<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/NCT01711008</url>
  </required_header>
  <id_info>
    <org_study_id>29W5</org_study_id>
    <nct_id>NCT01711008</nct_id>
  </id_info>
  <brief_title>The Effect of Breakfast Size Prior to Morning Exercise on Cognition, Mood and Appetite in Habitually Active Women</brief_title>
  <official_title>The Effect of Breakfast Size Prior to Morning Exercise on Cognition, Mood and Appetite Later in the Day in Habitually Active Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northumbria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northumbria University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Both regular exercise and breakfast consumption have well known health benefits. Consuming&#xD;
      breakfast prior to morning exercise may influence appetite, mood and cognitive function later&#xD;
      in the day. The purpose of this study is to test whether the amount of food consumed at&#xD;
      breakfast prior to exercise influences these parameters in active women.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cognitive function change from baseline scores</measure>
    <time_frame>Assessed hourly until 4.5 hours and at 6.5 and 10.5 hours</time_frame>
    <description>Participants will complete 4 cognitive tasks (Four Choice Reaction Time, NBack, Stroop and RVIP) measuring reaction time, short-term memory, speed of processing and attention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mood change from baseline scores</measure>
    <time_frame>Assessed hourly until 4.5 hours and at 6.5 and 10.5 hours</time_frame>
    <description>Mood will be assessed using Visual Analogue Scales (VAS) immediately before and after each set of cognitive tasks.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Appetite change from baseline scores</measure>
    <time_frame>Assessed hourly until 4.5 hours and at 6.5 and 10.5 hours</time_frame>
    <description>Appetite will be assessed using Visual Analogue Scales (VAS) immediately before each set of cognitive tasks.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Alteration of Cognitive Function</condition>
  <arm_group>
    <arm_group_label>No Breakfast</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Water only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>20g Cereal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20g Kelloggs Special K cereal with 83ml semi-skimmed milk</description>
  </arm_group>
  <arm_group>
    <arm_group_label>40g Cereal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>40g Kelloggs Special K cereal with 166ml semi-skimmed milk</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Cereal</intervention_name>
    <arm_group_label>20g Cereal</arm_group_label>
    <arm_group_label>40g Cereal</arm_group_label>
    <other_name>Breakfast cereal</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>No breakfast</intervention_name>
    <arm_group_label>No Breakfast</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be habitually active (exercising for least 30 minutes, 3 times per week for at&#xD;
             least the previous 6 months)&#xD;
&#xD;
          -  Must have a normal exercise routine includes a minimum of 1 morning exercise session&#xD;
             (which takes place between 6am-11am) each week&#xD;
&#xD;
          -  Must run on a regular basis (at least once per week) and be able to run at a moderate&#xD;
             pace for 30 minutes non-stop on a treadmill&#xD;
&#xD;
          -  Must consume breakfast on most days of the week, usually consume breakfast before&#xD;
             undertaking a morning exercise session and be comfortable consuming a bowl of cereal&#xD;
             45mins before running&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  English not first language&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Previous or current eating disorders, metabolic disorders, gastric problems or any&#xD;
             contraindications of exercise.&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  The habitual use of some prescription or over the counter medications (excluding&#xD;
             contraception) or herbal/dietary supplements (please ask the researcher)&#xD;
&#xD;
          -  A history of or current learning difficulties, ADHD or dyslexia&#xD;
&#xD;
          -  Daily use of an inhaler to control asthma&#xD;
&#xD;
          -  Allergies or intolerances to any of the foods provided in the study (Special K cereal,&#xD;
             semi-skimmed milk, pasta, tomato sauce, cheese, olive oil, rice, custard)&#xD;
      </textblock>
    </criteria>
    <gender>Female</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>Rachel Veasey</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northumbria University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brain, Performance and Nutrition Research Centre, Northumbria Univerity</name>
      <address>
        <city>Newcastle upon Tyne</city>
        <state>Tyne and Wear</state>
        <zip>NE19ST</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2013</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <last_update_submitted>April 30, 2013</last_update_submitted>
  <last_update_submitted_qc>April 30, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 1, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northumbria University</investigator_affiliation>
    <investigator_full_name>Rachel Veasey</investigator_full_name>
    <investigator_title>MSc</investigator_title>
  </responsible_party>
  <keyword>Breakfast size</keyword>
  <keyword>Exercise</keyword>
  <keyword>Cognitive performance</keyword>
  <keyword>Mood</keyword>
  <keyword>Appetite</keyword>
  <keyword>Active women</keyword>
  <!-- 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/NCT01711008
org study id: 29W5
nct id: NCT01711008
lead sponsor: 
has dmc: No
Both regular exercise and breakfast consumption have well known health benefits. Consuming
      breakfast prior to morning exercise may influence appetite, mood and cognitive function later
      in the day. The purpose of this study is to test whether the amount of food consumed at
      breakfast prior to exercise influences these parameters in active women.
allocation: Randomized
intervention model: Crossover Assignment
masking: None (Open Label)
measure: Cognitive function change from baseline scores
time frame: Assessed hourly until 4.5 hours and at 6.5 and 10.5 hours
description: Participants will complete 4 cognitive tasks (Four Choice Reaction Time, NBack, Stroop and RVIP) measuring reaction time, short-term memory, speed of processing and attention.
measure: Mood change from baseline scores
time frame: Assessed hourly until 4.5 hours and at 6.5 and 10.5 hours
description: Mood will be assessed using Visual Analogue Scales (VAS) immediately before and after each set of cognitive tasks.
measure: Appetite change from baseline scores
time frame: Assessed hourly until 4.5 hours and at 6.5 and 10.5 hours
description: Appetite will be assessed using Visual Analogue Scales (VAS) immediately before each set of cognitive tasks.
arm group label: No Breakfast
arm group type: Placebo Comparator
description: Water only
arm group label: 20g Cereal
arm group type: Active Comparator
description: 20g Kelloggs Special K cereal with 83ml semi-skimmed milk
arm group label: 40g Cereal
arm group type: Active Comparator
description: 40g Kelloggs Special K cereal with 166ml semi-skimmed milk
intervention type: Dietary Supplement
intervention name: Cereal
arm group label: 20g Cereal
arm group label: 40g Cereal
other name: Breakfast cereal
intervention type: Dietary Supplement
intervention name: No breakfast
arm group label: No Breakfast
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rachel Veasey
role: Principal Investigator
affiliation: Northumbria University
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Northumbria University
investigator full name: Rachel Veasey
investigator title: MSc