<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/NCT03257137</url>
  </required_header>
  <id_info>
    <org_study_id>17-0616</org_study_id>
    <nct_id>NCT03257137</nct_id>
  </id_info>
  <brief_title>Diet and Sleep Monitoring</brief_title>
  <official_title>Diet and Sleep Monitoring</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chicago</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will investigate the effect of two dietary patterns on sleep outcomes and measures&#xD;
      of reported appetite. Participants will be given two different diets on two separate stays.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Normal sleep consists of alternating periods of non-rapid eye movement (NREM) and rapid eye&#xD;
      movement (REM) sleep. The deeper stages of NREM sleep are also known as slow-wave sleep&#xD;
      (SWS). Genetic and environmental factors, such as age, gender, race, socioeconomic status and&#xD;
      others contribute to high inter-individual variability in sleep quality.&#xD;
&#xD;
      Current evidence from epidemiologic, clinical and experimental studies support a strong&#xD;
      relationship between insufficient sleep and increased risk for obesity. A reciprocal&#xD;
      connection between sleep and energy metabolism may exist between diet and sleep.&#xD;
&#xD;
      It is also well known that diet greatly influences body weight and metabolic health. Numerous&#xD;
      disease risk factors are known to be associated with dietary patters consisting low fiber,&#xD;
      high saturated fat, and added sugar, but the effects of diet on sleep quality remains&#xD;
      unknown.&#xD;
&#xD;
      A small group of studies have indicated an effect of diet on sleep quality (assessed&#xD;
      objectively by polysomnography [PSG]) under controlled laboratory conditions. However, none&#xD;
      have experimentally tested sleep and appetite outcomes under different dietary patterns&#xD;
      matched for macronutrients.&#xD;
&#xD;
      The overall objective of this study is to compare the effects of consumption of unhealthy&#xD;
      meals with low fiber, high saturated fat, and high added sugar content i.e. simulated fast&#xD;
      food diet [SFF] to healthy meals with high fiber, low saturated fat, and low added sugar&#xD;
      content i.e. healthy diet. We hypothesize that a healthy diet (as recommended by the Dietary&#xD;
      Guidelines Advisory Committee and the American Heart Association) compared to SFF diet will&#xD;
      promote better sleep quality (as assessed by PSG) reflected by higher sleep efficiency,&#xD;
      increased SWS and increased REM sleep and other improved sleep variables. We will also&#xD;
      evaluate subjective appetite, mood and sleepiness as secondary outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 24, 2017</start_date>
  <completion_date type="Actual">March 29, 2019</completion_date>
  <primary_completion_date type="Actual">March 1, 2019</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>Other</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Participants will undergo both diet pattern conditions but not be informed of their differences. The technologist scoring the sleep studies and actiwatches will be blinded to the condition</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Sleep quality night 2</measure>
    <time_frame>Bedtime (11:00PM) to Wake time (7:30AM)</time_frame>
    <description>Night 2 PSG recordings</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective appetite area under the curve</measure>
    <time_frame>7:30am-11:00PM</time_frame>
    <description>A collection of all subjective ratings (upon waking, pre and post meals, and hourly)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective appetite daily average</measure>
    <time_frame>7:30am-11:00PM</time_frame>
    <description>A collection of all subjective ratings (upon waking, pre and post meals, and hourly)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mood area under the curve</measure>
    <time_frame>7:30am-11:00PM</time_frame>
    <description>A collection of all subjective ratings (upon waking, pre and post meals, and hourly)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mood daily average</measure>
    <time_frame>7:30am-11:00PM</time_frame>
    <description>A collection of all subjective ratings (upon waking, pre and post meals, and hourly)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective sleep quality area under the curve</measure>
    <time_frame>7:30am-11:00PM</time_frame>
    <description>A collection of all subjective ratings (upon waking, pre and post meals, and hourly)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective sleep quality daily average</measure>
    <time_frame>7:30am-11:00PM</time_frame>
    <description>A collection of all subjective ratings (upon waking, pre and post meals, and hourly)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality night 1</measure>
    <time_frame>11:00PM to 7:30AM</time_frame>
    <description>Night 2 PSG recordings</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep night 1</measure>
    <time_frame>11:00PM to 7:30AM</time_frame>
    <description>Measured with wrist actigraphy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep night 2</measure>
    <time_frame>11:00PM to 7:30AM</time_frame>
    <description>Measured with wrist actigraphy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep night 3</measure>
    <time_frame>11:00PM to 7:30AM</time_frame>
    <description>Measured with wrist actigraphy</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Appetite upon waking</measure>
    <time_frame>First response in the morning</time_frame>
    <description>First response in the morning using subjective questionnaires</description>
  </other_outcome>
  <other_outcome>
    <measure>Mood upon waking</measure>
    <time_frame>7:30AM</time_frame>
    <description>First response in the morning using subjective questionnaires</description>
  </other_outcome>
  <other_outcome>
    <measure>Sleepiness upon waking</measure>
    <time_frame>7:30AM</time_frame>
    <description>First response in the morning using subjective questionnaires</description>
  </other_outcome>
  <other_outcome>
    <measure>Morning appetite</measure>
    <time_frame>7:30AM to 11:00AM</time_frame>
    <description>Morning hourly and pre and post meal response using subjective questionnaires</description>
  </other_outcome>
  <other_outcome>
    <measure>Morning mood</measure>
    <time_frame>7:30AM to 11:00AM</time_frame>
    <description>Morning hourly and pre and post meal response using subjective questionnaires</description>
  </other_outcome>
  <other_outcome>
    <measure>Morning sleepiness</measure>
    <time_frame>7:30AM to 11:00AM</time_frame>
    <description>Morning hourly and pre and post meal response using subjective questionnaires</description>
  </other_outcome>
  <other_outcome>
    <measure>Mid-day appetite</measure>
    <time_frame>11:00AM to 5:00PM</time_frame>
    <description>Mid-day hourly and pre and post meal response using subjective questionnaires</description>
  </other_outcome>
  <other_outcome>
    <measure>Mid-day mood</measure>
    <time_frame>11:00AM to 5:00PM</time_frame>
    <description>Mid-day hourly and pre and post meal response using subjective questionnaires</description>
  </other_outcome>
  <other_outcome>
    <measure>Mid-day sleepiness</measure>
    <time_frame>11:00AM to 5:00PM</time_frame>
    <description>Mid-day hourly and pre and post meal response using subjective questionnaires</description>
  </other_outcome>
  <other_outcome>
    <measure>Evening appetite</measure>
    <time_frame>5:00PM to 11:00PM</time_frame>
    <description>Evening hourly and pre and post meal response using subjective questionnaires</description>
  </other_outcome>
  <other_outcome>
    <measure>Evening mood</measure>
    <time_frame>5:00PM to 11:00PM</time_frame>
    <description>Evening hourly and pre and post meal response using subjective questionnaires</description>
  </other_outcome>
  <other_outcome>
    <measure>Evening sleepiness</measure>
    <time_frame>5:00PM to 11:00PM</time_frame>
    <description>Evening hourly and pre and post meal response using subjective questionnaires</description>
  </other_outcome>
  <other_outcome>
    <measure>Bedtime appetite</measure>
    <time_frame>Response at bedtime</time_frame>
    <description>Response at bedtime using subjective questionnaires</description>
  </other_outcome>
  <other_outcome>
    <measure>Bedtime mood</measure>
    <time_frame>11:00PM</time_frame>
    <description>Response at bedtime using subjective questionnaires</description>
  </other_outcome>
  <other_outcome>
    <measure>Bedtime sleepiness</measure>
    <time_frame>11:00PM</time_frame>
    <description>Response at bedtime using subjective questionnaires</description>
  </other_outcome>
  <other_outcome>
    <measure>Average sleep duration</measure>
    <time_frame>21 days</time_frame>
    <description>At home wrist actigraphy</description>
  </other_outcome>
  <other_outcome>
    <measure>Average sleep onset latency</measure>
    <time_frame>21 days</time_frame>
    <description>At home wrist actigraphy</description>
  </other_outcome>
  <other_outcome>
    <measure>Average night-time awakenings</measure>
    <time_frame>21 days</time_frame>
    <description>At home wrist actigraphy</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Sleep</condition>
  <condition>Diet Modification</condition>
  <arm_group>
    <arm_group_label>Healthy Diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This dietary pattern will represent recommendations for fiber and added sugar set forth in the 2015 Dietary Guidelines for Americans and saturated fat guidelines from the American Heart Association</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Simulated Fast Food (SFF)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This dietary pattern will represent the typical American diet for fiber, added sugar, and saturated fat intake.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diet Quality</intervention_name>
    <description>Diets matched for calorie intake and macronutrient distribution but differing by overall diet quality will be provided in a random order, cross-over design study.</description>
    <arm_group_label>Healthy Diet</arm_group_label>
    <arm_group_label>Simulated Fast Food (SFF)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and female participants (age: 21-40 years and BMI=19.0-26.0 kg/m2) who&#xD;
             habitually sleep on average 7-8 hours per night (as confirmed by actigraphy) and eat&#xD;
             at least 3 meals per day (as confirmed by food diaries) will be studied. Subjects will&#xD;
             be required to have stable sleep habits for the past 6 months and stable dietary&#xD;
             habits for the past 3 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Obstructive sleep apnea by laboratory polysomnography or history of any other sleep&#xD;
             disorder, night or rotating shift work (current or in the past 1 year), habitual&#xD;
             daytime naps, recent (&lt; 4 week) travel across time zones, extreme chronotypes, any&#xD;
             acute or chronic medical condition, prediabetes or diabetes, prior or current eating&#xD;
             or psychiatric disorders, claustrophobia, irregular menstrual periods, menopause,&#xD;
             currently pregnant (screened with urine test), recently postpartum (within 1 year),&#xD;
             currently lactating, alcohol abuse, excessive caffeine intake, smoking, illegal drug&#xD;
             use, currently following a weight loss regimen or any other special diet or exercise&#xD;
             programs, extreme food allergies or intolerances, and abnormal findings on screening&#xD;
             blood testing. Participants will also be required not to take any prescription or over&#xD;
             the counter medications, supplements that can affect sleep, metabolism, mood or&#xD;
             appetite. Women will be required to not be on hormone replacement therapy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Esra Tasali, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Univeristy of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>November 18, 2022</last_update_submitted>
  <last_update_submitted_qc>November 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>sleep</keyword>
  <keyword>macronutrients</keyword>
  <keyword>dietary patterns</keyword>
  <keyword>sleep quality</keyword>
  <keyword>diet quality</keyword>
  <keyword>polysomnography</keyword>
  <keyword>appetite</keyword>
  <keyword>mood</keyword>
  <keyword>hunger</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03257137
org study id: 17-0616
nct id: NCT03257137
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will investigate the effect of two dietary patterns on sleep outcomes and measures
      of reported appetite. Participants will be given two different diets on two separate stays.
Normal sleep consists of alternating periods of non-rapid eye movement (NREM) and rapid eye
      movement (REM) sleep. The deeper stages of NREM sleep are also known as slow-wave sleep
      (SWS). Genetic and environmental factors, such as age, gender, race, socioeconomic status and
      others contribute to high inter-individual variability in sleep quality.

      Current evidence from epidemiologic, clinical and experimental studies support a strong
      relationship between insufficient sleep and increased risk for obesity. A reciprocal
      connection between sleep and energy metabolism may exist between diet and sleep.

      It is also well known that diet greatly influences body weight and metabolic health. Numerous
      disease risk factors are known to be associated with dietary patters consisting low fiber,
      high saturated fat, and added sugar, but the effects of diet on sleep quality remains
      unknown.

      A small group of studies have indicated an effect of diet on sleep quality (assessed
      objectively by polysomnography [PSG]) under controlled laboratory conditions. However, none
      have experimentally tested sleep and appetite outcomes under different dietary patterns
      matched for macronutrients.

      The overall objective of this study is to compare the effects of consumption of unhealthy
      meals with low fiber, high saturated fat, and high added sugar content i.e. simulated fast
      food diet [SFF] to healthy meals with high fiber, low saturated fat, and low added sugar
      content i.e. healthy diet. We hypothesize that a healthy diet (as recommended by the Dietary
      Guidelines Advisory Committee and the American Heart Association) compared to SFF diet will
      promote better sleep quality (as assessed by PSG) reflected by higher sleep efficiency,
      increased SWS and increased REM sleep and other improved sleep variables. We will also
      evaluate subjective appetite, mood and sleepiness as secondary outcomes.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Double (Participant, Outcomes Assessor)
masking description: Participants will undergo both diet pattern conditions but not be informed of their differences. The technologist scoring the sleep studies and actiwatches will be blinded to the condition
measure: Sleep quality night 2
time frame: Bedtime (11:00PM) to Wake time (7:30AM)
description: Night 2 PSG recordings
measure: Subjective appetite area under the curve
time frame: 7:30am-11:00PM
description: A collection of all subjective ratings (upon waking, pre and post meals, and hourly)
measure: Subjective appetite daily average
time frame: 7:30am-11:00PM
description: A collection of all subjective ratings (upon waking, pre and post meals, and hourly)
measure: Mood area under the curve
time frame: 7:30am-11:00PM
description: A collection of all subjective ratings (upon waking, pre and post meals, and hourly)
measure: Mood daily average
time frame: 7:30am-11:00PM
description: A collection of all subjective ratings (upon waking, pre and post meals, and hourly)
measure: Subjective sleep quality area under the curve
time frame: 7:30am-11:00PM
description: A collection of all subjective ratings (upon waking, pre and post meals, and hourly)
measure: Subjective sleep quality daily average
time frame: 7:30am-11:00PM
description: A collection of all subjective ratings (upon waking, pre and post meals, and hourly)
measure: Sleep quality night 1
time frame: 11:00PM to 7:30AM
description: Night 2 PSG recordings
measure: Sleep night 1
time frame: 11:00PM to 7:30AM
description: Measured with wrist actigraphy
measure: Sleep night 2
time frame: 11:00PM to 7:30AM
description: Measured with wrist actigraphy
measure: Sleep night 3
time frame: 11:00PM to 7:30AM
description: Measured with wrist actigraphy
measure: Appetite upon waking
time frame: First response in the morning
description: First response in the morning using subjective questionnaires
measure: Mood upon waking
time frame: 7:30AM
description: First response in the morning using subjective questionnaires
measure: Sleepiness upon waking
time frame: 7:30AM
description: First response in the morning using subjective questionnaires
measure: Morning appetite
time frame: 7:30AM to 11:00AM
description: Morning hourly and pre and post meal response using subjective questionnaires
measure: Morning mood
time frame: 7:30AM to 11:00AM
description: Morning hourly and pre and post meal response using subjective questionnaires
measure: Morning sleepiness
time frame: 7:30AM to 11:00AM
description: Morning hourly and pre and post meal response using subjective questionnaires
measure: Mid-day appetite
time frame: 11:00AM to 5:00PM
description: Mid-day hourly and pre and post meal response using subjective questionnaires
measure: Mid-day mood
time frame: 11:00AM to 5:00PM
description: Mid-day hourly and pre and post meal response using subjective questionnaires
measure: Mid-day sleepiness
time frame: 11:00AM to 5:00PM
description: Mid-day hourly and pre and post meal response using subjective questionnaires
measure: Evening appetite
time frame: 5:00PM to 11:00PM
description: Evening hourly and pre and post meal response using subjective questionnaires
measure: Evening mood
time frame: 5:00PM to 11:00PM
description: Evening hourly and pre and post meal response using subjective questionnaires
measure: Evening sleepiness
time frame: 5:00PM to 11:00PM
description: Evening hourly and pre and post meal response using subjective questionnaires
measure: Bedtime appetite
time frame: Response at bedtime
description: Response at bedtime using subjective questionnaires
measure: Bedtime mood
time frame: 11:00PM
description: Response at bedtime using subjective questionnaires
measure: Bedtime sleepiness
time frame: 11:00PM
description: Response at bedtime using subjective questionnaires
measure: Average sleep duration
time frame: 21 days
description: At home wrist actigraphy
measure: Average sleep onset latency
time frame: 21 days
description: At home wrist actigraphy
measure: Average night-time awakenings
time frame: 21 days
description: At home wrist actigraphy
arm group label: Healthy Diet
arm group type: Experimental
description: This dietary pattern will represent recommendations for fiber and added sugar set forth in the 2015 Dietary Guidelines for Americans and saturated fat guidelines from the American Heart Association
arm group label: Simulated Fast Food (SFF)
arm group type: Experimental
description: This dietary pattern will represent the typical American diet for fiber, added sugar, and saturated fat intake.
intervention type: Other
intervention name: Diet Quality
description: Diets matched for calorie intake and macronutrient distribution but differing by overall diet quality will be provided in a random order, cross-over design study.
arm group label: Healthy Diet
arm group label: Simulated Fast Food (SFF)
criteria: 
gender: All
minimum age: 21 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Esra Tasali, MD
role: Principal Investigator
affiliation: University of Chicago
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No