Trial Outcomes & Findings for Maximizing the Dietary Pattern of Older Adults: the Effects of Protein Intake on Protein Kinetics (NCT NCT04830514)
NCT ID: NCT04830514
Last Updated: 2023-08-24
Results Overview
Isotope Tracer
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
24 hour
Results posted on
2023-08-24
Participant Flow
Participant milestones
| Measure |
Recommended Dietary Allowance (RDA) for Protein
(RDA; 0.8g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks.
Recommended Dietary Allowance of Protein: 0.8 g/kg/day protein intake
|
Habitual Protein Intake Consistent With Population Level Norms
(NHANES; 1.0g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks.
Habitual protein intake: 1.0 g/kg/day protein intake
|
Optimal Protein Intake (OPI)
(OPI; 1.5g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks.
Optimal Protein Intake: 1.5 g/kg/day protein intake
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
14
|
12
|
|
Overall Study
COMPLETED
|
10
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
8
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Maximizing the Dietary Pattern of Older Adults: the Effects of Protein Intake on Protein Kinetics
Baseline characteristics by cohort
| Measure |
Recommended Dietary Allowance (RDA) for Protein
n=10 Participants
(RDA; 0.8g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks.
Recommended Dietary Allowance of Protein: 0.8 g/kg/day protein intake
|
Habitual Protein Intake Consistent With Population Level Norms
n=11 Participants
(NHANES; 1.0g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks.
Habitual protein intake: 1.0 g/kg/day protein intake
|
Optimal Protein Intake (OPI)
n=9 Participants
(OPI; 1.5g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks.
Optimal Protein Intake: 1.5 g/kg/day protein intake
|
Total
n=30 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
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Ethnicity (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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 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
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
26 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
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
9 participants
n=5 Participants
|
30 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 24 hourIsotope Tracer
Outcome measures
| Measure |
Recommended Dietary Allowance (RDA) for Protein
n=10 Participants
(RDA; 0.8g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks.
Recommended Dietary Allowance of Protein: 0.8 g/kg/day protein intake
|
Habitual Protein Intake Consistent With Population Level Norms
n=11 Participants
(NHANES; 1.0g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks.
Habitual protein intake: 1.0 g/kg/day protein intake
|
Optimal Protein Intake (OPI)
n=9 Participants
(OPI; 1.5g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks.
Optimal Protein Intake: 1.5 g/kg/day protein intake
|
|---|---|---|---|
|
Whole Body Protein Turnover
|
-0.16 g/kg lean body mass/day
Standard Deviation 0.08
|
-0.17 g/kg lean body mass/day
Standard Deviation 0.11
|
0.48 g/kg lean body mass/day
Standard Deviation 0.11
|
Adverse Events
Recommended Dietary Allowance (RDA) for Protein
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Habitual Protein Intake Consistent With Population Level Norms
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Optimal Protein Intake (OPI)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Recommended Dietary Allowance (RDA) for Protein
n=18 participants at risk
(RDA; 0.8g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks.
Recommended Dietary Allowance of Protein: 0.8 g/kg/day protein intake
|
Habitual Protein Intake Consistent With Population Level Norms
n=14 participants at risk
(NHANES; 1.0g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks.
Habitual protein intake: 1.0 g/kg/day protein intake
|
Optimal Protein Intake (OPI)
n=12 participants at risk
(OPI; 1.5g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks.
Optimal Protein Intake: 1.5 g/kg/day protein intake
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Laceration from fall
|
5.6%
1/18 • Number of events 1 • Starting with enrollment and ending with completion of last study visit; in most cases within 30 days.
|
0.00%
0/14 • Starting with enrollment and ending with completion of last study visit; in most cases within 30 days.
|
0.00%
0/12 • Starting with enrollment and ending with completion of last study visit; in most cases within 30 days.
|
Other adverse events
| Measure |
Recommended Dietary Allowance (RDA) for Protein
n=18 participants at risk
(RDA; 0.8g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks.
Recommended Dietary Allowance of Protein: 0.8 g/kg/day protein intake
|
Habitual Protein Intake Consistent With Population Level Norms
n=14 participants at risk
(NHANES; 1.0g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks.
Habitual protein intake: 1.0 g/kg/day protein intake
|
Optimal Protein Intake (OPI)
n=12 participants at risk
(OPI; 1.5g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks.
Optimal Protein Intake: 1.5 g/kg/day protein intake
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Laceration from fall
|
0.00%
0/18 • Starting with enrollment and ending with completion of last study visit; in most cases within 30 days.
|
0.00%
0/14 • Starting with enrollment and ending with completion of last study visit; in most cases within 30 days.
|
8.3%
1/12 • Number of events 1 • Starting with enrollment and ending with completion of last study visit; in most cases within 30 days.
|
|
Ear and labyrinth disorders
Dizziness
|
27.8%
5/18 • Number of events 5 • Starting with enrollment and ending with completion of last study visit; in most cases within 30 days.
|
14.3%
2/14 • Number of events 2 • Starting with enrollment and ending with completion of last study visit; in most cases within 30 days.
|
41.7%
5/12 • Number of events 5 • Starting with enrollment and ending with completion of last study visit; in most cases within 30 days.
|
|
Gastrointestinal disorders
Nausea
|
22.2%
4/18 • Number of events 4 • Starting with enrollment and ending with completion of last study visit; in most cases within 30 days.
|
14.3%
2/14 • Number of events 2 • Starting with enrollment and ending with completion of last study visit; in most cases within 30 days.
|
16.7%
2/12 • Number of events 2 • Starting with enrollment and ending with completion of last study visit; in most cases within 30 days.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
3/18 • Number of events 3 • Starting with enrollment and ending with completion of last study visit; in most cases within 30 days.
|
7.1%
1/14 • Number of events 1 • Starting with enrollment and ending with completion of last study visit; in most cases within 30 days.
|
8.3%
1/12 • Number of events 1 • Starting with enrollment and ending with completion of last study visit; in most cases within 30 days.
|
|
Gastrointestinal disorders
GI illness with reflux
|
5.6%
1/18 • Number of events 1 • Starting with enrollment and ending with completion of last study visit; in most cases within 30 days.
|
0.00%
0/14 • Starting with enrollment and ending with completion of last study visit; in most cases within 30 days.
|
0.00%
0/12 • Starting with enrollment and ending with completion of last study visit; in most cases within 30 days.
|
Additional Information
David D. Church, Ph.D., Assistant Professor
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