Trial Outcomes & Findings for "Ounce-equivalents" in the Protein Foods Group: Benefits of Quality (NCT NCT03179462)
NCT ID: NCT03179462
Last Updated: 2021-12-06
Results Overview
Net protein synthesis rate is determined in the 4.5-hours basal fasted period and 4-hours post-meal period over the 8.5-hour experimental period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
Change from 4.5 to 8.5 hours.
Results posted on
2021-12-06
Participant Flow
Participant milestones
| Measure |
Pork Intake
Subjects will consume 2 ounces of cooked lean pork following diet normalization for 3 days.
Pork intake: Each participant will consume 2 ounces of cooked lean pork.
|
Mixed Nuts Intake
Subjects will consume 1 ounce of mixed nuts following diet normalization for 3 days.
Mixed nuts intake: Each participant will consume 1 ounce of mixed nuts.
|
Tofu Intake
Subjects will consume 2 ounces of tofu following diet normalization for 3 days.
Tofu intake: Each participant will consume 2 ounces of tofu.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
0
|
Reasons for withdrawal
| Measure |
Pork Intake
Subjects will consume 2 ounces of cooked lean pork following diet normalization for 3 days.
Pork intake: Each participant will consume 2 ounces of cooked lean pork.
|
Mixed Nuts Intake
Subjects will consume 1 ounce of mixed nuts following diet normalization for 3 days.
Mixed nuts intake: Each participant will consume 1 ounce of mixed nuts.
|
Tofu Intake
Subjects will consume 2 ounces of tofu following diet normalization for 3 days.
Tofu intake: Each participant will consume 2 ounces of tofu.
|
|---|---|---|---|
|
Overall Study
screening failure
|
1
|
2
|
0
|
Baseline Characteristics
"Ounce-equivalents" in the Protein Foods Group: Benefits of Quality
Baseline characteristics by cohort
| Measure |
Pork Intake
n=9 Participants
Subjects will consume 2 ounces of cooked lean pork following diet normalization for 3 days.
Pork intake: Each participant will consume 2 ounces of cooked lean pork.
|
Mixed Nuts Intake
n=10 Participants
Subjects will consume 1 ounce of mixed nuts following diet normalization for 3 days.
Mixed nuts intake: Each participant will consume 1 ounce of mixed nuts.
|
Tofu Intake
n=8 Participants
Subjects will consume 2 ounces of tofu following diet normalization for 3 days.
Tofu intake: Each participant will consume 2 ounces of tofu.
|
Total
n=27 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
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
27 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
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other Race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic ethnicity
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
non-Hispanic ethnicity
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Change from 4.5 to 8.5 hours.Net protein synthesis rate is determined in the 4.5-hours basal fasted period and 4-hours post-meal period over the 8.5-hour experimental period.
Outcome measures
| Measure |
Pork Intake
n=8 Participants
Subjects will consume 2 ounces of cooked lean pork following diet normalization for 3 days.
Pork intake: Each participant will consume 2 ounces of cooked lean pork.
|
Mixed Nuts Intake
n=8 Participants
Subjects will consume 1 ounce of mixed nuts following diet normalization for 3 days.
Mixed nuts intake: Each participant will consume 1 ounce of mixed nuts.
|
Tofu Intake
n=8 Participants
Subjects will consume 2 ounces of tofu following diet normalization for 3 days.
Tofu intake: Each participant will consume 2 ounces of tofu.
|
|---|---|---|---|
|
Net Protein Synthesis Rate
|
8.65 grams
Standard Deviation 1.6
|
1.97 grams
Standard Deviation 1.04
|
5.69 grams
Standard Deviation 0.54
|
Adverse Events
Pork Intake
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mixed Nuts Intake
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tofu Intake
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