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| Name | Class |
|---|---|
| National Cattlemen's Beef Association, a contractor to the Beef Checkoff | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Energy Balance Comparison | Experimental | 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) |
|
| Energy Restriction Comparison | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN) | Other | Diet contains all plant proteins. Meals are evenly distributed throughout the day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heather J Leidy, PhD | University of Missouri-Columbia | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25926512 | Background | Leidy HJ, Clifton PM, Astrup A, Wycherley TP, Westerterp-Plantenga MS, Luscombe-Marsh ND, Woods SC, Mattes RD. The role of protein in weight loss and maintenance. Am J Clin Nutr. 2015 Jun;101(6):1320S-1329S. doi: 10.3945/ajcn.114.084038. Epub 2015 Apr 29. | |
| 7498104 | Background | Holt SH, Miller JC, Petocz P, Farmakalidis E. A satiety index of common foods. Eur J Clin Nutr. 1995 Sep;49(9):675-90. |
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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).
All participants were recruited from Columbia, Missouri and the surrounding area from January 2014 to May 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN) | Other | Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day. |
|
| High Protein-Beef, Even Distribution (HP-BEEF-EVEN) | Other | Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day. |
|
| High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN) | Other | Diet contains combination of beef and plant proteins. Meals are unevenly distributed throughout the day. |
|
| 5 months |
| 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. | 5 months |
| 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. | 5 months |
| 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. | 5 months |
| 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. | 5 months |
| 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. | 5 months |
| 17299116 | Background | Leidy HJ, Carnell NS, Mattes RD, Campbell WW. Higher protein intake preserves lean mass and satiety with weight loss in pre-obese and obese women. Obesity (Silver Spring). 2007 Feb;15(2):421-9. doi: 10.1038/oby.2007.531. |
| 12566476 | Background | Layman DK, Boileau RA, Erickson DJ, Painter JE, Shiue H, Sather C, Christou DD. A reduced ratio of dietary carbohydrate to protein improves body composition and blood lipid profiles during weight loss in adult women. J Nutr. 2003 Feb;133(2):411-7. doi: 10.1093/jn/133.2.411. |
| 14988451 | Background | Johnston CS, Tjonn SL, Swan PD. High-protein, low-fat diets are effective for weight loss and favorably alter biomarkers in healthy adults. J Nutr. 2004 Mar;134(3):586-91. doi: 10.1093/jn/134.3.586. |
| 24477298 | Background | Mamerow MM, Mettler JA, English KL, Casperson SL, Arentson-Lantz E, Sheffield-Moore M, Layman DK, Paddon-Jones D. Dietary protein distribution positively influences 24-h muscle protein synthesis in healthy adults. J Nutr. 2014 Jun;144(6):876-80. doi: 10.3945/jn.113.185280. Epub 2014 Jan 29. |
| 19283886 | Background | Leidy HJ, Bossingham MJ, Mattes RD, Campbell WW. Increased dietary protein consumed at breakfast leads to an initial and sustained feeling of fullness during energy restriction compared to other meal times. Br J Nutr. 2009 Mar;101(6):798-803. doi: 10.1017/s0007114508051532. |
| 19930787 | Background | Hoyland A, Dye L, Lawton CL. A systematic review of the effect of breakfast on the cognitive performance of children and adolescents. Nutr Res Rev. 2009 Dec;22(2):220-43. doi: 10.1017/S0954422409990175. |
| 24583414 | Background | Benau EM, Orloff NC, Janke EA, Serpell L, Timko CA. A systematic review of the effects of experimental fasting on cognition. Appetite. 2014 Jun;77:52-61. doi: 10.1016/j.appet.2014.02.014. Epub 2014 Feb 27. |
| 6764932 | Background | Spring B, Maller O, Wurtman J, Digman L, Cozolino L. Effects of protein and carbohydrate meals on mood and performance: interactions with sex and age. J Psychiatr Res. 1982-1983;17(2):155-67. doi: 10.1016/0022-3956(82)90017-6. |
| 21239090 | Background | Jakobsen LH, Kondrup J, Zellner M, Tetens I, Roth E. Effect of a high protein meat diet on muscle and cognitive functions: a randomised controlled dietary intervention trial in healthy men. Clin Nutr. 2011 Jun;30(3):303-11. doi: 10.1016/j.clnu.2010.12.010. Epub 2011 Jan 15. |
| 2980858 | Background | Lieberman HR, Spring BJ, Garfield GS. The behavioral effects of food constituents: strategies used in studies of amino acids, protein, carbohydrate and caffeine. Nutr Rev. 1986 May;44 Suppl:61-70. doi: 10.1111/j.1753-4887.1986.tb07679.x. No abstract available. |
| 9920688 | Background | Finnigan F, Hammersley R, Millar K. Effects of meal composition on blood alcohol level, psychomotor performance and subjective state after ingestion of alcohol. Appetite. 1998 Dec;31(3):361-75. doi: 10.1006/appe.1998.0168. |
| 10100834 | Background | Nyenhuis DL, Yamamoto C, Luchetta T, Terrien A, Parmentier A. Adult and geriatric normative data and validation of the profile of mood states. J Clin Psychol. 1999 Jan;55(1):79-86. doi: 10.1002/(sici)1097-4679(199901)55:13.0.co;2-7. |
| 19722288 | Background | Patterson K, Young C, Woods SP, Vigil O, Grant I, Atkinson JH; HIV Neurobehavioral Research Center Group. Screening for major depression in persons with HIV infection: the concurrent predictive validity of the Profile of Mood States Depression-Dejection Scale. Int J Methods Psychiatr Res. 2006 Jun;15(2):75-82. doi: 10.1002/mpr.184. |
| 24310053 | Background | Paddon-Jones D, Leidy H. Dietary protein and muscle in older persons. Curr Opin Clin Nutr Metab Care. 2014 Jan;17(1):5-11. doi: 10.1097/MCO.0000000000000011. |
| 11836456 | Background | White MA, Whisenhunt BL, Williamson DA, Greenway FL, Netemeyer RG. Development and validation of the food-craving inventory. Obes Res. 2002 Feb;10(2):107-14. doi: 10.1038/oby.2002.17. |
| 17014981 | Background | Gualtieri CT, Johnson LG. Reliability and validity of a computerized neurocognitive test battery, CNS Vital Signs. Arch Clin Neuropsychol. 2006 Oct;21(7):623-43. doi: 10.1016/j.acn.2006.05.007. Epub 2006 Oct 2. |
| 20847729 | Background | Leidy HJ, Tang M, Armstrong CL, Martin CB, Campbell WW. The effects of consuming frequent, higher protein meals on appetite and satiety during weight loss in overweight/obese men. Obesity (Silver Spring). 2011 Apr;19(4):818-24. doi: 10.1038/oby.2010.203. Epub 2010 Sep 16. |
| 20339363 | Background | Leidy HJ, Armstrong CL, Tang M, Mattes RD, Campbell WW. The influence of higher protein intake and greater eating frequency on appetite control in overweight and obese men. Obesity (Silver Spring). 2010 Sep;18(9):1725-32. doi: 10.1038/oby.2010.45. Epub 2010 Mar 25. |
| 16002798 | Background | Weigle DS, Breen PA, Matthys CC, Callahan HS, Meeuws KE, Burden VR, Purnell JQ. A high-protein diet induces sustained reductions in appetite, ad libitum caloric intake, and body weight despite compensatory changes in diurnal plasma leptin and ghrelin concentrations. Am J Clin Nutr. 2005 Jul;82(1):41-8. doi: 10.1093/ajcn.82.1.41. |
| 25995282 | Background | Leidy HJ, Todd CB, Zino AZ, Immel JE, Mukherjea R, Shafer RS, Ortinau LC, Braun M. Consuming High-Protein Soy Snacks Affects Appetite Control, Satiety, and Diet Quality in Young People and Influences Select Aspects of Mood and Cognition. J Nutr. 2015 Jul;145(7):1614-22. doi: 10.3945/jn.115.212092. Epub 2015 May 20. |
| Background | Zeng YC, Li SM, Xiong GL, Su HM, Wan JC. Influences of protein to energy ratios in breakfast on mood, alertness and attention in the healthy undergraduate students. Health 3(6): 383-393. 2011 |
| Background | Russell JA. Affect Grid: A single-item scale of pleasure and arousal. J Personality Soc Psychol 57 (3): 493-502, 1989. |
| 39310667 | Derived | Piacquadio KA, Gwin JA, Leidy HJ. A Higher-Protein, Energy Restriction Diet Containing 4 Servings of Fresh, Lean Beef per Day Does Not Negatively Influence Circulating miRNAs Associated with Cardiometabolic Disease Risk in Women with Overweight. Curr Dev Nutr. 2024 Aug 18;8(9):104442. doi: 10.1016/j.cdnut.2024.104442. eCollection 2024 Sep. |
| 39224138 | Derived | Braden ML, Gwin JA, Leidy HJ. A Diet Containing Animal Source Protein as Fresh, Lean Beef Is More Well Liked and Promotes Healthier Eating Behavior Compared with Plant-Based Alternatives in Women with Overweight. Curr Dev Nutr. 2024 Jul 14;8(8):104415. doi: 10.1016/j.cdnut.2024.104415. eCollection 2024 Aug. |
| 38677478 | Derived | Piacquadio KA, Margolis LM, Gwin JA, Leidy HJ. Higher Expression of miR-15b-5p with Inclusion of Fresh, Lean Beef as Part of a Healthy Dietary Pattern Is Inversely Associated with Markers of Cardiometabolic Disease Risk. J Nutr. 2024 Jun;154(6):1758-1765. doi: 10.1016/j.tjnut.2024.04.026. Epub 2024 Apr 25. |
| 29955692 | Derived | Gwin JA, Maki KC, Alwattar AY, Leidy HJ. Examination of Protein Quantity and Protein Distribution across the Day on Ad Libitum Carbohydrate and Fat Intake in Overweight Women. Curr Dev Nutr. 2017 Oct 25;1(12):e001933. doi: 10.3945/cdn.117.001933. eCollection 2017 Dec. |
| 29070709 | Derived | Gwin JA, Maki KC, Leidy HJ. Increased Protein Consumption during the Day from an Energy-Restricted Diet Augments Satiety but Does Not Reduce Daily Fat or Carbohydrate Intake on a Free-Living Test Day in Overweight Women. J Nutr. 2017 Dec;147(12):2338-2346. doi: 10.3945/jn.117.255554. Epub 2017 Oct 25. |
| FG001 | 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. |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | kcal | 5 months |
|
|
| ||||||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Error | Total Fullness AUC (mm*630 min) | 5 months |
| ||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Error | ms | 5 months |
| ||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Error | Total AUC (T-score*min) | 5 months |
| ||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Error | Total Fullness AUC (mm*630 min) | 5 months |
| ||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Error | Total PFC AUC (mm*630 min) | 5 months |
| ||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Error | Total Desire to Eat AUC (mm*630 min) | 5 months |
|
1 year, 4 months
Adverse event monitoring occurred throughout the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 17 | 0 | 17 | ||
| EG001 | 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. | 0 | 17 | 0 | 17 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Heather Leidy | Purdue University | 765-496-0184 | hleidy@purdue.edu |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| >=65 years |
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| Male |
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| HP-BEEF-EVEN |
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| HP-BEEF-SKEW |
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| 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. |
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| OG001 | 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. |
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| OG001 | 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. |
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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): 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.
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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): 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.
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|
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): 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.
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