<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/NCT03305237</url>
  </required_header>
  <id_info>
    <org_study_id>806</org_study_id>
    <secondary_id>MR/P012205/1</secondary_id>
    <nct_id>NCT03305237</nct_id>
  </id_info>
  <brief_title>The Meal Time Study</brief_title>
  <official_title>The Big Breakfast Study: Chrono-nutrition Influence on Energy Expenditure and Body Weight</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aberdeen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Surrey</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Maastricht University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Aberdeen</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 weight loss study will investigate the impact of calorie distribution across a day&#xD;
      (large breakfast meals and smaller evening meals versus small breakfast meals and large&#xD;
      evening meals) on body weight, and physiological and behavioral mechanisms regulating energy&#xD;
      balance.&#xD;
&#xD;
      Participants will undergo 2 x 4 week energy restriction protocols in a randomized cross over&#xD;
      design; big breakfast (45% of calories in the morning meal, 20% at dinner) and big dinner&#xD;
      (45% of calories in the evening meal, 20% at breakfast). We predict that timing of eating&#xD;
      will influence energy balance, because morning energy expenditure is amplified in comparison&#xD;
      to the evening. This study will allow us to assess whether the increased energy expenditure&#xD;
      in the morning is linked to natural biological circadian rhythm or behavioral adaptions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dietary advice for weight management is broadly based on the assumption that a 'calorie is a&#xD;
      calorie' and it does not matter when calories are consumed across the day. Recent evidence&#xD;
      has challenged this assumption, suggesting that we may utilize calories more efficiently when&#xD;
      consumed in the morning relative to the evening, and this could be used as a beneficial&#xD;
      strategy for weight loss - this is a newly developing field of investigation which merges&#xD;
      circadian biology with nutrition (chrono-nutrition).&#xD;
&#xD;
      Timing of food consumption is a modifiable factor influencing energy balance and body weight&#xD;
      (and thus, disease risk). Previous research has shown that calories ingested at different&#xD;
      times of the day have different effects on energy utilization, leading to differential weight&#xD;
      loss, even at iso-caloric amounts. This study will aim to increase our understanding of the&#xD;
      underlying behavioral and physiological mechanisms associated with differential weight loss&#xD;
      and energy balance when calories are consumed predominantly in the morning versus in the&#xD;
      evening.&#xD;
&#xD;
      This study will be a cross-over study comparing large breakfast versus large evening meals&#xD;
      (percent daily calories split between breakfast, lunch and dinner as 45-35-20&#xD;
      (breakfast-loaded) or 20-35-45 (evening-loaded)) during energy restriction (Fed to measured&#xD;
      RMR) on energy balance, through differences in both physiological and behavioural changes in&#xD;
      energy expenditure and substrate utilization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 24, 2017</start_date>
  <completion_date type="Actual">February 28, 2020</completion_date>
  <primary_completion_date type="Actual">February 28, 2020</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Energy balance</measure>
    <time_frame>Measured up to day 71 of study</time_frame>
    <description>Change in energy balance during each diet protocol (body weight (kg))</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total Daily Energy Expenditure</measure>
    <time_frame>4 x 2 weeks. Throughout weeks 2-5 and 7-10.</time_frame>
    <description>Total energy expenditure measured by DLW for the 4 week BB and BD diet phases</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resting Metabolic Rate (RMR)</measure>
    <time_frame>Baseline,week 1, week 5, week 6, week 10.</time_frame>
    <description>RMR measured with indirect calorimetry (ventilated hood)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thermic effect of food (TEF)</measure>
    <time_frame>Week 1, week 5, week 6, week 10.</time_frame>
    <description>TEF measured with indirect calorimetry (ventilated hood) for 6 hours after a breakfast meal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Volume</measure>
    <time_frame>Week 1, week 5, week 6, week 10.</time_frame>
    <description>Measured with Air Displacement plethysmography (BODPOD),</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bone Mineral Content</measure>
    <time_frame>Week 1, week 5, week 6, week 10.</time_frame>
    <description>Measured with Dual energy x-ray absorptiometry (DEXA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Body Water</measure>
    <time_frame>Week 1, week 5, week 6, week 10.</time_frame>
    <description>Measured with deuterium dilution</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Composition</measure>
    <time_frame>Week 1, week 5, week 6, week 10.</time_frame>
    <description>4 compartment model to assess changes in body composition (Combined from the measures of body weight, body volume, total body water and bone mineral)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastric emptying</measure>
    <time_frame>Week 1, week 5, week 6, week 10.</time_frame>
    <description>Gastric emptying measured using stable isotope, Octanoic acid labelled breath samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist and hip circumference</measure>
    <time_frame>Week 1, week 5, week 6, week 10.</time_frame>
    <description>Change in waist and hip circumferences and waist to hip ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gut appetite hormones</measure>
    <time_frame>Week 1, week 5, week 6, week 10.</time_frame>
    <description>Change in plasma fasting and 2 hr post-meal appetite hormones</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma glucose</measure>
    <time_frame>Week 1, week 5, week 6, week 10.</time_frame>
    <description>Change in plasma fasting and 2 hr post-meal glucose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma insulin</measure>
    <time_frame>Week 1, week 5, week 6, week 10.</time_frame>
    <description>Change in plasma fasting and 2 hr post-meal insulin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood lipids</measure>
    <time_frame>Week 1, week 5, week 6, week 10.</time_frame>
    <description>Change in plasma fasting and 2 hr post-meal blood lipids</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily Subjective Appetite</measure>
    <time_frame>Hourly measures for 3 days in week 1,week 5, week 6, week 10.</time_frame>
    <description>Changes in subjective appetite (hunger, fullness, desire to eat) measured using visual analogue scale questionnaires every waking hour for 3 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postprandial Subjective Appetite</measure>
    <time_frame>Week 1, week 5, week 6, week 10.</time_frame>
    <description>Changes in subjective appetite (hunger, fullness, desire to eat) measured using visual analogue scale questionnaires every 30 minutes for 6 hours after test meals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Faecal sample analysis for gut health</measure>
    <time_frame>Week 1, week 5, week 6, week 10.</time_frame>
    <description>Chronic influence on changes in gut microbiota</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>Measured continuously for 24 hours for 3 days in week 1,week 5, week 6, week 10.</time_frame>
    <description>Change in physical activity levels measured with accelerometer (actigraph)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>24 hour blood glucose</measure>
    <time_frame>Measured continuously for 24 hours for 3 days in week 1,week 5, week 6, week 10.</time_frame>
    <description>Changes in 24 hour blood glucose levels measured with a continuous glucose monitor</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Obesity</condition>
  <condition>Weight Loss</condition>
  <arm_group>
    <arm_group_label>big breakfast (BB) to big dinner (BD)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phase 1: no intervention, habitual diet for 4 days and then 4day maintenance diet Phase 2: consumption of BB energy restriction diets for 4 weeks Phase 3: washout for 1 week, controlled maintenance diet Phase 4: consumption of BD energy restriction diets for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>big dinner (BD) to big breakfast (BB)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phase 1: no intervention, habitual diet for 4 days and then 4day maintenance diet Phase 2: consumption of BD energy restriction diets for 4 weeks Phase 3: washout for 1 week, controlled maintenance diet Phase 4: consumption of BB energy restriction diets for 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Big Breakfast</intervention_name>
    <description>Weight loss diet (Calories fed to measured RMR) with calories distributed predominantly at breakfast (percent daily calories split between breakfast, lunch and dinner as 45-35-20%). The diet will be high protein (30% protein, 35% fat and 35% CHO) with all meals provided.</description>
    <arm_group_label>big breakfast (BB) to big dinner (BD)</arm_group_label>
    <arm_group_label>big dinner (BD) to big breakfast (BB)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Big Dinner</intervention_name>
    <description>Weight loss diet (Calories fed to measured RMR) with calories distributed predominantly at dinner (percent daily calories split between breakfast, lunch and dinner as 20-35-45%). The diet will be high protein (30% protein, 35% fat and 35% CHO) with all meals provided.</description>
    <arm_group_label>big breakfast (BB) to big dinner (BD)</arm_group_label>
    <arm_group_label>big dinner (BD) to big breakfast (BB)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI ranging from 27-42 kg/m2;&#xD;
&#xD;
          -  Those habitually consuming breakfast (at least 5 times a week).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  women who are pregnant, planning to be pregnant or breastfeeding&#xD;
&#xD;
          -  subjects with food allergies which prevent consumption of the study diet.&#xD;
&#xD;
          -  diagnosis of diabetes, hypertension, renal, hepatic, haematological disease, coronary&#xD;
             heart disease, metabolic disease, gastrointestinal disease&#xD;
&#xD;
          -  having given a pint of blood for transfusion purposes within the last month&#xD;
&#xD;
          -  unsuitable veins for blood sampling&#xD;
&#xD;
          -  inability to understand the participant information sheet&#xD;
&#xD;
          -  inability to speak, read and understand the English language&#xD;
&#xD;
          -  those on any prescription medications (other than oral contraceptives) which will&#xD;
             adversely affect the study outcomes (i.e. medications affecting, circadian timing,&#xD;
             sleep or metabolic function).&#xD;
&#xD;
          -  those on any specific diet regimes&#xD;
&#xD;
          -  those on any weight loss programmes (that may be affecting lifestyle, physical&#xD;
             activity and diet).&#xD;
&#xD;
          -  Extremes of chronotypes, sleep patterns and physical activity.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexandra M Johnstone, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Aberdeen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Rowett Institute</name>
      <address>
        <city>Aberdeen</city>
        <zip>AB25 2ZD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>April 3, 2020</last_update_submitted>
  <last_update_submitted_qc>April 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Weight loss</keyword>
  <keyword>Chrono-nutrition</keyword>
  <keyword>Diet</keyword>
  <keyword>energy expenditure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <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/NCT03305237
org study id: 806
secondary id: MR/P012205/1
nct id: NCT03305237
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This weight loss study will investigate the impact of calorie distribution across a day
      (large breakfast meals and smaller evening meals versus small breakfast meals and large
      evening meals) on body weight, and physiological and behavioral mechanisms regulating energy
      balance.

      Participants will undergo 2 x 4 week energy restriction protocols in a randomized cross over
      design; big breakfast (45% of calories in the morning meal, 20% at dinner) and big dinner
      (45% of calories in the evening meal, 20% at breakfast). We predict that timing of eating
      will influence energy balance, because morning energy expenditure is amplified in comparison
      to the evening. This study will allow us to assess whether the increased energy expenditure
      in the morning is linked to natural biological circadian rhythm or behavioral adaptions.
Dietary advice for weight management is broadly based on the assumption that a 'calorie is a
      calorie' and it does not matter when calories are consumed across the day. Recent evidence
      has challenged this assumption, suggesting that we may utilize calories more efficiently when
      consumed in the morning relative to the evening, and this could be used as a beneficial
      strategy for weight loss - this is a newly developing field of investigation which merges
      circadian biology with nutrition (chrono-nutrition).

      Timing of food consumption is a modifiable factor influencing energy balance and body weight
      (and thus, disease risk). Previous research has shown that calories ingested at different
      times of the day have different effects on energy utilization, leading to differential weight
      loss, even at iso-caloric amounts. This study will aim to increase our understanding of the
      underlying behavioral and physiological mechanisms associated with differential weight loss
      and energy balance when calories are consumed predominantly in the morning versus in the
      evening.

      This study will be a cross-over study comparing large breakfast versus large evening meals
      (percent daily calories split between breakfast, lunch and dinner as 45-35-20
      (breakfast-loaded) or 20-35-45 (evening-loaded)) during energy restriction (Fed to measured
      RMR) on energy balance, through differences in both physiological and behavioural changes in
      energy expenditure and substrate utilization.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Energy balance
time frame: Measured up to day 71 of study
description: Change in energy balance during each diet protocol (body weight (kg))
measure: Total Daily Energy Expenditure
time frame: 4 x 2 weeks. Throughout weeks 2-5 and 7-10.
description: Total energy expenditure measured by DLW for the 4 week BB and BD diet phases
measure: Resting Metabolic Rate (RMR)
time frame: Baseline,week 1, week 5, week 6, week 10.
description: RMR measured with indirect calorimetry (ventilated hood)
measure: Thermic effect of food (TEF)
time frame: Week 1, week 5, week 6, week 10.
description: TEF measured with indirect calorimetry (ventilated hood) for 6 hours after a breakfast meal
measure: Body Volume
time frame: Week 1, week 5, week 6, week 10.
description: Measured with Air Displacement plethysmography (BODPOD),
measure: Bone Mineral Content
time frame: Week 1, week 5, week 6, week 10.
description: Measured with Dual energy x-ray absorptiometry (DEXA)
measure: Total Body Water
time frame: Week 1, week 5, week 6, week 10.
description: Measured with deuterium dilution
measure: Body Composition
time frame: Week 1, week 5, week 6, week 10.
description: 4 compartment model to assess changes in body composition (Combined from the measures of body weight, body volume, total body water and bone mineral)
measure: Gastric emptying
time frame: Week 1, week 5, week 6, week 10.
description: Gastric emptying measured using stable isotope, Octanoic acid labelled breath samples.
measure: Waist and hip circumference
time frame: Week 1, week 5, week 6, week 10.
description: Change in waist and hip circumferences and waist to hip ratio
measure: Gut appetite hormones
time frame: Week 1, week 5, week 6, week 10.
description: Change in plasma fasting and 2 hr post-meal appetite hormones
measure: Plasma glucose
time frame: Week 1, week 5, week 6, week 10.
description: Change in plasma fasting and 2 hr post-meal glucose
measure: Plasma insulin
time frame: Week 1, week 5, week 6, week 10.
description: Change in plasma fasting and 2 hr post-meal insulin
measure: Blood lipids
time frame: Week 1, week 5, week 6, week 10.
description: Change in plasma fasting and 2 hr post-meal blood lipids
measure: Daily Subjective Appetite
time frame: Hourly measures for 3 days in week 1,week 5, week 6, week 10.
description: Changes in subjective appetite (hunger, fullness, desire to eat) measured using visual analogue scale questionnaires every waking hour for 3 days.
measure: Postprandial Subjective Appetite
time frame: Week 1, week 5, week 6, week 10.
description: Changes in subjective appetite (hunger, fullness, desire to eat) measured using visual analogue scale questionnaires every 30 minutes for 6 hours after test meals.
measure: Faecal sample analysis for gut health
time frame: Week 1, week 5, week 6, week 10.
description: Chronic influence on changes in gut microbiota
measure: Physical activity
time frame: Measured continuously for 24 hours for 3 days in week 1,week 5, week 6, week 10.
description: Change in physical activity levels measured with accelerometer (actigraph)
measure: 24 hour blood glucose
time frame: Measured continuously for 24 hours for 3 days in week 1,week 5, week 6, week 10.
description: Changes in 24 hour blood glucose levels measured with a continuous glucose monitor
arm group label: big breakfast (BB) to big dinner (BD)
arm group type: Experimental
description: Phase 1: no intervention, habitual diet for 4 days and then 4day maintenance diet Phase 2: consumption of BB energy restriction diets for 4 weeks Phase 3: washout for 1 week, controlled maintenance diet Phase 4: consumption of BD energy restriction diets for 4 weeks
arm group label: big dinner (BD) to big breakfast (BB)
arm group type: Experimental
description: Phase 1: no intervention, habitual diet for 4 days and then 4day maintenance diet Phase 2: consumption of BD energy restriction diets for 4 weeks Phase 3: washout for 1 week, controlled maintenance diet Phase 4: consumption of BB energy restriction diets for 4 weeks
intervention type: Other
intervention name: Big Breakfast
description: Weight loss diet (Calories fed to measured RMR) with calories distributed predominantly at breakfast (percent daily calories split between breakfast, lunch and dinner as 45-35-20%). The diet will be high protein (30% protein, 35% fat and 35% CHO) with all meals provided.
arm group label: big breakfast (BB) to big dinner (BD)
arm group label: big dinner (BD) to big breakfast (BB)
intervention type: Other
intervention name: Big Dinner
description: Weight loss diet (Calories fed to measured RMR) with calories distributed predominantly at dinner (percent daily calories split between breakfast, lunch and dinner as 20-35-45%). The diet will be high protein (30% protein, 35% fat and 35% CHO) with all meals provided.
arm group label: big breakfast (BB) to big dinner (BD)
arm group label: big dinner (BD) to big breakfast (BB)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alexandra M Johnstone, PhD
role: Principal Investigator
affiliation: University of Aberdeen
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Weight Loss
sharing ipd: No