<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03031132</url>
  </required_header>
  <id_info>
    <org_study_id>2005823 HS</org_study_id>
    <nct_id>NCT03031132</nct_id>
  </id_info>
  <brief_title>The Effects of a High Protein Breakfast on Appetite and Sleep in Young Adults</brief_title>
  <official_title>The Effects of a High Protein Breakfast on Appetite and Sleep in Young Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Purdue University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Purdue University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine the effects of breakfast skipping (SKIP) vs. the&#xD;
      consumption of a high protein solid (HP-S) breakfast vs. the consumption of a high protein&#xD;
      beverage (HP-B) breakfast on daily appetite control, food cravings, food intake, and sleep&#xD;
      quality in young adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Young adults will consume the following breakfasts (in randomized order) for 7 days/pattern:&#xD;
      350kcal HP breakfasts (30g protein) in solid or beverage form or will skip breakfast. During&#xD;
      the breakfast treatment periods, the participants will be provided with isocaloric breakfast&#xD;
      meals containing 34% protein (30g protein), 40% CHO, and 26% fat. The participants will&#xD;
      consume these meals each day throughout each of the 7 day testing periods. During the&#xD;
      breakfast skipping treatment period, the participants will skip breakfast every morning with&#xD;
      nothing to eat or drink (besides water) until 12:00 pm. During the acclimation days (i.e.,&#xD;
      days 1-6), participants will eat their breakfasts at home or work or simply skip the morning&#xD;
      meal. An actigraph (to assess key indices of sleep) will be continuously worn and sleep&#xD;
      diaries will be completed for all 7 testing days. During the afternoon of Day 3, the&#xD;
      participant will arrive at the University of Missouri-Physical Activity and Wellness Center&#xD;
      (MU-PAW) and fitted with a Continuous Glucose Monitor (CGM) measure glycemic control over the&#xD;
      next 3 days. On day 6, the participant will complete hourly appetite questionnaires, consume&#xD;
      a standardized dinner meal, and complete a salivary sample prior to sleep onset (sleep&#xD;
      related hormones). On the 7th day of each pattern, the participants will report to the MU-PAW&#xD;
      in the morning to complete the respective testing day. The participants will begin the&#xD;
      testing day by either skipping breakfast or consuming their respective breakfast meal. Blood&#xD;
      samples, salivary samples, and assessments of perceived appetite will be collected/completed&#xD;
      at specific times throughout the day. Prior to lunch, a brain scan will be completed using&#xD;
      functional magnetic resonance imaging (fMRI) to identify bain activation patterns in response&#xD;
      to food pictures. Following the fMRI, the participants will be provided with an a&#xD;
      standardized lunch. The participants will then complete the remainder of the testing day. An&#xD;
      ad libitum food buffet will be provided for the participants to consume after their departure&#xD;
      at home throughout the remainder of the day. . They will continue to wear the actigraph and&#xD;
      eat/drink from the ad libitum packout cooler until going to bed that evening. Lastly,&#xD;
      participants will complete a salivary sample and sleep diary immediately before bed. Between&#xD;
      days 8-10, the participants will return all testing day equipment and the packout cooler,&#xD;
      including all empty wrappers and any uneaten foods. A 3-7 day washout period will occur&#xD;
      between patterns in which the participant will return to their habitual (i.e. pre-study)&#xD;
      breakfast behaviors. Study outcomes include morning, mid-day, afternoon, and evening&#xD;
      appetite, satiety, pleasure, perceived energy/sleepiness, hormonal responses (plasma glucose,&#xD;
      insulin, ghrelin, PYY, melatonin, and cortisol concentrations), sleep indices (i.e total&#xD;
      sleep time, sleep efficiency, perceived sleep quality), brain activation patterns, evening&#xD;
      energy intake, and daily energy intake.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Transferring study to another University&#xD;
  </why_stopped>
  <start_date>June 2016</start_date>
  <completion_date type="Anticipated">May 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hunger</measure>
    <time_frame>4 weeks</time_frame>
    <description>Questionnaires, assessing appetite sensations of hunger will be completed throughout each of the testing days (which are separated by 7-10 days). The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response. The questions are worded in the following manner &quot;how strong is your feeling of&quot; with anchors of &quot;not all&quot; to &quot;extremely.&quot;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fullness</measure>
    <time_frame>4 weeks</time_frame>
    <description>Questionnaires, assessing appetite sensations of fullness will be completed throughout each of the testing days (which are separated by 7-10 days). The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response. The questions are worded in the following manner &quot;how strong is your feeling of&quot; with anchors of &quot;not all&quot; to &quot;extremely.&quot;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prospective Food Consumption</measure>
    <time_frame>4 weeks</time_frame>
    <description>Questionnaires, assessing appetite sensations of prospective food consumption will be completed throughout each of the testing days (which are separated by 7-10 days). The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response. The questions are worded in the following manner &quot;how strong is your feeling of&quot; with anchors of &quot;not all&quot; to &quot;extremely.&quot;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Motivation to Eat</measure>
    <time_frame>4 weeks</time_frame>
    <description>Questionnaires, assessing appetite sensations of motivation to eat will be completed throughout each of the testing days (which are separated by 7-10 days). The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response. The questions are worded in the following manner &quot;how strong is your feeling of&quot; with anchors of &quot;not all&quot; to &quot;extremely.&quot;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hedonic Ratings (pleasure)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Questionnaires, assessing appetite sensations of hedonic pleasure will be completed throughout each of the testing days (which are separated by 7-10 days). The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response. The questions are worded in the following manner &quot;how strong is your feeling of&quot; with anchors of &quot;not all&quot; to &quot;extremely.&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Sleep Status - Total Sleep Time</measure>
    <time_frame>4 weeks</time_frame>
    <description>Indices of sleep status and habits will be assessed throughout the acclimation and testing days in each of the 3 study arms. The participants will wear armband accelerometers / actigraphs to measure objective sleep parameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Sleep Quality</measure>
    <time_frame>4 weeks</time_frame>
    <description>Indices of sleep status and habits will be assessed throughout the acclimation and testing days in each of the 3 study arms. The participants will wear armband accelerometers / actigraphs to measure objective sleep parameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Sleep Efficiency</measure>
    <time_frame>4 weeks</time_frame>
    <description>Indices of sleep status and habits will be assessed throughout the acclimation and testing days in each of the 3 study arms. The participants will wear armband accelerometers / actigraphs to measure objective sleep parameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Sleep and Circadian Patterns - Salivary Cortisol</measure>
    <time_frame>4 weeks</time_frame>
    <description>Indices of sleep status and habits salivary sampling will be completed on days 6 and 7 of each study arm to assess sleep related hormones (cortisol).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Sleep and Circadian Patterns - Salivary Melatonin</measure>
    <time_frame>4 weeks</time_frame>
    <description>Indices of sleep status and habits salivary sampling will be completed on days 6 and 7 of each study arm to assess sleep related hormones (melatonin).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Sleep Quality - Mood</measure>
    <time_frame>4 weeks</time_frame>
    <description>Indices of perceived sleep quality (mood, energy, arousal, awakenings) will be assessed throughout the acclimation and testing days in each of the 3 study arms. The participants will complete bedtime and wake time sleep diaries to measure subjective sleep parameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Sleep Quality - Energy</measure>
    <time_frame>4 weeks</time_frame>
    <description>Indices of perceived sleep quality (mood, energy, arousal, awakenings) will be assessed throughout the acclimation and testing days in each of the 3 study arms. The participants will complete bedtime and wake time sleep diaries to measure subjective sleep parameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Sleep Quality - Arousal</measure>
    <time_frame>4 weeks</time_frame>
    <description>Indices of perceived sleep quality (mood, energy, arousal, awakenings) will be assessed throughout the acclimation and testing days in each of the 3 study arms. The participants will complete bedtime and wake time sleep diaries to measure subjective sleep parameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Sleep Quality - Awakenings</measure>
    <time_frame>4 weeks</time_frame>
    <description>Indices of perceived sleep quality (mood, energy, arousal, awakenings) will be assessed throughout the acclimation and testing days in each of the 3 study arms. The participants will complete bedtime and wake time sleep diaries to measure subjective sleep parameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Magnetic Resonance Imaging (fMRI) Brain Activation Responses</measure>
    <time_frame>4 weeks</time_frame>
    <description>Brain activation responses will be assessed prior to lunch in each of the 3 testing days (separated by 2 weeks). During the fMRI brain scan procedure, the participants will focus on a set of photographs which will be projected onto a screen and easily viewed through a mirror. The fMRI paradigm incorporates stimuli from three categories of pictures including food, nonfood (animals), and blurred baseline images. Brain activation in the Insula, Amygdala, Hippocampus, and Parahippocampus will be examined when viewing food vs. animal pictures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evening / Dinner Energy Intake - Calories</measure>
    <time_frame>4 weeks</time_frame>
    <description>Energy intake during dinner and evening snacks of each testing day will be measured in calories consumed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evening / Dinner Energy Intake - Macronutrients or food categories</measure>
    <time_frame>4 weeks</time_frame>
    <description>Energy intake during dinner and evening snacks of each testing day will be measured as macronutrient or food category (i.e. amount of food consumed as protein, carbohydrates, fats, sugars, fiber).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evening / Dinner Energy Intake - Food Choice</measure>
    <time_frame>4 weeks</time_frame>
    <description>Energy intake during dinner and evening snacks of each testing day will be measured as types of foods consumed (i.e. foods typically consumed as snacks, protein-rich foods, high carbohydrate/high fat convenience foods).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appetite and Satiety Hormones (i.e., Ghrelin, PYY)</measure>
    <time_frame>4 weeks</time_frame>
    <description>10 total blood samples will be drawn throughout each of the testing days (which are separated by 7-10 days). Specifically, there will be seven 5 ml samples and three 9 ml samples; ~62 ml/testing day. The samples will be collected in test tubes containing EDTA (ethylenediaminetetraacetic acid). Protease inhibitors will be added to the sample to reduce protein degradation. Samples will be centrifuged at -4°C for 10 minutes. The plasma will then be separated and stored in microcentrifuge tubes at -80°C for future analysis. Appetite related hormones will be measured (ex. plasma total ghrelin and total PYY).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Appetite and General Nutritional Disorders</condition>
  <arm_group>
    <arm_group_label>HP-Beverage Breakfast</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For 7 days, the participants will consume high protein beverage breakfast meals each morning. These meals will consist of shakes and will be 350 kcal. The macronutrient composition of these meals will contain 30 g of dietary protein, 35g CHO, and 10g fat. The HP-S and HP-B meals will be matched for energy density, sugar content, macronutrient content and types of proteins.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HP-Solid Breakfast</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For 7 days, the participants will consume high protein solid breakfast meals each morning. These meals will consist of traditional solid breakfast meals and will include commonly consumed breakfast foods (e.g., burritos, waffles, etc.) and will be 350 kcal. The macronutrient composition of these meals will contain 30 g of dietary protein, 35 g CHO, and 10 g fat. The HP-S and HP-B meals will be matched for energy density, sugar content, macronutrient content and types of proteins.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Breakfast Skipping</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For 7 days, the participants will skip the morning meal. No food or calorie-containing beverages will be consumed before 12pm on acclimation days and no food consumed until ~5h post habitual breakfast time on testing day 7.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HP-Beverage Breakfast</intervention_name>
    <description>Participants will consume high protein beverage (shake) breakfast meals each morning.</description>
    <arm_group_label>HP-Beverage Breakfast</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HP-Solid Breakfast</intervention_name>
    <description>Participants will consume high protein solid (traditional food items) breakfast meals each morning.</description>
    <arm_group_label>HP-Solid Breakfast</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Breakfast Skipping</intervention_name>
    <description>Participants will skip breakfast each morning.</description>
    <arm_group_label>Breakfast Skipping</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 20-32y&#xD;
&#xD;
          -  BMI 22-30kg/m2&#xD;
&#xD;
          -  non-smoker, non-user of tobacco products&#xD;
&#xD;
          -  generally healthy (as assessed by Medical History Questionnaire)&#xD;
&#xD;
          -  right-handed (fMRI requirement)&#xD;
&#xD;
          -  not pregnant or lactating in the past 6 months&#xD;
&#xD;
          -  not clinically diagnosed with and eating disorder&#xD;
&#xD;
          -  no metabolic, hormonal, and/or neural conditions/diseases/medications that influence&#xD;
             metabolism or food intake&#xD;
&#xD;
          -  no known bleeding disorders&#xD;
&#xD;
          -  not currently or previously (In the past 6 months) on a weight loss or other special&#xD;
             diet&#xD;
&#xD;
          -  no weight loss/gain (&gt;10lbs) in the past 6 months&#xD;
&#xD;
          -  normal cognitive restraint, as assessed by a score of &lt;4 on the Three Factors Eating&#xD;
             Habits Questionnaire (TFEQ)&#xD;
&#xD;
          -  rating of ≥ 5 illustrating a minimum of &quot;neither like nor dislike&quot; on a 9-point&#xD;
             hedonic scale rating for the study breakfasts&#xD;
&#xD;
          -  not clinically diagnosed with obstructive sleep apnea or insomnia and does not&#xD;
             participate in shiftwork&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The potential participants will be excluded if they do not meet the inclusion&#xD;
             criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>32 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Heather J Leidy, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Purdue University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Missouri</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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  <verification_date>May 2017</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>May 17, 2017</last_update_submitted>
  <last_update_submitted_qc>May 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Purdue University</investigator_affiliation>
    <investigator_full_name>Heather Leidy</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Protein-rich breakfast</keyword>
  <keyword>Breakfast Skipping</keyword>
  <keyword>Young Adults</keyword>
  <keyword>Breakfast</keyword>
  <keyword>Food form</keyword>
  <keyword>fMRI</keyword>
  <keyword>Ghrelin</keyword>
  <keyword>PYY</keyword>
  <keyword>Sleep</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nutrition Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>June 12, 2018</submitted>
    <returned>October 18, 2018</returned>
    <submitted>April 30, 2019</submitted>
    <returned>May 3, 2019</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03031132
org study id: 2005823 HS
nct id: NCT03031132
lead sponsor: 
has dmc: Yes
The purpose of this study is to examine the effects of breakfast skipping (SKIP) vs. the
      consumption of a high protein solid (HP-S) breakfast vs. the consumption of a high protein
      beverage (HP-B) breakfast on daily appetite control, food cravings, food intake, and sleep
      quality in young adults.
Young adults will consume the following breakfasts (in randomized order) for 7 days/pattern:
      350kcal HP breakfasts (30g protein) in solid or beverage form or will skip breakfast. During
      the breakfast treatment periods, the participants will be provided with isocaloric breakfast
      meals containing 34% protein (30g protein), 40% CHO, and 26% fat. The participants will
      consume these meals each day throughout each of the 7 day testing periods. During the
      breakfast skipping treatment period, the participants will skip breakfast every morning with
      nothing to eat or drink (besides water) until 12:00 pm. During the acclimation days (i.e.,
      days 1-6), participants will eat their breakfasts at home or work or simply skip the morning
      meal. An actigraph (to assess key indices of sleep) will be continuously worn and sleep
      diaries will be completed for all 7 testing days. During the afternoon of Day 3, the
      participant will arrive at the University of Missouri-Physical Activity and Wellness Center
      (MU-PAW) and fitted with a Continuous Glucose Monitor (CGM) measure glycemic control over the
      next 3 days. On day 6, the participant will complete hourly appetite questionnaires, consume
      a standardized dinner meal, and complete a salivary sample prior to sleep onset (sleep
      related hormones). On the 7th day of each pattern, the participants will report to the MU-PAW
      in the morning to complete the respective testing day. The participants will begin the
      testing day by either skipping breakfast or consuming their respective breakfast meal. Blood
      samples, salivary samples, and assessments of perceived appetite will be collected/completed
      at specific times throughout the day. Prior to lunch, a brain scan will be completed using
      functional magnetic resonance imaging (fMRI) to identify bain activation patterns in response
      to food pictures. Following the fMRI, the participants will be provided with an a
      standardized lunch. The participants will then complete the remainder of the testing day. An
      ad libitum food buffet will be provided for the participants to consume after their departure
      at home throughout the remainder of the day. . They will continue to wear the actigraph and
      eat/drink from the ad libitum packout cooler until going to bed that evening. Lastly,
      participants will complete a salivary sample and sleep diary immediately before bed. Between
      days 8-10, the participants will return all testing day equipment and the packout cooler,
      including all empty wrappers and any uneaten foods. A 3-7 day washout period will occur
      between patterns in which the participant will return to their habitual (i.e. pre-study)
      breakfast behaviors. Study outcomes include morning, mid-day, afternoon, and evening
      appetite, satiety, pleasure, perceived energy/sleepiness, hormonal responses (plasma glucose,
      insulin, ghrelin, PYY, melatonin, and cortisol concentrations), sleep indices (i.e total
      sleep time, sleep efficiency, perceived sleep quality), brain activation patterns, evening
      energy intake, and daily energy intake.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Hunger
time frame: 4 weeks
description: Questionnaires, assessing appetite sensations of hunger will be completed throughout each of the testing days (which are separated by 7-10 days). The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response. The questions are worded in the following manner "how strong is your feeling of" with anchors of "not all" to "extremely."
measure: Fullness
time frame: 4 weeks
description: Questionnaires, assessing appetite sensations of fullness will be completed throughout each of the testing days (which are separated by 7-10 days). The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response. The questions are worded in the following manner "how strong is your feeling of" with anchors of "not all" to "extremely."
measure: Prospective Food Consumption
time frame: 4 weeks
description: Questionnaires, assessing appetite sensations of prospective food consumption will be completed throughout each of the testing days (which are separated by 7-10 days). The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response. The questions are worded in the following manner "how strong is your feeling of" with anchors of "not all" to "extremely."
measure: Motivation to Eat
time frame: 4 weeks
description: Questionnaires, assessing appetite sensations of motivation to eat will be completed throughout each of the testing days (which are separated by 7-10 days). The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response. The questions are worded in the following manner "how strong is your feeling of" with anchors of "not all" to "extremely."
measure: Hedonic Ratings (pleasure)
time frame: 4 weeks
description: Questionnaires, assessing appetite sensations of hedonic pleasure will be completed throughout each of the testing days (which are separated by 7-10 days). The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response. The questions are worded in the following manner "how strong is your feeling of" with anchors of "not all" to "extremely."
measure: Objective Sleep Status - Total Sleep Time
time frame: 4 weeks
description: Indices of sleep status and habits will be assessed throughout the acclimation and testing days in each of the 3 study arms. The participants will wear armband accelerometers / actigraphs to measure objective sleep parameters.
measure: Objective Sleep Quality
time frame: 4 weeks
description: Indices of sleep status and habits will be assessed throughout the acclimation and testing days in each of the 3 study arms. The participants will wear armband accelerometers / actigraphs to measure objective sleep parameters.
measure: Objective Sleep Efficiency
time frame: 4 weeks
description: Indices of sleep status and habits will be assessed throughout the acclimation and testing days in each of the 3 study arms. The participants will wear armband accelerometers / actigraphs to measure objective sleep parameters.
measure: Objective Sleep and Circadian Patterns - Salivary Cortisol
time frame: 4 weeks
description: Indices of sleep status and habits salivary sampling will be completed on days 6 and 7 of each study arm to assess sleep related hormones (cortisol).
measure: Objective Sleep and Circadian Patterns - Salivary Melatonin
time frame: 4 weeks
description: Indices of sleep status and habits salivary sampling will be completed on days 6 and 7 of each study arm to assess sleep related hormones (melatonin).
measure: Subjective Sleep Quality - Mood
time frame: 4 weeks
description: Indices of perceived sleep quality (mood, energy, arousal, awakenings) will be assessed throughout the acclimation and testing days in each of the 3 study arms. The participants will complete bedtime and wake time sleep diaries to measure subjective sleep parameters.
measure: Subjective Sleep Quality - Energy
time frame: 4 weeks
description: Indices of perceived sleep quality (mood, energy, arousal, awakenings) will be assessed throughout the acclimation and testing days in each of the 3 study arms. The participants will complete bedtime and wake time sleep diaries to measure subjective sleep parameters.
measure: Subjective Sleep Quality - Arousal
time frame: 4 weeks
description: Indices of perceived sleep quality (mood, energy, arousal, awakenings) will be assessed throughout the acclimation and testing days in each of the 3 study arms. The participants will complete bedtime and wake time sleep diaries to measure subjective sleep parameters.
measure: Subjective Sleep Quality - Awakenings
time frame: 4 weeks
description: Indices of perceived sleep quality (mood, energy, arousal, awakenings) will be assessed throughout the acclimation and testing days in each of the 3 study arms. The participants will complete bedtime and wake time sleep diaries to measure subjective sleep parameters.
measure: Functional Magnetic Resonance Imaging (fMRI) Brain Activation Responses
time frame: 4 weeks
description: Brain activation responses will be assessed prior to lunch in each of the 3 testing days (separated by 2 weeks). During the fMRI brain scan procedure, the participants will focus on a set of photographs which will be projected onto a screen and easily viewed through a mirror. The fMRI paradigm incorporates stimuli from three categories of pictures including food, nonfood (animals), and blurred baseline images. Brain activation in the Insula, Amygdala, Hippocampus, and Parahippocampus will be examined when viewing food vs. animal pictures.
measure: Evening / Dinner Energy Intake - Calories
time frame: 4 weeks
description: Energy intake during dinner and evening snacks of each testing day will be measured in calories consumed.
measure: Evening / Dinner Energy Intake - Macronutrients or food categories
time frame: 4 weeks
description: Energy intake during dinner and evening snacks of each testing day will be measured as macronutrient or food category (i.e. amount of food consumed as protein, carbohydrates, fats, sugars, fiber).
measure: Evening / Dinner Energy Intake - Food Choice
time frame: 4 weeks
description: Energy intake during dinner and evening snacks of each testing day will be measured as types of foods consumed (i.e. foods typically consumed as snacks, protein-rich foods, high carbohydrate/high fat convenience foods).
measure: Appetite and Satiety Hormones (i.e., Ghrelin, PYY)
time frame: 4 weeks
description: 10 total blood samples will be drawn throughout each of the testing days (which are separated by 7-10 days). Specifically, there will be seven 5 ml samples and three 9 ml samples; ~62 ml/testing day. The samples will be collected in test tubes containing EDTA (ethylenediaminetetraacetic acid). Protease inhibitors will be added to the sample to reduce protein degradation. Samples will be centrifuged at -4°C for 10 minutes. The plasma will then be separated and stored in microcentrifuge tubes at -80°C for future analysis. Appetite related hormones will be measured (ex. plasma total ghrelin and total PYY).
arm group label: HP-Beverage Breakfast
arm group type: Experimental
description: For 7 days, the participants will consume high protein beverage breakfast meals each morning. These meals will consist of shakes and will be 350 kcal. The macronutrient composition of these meals will contain 30 g of dietary protein, 35g CHO, and 10g fat. The HP-S and HP-B meals will be matched for energy density, sugar content, macronutrient content and types of proteins.
arm group label: HP-Solid Breakfast
arm group type: Experimental
description: For 7 days, the participants will consume high protein solid breakfast meals each morning. These meals will consist of traditional solid breakfast meals and will include commonly consumed breakfast foods (e.g., burritos, waffles, etc.) and will be 350 kcal. The macronutrient composition of these meals will contain 30 g of dietary protein, 35 g CHO, and 10 g fat. The HP-S and HP-B meals will be matched for energy density, sugar content, macronutrient content and types of proteins.
arm group label: Breakfast Skipping
arm group type: Experimental
description: For 7 days, the participants will skip the morning meal. No food or calorie-containing beverages will be consumed before 12pm on acclimation days and no food consumed until ~5h post habitual breakfast time on testing day 7.
intervention type: Behavioral
intervention name: HP-Beverage Breakfast
description: Participants will consume high protein beverage (shake) breakfast meals each morning.
arm group label: HP-Beverage Breakfast
intervention type: Behavioral
intervention name: HP-Solid Breakfast
description: Participants will consume high protein solid (traditional food items) breakfast meals each morning.
arm group label: HP-Solid Breakfast
intervention type: Behavioral
intervention name: Breakfast Skipping
description: Participants will skip breakfast each morning.
arm group label: Breakfast Skipping
criteria: 
gender: All
minimum age: 20 Years
maximum age: 32 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Heather J Leidy, PhD
role: Principal Investigator
affiliation: Purdue University
facility: 
country: United States
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responsible party type: Principal Investigator
investigator affiliation: Purdue University
investigator full name: Heather Leidy
investigator title: Associate Professor
mesh term: Nutrition Disorders
sharing ipd: No
submitted: June 12, 2018
returned: October 18, 2018
submitted: April 30, 2019
returned: May 3, 2019