Trial Outcomes & Findings for The Consumption of Beef on Appetite and Cognitive Function (NCT NCT02614729)
NCT ID: NCT02614729
Last Updated: 2019-07-08
Results Overview
Energy intake during breakfast, lunch, dinner, and evening snacks of each day 7 testing day (separated by 3-4 weeks) will be measured.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
5 months
Results posted on
2019-07-08
Participant Flow
All participants were recruited from Columbia, Missouri and the surrounding area from January 2014 to May 2015.
Following recruitment and screening, 17 met women met the screening criteria, signed the study consent, and completed the study procedures. All participants received the following treatments: Energy Balance Comparison (n=17) (SP-PLANT, SP-BEEF, HP-BEEF-EVEN, HP-BEEF-SKEW) \& Energy Restriction Comparison (n=17) (SP-PLANT, SP-BEEF, HP-BEEF-EVEN).
Participant milestones
| Measure |
Energy Balance Comparison
Participants will randomly consume 4 eucaloric diets for 7 consecutive days/treatment. Energy levels for all diets are established according to needs for energy balance.
Interventions:
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN); Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN); High Protein-Beef, Even Distribution (HP-BEEF-EVEN); High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN)
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN): Diet contains all plant proteins. Meals are evenly distributed throughout the day.
Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
High Protein-Beef, Even Distribution (HP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN): Diet contains combination of beef and plant proteins. Meals
|
Energy Restriction Comparison
Participants will randomly consume 3 energy restriction diets (1250 kcal/day) for 7 consecutive days/treatment. Energy levels for all diets are established according to needs for energy restriction.
Interventions:
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN); Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN); High Protein-Beef, Even Distribution (HP-BEEF-EVEN)
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN): Diet contains all plant proteins. Meals are evenly distributed throughout the day.
Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
High Protein-Beef, Even Distribution (HP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
17
|
|
Overall Study
COMPLETED
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Energy Balance Comparison
Participants will randomly consume 4 eucaloric diets for 7 consecutive days/treatment. Energy levels for all diets are established according to needs for energy balance.
Interventions:
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN); Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN); High Protein-Beef, Even Distribution (HP-BEEF-EVEN); High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN)
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN): Diet contains all plant proteins. Meals are evenly distributed throughout the day.
Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
High Protein-Beef, Even Distribution (HP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN): Diet contains combination of beef and plant proteins. Meals
|
Energy Restriction Comparison
Participants will randomly consume 3 energy restriction diets (1250 kcal/day) for 7 consecutive days/treatment. Energy levels for all diets are established according to needs for energy restriction.
Interventions:
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN); Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN); High Protein-Beef, Even Distribution (HP-BEEF-EVEN)
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN): Diet contains all plant proteins. Meals are evenly distributed throughout the day.
Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
High Protein-Beef, Even Distribution (HP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
The Consumption of Beef on Appetite and Cognitive Function
Baseline characteristics by cohort
| Measure |
Energy Balance Comparison
n=18 Participants
Participants will randomly consume 4 eucaloric diets for 7 consecutive days/treatment. Energy levels for all diets are established according to needs for energy balance.
Interventions:
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN); Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN); High Protein-Beef, Even Distribution (HP-BEEF-EVEN); High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN)
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN): Diet contains all plant proteins. Meals are evenly distributed throughout the day.
Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
High Protein-Beef, Even Distribution (HP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN): Diet contains combination of beef and plant proteins. Meals
|
Energy Restriction Comparison
n=17 Participants
Participants will randomly consume 3 energy restriction diets (1250 kcal/day) for 7 consecutive days/treatment. Energy levels for all diets are established according to needs for energy restriction.
Interventions:
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN); Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN); High Protein-Beef, Even Distribution (HP-BEEF-EVEN)
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN): Diet contains all plant proteins. Meals are evenly distributed throughout the day.
Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
High Protein-Beef, Even Distribution (HP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
|
Total
n=35 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
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 monthsEnergy intake during breakfast, lunch, dinner, and evening snacks of each day 7 testing day (separated by 3-4 weeks) will be measured.
Outcome measures
| Measure |
Energy Balance Comparison
n=17 Participants
Participants will randomly consume 4 eucaloric diets for 7 consecutive days/treatment. Energy levels for all diets are established according to needs for energy balance.
Interventions:
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN); Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN); High Protein-Beef, Even Distribution (HP-BEEF-EVEN); High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN)
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN): Diet contains all plant proteins. Meals are evenly distributed throughout the day.
Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
High Protein-Beef, Even Distribution (HP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN): Diet contains combination of beef and plant proteins. Meals
|
Energy Restriction Comparison
n=17 Participants
Participants will randomly consume 3 energy restriction diets (1250 kcal/day) for 7 consecutive days/treatment. Energy levels for all diets are established according to needs for energy restriction.
Interventions:
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN); Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN); High Protein-Beef, Even Distribution (HP-BEEF-EVEN)
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN): Diet contains all plant proteins. Meals are evenly distributed throughout the day.
Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
High Protein-Beef, Even Distribution (HP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
|
|---|---|---|
|
Daily Energy Intake: Total Daily Intake
SP-PLANT
|
2859 kcal
Standard Error 147
|
2313 kcal
Standard Error 170
|
|
Daily Energy Intake: Total Daily Intake
SP-BEEF
|
2714 kcal
Standard Error 219
|
2396 kcal
Standard Error 181
|
|
Daily Energy Intake: Total Daily Intake
HP-BEEF-EVEN
|
2830 kcal
Standard Error 214
|
2820 kcal
Standard Error 173
|
|
Daily Energy Intake: Total Daily Intake
HP-BEEF-SKEW
|
3039 kcal
Standard Error 184
|
NA kcal
Standard Error NA
This group did not receive the HP-BEEF-SKEW Treatment.
|
SECONDARY outcome
Timeframe: 5 monthsQuestionnaires assessing fullness will be completed throughout each of the 12-hour testing days (which are separated by 3-4 weeks). The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response. The scale is 0 to 100mm. The questions are worded in the following manner "how strong is your feeling of" with anchors of "not at all" (indicated at 0 mm) to "extremely" (indicated at 100 mm). All measures are reported at area under the curve for 0 to 630 min.
Outcome measures
| Measure |
Energy Balance Comparison
n=17 Participants
Participants will randomly consume 4 eucaloric diets for 7 consecutive days/treatment. Energy levels for all diets are established according to needs for energy balance.
Interventions:
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN); Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN); High Protein-Beef, Even Distribution (HP-BEEF-EVEN); High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN)
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN): Diet contains all plant proteins. Meals are evenly distributed throughout the day.
Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
High Protein-Beef, Even Distribution (HP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN): Diet contains combination of beef and plant proteins. Meals
|
Energy Restriction Comparison
n=17 Participants
Participants will randomly consume 3 energy restriction diets (1250 kcal/day) for 7 consecutive days/treatment. Energy levels for all diets are established according to needs for energy restriction.
Interventions:
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN); Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN); High Protein-Beef, Even Distribution (HP-BEEF-EVEN)
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN): Diet contains all plant proteins. Meals are evenly distributed throughout the day.
Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
High Protein-Beef, Even Distribution (HP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
|
|---|---|---|
|
Perceived Fullness
HP-BEEF-SKEW: Daily Fullness
|
38464 Total Fullness AUC (mm*630 min)
Standard Error 2693
|
NA Total Fullness AUC (mm*630 min)
Standard Error NA
This group did not receive the HP-BEEF-SKEW Treatment.
|
|
Perceived Fullness
SP-PLANT: Daily Fullness
|
38849 Total Fullness AUC (mm*630 min)
Standard Error 2302
|
32167 Total Fullness AUC (mm*630 min)
Standard Error 2745
|
|
Perceived Fullness
SP-BEEF: Daily Fullness
|
38689 Total Fullness AUC (mm*630 min)
Standard Error 2235
|
30862 Total Fullness AUC (mm*630 min)
Standard Error 2896
|
|
Perceived Fullness
HP-BEEF-EVEN: Daily Fullness
|
39560 Total Fullness AUC (mm*630 min)
Standard Error 2536
|
36313 Total Fullness AUC (mm*630 min)
Standard Error 2260
|
SECONDARY outcome
Timeframe: 5 monthsCognitive function will be assessed during each of the 12-hour testing days using CNS Vital Signs, a validated computerized assessment. This system contains a core battery of tasks. Reaction Time is the outcome of interest measured with the Stroop Test. In the first part, the words RED, YELLOW, BLUE, \& GREEN (printed in black) appear at random on the screen, \& the participant presses the space bar as soon as the test subject sees the word. In the second part, the words RED, YELLOW, BLUE, \& GREEN appear on the screen, printed in color. The participant is asked to press the space bar when the color of the word matches what the word says. In the third part, the words RED, YELLOW, BLUE, \& GREEN appear on the screen, printed in color. The participant is asked to press the space bar when the color of the word does not match what the word says. Reaction time is in milliseconds.
Outcome measures
| Measure |
Energy Balance Comparison
n=17 Participants
Participants will randomly consume 4 eucaloric diets for 7 consecutive days/treatment. Energy levels for all diets are established according to needs for energy balance.
Interventions:
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN); Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN); High Protein-Beef, Even Distribution (HP-BEEF-EVEN); High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN)
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN): Diet contains all plant proteins. Meals are evenly distributed throughout the day.
Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
High Protein-Beef, Even Distribution (HP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN): Diet contains combination of beef and plant proteins. Meals
|
Energy Restriction Comparison
n=17 Participants
Participants will randomly consume 3 energy restriction diets (1250 kcal/day) for 7 consecutive days/treatment. Energy levels for all diets are established according to needs for energy restriction.
Interventions:
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN); Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN); High Protein-Beef, Even Distribution (HP-BEEF-EVEN)
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN): Diet contains all plant proteins. Meals are evenly distributed throughout the day.
Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
High Protein-Beef, Even Distribution (HP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
|
|---|---|---|
|
Reaction Time as a Measure of Cognitive Performance Assessed Using the Stroop Test
SP-PLANT: Reaction Time
|
309 ms
Standard Error 7
|
303 ms
Standard Error 8
|
|
Reaction Time as a Measure of Cognitive Performance Assessed Using the Stroop Test
SP-BEEF: Reaction Time
|
321 ms
Standard Error 7
|
311 ms
Standard Error 6
|
|
Reaction Time as a Measure of Cognitive Performance Assessed Using the Stroop Test
HP-BEEF-EVEN: Reaction Time
|
320 ms
Standard Error 9
|
312 ms
Standard Error 7
|
|
Reaction Time as a Measure of Cognitive Performance Assessed Using the Stroop Test
HP-BEEF-SKEW: Reaction Time
|
317 ms
Standard Error 9
|
NA ms
Standard Error NA
This group did not receive the HP-BEEF-SKEW Treatment.
|
SECONDARY outcome
Timeframe: 5 monthsAlertness will be assessed during each of the 12-hour testing days (which are separated by 3-4 weeks) using the Profile of Mood States 2nd Edition (POMS2) with sub-categories of perceived vigor. POM2 is a self-report measure that allows for the quick assessment of transient, fluctuating feelings, and enduring affect states. There are 35 items. Items are rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). The Alertness (Vigor-Activity) scale score indicates the extent to which individual felt alert (vigorous and/or energetic); the higher are her positive feelings and/or energy, the greater is her score (i.e., a low score indicates relatively fewer positive feelings and/or low energy). Ratings on this scale yielded a T-score of 25 (95% CI =18-32), which is ranked at the 1st percentile, and falls within the Very Low score range. The T scores were then used to calculate area under the curve.
Outcome measures
| Measure |
Energy Balance Comparison
n=17 Participants
Participants will randomly consume 4 eucaloric diets for 7 consecutive days/treatment. Energy levels for all diets are established according to needs for energy balance.
Interventions:
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN); Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN); High Protein-Beef, Even Distribution (HP-BEEF-EVEN); High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN)
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN): Diet contains all plant proteins. Meals are evenly distributed throughout the day.
Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
High Protein-Beef, Even Distribution (HP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN): Diet contains combination of beef and plant proteins. Meals
|
Energy Restriction Comparison
n=17 Participants
Participants will randomly consume 3 energy restriction diets (1250 kcal/day) for 7 consecutive days/treatment. Energy levels for all diets are established according to needs for energy restriction.
Interventions:
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN); Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN); High Protein-Beef, Even Distribution (HP-BEEF-EVEN)
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN): Diet contains all plant proteins. Meals are evenly distributed throughout the day.
Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
High Protein-Beef, Even Distribution (HP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
|
|---|---|---|
|
Perceived Alertness
SP-PLANT: Total Alertness
|
1631 Total AUC (T-score*min)
Standard Error 448
|
2151 Total AUC (T-score*min)
Standard Error 883
|
|
Perceived Alertness
SP-BEEF: Total Alertness
|
1525 Total AUC (T-score*min)
Standard Error 638
|
1950 Total AUC (T-score*min)
Standard Error 631
|
|
Perceived Alertness
HP-BEEF-EVEN: Total Alertness
|
1374 Total AUC (T-score*min)
Standard Error 424
|
2434 Total AUC (T-score*min)
Standard Error 954
|
|
Perceived Alertness
HP-BEEF-SKEW: Total Alertness
|
1414 Total AUC (T-score*min)
Standard Error 712
|
NA Total AUC (T-score*min)
Standard Error NA
This group did not receive the HP-BEEF-SKEW Treatment.
|
SECONDARY outcome
Timeframe: 5 monthsQuestionnaires assessing hunger will be completed throughout each of the 12-hour testing days (which are separated by 3-4 weeks). The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response. The scale is 0 to 100mm. The questions are worded in the following manner "how strong is your feeling of" with anchors of "not at all" (indicated at 0 mm) to "extremely" (indicated at 100 mm). All measures are reported at area under the curve for 0 to 630 min.
Outcome measures
| Measure |
Energy Balance Comparison
n=17 Participants
Participants will randomly consume 4 eucaloric diets for 7 consecutive days/treatment. Energy levels for all diets are established according to needs for energy balance.
Interventions:
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN); Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN); High Protein-Beef, Even Distribution (HP-BEEF-EVEN); High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN)
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN): Diet contains all plant proteins. Meals are evenly distributed throughout the day.
Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
High Protein-Beef, Even Distribution (HP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN): Diet contains combination of beef and plant proteins. Meals
|
Energy Restriction Comparison
n=17 Participants
Participants will randomly consume 3 energy restriction diets (1250 kcal/day) for 7 consecutive days/treatment. Energy levels for all diets are established according to needs for energy restriction.
Interventions:
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN); Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN); High Protein-Beef, Even Distribution (HP-BEEF-EVEN)
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN): Diet contains all plant proteins. Meals are evenly distributed throughout the day.
Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
High Protein-Beef, Even Distribution (HP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
|
|---|---|---|
|
Perceived Hunger
SP-PLANT: Daily Hunger
|
16624 Total Fullness AUC (mm*630 min)
Standard Error 1989
|
21833 Total Fullness AUC (mm*630 min)
Standard Error 2370
|
|
Perceived Hunger
SP-BEEF: Daily Hunger
|
17496 Total Fullness AUC (mm*630 min)
Standard Error 1836
|
24849 Total Fullness AUC (mm*630 min)
Standard Error 2557
|
|
Perceived Hunger
HP-BEEF-EVEN: Daily Hunger
|
16713 Total Fullness AUC (mm*630 min)
Standard Error 1831
|
18598 Total Fullness AUC (mm*630 min)
Standard Error 1868
|
|
Perceived Hunger
HP-BEEF-SKEW: Daily Hunger
|
17689 Total Fullness AUC (mm*630 min)
Standard Error 1829
|
NA Total Fullness AUC (mm*630 min)
Standard Error NA
This group did not receive the HP-BEEF-SKEW Treatment.
|
SECONDARY outcome
Timeframe: 5 monthsQuestionnaires assessing prospective food consumption will be completed throughout each of the 12-hour testing days (which are separated by 3-4 weeks). The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response. The scale is 0 to 100mm. The questions are worded in the following manner "how strong is your feeling of" with anchors of "not at all" (indicated at 0 mm) to "extremely" (indicated at 100 mm). All measures are reported at area under the curve for 0 to 630 min.
Outcome measures
| Measure |
Energy Balance Comparison
n=17 Participants
Participants will randomly consume 4 eucaloric diets for 7 consecutive days/treatment. Energy levels for all diets are established according to needs for energy balance.
Interventions:
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN); Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN); High Protein-Beef, Even Distribution (HP-BEEF-EVEN); High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN)
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN): Diet contains all plant proteins. Meals are evenly distributed throughout the day.
Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
High Protein-Beef, Even Distribution (HP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN): Diet contains combination of beef and plant proteins. Meals
|
Energy Restriction Comparison
n=17 Participants
Participants will randomly consume 3 energy restriction diets (1250 kcal/day) for 7 consecutive days/treatment. Energy levels for all diets are established according to needs for energy restriction.
Interventions:
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN); Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN); High Protein-Beef, Even Distribution (HP-BEEF-EVEN)
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN): Diet contains all plant proteins. Meals are evenly distributed throughout the day.
Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
High Protein-Beef, Even Distribution (HP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
|
|---|---|---|
|
Perceived Prospective Food Consumption
SP-PLANT: Prospective Food Consumption
|
19158 Total PFC AUC (mm*630 min)
Standard Error 1638
|
24889 Total PFC AUC (mm*630 min)
Standard Error 2060
|
|
Perceived Prospective Food Consumption
SP-BEEF: Prospective Food Consumption
|
19847 Total PFC AUC (mm*630 min)
Standard Error 1583
|
25929 Total PFC AUC (mm*630 min)
Standard Error 2270
|
|
Perceived Prospective Food Consumption
HP-BEEF-EVEN: Prospective Food Consumption
|
19087 Total PFC AUC (mm*630 min)
Standard Error 1537
|
21015 Total PFC AUC (mm*630 min)
Standard Error 1746
|
|
Perceived Prospective Food Consumption
HP-BEEF-Skew: Prospective Food Consumption
|
20520 Total PFC AUC (mm*630 min)
Standard Error 1809
|
NA Total PFC AUC (mm*630 min)
Standard Error NA
This group did not receive the HP-BEEF-SKEW Treatment.
|
SECONDARY outcome
Timeframe: 5 monthsQuestionnaires assessing desire to eat will be completed throughout each of the 12-hour testing days (which are separated by 3-4 weeks). The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response. The scale is 0 to 100mm. The questions are worded in the following manner "how strong is your feeling of" with anchors of "not at all" (indicated at 0 mm) to "extremely" (indicated at 100 mm). All measures are reported at area under the curve for 0 to 630 min.
Outcome measures
| Measure |
Energy Balance Comparison
n=17 Participants
Participants will randomly consume 4 eucaloric diets for 7 consecutive days/treatment. Energy levels for all diets are established according to needs for energy balance.
Interventions:
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN); Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN); High Protein-Beef, Even Distribution (HP-BEEF-EVEN); High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN)
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN): Diet contains all plant proteins. Meals are evenly distributed throughout the day.
Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
High Protein-Beef, Even Distribution (HP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN): Diet contains combination of beef and plant proteins. Meals
|
Energy Restriction Comparison
n=17 Participants
Participants will randomly consume 3 energy restriction diets (1250 kcal/day) for 7 consecutive days/treatment. Energy levels for all diets are established according to needs for energy restriction.
Interventions:
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN); Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN); High Protein-Beef, Even Distribution (HP-BEEF-EVEN)
Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN): Diet contains all plant proteins. Meals are evenly distributed throughout the day.
Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
High Protein-Beef, Even Distribution (HP-BEEF-EVEN): Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
|
|---|---|---|
|
Perceived Desire to Eat
SP-PLANT: Daily Desire to Eat
|
18132 Total Desire to Eat AUC (mm*630 min)
Standard Error 1952
|
24309 Total Desire to Eat AUC (mm*630 min)
Standard Error 2601
|
|
Perceived Desire to Eat
SP-BEEF: Daily Desire to Eat
|
18753 Total Desire to Eat AUC (mm*630 min)
Standard Error 1875
|
25886 Total Desire to Eat AUC (mm*630 min)
Standard Error 2566
|
|
Perceived Desire to Eat
HP-BEEF-EVEN: Daily Desire to Eat
|
18179 Total Desire to Eat AUC (mm*630 min)
Standard Error 1951
|
19921 Total Desire to Eat AUC (mm*630 min)
Standard Error 1904
|
|
Perceived Desire to Eat
HP-BEEF-SKEW: Daily Desire to Eat
|
19540 Total Desire to Eat AUC (mm*630 min)
Standard Error 1998
|
NA Total Desire to Eat AUC (mm*630 min)
Standard Error NA
This group did not receive the HP-BEEF-SKEW Treatment.
|
Adverse Events
Energy Balance Comparison
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Energy Restriction Comparison
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