<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/NCT03294642</url>
  </required_header>
  <id_info>
    <org_study_id>18104</org_study_id>
    <nct_id>NCT03294642</nct_id>
  </id_info>
  <brief_title>Potato Ingestion and Time-trial Performance</brief_title>
  <official_title>Ingestion of Potatoes as a Nutritional Strategy to Improve Cycling Time-trial Performance in Endurance Trained Cyclists</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Illinois at Urbana-Champaign</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alliance for Potato Research and Education</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Illinois at Urbana-Champaign</source>
  <oversight_info>
    <has_dmc>Yes</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 research study evaluates the feasibility and appropriateness of potatoes as an ergogenic&#xD;
      aid in comparison to the currently promoted sports gels during a cycling challenge and time&#xD;
      trial. Using a crossover design, trained cyclists will complete three separate cycling&#xD;
      challenges and subsequent time trials in which they will consume either potatoes,&#xD;
      commercially available sports gels, or water only.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The metabolic demands created by endurance activities, which include muscle and liver&#xD;
      glycogen depletion as well as losses in body fluids and electrolytes, are significant&#xD;
      limitations to the performance potential of the athlete. For this reason, a well-supported&#xD;
      recommendation exists for such athletes to consume a carbohydrate formula, in particular, one&#xD;
      containing electrolytes during their activity.&#xD;
&#xD;
      Currently, most commercially available exercise-nutrition products for use in endurance&#xD;
      activities come at relatively high costs to the athlete. Moreover, the ingredients used&#xD;
      within this market vary and could therefore hinder their effectiveness. For example,&#xD;
      Fermentable Oligosaccharides Disaccharides Monosaccharides and Polyols (FODMAPs) potentially&#xD;
      present in common sports foods (i.e. excess fructose) are known to alter gastrointestinal&#xD;
      (GI) function in some individuals. Indeed, 25-70% of endurance athletes experience GI&#xD;
      symptoms during exercise. Given the prevalence of exercise induced GI discomfort in this&#xD;
      population, it is possible that GI symptoms limit the adherence to nutritional&#xD;
      recommendations during exercise. Therefore identification of a targeted nutrition strategy&#xD;
      that maximizes GI effectiveness and dietary adherence is warranted.&#xD;
&#xD;
      An alternative to the commercially available sports foods are whole foods. Specifically,&#xD;
      white potatoes, which have a high GI index, indicates that their carbohydrate content is&#xD;
      readily available. Additionally, potatoes naturally contain potassium, an important&#xD;
      electrolyte. Because of these characteristics, potatoes provide the potential to be a&#xD;
      low-cost alternative, and merit investigation. To this point, we know of no studies that have&#xD;
      explored the effectiveness of white potatoes as an ergogenic aid. Therefore, the purpose of&#xD;
      this study is to examine how capable potatoes are at off-setting the losses in muscle and&#xD;
      liver glycogen and electrolytes compared to the current products available on the market,&#xD;
      i.e. &quot;sports gels.&quot;&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 29, 2017</start_date>
  <completion_date type="Actual">September 29, 2019</completion_date>
  <primary_completion_date type="Actual">September 29, 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time trial performance measured in minutes</measure>
    <time_frame>1 year</time_frame>
    <description>Comparison of time trial performance times between potatoes and sports gel conditions to determine effectiveness of potatoes as an ergogenic aid.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Exercise Performance</condition>
  <arm_group>
    <arm_group_label>Trial 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Water Intervention: In one of the 3 cycling trials, participants will receive only water and no carbohydrate supplementation during the 2 hour cycling challenge.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trial 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Carbohydrate Gel Intervention: In one of the 3 cycling trials, participants will receive carbohydrate supplementation in the form of commercially available gels (15g every 15 minutes) during the 2 hour cycling challenge.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trial 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Potatoes Intervention: In one of the 3 cycling trials, participants will receive carbohydrate supplementation in the form of pureed russet potato (15g every 15 minutes) during the 2 hour cycling challenge.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Potatoes</intervention_name>
    <description>Pureed russet potatoes will be used as a carbohydrate supplement for participants during one of the three cycling challenges.</description>
    <arm_group_label>Trial 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Carbohydrate Gel</intervention_name>
    <description>Commercially available PowerBar PowerGel will be used for the carbohydrate gel condition during one of the three cycling challenges.</description>
    <arm_group_label>Trial 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Water</intervention_name>
    <description>Water will be used as a control during one of the three cycling challenges (participants will not receive any carbohydrate supplementation).</description>
    <arm_group_label>Trial 1</arm_group_label>
    <other_name>Control</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  ≥150 km/wk of cycling mileage&#xD;
&#xD;
          -  ≥6 months of prior training history&#xD;
&#xD;
          -  VO2peak values ≥45 ml/kg/min for females and ≥50 ml/kg/min for males&#xD;
&#xD;
          -  Aged between 20-40 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic Smoking or tobacco use&#xD;
&#xD;
          -  Active cardiovascular disease&#xD;
&#xD;
          -  Diabetes Mellitus or other metabolic disorders&#xD;
&#xD;
          -  Liver kidney, or urinary disease&#xD;
&#xD;
          -  Musculoskeletal/Orthopedic disorders (e.g., osteoarthritis, rheumatoid arthritis,&#xD;
             tendinitis, gout, fibromyalgia, patellar tendinopathy, or chronic low back pain)&#xD;
&#xD;
          -  Neuromuscular disorders&#xD;
&#xD;
          -  hypertension&#xD;
&#xD;
          -  Diagnosed GI tract diseases&#xD;
&#xD;
          -  Heart Disease&#xD;
&#xD;
          -  Bleeding or clotting disorders&#xD;
&#xD;
          -  Neurological disease&#xD;
&#xD;
          -  Epilepsy&#xD;
&#xD;
          -  Respiratory disease&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Contraindications for exercise&#xD;
&#xD;
          -  &lt;150 km/wk of cycling mileage&#xD;
&#xD;
          -  &lt;6 months of prior training history&#xD;
&#xD;
          -  VO2peak values &lt;45 ml/kg/min for females and &lt;50 ml/kg/min for males&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicholas A Burd, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Illinois at Urbana-Champaign, Department of Kinesiology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Freer Hall</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>October 7, 2019</last_update_submitted>
  <last_update_submitted_qc>October 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>exercise</keyword>
  <keyword>FODMAP</keyword>
  <keyword>gastrointestinal</keyword>
  <keyword>endurance</keyword>
  <keyword>cycling</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/NCT03294642
org study id: 18104
nct id: NCT03294642
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This research study evaluates the feasibility and appropriateness of potatoes as an ergogenic
      aid in comparison to the currently promoted sports gels during a cycling challenge and time
      trial. Using a crossover design, trained cyclists will complete three separate cycling
      challenges and subsequent time trials in which they will consume either potatoes,
      commercially available sports gels, or water only.
The metabolic demands created by endurance activities, which include muscle and liver
      glycogen depletion as well as losses in body fluids and electrolytes, are significant
      limitations to the performance potential of the athlete. For this reason, a well-supported
      recommendation exists for such athletes to consume a carbohydrate formula, in particular, one
      containing electrolytes during their activity.

      Currently, most commercially available exercise-nutrition products for use in endurance
      activities come at relatively high costs to the athlete. Moreover, the ingredients used
      within this market vary and could therefore hinder their effectiveness. For example,
      Fermentable Oligosaccharides Disaccharides Monosaccharides and Polyols (FODMAPs) potentially
      present in common sports foods (i.e. excess fructose) are known to alter gastrointestinal
      (GI) function in some individuals. Indeed, 25-70% of endurance athletes experience GI
      symptoms during exercise. Given the prevalence of exercise induced GI discomfort in this
      population, it is possible that GI symptoms limit the adherence to nutritional
      recommendations during exercise. Therefore identification of a targeted nutrition strategy
      that maximizes GI effectiveness and dietary adherence is warranted.

      An alternative to the commercially available sports foods are whole foods. Specifically,
      white potatoes, which have a high GI index, indicates that their carbohydrate content is
      readily available. Additionally, potatoes naturally contain potassium, an important
      electrolyte. Because of these characteristics, potatoes provide the potential to be a
      low-cost alternative, and merit investigation. To this point, we know of no studies that have
      explored the effectiveness of white potatoes as an ergogenic aid. Therefore, the purpose of
      this study is to examine how capable potatoes are at off-setting the losses in muscle and
      liver glycogen and electrolytes compared to the current products available on the market,
      i.e. "sports gels."
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Time trial performance measured in minutes
time frame: 1 year
description: Comparison of time trial performance times between potatoes and sports gel conditions to determine effectiveness of potatoes as an ergogenic aid.
arm group label: Trial 1
arm group type: Experimental
description: Water Intervention: In one of the 3 cycling trials, participants will receive only water and no carbohydrate supplementation during the 2 hour cycling challenge.
arm group label: Trial 2
arm group type: Experimental
description: Carbohydrate Gel Intervention: In one of the 3 cycling trials, participants will receive carbohydrate supplementation in the form of commercially available gels (15g every 15 minutes) during the 2 hour cycling challenge.
arm group label: Trial 3
arm group type: Experimental
description: Potatoes Intervention: In one of the 3 cycling trials, participants will receive carbohydrate supplementation in the form of pureed russet potato (15g every 15 minutes) during the 2 hour cycling challenge.
intervention type: Dietary Supplement
intervention name: Potatoes
description: Pureed russet potatoes will be used as a carbohydrate supplement for participants during one of the three cycling challenges.
arm group label: Trial 3
intervention type: Dietary Supplement
intervention name: Carbohydrate Gel
description: Commercially available PowerBar PowerGel will be used for the carbohydrate gel condition during one of the three cycling challenges.
arm group label: Trial 2
intervention type: Dietary Supplement
intervention name: Water
description: Water will be used as a control during one of the three cycling challenges (participants will not receive any carbohydrate supplementation).
arm group label: Trial 1
other name: Control
criteria: 
gender: All
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nicholas A Burd, Ph.D
role: Principal Investigator
affiliation: University of Illinois at Urbana-Champaign, Department of Kinesiology
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No