<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/NCT03301948</url>
  </required_header>
  <id_info>
    <org_study_id>34693</org_study_id>
    <nct_id>NCT03301948</nct_id>
  </id_info>
  <brief_title>Effects of a Single Day of Mixed Macronutrient Overfeeding on Energy Balance and Metabolic Responses</brief_title>
  <official_title>The Effects of a Single Day of Mixed Macronutrient Overfeeding on Energy Balance and Metabolic Responses in Healthy Young Men</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Leeds Beckett University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Leeds Beckett University</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>
      Healthy male participants are recruited to observe potentially deleterious changes in&#xD;
      appetite regulation and metabolic control. Participants will be provided with an energy&#xD;
      intake representative of their daily requirements on the first day of one trial and will be&#xD;
      provided with an additional 50% energy intake on the first day of another trial. Outcome&#xD;
      variables will be assessed during the second day of each trial in response to a fixed mixed&#xD;
      macronutrient meal tolerance test.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All testing will take place within the Carnegie Research Institute, Leeds Beckett University.&#xD;
      We will ask all the participants to visit on five occasions for the completion of a&#xD;
      preliminary screening trial and two single-blind counterbalanced experimental trials which&#xD;
      each require the participants to visit the laboratory on two consecutive days. The&#xD;
      experimental trials will be separated by a minimum of one week.&#xD;
&#xD;
      Visit 1: Preliminary Screening:&#xD;
&#xD;
      Before an individual can take part in the experiment, they will need to undergo screening.&#xD;
      Individuals will need to complete a Health Screen Questionnaire. Individuals will be excluded&#xD;
      from the study if they are not currently in good health, have any condition that would alter&#xD;
      their metabolism and/or have had significant medical problems in the past that may affect the&#xD;
      outcomes of the study. Individuals will also be asked to be complete a Three-Factor Eating&#xD;
      Questionnaire, to check that they are not restrained eaters, and an International Physical&#xD;
      Activity Questionnaire (IPAQ) to ensure that all participants are either sedentary or&#xD;
      moderately active. All individuals will be asked to confirm that they have been weight stable&#xD;
      for at least six months before participating and that they are not currently dieting. Height,&#xD;
      body mass and age will be collected to calculate the energy requirements for the main trials&#xD;
      based on the Mifflin equation.&#xD;
&#xD;
      Visits 2, 3, 4 and 5: Experimental Trials:&#xD;
&#xD;
      The participants will be asked to record their food intakes and activity patterns during the&#xD;
      three days prior to the first experimental test using a food and physical activity diary.&#xD;
      They will then be instructed to repeat this diet and activity pattern prior to the second&#xD;
      experimental trial. Participants will be required to arrive at the laboratory for all&#xD;
      experimental trials after an overnight fast of at least 10 hours and having refrained from&#xD;
      any strenuous activity for 48 hours, and alcohol and caffeine consumption in the previous 24&#xD;
      hours. Two hours before arriving at the laboratory on the day of the experimental trials,&#xD;
      participants will be required to ingest 300 mL of water to standardise hydration levels for&#xD;
      the trial.&#xD;
&#xD;
      During Day One of each experimental trial, participants will consume a porridge-based&#xD;
      breakfast, soup- and pasta-based lunch, and rice-based evening meal under laboratory&#xD;
      observation. The meals will contain macronutrient contents representative of current dietary&#xD;
      recommendations of 50% carbohydrate, 15% protein and 35% fat. These meals have been selected&#xD;
      to facilitate manipulation of the energy content, while matching the meals for appearance and&#xD;
      palatability. During one trial, these meals will provide the calculated energy requirement&#xD;
      for each individual based on the Mifflin equation and a physical activity factor of 1.4. The&#xD;
      meals will be covertly manipulated to provide an additional 50% energy intake during the&#xD;
      other trial. The provision of 150% of the estimated energy requirements for participants has&#xD;
      been used in previous research for five day periods but will only be provided for a single&#xD;
      day in the present study. Participants will be required to consume all of the diet during the&#xD;
      standardised phase (i.e. either their daily energy requirements or the 50% overfeed) and will&#xD;
      be blinded to the energy content of the trials. After the consumption of the evening meal&#xD;
      (~6pm), participants will have fulfilled the requirements for day one and will be asked not&#xD;
      to consume any food prior to returning to the laboratory between 7am and 9am the next&#xD;
      morning.&#xD;
&#xD;
      On Day Two of each experimental trial day, participants will arrive at the laboratory after&#xD;
      an overnight fast and an Introcan Safety Cannula will be placed into a vein in the&#xD;
      anticubital space for regular venous blood sampling. Blood samples will be collected in the&#xD;
      fasted state and every 30 min after consumption of a standardised breakfast for a period of&#xD;
      three hours. After the collection of the final blood sample, the cannula will be removed and&#xD;
      participants will be provided with an ad libitum pasta meal (50% carbohydrate, 15% protein,&#xD;
      35% fat) for the assessment of energy intake. Participants will consume ad libitum meals in&#xD;
      isolation to prevent any social influences and will be instructed to eat until 'satisfied'.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">January 11, 2019</completion_date>
  <primary_completion_date type="Actual">January 11, 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>
    <intervention_model_description>Single blind, counterbalanced, crossover trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Appetite perceptions assessed using 100mm visual analogue scales</measure>
    <time_frame>28 hours</time_frame>
    <description>Appetite perceptions using 100mm visual analogue scales</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ad libitum energy intake</measure>
    <time_frame>28 hours</time_frame>
    <description>Ad libitum energy intake using an ad libitum pasta meal</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma acylated ghrelin concentrations</measure>
    <time_frame>28 hours</time_frame>
    <description>Measured using ELISA from venous blood samples</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma peptide YY concentrations</measure>
    <time_frame>28 hours</time_frame>
    <description>Measured using ELISA from venous blood samples</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma GLP-1 concentrations</measure>
    <time_frame>28 hours</time_frame>
    <description>Measured using ELISA from venous blood samples</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Palatability perceptions assessed using 100mm visual analogue scales</measure>
    <time_frame>28 hours</time_frame>
    <description>Palatability of the test meals assessed via 100mm visual analogue scales during the first day of each trial</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blinding assessment</measure>
    <time_frame>One week</time_frame>
    <description>To assess whether the blinding of dietary manipulation of the first day of each trial was successful. This will be assessed via an exit questionnaire which requires qualitative responses regarding any noticeable differences in the foods provided and what aspect of the food the participants thought had been manipulated during the trials.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma insulin concentrations</measure>
    <time_frame>28 hours</time_frame>
    <description>Measured using ELISA from venous blood samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma glucose concentrations</measure>
    <time_frame>28 hours</time_frame>
    <description>Measured using photometric analysis from venous blood samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma triglyceride concentrations</measure>
    <time_frame>28 hours</time_frame>
    <description>Measured using photometric analysis from venous blood samples</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Metabolic Disease</condition>
  <condition>Appetitive Behavior</condition>
  <arm_group>
    <arm_group_label>Overfeed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental trial where participants are provided with 50% higher energy intake than their estimated requirements on the first day of the trial.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Energy Balance</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental trial where participants are provided with an energy intake equal to their estimated requirements on the first day of the trial.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Overfeed</intervention_name>
    <description>Participants consume energy intakes that are 50% higher than their estimated requirements instead of consuming energy intakes equal to their estimated requirements</description>
    <arm_group_label>Overfeed</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Energy Balance</intervention_name>
    <description>Participants consume energy intakes equal to their estimated requirements instead of consuming intakes that are 50% higher than their estimated requirements</description>
    <arm_group_label>Energy Balance</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  weight stable&#xD;
&#xD;
          -  healthy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any personal history of cardiovascular or metabolic disease&#xD;
&#xD;
          -  smokers&#xD;
&#xD;
          -  currently dieting&#xD;
&#xD;
          -  taking any medication known to influence appetite or metabolic outcomes&#xD;
&#xD;
          -  highly active (IPAQ category 3)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kevin Deighton, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Leeds Beckett University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Leeds Beckett University</name>
      <address>
        <city>Leeds</city>
        <zip>LS6 3QS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>January 11, 2019</last_update_submitted>
  <last_update_submitted_qc>January 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Diseases</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/NCT03301948
org study id: 34693
nct id: NCT03301948
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Healthy male participants are recruited to observe potentially deleterious changes in
      appetite regulation and metabolic control. Participants will be provided with an energy
      intake representative of their daily requirements on the first day of one trial and will be
      provided with an additional 50% energy intake on the first day of another trial. Outcome
      variables will be assessed during the second day of each trial in response to a fixed mixed
      macronutrient meal tolerance test.
All testing will take place within the Carnegie Research Institute, Leeds Beckett University.
      We will ask all the participants to visit on five occasions for the completion of a
      preliminary screening trial and two single-blind counterbalanced experimental trials which
      each require the participants to visit the laboratory on two consecutive days. The
      experimental trials will be separated by a minimum of one week.

      Visit 1: Preliminary Screening:

      Before an individual can take part in the experiment, they will need to undergo screening.
      Individuals will need to complete a Health Screen Questionnaire. Individuals will be excluded
      from the study if they are not currently in good health, have any condition that would alter
      their metabolism and/or have had significant medical problems in the past that may affect the
      outcomes of the study. Individuals will also be asked to be complete a Three-Factor Eating
      Questionnaire, to check that they are not restrained eaters, and an International Physical
      Activity Questionnaire (IPAQ) to ensure that all participants are either sedentary or
      moderately active. All individuals will be asked to confirm that they have been weight stable
      for at least six months before participating and that they are not currently dieting. Height,
      body mass and age will be collected to calculate the energy requirements for the main trials
      based on the Mifflin equation.

      Visits 2, 3, 4 and 5: Experimental Trials:

      The participants will be asked to record their food intakes and activity patterns during the
      three days prior to the first experimental test using a food and physical activity diary.
      They will then be instructed to repeat this diet and activity pattern prior to the second
      experimental trial. Participants will be required to arrive at the laboratory for all
      experimental trials after an overnight fast of at least 10 hours and having refrained from
      any strenuous activity for 48 hours, and alcohol and caffeine consumption in the previous 24
      hours. Two hours before arriving at the laboratory on the day of the experimental trials,
      participants will be required to ingest 300 mL of water to standardise hydration levels for
      the trial.

      During Day One of each experimental trial, participants will consume a porridge-based
      breakfast, soup- and pasta-based lunch, and rice-based evening meal under laboratory
      observation. The meals will contain macronutrient contents representative of current dietary
      recommendations of 50% carbohydrate, 15% protein and 35% fat. These meals have been selected
      to facilitate manipulation of the energy content, while matching the meals for appearance and
      palatability. During one trial, these meals will provide the calculated energy requirement
      for each individual based on the Mifflin equation and a physical activity factor of 1.4. The
      meals will be covertly manipulated to provide an additional 50% energy intake during the
      other trial. The provision of 150% of the estimated energy requirements for participants has
      been used in previous research for five day periods but will only be provided for a single
      day in the present study. Participants will be required to consume all of the diet during the
      standardised phase (i.e. either their daily energy requirements or the 50% overfeed) and will
      be blinded to the energy content of the trials. After the consumption of the evening meal
      (~6pm), participants will have fulfilled the requirements for day one and will be asked not
      to consume any food prior to returning to the laboratory between 7am and 9am the next
      morning.

      On Day Two of each experimental trial day, participants will arrive at the laboratory after
      an overnight fast and an Introcan Safety Cannula will be placed into a vein in the
      anticubital space for regular venous blood sampling. Blood samples will be collected in the
      fasted state and every 30 min after consumption of a standardised breakfast for a period of
      three hours. After the collection of the final blood sample, the cannula will be removed and
      participants will be provided with an ad libitum pasta meal (50% carbohydrate, 15% protein,
      35% fat) for the assessment of energy intake. Participants will consume ad libitum meals in
      isolation to prevent any social influences and will be instructed to eat until 'satisfied'.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Single blind, counterbalanced, crossover trial
primary purpose: Prevention
masking: Single (Participant)
measure: Appetite perceptions assessed using 100mm visual analogue scales
time frame: 28 hours
description: Appetite perceptions using 100mm visual analogue scales
measure: Ad libitum energy intake
time frame: 28 hours
description: Ad libitum energy intake using an ad libitum pasta meal
measure: Plasma acylated ghrelin concentrations
time frame: 28 hours
description: Measured using ELISA from venous blood samples
measure: Plasma peptide YY concentrations
time frame: 28 hours
description: Measured using ELISA from venous blood samples
measure: Plasma GLP-1 concentrations
time frame: 28 hours
description: Measured using ELISA from venous blood samples
measure: Palatability perceptions assessed using 100mm visual analogue scales
time frame: 28 hours
description: Palatability of the test meals assessed via 100mm visual analogue scales during the first day of each trial
measure: Blinding assessment
time frame: One week
description: To assess whether the blinding of dietary manipulation of the first day of each trial was successful. This will be assessed via an exit questionnaire which requires qualitative responses regarding any noticeable differences in the foods provided and what aspect of the food the participants thought had been manipulated during the trials.
measure: Plasma insulin concentrations
time frame: 28 hours
description: Measured using ELISA from venous blood samples
measure: Plasma glucose concentrations
time frame: 28 hours
description: Measured using photometric analysis from venous blood samples
measure: Plasma triglyceride concentrations
time frame: 28 hours
description: Measured using photometric analysis from venous blood samples
arm group label: Overfeed
arm group type: Experimental
description: Experimental trial where participants are provided with 50% higher energy intake than their estimated requirements on the first day of the trial.
arm group label: Energy Balance
arm group type: Experimental
description: Experimental trial where participants are provided with an energy intake equal to their estimated requirements on the first day of the trial.
intervention type: Other
intervention name: Overfeed
description: Participants consume energy intakes that are 50% higher than their estimated requirements instead of consuming energy intakes equal to their estimated requirements
arm group label: Overfeed
intervention type: Other
intervention name: Energy Balance
description: Participants consume energy intakes equal to their estimated requirements instead of consuming intakes that are 50% higher than their estimated requirements
arm group label: Energy Balance
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kevin Deighton, PhD
role: Principal Investigator
affiliation: Leeds Beckett University
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Metabolic Diseases
sharing ipd: No