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| Name | Class |
|---|---|
| Solae, LLC | INDUSTRY |
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The purpose of this study is to examine the effects of normal vs. protein-rich afternoon snacks on appetite control, satiety, and reward-driven eating (particularly in the evening) in young people. Indices of attention and mood will also be assessed.
Study hypotheses include the following:
Forty adolescents will participate in the following randomized crossover-design study. Prior to the start of the study, the participants will be asked to document their habitual breakfast, lunch, and afternoon snack times. The snack patterns and associated testing days will be scheduled so that each participant consumes the afternoon snack (or refrains from snacking) 3 hours after lunch; however, the time of day when this occurs is based on the participant's previous, habitual snack time. Once this is determined, each participant will randomly acclimate to the following snack pattern for 3 consecutive days: 1) Higher Protein Soy-based Snacks (250 kcal; 40% Protein; 40% Carbohydrates; 20% Fat); 2) Typical, Low Protein Snacks (5% Protein; 50% Carbohydrates; 45% Fat); and 3) No Snack.
On day 4, the participants will consume a standard breakfast, at home, and lunch, at school, and will come in to our facility 1 hour prior to their habitual snack time. The participants will be placed in a window-less, comfortable room, void of all time cues. They will be informed that they will remain in this room for the next 6 hours. The participants will begin the testing day by completing baseline questionnaires assessing appetite, satiety, mood, and cognitive function. A brain scan will be completed using functional magnetic resonance imaging (fMRI) to identify brain activation patterns in response to food stimuli. Following the fMRI scan, the respective snack will be given to the participants; they will have 15 minutes to eat the snack. A second fMRI scan will then be performed. The participants will continue to complete the previous questionnaires until they voluntarily choose to eat. At this time, the volunteers will be presented with an 'all you can eat' snack buffet. They will be permitted to eat as much or as little as they would like to eat over the next 3-hour period. The participants will remain in the facility until the full 8-hour testing day is completed, regardless of when they requested to eat. Following the 6 hours, the participants will be permitted to leave the facility.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Protein | Active Comparator | Higher Protein Soy-based Snacks |
|
| Low Protein | Active Comparator | Typical, Low Protein Snacks |
|
| No Snack | No Intervention | No Snack |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Protein | Behavioral | 250 kcal; 40% Protein; 40% Carbohydrate; 20% Fat |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Dinner Request | The participants will be asked whether they would like to request a dinner buffet throughout the 5 h post-snack period. When the response is "Yes, I want to eat right now", the time from snack consumption will be recorded. | 1 Day |
| Measure | Description | Time Frame |
|---|---|---|
| Appetite Questionnaires | Computerized questionnaires, assessing perceived sensations of appetite will be completed throughout the testing days. The questionnaires contain visual analog scales incorporating a 100 mm horizontal line rating scale for each response. The questions are worded as "how strong is your feeling of" with anchors of "not all" (scored as 0 out of 100) to "extremely" (scored as 100 out of 100). The following questions will be incorporated as 1 composite score ((Questions 1 + 3 + 4 - 2)/4) multiplied by the 300 minutes (a max of 30,000 mm*min and a minimum of -30,000 mm*min):
The Adaptive Visual Analog Scale Software (Neurobehavioral Research Laboratory and Clinic; San Antonio, TX) was used for these assessments. |
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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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri-Columbia | Columbia | Missouri | 65211 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25995282 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | High Fat Snack > No Snack > High Protein Snack | 8 Participants began testing procedures but only 31 completed all procedures. Each participant was randomly acclimated to the following snack patterns for 3 consecutive days: 1) Typical, Low Protein Snacks (5% Protein; 50% Carbohydrates; 45% Fat); 2) No Snack and 3) Higher Protein Soy-based Snacks (250 kcal; 40% Protein; 40% Carbohydrates; 20% Fat). On day 4, participants completed all testing day procedures outlined in the study description. Three participants signed the consent form but never began testing procedures. One dropped out before completing the second testing day and another before the third. Upon completion of all thirty two participants, one was later found to be noncompliant with testing day procedures. |
| FG001 | High Fat Snack > High Protein Snack > No Snack | 4 Participants began testing procedures but only 31 completed all procedures. Each participant was randomly acclimated to the following snack patterns for 3 consecutive days: 1) Typical, Low Protein Snacks (5% Protein; 50% Carbohydrates; 45% Fat); 2) Higher Protein Soy-based Snacks (250 kcal; 40% Protein; 40% Carbohydrates; 20% Fat) and 3) No Snack. On day 4, participants completed all testing day procedures outlined in the study description. Three participants signed the consent form but never began testing procedures. One dropped out before completing the second testing day and another before the third. Upon completion of all thirty two participants, one was later found to be noncompliant with testing day procedures. |
| FG002 | No Snack > High Protein Snack > High Fat Snack | 9 Participants began testing procedures but only 31 completed all procedures. Each participant was randomly acclimated to the following snack patterns for 3 consecutive days: 1) No Snack; 2) Higher Protein Soy-based Snacks (250 kcal; 40% Protein; 40% Carbohydrates; 20% Fat) and 3) Typical, Low Protein Snacks (5% Protein; 50% Carbohydrates; 45% Fat). On day 4, participants completed all testing day procedures outlined in the study description. Three participants signed the consent form but never began testing procedures. One dropped out before completing the second testing day and another before the third. Upon completion of all thirty two participants, one was later found to be noncompliant with testing day procedures. |
| FG003 | No Snack > High Fat Snack > High Protein Snack | 8 Participants began testing procedures but only 31 completed all procedures. Each participant was randomly acclimated to the following snack patterns for 3 consecutive days: 1) No Snack; 2) Typical, Low Protein Snacks (5% Protein; 50% Carbohydrates; 45% Fat and 3) Higher Protein Soy-based Snacks (250 kcal; 40% Protein; 40% Carbohydrates; 20% Fat). On day 4, participants completed all testing day procedures outlined in the study description. Three participants signed the consent form but never began testing procedures. One dropped out before completing the second testing day and another before the third. Upon completion of all thirty two participants, one was later found to be noncompliant with testing day procedures. |
| FG004 | High Protein Snack > No Snack > High Fat Snack | 6 Participants began testing procedures but only 31 completed all procedures. Each participant was randomly acclimated to the following snack patterns for 3 consecutive days: 1) Higher Protein Soy-based Snacks (250 kcal; 40% Protein; 40% Carbohydrates; 20% Fat); 2) No Snack and 3) Typical, Low Protein Snacks (5% Protein; 50% Carbohydrates; 45% Fat. On day 4, participants completed all testing day procedures outlined in the study description. Three participants signed the consent form but never began testing procedures. One dropped out before completing the second testing day and another before the third. Upon completion of all thirty two participants, one was later found to be noncompliant with testing day procedures. |
| FG005 | High Protein Snack > High Fat Snack > No Snack | 3 Participants began testing procedures but only 31 completed all procedures. Each participant was randomly acclimated to the following snack patterns for 3 consecutive days: 1) Higher Protein Soy-based Snacks (250 kcal; 40% Protein; 40% Carbohydrates; 20% Fat); 2) Typical, Low Protein Snacks (5% Protein; 50% Carbohydrates; 45% Fat and 3) No Snack. On day 4, participants completed all testing day procedures outlined in the study description. Three participants signed the consent form but never began testing procedures. One dropped out before completing the second testing day and another before the third. Upon completion of all thirty two participants, one was later found to be noncompliant with testing day procedures. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Each participant was randomly acclimated to the following snack patterns for 3 consecutive days: 1) Higher Protein Soy-based Snacks (250 kcal; 40% Protein; 40% Carbohydrates; 20% Fat); 2) Typical, Low Protein Snacks (5% Protein; 50% Carbohydrates; 45% Fat); and 3) No Snack. On day 4, participants completed all testing day procedures outlined in the study description. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Time to Dinner Request | The participants will be asked whether they would like to request a dinner buffet throughout the 5 h post-snack period. When the response is "Yes, I want to eat right now", the time from snack consumption will be recorded. | Posted | Mean | Standard Error | minutes | 1 Day |
|
4 months (May 2013 through August 2013).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Protein | Higher Protein Soy-based Snacks High Protein: 250 kcal; 40% Protein; 40% Carbohydrate; 20% Fat |
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Menstrual cycle was not controlled for within the female participants. However, menstrual cyclicity varied between testing days and between participants, thus, reducing any systematic bias/effect.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Heather Leidy | University of Missouri | (573) 882-4288 | leidyh@health.missouri.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D018753 | Diet, Protein-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| Low Protein |
| Behavioral |
5% Protein; 50% Carbohydrates; 45% Fat |
|
| 0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +270 min, +300 min |
| Snack Palatability and Perception Questionnaires | Computerized questionnaires, assessing snack palatability and perceptions of the snack will be completed during screening and after the first and last bite of each snack during the acclimation and testing days. The questionnaires contain visual analog scales incorporating a 100 mm horizontal line rating scale for each response. The questions are worded as "how strong is your feeling of" with anchors of "not all" (scores 0 out of 100) to "extremely" (scores 100 out of 100). The questions assess snack appearance, smell, flavor, texture (feel), liking. The Adaptive Visual Analog Scale Software (Neurobehavioral Research Laboratory and Clinic; San Antonio, TX) was used for these assessments. | 5 min |
| Attention & Memory Questionnaires | Cognitive function will be assessed immediately before (-30 min) and 60 min post-snack using the lap-top based Cantab® computerized assessment system. This program consisted of a core battery of tests grouped into main categories including 1) Working Memory; 2) Reasoning; 3) Executive Function; 4) Reaction Time; 5) Sustained Attention; 6) Cognitive Flexibility; and 7) Processing Speed. This program has been used in our previous breakfast studies with success. A greater raw score for working memory, reasoning, executive function, sustained attention, and cognitive flexibility is considered to be greater performance. A lower score for reaction time and processing speed is considered to be greater performance. The raw scores are determined by Cantab® computerized assessment system. Therefore, maximum and minimum values for each test are unknown. | 90 min |
| Mood-state Questionnaires | Indices of mood state will be assessed immediately before and 60 min post-snack using the on-line, Profile of Mood States, 2nd Edition (POMS2). This program consisted of a core battery of tests with the following sub-categories 1) Tension; 2) Depression; 3) Anger; 4) Vigor; 5) Fatigue; 6) Confusion; and 7) Friendliness. Outcomes are scored as a T-score which could be a minimum of zero with no upper limit. A lower score represents a more positive mood state and a higher score represents a more negative mood state. | -30 min, +60 min |
| Energy Intake | Post-snack energy intake will be assessed through ad libitum dinner and snacking assessments. The ad libitum dinner will contain approximately 2,000 kcal and will consist of a chicken, rice, and stir-fry meal, chips, chocolate mints, ice tea, and water. The dinner meal will be consumed in the testing facility. The participants will be instructed to eat as much as or as little as they choose over a 30 min period. All contents will be weighed before the dinner and any remains will be re-weighed afterwards to determine the type and quantity of foods consumed. The ad libitum evening snacks will contain 3,000 kcal and will include common snack foods. After the testing day is complete, the participants will take the snack packout home and consume any of the foods he/she chooses until going to bed. All contents will be weighed before the packout and any remains will be re-weighed afterwards to determine the type and quantity of foods consumed. | +300 min, 24 h |
| Time Constraints |
|
| Noncompliance |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | centimeters |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| BMI (kg/m2) | Mean | Standard Deviation | kg/m2 |
|
| BMI (%) | Mean | Standard Deviation | Percentile |
|
| Frequency of Snacking | Mean | Standard Deviation | days/week |
|
| Commonly consumed chips/crackers as a snack | Number | % of total participants |
|
| Commonly consumed fruit as a snack | Number | % of total participants |
|
| Commonly consumed cereal as a snack | Number | % of total participants |
|
No snack was received |
|
|
| Secondary | Appetite Questionnaires | Computerized questionnaires, assessing perceived sensations of appetite will be completed throughout the testing days. The questionnaires contain visual analog scales incorporating a 100 mm horizontal line rating scale for each response. The questions are worded as "how strong is your feeling of" with anchors of "not all" (scored as 0 out of 100) to "extremely" (scored as 100 out of 100). The following questions will be incorporated as 1 composite score ((Questions 1 + 3 + 4 - 2)/4) multiplied by the 300 minutes (a max of 30,000 mm*min and a minimum of -30,000 mm*min):
The Adaptive Visual Analog Scale Software (Neurobehavioral Research Laboratory and Clinic; San Antonio, TX) was used for these assessments. | Posted | Mean | Standard Error | mm*min | 0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +270 min, +300 min |
|
|
|
| Secondary | Snack Palatability and Perception Questionnaires | Computerized questionnaires, assessing snack palatability and perceptions of the snack will be completed during screening and after the first and last bite of each snack during the acclimation and testing days. The questionnaires contain visual analog scales incorporating a 100 mm horizontal line rating scale for each response. The questions are worded as "how strong is your feeling of" with anchors of "not all" (scores 0 out of 100) to "extremely" (scores 100 out of 100). The questions assess snack appearance, smell, flavor, texture (feel), liking. The Adaptive Visual Analog Scale Software (Neurobehavioral Research Laboratory and Clinic; San Antonio, TX) was used for these assessments. | Posted | Mean | Standard Error | millimeters | 5 min |
|
|
|
| Secondary | Attention & Memory Questionnaires | Cognitive function will be assessed immediately before (-30 min) and 60 min post-snack using the lap-top based Cantab® computerized assessment system. This program consisted of a core battery of tests grouped into main categories including 1) Working Memory; 2) Reasoning; 3) Executive Function; 4) Reaction Time; 5) Sustained Attention; 6) Cognitive Flexibility; and 7) Processing Speed. This program has been used in our previous breakfast studies with success. A greater raw score for working memory, reasoning, executive function, sustained attention, and cognitive flexibility is considered to be greater performance. A lower score for reaction time and processing speed is considered to be greater performance. The raw scores are determined by Cantab® computerized assessment system. Therefore, maximum and minimum values for each test are unknown. | Posted | Mean | Standard Error | Units on a Scale | 90 min |
|
|
|
| Secondary | Mood-state Questionnaires | Indices of mood state will be assessed immediately before and 60 min post-snack using the on-line, Profile of Mood States, 2nd Edition (POMS2). This program consisted of a core battery of tests with the following sub-categories 1) Tension; 2) Depression; 3) Anger; 4) Vigor; 5) Fatigue; 6) Confusion; and 7) Friendliness. Outcomes are scored as a T-score which could be a minimum of zero with no upper limit. A lower score represents a more positive mood state and a higher score represents a more negative mood state. | Posted | Mean | Standard Error | T-Score | -30 min, +60 min |
|
|
|
| Secondary | Energy Intake | Post-snack energy intake will be assessed through ad libitum dinner and snacking assessments. The ad libitum dinner will contain approximately 2,000 kcal and will consist of a chicken, rice, and stir-fry meal, chips, chocolate mints, ice tea, and water. The dinner meal will be consumed in the testing facility. The participants will be instructed to eat as much as or as little as they choose over a 30 min period. All contents will be weighed before the dinner and any remains will be re-weighed afterwards to determine the type and quantity of foods consumed. The ad libitum evening snacks will contain 3,000 kcal and will include common snack foods. After the testing day is complete, the participants will take the snack packout home and consume any of the foods he/she chooses until going to bed. All contents will be weighed before the packout and any remains will be re-weighed afterwards to determine the type and quantity of foods consumed. | Posted | Mean | Standard Error | kilojoules | +300 min, 24 h |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Low Protein | Typical, Low Protein Snacks Low Protein: 5% Protein; 50% Carbohydrates; 45% Fat | 0 | 31 | 0 | 31 |
| EG002 | No Snack | No snack was received (0 kJ) | 0 | 31 | 0 | 31 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
|
| Executive Function (pre-snack) |
|
| Reaction Time (pre-snack) |
|
| Sustained Attention (pre-snack) |
|
| Cognitive Flexibility (pre-snack) |
|
| Processing Speed (pre-snack) |
|
| Working Memory (post-snack) |
|
| Reasoning (post-snack) |
|
| Executive function (post-snack) |
|
| Reaction Time (post-snack) |
|
| Sustained Attention (post-snack) |
|
| Cognitive Flexibility (post-snack) |
|
| Processing Speed (post-snack) |
|
|
| Fatigue (-30 min) |
|
| Fatigue (+60 min) |
|
| Tension (-30 min |
|
| Tension (+60 min) |
|
| Vigor (-30 min) |
|
| Vigor (+60 min) |
|
| Anger (-30 min) |
|
| Anger (+60 min) |
|
| Depression (-30 min) |
|
| Depression (+60 min) |
|
| Friendliness (-30 min) |
|
| Friendliness (+60 min) |
|