs 45 to 75 minutes after consumption of the amino acid drink
Outcome measures
| Measure |
Healthy Young
n=9 Participants
18 to 30 years old.
|
Healthy Elderly
n=10 Participants
Greater than or equal to 70 years of age. Handgrip greater than 35.5 and 20 for men and women, respectively.
|
Sarcopenic Elderly
n=9 Participants
Greater than or equal to 70 years of age. Handgrip less than 35.5 and 20 for men and women, respectively.
|
|---|---|---|---|
|
Resting and Maximum Plasma Leucine Concentration
Max Plasma Leucine Concentration
|
659 micromoles per liter
Standard Deviation 128
|
755 micromoles per liter
Standard Deviation 67
|
721 micromoles per liter
Standard Deviation 114
|
|
Resting and Maximum Plasma Leucine Concentration
Resting Plasma Leucine Concentration
|
95 micromoles per liter
Standard Deviation 21
|
100 micromoles per liter
Standard Deviation 22
|
100 micromoles per liter
Standard Deviation 21
|
Adverse Events
Healthy Young
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Elderly
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sarcopenic Elderly
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