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The Beneficial Effects of Healthy Snacks on Appetite Control, Satiety, and Reward-driven Eating Behavior in Young People

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ClinicalTrials.gov Identifier: NCT01781286
Recruitment Status : Completed
First Posted : January 31, 2013
Results First Posted : July 23, 2018
Last Update Posted : July 23, 2018
Sponsor:
Collaborator:
Solae, LLC
Information provided by (Responsible Party):
Heather Leidy, University of Missouri-Columbia

Tracking Information
First Submitted Date  ICMJE January 9, 2013
First Posted Date  ICMJE January 31, 2013
Results First Submitted Date  ICMJE May 2, 2017
Results First Posted Date  ICMJE July 23, 2018
Last Update Posted Date July 23, 2018
Study Start Date  ICMJE January 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2018)
Time to Dinner Request [ Time Frame: 1 Day ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 29, 2013)
Time to Dinner Request [ Time Frame: +30 min ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2018)
  • Appetite Questionnaires [ Time Frame: 0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +270 min, +300 min ]
    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):
    1. How strong is your feeling of hunger?
    2. How strong is your feeling of being full?
    3. How strong is your desire to eat?
    4. How much food could you consume right now?
    The Adaptive Visual Analog Scale Software (Neurobehavioral Research Laboratory and Clinic; San Antonio, TX) was used for these assessments.
  • Snack Palatability and Perception Questionnaires [ Time Frame: 5 min ]
    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.
  • Attention & Memory Questionnaires [ Time Frame: 90 min ]
    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.
  • Mood-state Questionnaires [ Time Frame: -30 min, +60 min ]
    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.
  • Energy Intake [ Time Frame: +300 min, 24 h ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2013)
  • Functional Magnetic Resonance Imaging (fMRI) for Assessing Brain Activation [ Time Frame: -30 min, +30 min ]
    Brain activation responses will be assessed before and after the snack during each testing day. During the fMRI brain scan procedure, the participants will be placed in a supine position. A structural scan will be performed to identify anatomical structures. During the fMRI phase, the participants will view a set of photographs. The fMRI paradigm incorporates stimuli from 3 categories of pictures including food, nonfood (animals), and blurred baseline images. The pictures from each category will be presented in blocks of images (10 photographs (of the same type of stimuli) per block). The scan involves 3 repetitions of each block of stimulus-producing images (i.e., food, animal), alternated with blocks of randomized blurred images. The functional scan lasts 7 min and is performed in duplicate. Scanning will be performed at the MU-Brain Imaging Center on a 3 Tesla Siemens Trio scanner (Siemens Medical Solutions, Erlangen, Germany).
  • Appetite,Satiety, and Cravings Questionnaires [ Time Frame: -30 min, 0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +270 min, +300 min ]
    Computerized questionnaires, assessing perceived sensations of appetite and satiety 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" to "extremely." The following questions will be incorporated:
    1. How strong is your feeling of hunger?
    2. How strong is your feeling of being full?
    3. How strong is your desire to eat?
    4. How much food could you consume right now?
    5. How strong is your feeling of thirst?
    6. How strong is your craving for something sweet?
    7. How strong is your craving for something salty?
    8. Host strong is your craving for something savory?
    The Adaptive Visual Analog Scale Software (Neurobehavioral Research Laboratory and Clinic; San Antonio, TX) was used for these assessments.
  • Snack Palatability and Perception Questionnaires [ Time Frame: -30 min, 0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +270 min, +300 min ]
    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" to "extremely." The questions assess snack appearance, smell, flavor, texure (feel), liking. The Adaptive Visual Analog Scale Software (Neurobehavioral Research Laboratory and Clinic; San Antonio, TX) was used for these assessments.
  • Attention & Memory Questionnaires [ Time Frame: -30 min, + 60 min ]
    Cognitive function will be assessed immediately before 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 3 main categories including 1) Visual Memory; 2) Working Memory; 3) Executive Function; 4) Attention/Alertness; and 5) Planning. This program has been used in our previous breakfast studies with success.
  • Mood-state Questionnaires [ Time Frame: -30 min, +60 min ]
    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.
  • Energy Intake [ Time Frame: +300 min, 24 h ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Beneficial Effects of Healthy Snacks on Appetite Control, Satiety, and Reward-driven Eating Behavior in Young People
Official Title  ICMJE The Beneficial Effects of Protein-rich, Afternoon Snacks on Appetite Control, Satiety, and Reward-driven Eating Behavior in Young People
Brief Summary

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:

  1. The consumption of a high-protein, soy-rich afternoon snack will lead to significant improvements in appetite control and satiety, reductions in food motivation and reward, and will delay the drive to eat in normal to overweight young people.
  2. The consumption of a high-protein, soy-rich afternoon snack will lead to reduced unhealthy, evening snacking, particularly on foods high in fat and/or sugar, in normal to overweight young people.
  3. The daily consumption of a high-protein, soy-rich afternoon snack will lead to significant improvements in afternoon alertness, concentration, fatigue, and well-being in normal to overweight young people.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Behavioral: High Protein
    250 kcal; 40% Protein; 40% Carbohydrate; 20% Fat
  • Behavioral: Low Protein
    5% Protein; 50% Carbohydrates; 45% Fat
Study Arms  ICMJE
  • Active Comparator: High Protein
    Higher Protein Soy-based Snacks
    Intervention: Behavioral: High Protein
  • Active Comparator: Low Protein
    Typical, Low Protein Snacks
    Intervention: Behavioral: Low Protein
  • No Intervention: No Snack
    No Snack
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 21, 2014)
37
Original Estimated Enrollment  ICMJE
 (submitted: January 29, 2013)
40
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age range 13-19 years
  • Normal to overweight (BMI: 50-85th percentile for BMI for age or BMI: 18-29.9 kg/m2)
  • No metabolic, psychological, or neurological diseases/conditions
  • Not currently or previously on a weight loss or other special diet (in the past 6 months)
  • Not clinically diagnosed with an eating disorder
  • Habitually eat (i.e., at least 5 times/week) breakfast between 7:00-9:00 am, lunch between 11:00 am-1:00 pm, an afternoon snack between 2:00-4:00 pm, and dinner
  • No food allergies or intolerances to soy products
  • Rates the overall liking of the study snack foods higher than "Neither Like nor Dislike" on the screening palatability questionnaire
  • Right handed

Exclusion Criteria:

  • Age 12 years or younger, or 20 years or older
  • Underweight or Obese (below 50th or above 85th percentile for BMI for age, or BMI below 18 or above 29.9 kg/m2)
  • Any metabolic, psychological, or neurological diseases/conditions
  • Currently or previously on a weight loss or other special diet (in the past 6 months)
  • Clinically diagnosed with an eating disorder
  • Does not habitually eat (i.e., at least 5 times/week) breakfast between 7:00-9:00 am, lunch between 11:00 am-1:00 pm, an afternoon snack between 2:00-4:00 pm, and dinner
  • Food allergies or intolerances to soy products
  • Does not rate the overall liking of the study snack foods higher than "Neither Like nor Dislike" on the screening palatability questionnaire
  • Not right handed
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01781286
Other Study ID Numbers  ICMJE 00039414
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Heather Leidy, University of Missouri-Columbia
Study Sponsor  ICMJE University of Missouri-Columbia
Collaborators  ICMJE Solae, LLC
Investigators  ICMJE
Principal Investigator: Heather J Leidy, PhD University of Missouri-Columbia
PRS Account University of Missouri-Columbia
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP