Dietary Interventions, Obesity, Poor Glycemic Control
Conditions
Keywords
High Protein, Satiety, Appetite Control, Protein Distribution, Cognitive Function, Ad libitum Food Intake, Obesity prevention, Obesity treatment
Brief summary
The purpose of the main study is to determine whether the daily consumption of protein-rich meals containing high quality, lean beef products improves appetite control and cognitive function during a weight maintenance diet. The purpose of the sub-study is to determine whether the daily consumption of protein-rich meals containing the same amount of high quality, lean beef products improves appetite control and cognitive function during a modest energy restriction, weight loss diet.
Detailed description
Two cross-over design studies were completed in overweight, sedentary but otherwise healthy women. For study 1, 17 participants randomly consumed 4 eucaloric diets containing standard-protein (SP; 76±1g protein/d) or high-protein (HP; 126±1g protein/d) for 7 consecutive days/treatment. The SP treatments contained all plant proteins (PLANT) or a combination of beef and plant proteins (BEEF) that were evenly distributed throughout the day (EVEN). The HP treatments were also BEEF provided as EVEN or an uneven distribution (UNEVEN) pattern. For study 2, 17 participants randomly consumed 3 energy restriction (1250 kcal/d) diets containing SP-PLANT (EVEN) and SP-BEEF (EVEN) (both, 48±1g protein/d) or HP-BEEF (EVEN) (123±1g protein/d). During day 6 of each treatment (for both studies), the participants completed a 12-h controlled-feeding, clinical testing day which included repeated appetite, satiety, food cravings, and mood questionnaires; blood sampling; and cognitive function/performance testing. During day 7 of each treatment (for both studies), the participants completed a free-living, ad libitum testing day at home/work to assess ad libitum (voluntary) daily intake and food choice. Each of the 7-day dietary patterns occurred during the follicular phase of the menstrual cycle; thus, there were 2-3 week washout periods between dietary treatments.
Interventions
OTHERStandard Protein-Plant, Even Distribution (SP-PLANT-EVEN)
Diet contains all plant proteins. Meals are evenly distributed throughout the day.
OTHERStandard Protein-Beef, Even Distribution (SP-BEEF-EVEN)
Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
OTHERHigh Protein-Beef, Even Distribution (HP-BEEF-EVEN)
Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
OTHERHigh Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN)
Diet contains combination of beef and plant proteins. Meals are unevenly distributed throughout the day.
Sponsors
National Cattlemen's Beef Association, a contractor to the Beef Checkoff
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 52 Years
Healthy volunteers
Yes
Inclusion criteria
* Women * Ages: 18-52 y * BMI: 25-32 kg/m2 * No metabolic, hormonal, and/or neural conditions/diseases that influence metabolism, appetite, or cognition * No blood donations to American Red Cross within past 6 months * No medication that would influence directly appetite or cognition * No change in any medications (over the past 3 months) * Non-smoking (for the past year) * Not pregnant within the past 6 months (or planning to become pregnant during study) * Have not given birth and/or lactating within the past 6 months * Normal menstrual cycles between 26-32 days in duration; 5 menstrual cycles within the past 6 months; or able to provide documentation of oral/hormonal contraceptive use which contains low-dose estrogen/progesterone to maintain continuous levels throughout the 28-day cycle (i.e., no placebos) * Not clinically diagnosed with an eating disorder * No weight loss/gain (≥10 lb. in the past 6 months) * No past history of surgical interventions for the treatment of obesity * No allergies and/or aversions to the study foods, particularly beef * Consumes ≤ 800 mg caffeine/day * Of this, ≤260 mg caffeine is consumed prior to lunch (\ 12 oz. Starbucks coffee) * Not currently and/or previously on a specific diet including high protein, vegan, vegetarian, etc. * Willing and able to consume all study foods * Habitually consumes breakfast, lunch, and dinner \>4 days/week * No history of drug abuse or alcohol abuse (i.e., \>14 drinks/week; 1 drink=12 oz. beer; 5 oz. wine; 1.5 oz. liquor) * Displays a score of \<4 on the Three Factor Eating Habits Questionnaire (TFEQ) * Conventional (typical) and consistent sleep patterns * awake hours somewhere between 5 am - 11 pm with no afternoon naps * rates quality of sleep as Fairly to Very Good on the Pittsburg Sleep Quality Index (PSQI) * averages ≥ 6 sleep hours/night over the past month * Displays a Profile of Mood State 2nd Edition (POMS2; 60-item) Depression-Dejection Scale score within 1.5 SD of the age, gender, and racial-specific normative mean (Nyenhuis et al., 1999; Petterson K et al., 2006) * Obtained a Yes on the validity indicator and displayed a score of \>70 (\>2%) on the CNS Vital Signs Battery * Sedentary (i.e., limited purposeful physical activity) * Willing and able to maintain current inactivity patterns throughout the study * Willing and able to follow all study procedures * Generally healthy, as assessed from the medical history questionnaire
Exclusion criteria
* Men * Ages: \<18 or \>52 y * BMI: \<25 or \>32 kg/m2 * Any metabolic, hormonal, and/or neural conditions/diseases that influence metabolism, appetite, or cognition * Have donated blood to American Red Cross within past 6 months * Medication that would influence directly appetite or cognition * Change in medications (over the past 3 months) * Have smoked in the past year * Pregnant within the past 6 months (or planning to become pregnant during study) * Have given birth and/or lactating within the past 6 months * Abnormal menstrual cycles \[not between 26-32 days in duration; or not 5-6 menstrual cycles within the past 6 months; or not able to provide documentation of oral/hormonal contraceptive use which contains low-dose estrogen/progesterone to maintain continuous levels throughout the 28-day cycle (i.e., no placebos)\] * Clinically diagnosed with an eating disorder * Weight loss/gain (≥10 lb. in the past 6 months) * Past history of surgical interventions for the treatment of obesity * Allergies and/or aversions to the study foods, particularly beef * Consumes \> 800 mg caffeine/day * Or, of caffeine consumed, \>260 mg caffeine is consumed prior to lunch (\ 12 oz. Starbucks coffee) * Currently and/or previously on a specific diet including high protein, vegan, vegetarian, etc. * Unwilling and/or unable to consume all study foods * Habitually consumes breakfast, lunch, and dinner \<4 days/week * History of drug abuse or alcohol abuse (i.e., \>14 drinks/week; 1 drink=12 oz. beer; 5 oz. wine; 1.5 oz. liquor) * Displays a score of \>4 on the Three Factor Eating Habits Questionnaire (TFEQ) * Unconventional (atypical) and/or inconsistent sleep patterns * awake hours not somewhere between 5 am - 11 pm and/or afternoon naps * does not rate quality of sleep as Fairly to Very Good on the Pittsburg Sleep Quality Index (PSQI) * averages \< 6 sleep hours/night over the past month * Does not display a Profile of Mood State 2nd Edition (POMS2; 60-item) Depression-Dejection Scale score within 1.5 SD of the age, gender, and racial-specific normative mean (Nyenhuis et al., 1999; Petterson K et al., 2006) * Did not obtain a Yes on the validity indicator and/or did not display a score of \>70 (\>2%) on the CNS Vital Signs Battery * Not sedentary (i.e., purposeful physical activity) * Unwilling and/or unable to maintain current inactivity patterns throughout the study * Unwilling and/or unable to follow all study procedures * Not generally healthy, as assessed from the medical history questionnaire
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Energy Intake: Total Daily Intake | 5 months | Energy intake during breakfast, lunch, dinner, and evening snacks of each day 7 testing day (separated by 3-4 weeks) will be measured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reaction Time as a Measure of Cognitive Performance Assessed Using the Stroop Test | 5 months | Cognitive 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. |
| Perceived Alertness | 5 months | Alertness 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. |
| Perceived Fullness | 5 months | Questionnaires 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. |
| Perceived Prospective Food Consumption | 5 months | Questionnaires 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. |
| Perceived Desire to Eat | 5 months | Questionnaires 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. |
| Perceived Hunger | 5 months | Questionnaires 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. |
Participant flow
Recruitment details
All participants were recruited from Columbia, Missouri and the surrounding area from January 2014 to May 2015.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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 | 18 |
| 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. | 17 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Energy Balance Comparison | Energy Restriction Comparison | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 17 Participants | 35 Participants |
| Region of Enrollment United States | 18 Participants | 17 Participants | 35 Participants |
| Sex: Female, Male Female | 18 Participants | 17 Participants | 35 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
Outcome results
Primary
Daily Energy Intake: Total Daily Intake
Energy intake during breakfast, lunch, dinner, and evening snacks of each day 7 testing day (separated by 3-4 weeks) will be measured.
Time frame: 5 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Energy Balance Comparison | Daily Energy Intake: Total Daily Intake | SP-PLANT | 2859 kcal | Standard Error 147 |
| Energy Balance Comparison | Daily Energy Intake: Total Daily Intake | SP-BEEF | 2714 kcal | Standard Error 219 |
| Energy Balance Comparison | Daily Energy Intake: Total Daily Intake | HP-BEEF-EVEN | 2830 kcal | Standard Error 214 |
| Energy Balance Comparison | Daily Energy Intake: Total Daily Intake | HP-BEEF-SKEW | 3039 kcal | Standard Error 184 |
| Energy Restriction Comparison | Daily Energy Intake: Total Daily Intake | HP-BEEF-SKEW | NA kcal | — |
| Energy Restriction Comparison | Daily Energy Intake: Total Daily Intake | SP-PLANT | 2313 kcal | Standard Error 170 |
| Energy Restriction Comparison | Daily Energy Intake: Total Daily Intake | HP-BEEF-EVEN | 2820 kcal | Standard Error 173 |
| Energy Restriction Comparison | Daily Energy Intake: Total Daily Intake | SP-BEEF | 2396 kcal | Standard Error 181 |
Secondary
Perceived Alertness
Alertness 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.
Time frame: 5 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Energy Balance Comparison | Perceived Alertness | SP-BEEF: Total Alertness | 1525 Total AUC (T-score*min) | Standard Error 638 |
| Energy Balance Comparison | Perceived Alertness | HP-BEEF-EVEN: Total Alertness | 1374 Total AUC (T-score*min) | Standard Error 424 |
| Energy Balance Comparison | Perceived Alertness | HP-BEEF-SKEW: Total Alertness | 1414 Total AUC (T-score*min) | Standard Error 712 |
| Energy Balance Comparison | Perceived Alertness | SP-PLANT: Total Alertness | 1631 Total AUC (T-score*min) | Standard Error 448 |
| Energy Restriction Comparison | Perceived Alertness | HP-BEEF-SKEW: Total Alertness | NA Total AUC (T-score*min) | — |
| Energy Restriction Comparison | Perceived Alertness | HP-BEEF-EVEN: Total Alertness | 2434 Total AUC (T-score*min) | Standard Error 954 |
| Energy Restriction Comparison | Perceived Alertness | SP-PLANT: Total Alertness | 2151 Total AUC (T-score*min) | Standard Error 883 |
| Energy Restriction Comparison | Perceived Alertness | SP-BEEF: Total Alertness | 1950 Total AUC (T-score*min) | Standard Error 631 |
Secondary
Perceived Desire to Eat
Questionnaires 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.
Time frame: 5 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Energy Balance Comparison | Perceived Desire to Eat | SP-BEEF: Daily Desire to Eat | 18753 Total Desire to Eat AUC (mm*630 min) | Standard Error 1875 |
| Energy Balance Comparison | Perceived Desire to Eat | SP-PLANT: Daily Desire to Eat | 18132 Total Desire to Eat AUC (mm*630 min) | Standard Error 1952 |
| Energy Balance Comparison | Perceived Desire to Eat | HP-BEEF-EVEN: Daily Desire to Eat | 18179 Total Desire to Eat AUC (mm*630 min) | Standard Error 1951 |
| Energy Balance Comparison | Perceived Desire to Eat | HP-BEEF-SKEW: Daily Desire to Eat | 19540 Total Desire to Eat AUC (mm*630 min) | Standard Error 1998 |
| Energy Restriction Comparison | Perceived Desire to Eat | HP-BEEF-SKEW: Daily Desire to Eat | NA Total Desire to Eat AUC (mm*630 min) | — |
| Energy Restriction Comparison | Perceived Desire to Eat | HP-BEEF-EVEN: Daily Desire to Eat | 19921 Total Desire to Eat AUC (mm*630 min) | Standard Error 1904 |
| Energy Restriction Comparison | Perceived Desire to Eat | SP-PLANT: Daily Desire to Eat | 24309 Total Desire to Eat AUC (mm*630 min) | Standard Error 2601 |
| Energy Restriction Comparison | Perceived Desire to Eat | SP-BEEF: Daily Desire to Eat | 25886 Total Desire to Eat AUC (mm*630 min) | Standard Error 2566 |
Secondary
Perceived Fullness
Questionnaires 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.
Time frame: 5 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Energy Balance Comparison | Perceived Fullness | SP-PLANT: Daily Fullness | 38849 Total Fullness AUC (mm*630 min) | Standard Error 2302 |
| Energy Balance Comparison | Perceived Fullness | SP-BEEF: Daily Fullness | 38689 Total Fullness AUC (mm*630 min) | Standard Error 2235 |
| Energy Balance Comparison | Perceived Fullness | HP-BEEF-EVEN: Daily Fullness | 39560 Total Fullness AUC (mm*630 min) | Standard Error 2536 |
| Energy Balance Comparison | Perceived Fullness | HP-BEEF-SKEW: Daily Fullness | 38464 Total Fullness AUC (mm*630 min) | Standard Error 2693 |
| Energy Restriction Comparison | Perceived Fullness | HP-BEEF-SKEW: Daily Fullness | NA Total Fullness AUC (mm*630 min) | — |
| Energy Restriction Comparison | Perceived Fullness | SP-PLANT: Daily Fullness | 32167 Total Fullness AUC (mm*630 min) | Standard Error 2745 |
| Energy Restriction Comparison | Perceived Fullness | HP-BEEF-EVEN: Daily Fullness | 36313 Total Fullness AUC (mm*630 min) | Standard Error 2260 |
| Energy Restriction Comparison | Perceived Fullness | SP-BEEF: Daily Fullness | 30862 Total Fullness AUC (mm*630 min) | Standard Error 2896 |
Secondary
Perceived Hunger
Questionnaires 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.
Time frame: 5 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Energy Balance Comparison | Perceived Hunger | SP-BEEF: Daily Hunger | 17496 Total Fullness AUC (mm*630 min) | Standard Error 1836 |
| Energy Balance Comparison | Perceived Hunger | SP-PLANT: Daily Hunger | 16624 Total Fullness AUC (mm*630 min) | Standard Error 1989 |
| Energy Balance Comparison | Perceived Hunger | HP-BEEF-EVEN: Daily Hunger | 16713 Total Fullness AUC (mm*630 min) | Standard Error 1831 |
| Energy Balance Comparison | Perceived Hunger | HP-BEEF-SKEW: Daily Hunger | 17689 Total Fullness AUC (mm*630 min) | Standard Error 1829 |
| Energy Restriction Comparison | Perceived Hunger | HP-BEEF-SKEW: Daily Hunger | NA Total Fullness AUC (mm*630 min) | — |
| Energy Restriction Comparison | Perceived Hunger | SP-BEEF: Daily Hunger | 24849 Total Fullness AUC (mm*630 min) | Standard Error 2557 |
| Energy Restriction Comparison | Perceived Hunger | HP-BEEF-EVEN: Daily Hunger | 18598 Total Fullness AUC (mm*630 min) | Standard Error 1868 |
| Energy Restriction Comparison | Perceived Hunger | SP-PLANT: Daily Hunger | 21833 Total Fullness AUC (mm*630 min) | Standard Error 2370 |
Secondary
Perceived Prospective Food Consumption
Questionnaires 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.
Time frame: 5 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Energy Balance Comparison | Perceived Prospective Food Consumption | HP-BEEF-Skew: Prospective Food Consumption | 20520 Total PFC AUC (mm*630 min) | Standard Error 1809 |
| Energy Balance Comparison | Perceived Prospective Food Consumption | HP-BEEF-EVEN: Prospective Food Consumption | 19087 Total PFC AUC (mm*630 min) | Standard Error 1537 |
| Energy Balance Comparison | Perceived Prospective Food Consumption | SP-PLANT: Prospective Food Consumption | 19158 Total PFC AUC (mm*630 min) | Standard Error 1638 |
| Energy Balance Comparison | Perceived Prospective Food Consumption | SP-BEEF: Prospective Food Consumption | 19847 Total PFC AUC (mm*630 min) | Standard Error 1583 |
| Energy Restriction Comparison | Perceived Prospective Food Consumption | HP-BEEF-Skew: Prospective Food Consumption | NA Total PFC AUC (mm*630 min) | — |
| Energy Restriction Comparison | Perceived Prospective Food Consumption | SP-BEEF: Prospective Food Consumption | 25929 Total PFC AUC (mm*630 min) | Standard Error 2270 |
| Energy Restriction Comparison | Perceived Prospective Food Consumption | HP-BEEF-EVEN: Prospective Food Consumption | 21015 Total PFC AUC (mm*630 min) | Standard Error 1746 |
| Energy Restriction Comparison | Perceived Prospective Food Consumption | SP-PLANT: Prospective Food Consumption | 24889 Total PFC AUC (mm*630 min) | Standard Error 2060 |
Secondary
Reaction Time as a Measure of Cognitive Performance Assessed Using the Stroop Test
Cognitive 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.
Time frame: 5 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Energy Balance Comparison | Reaction Time as a Measure of Cognitive Performance Assessed Using the Stroop Test | HP-BEEF-SKEW: Reaction Time | 317 ms | Standard Error 9 |
| Energy Balance Comparison | Reaction Time as a Measure of Cognitive Performance Assessed Using the Stroop Test | HP-BEEF-EVEN: Reaction Time | 320 ms | Standard Error 9 |
| Energy Balance Comparison | Reaction Time as a Measure of Cognitive Performance Assessed Using the Stroop Test | SP-BEEF: Reaction Time | 321 ms | Standard Error 7 |
| Energy Balance Comparison | Reaction Time as a Measure of Cognitive Performance Assessed Using the Stroop Test | SP-PLANT: Reaction Time | 309 ms | Standard Error 7 |
| Energy Restriction Comparison | Reaction Time as a Measure of Cognitive Performance Assessed Using the Stroop Test | HP-BEEF-SKEW: Reaction Time | NA ms | — |
| Energy Restriction Comparison | Reaction Time as a Measure of Cognitive Performance Assessed Using the Stroop Test | SP-PLANT: Reaction Time | 303 ms | Standard Error 8 |
| Energy Restriction Comparison | Reaction Time as a Measure of Cognitive Performance Assessed Using the Stroop Test | SP-BEEF: Reaction Time | 311 ms | Standard Error 6 |
| Energy Restriction Comparison | Reaction Time as a Measure of Cognitive Performance Assessed Using the Stroop Test | HP-BEEF-EVEN: Reaction Time | 312 ms | Standard Error 7 |