<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/NCT03231514</url>
  </required_header>
  <id_info>
    <org_study_id>19151</org_study_id>
    <nct_id>NCT03231514</nct_id>
  </id_info>
  <brief_title>Determining the Ergogenic Effects of Carb10™ Supplementation on Carbohydrate-Rich and Carbohydrate-Restricted Diets</brief_title>
  <official_title>Determining the Ergogenic Effects of Carb10™ Supplementation on Carbohydrate-Rich and Carbohydrate-Restricted Diets</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Texas Woman's University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Compound Solutions Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Texas Woman's 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>
      The study will examine the performance and body composition effects of ketogenic vs&#xD;
      carbohydrate-based diets, determine the carbohydrate tolerance (&quot;carbohydrate threshold&quot;) for&#xD;
      active individuals on a ketogenic diet, and then, reexamine the performance and body&#xD;
      composition effects when the diets are modified with supplemental carbohydrate up to the&#xD;
      newly defined &quot;ketogenic threshold.&quot;&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be recruited from TWU and the Denton area and grouped in a semi-randomized&#xD;
      fashion that considers dietary preferences. They will then undergo baseline testing, begin&#xD;
      the diet and training interventions, followed by post-testing (phase 1) and a carbohydrate&#xD;
      titration period in the ketogenic diet group (phase 2). In the following academic semester,&#xD;
      the training intervention will be repeated with an adjusted dietary carbohydrate level,&#xD;
      delivered as a pre-workout supplement, corresponding to Phase 2 (Phase 3).&#xD;
&#xD;
      Phase 1 will consist of diets at an energy level estimated by the Mifflin St. Jeor equation&#xD;
      adjusted by 1.625 for exercise. The exercise intervention will be a supervised, periodized&#xD;
      (daily undulating), 9-week concurrent resistance (3 days/week) and cardiovascular (2&#xD;
      days/week) exercise program designed to improve body composition and performance variables.&#xD;
      During phase 2, the ketogenic diet participants will continue exercising with the same&#xD;
      program while consuming incrementally greater quantities of carbohydrate pre-workout until&#xD;
      the state of ketosis is lost. Phase 3 will be identical to Phase 1, but diets will be&#xD;
      modified to include more carbohydrate. As of completing Phase 2, this amount has been&#xD;
      determined to be 20g of Carb10 (pea starch).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Semi-randomized, parallel-group, single-blind diet and exercise intervention</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants are blinded to the pre-workout drink content.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Body Composition</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>Will be measured as fat and lean soft tissue mass in kg by dual x-ray absorptiometry (DXA)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Anaerobic Cardiovascular Performance</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>Will be measured as peak and average power output in Watts during a repeated Wingate sprint test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Body Composition</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>In addition to DXA, body composition will be verified using bioelectric impedance (BIS) estimations of fat-free and fat mass in kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Water</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>BIS determined total, intra-, and extra-cellular fluid in Liters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cross-sectional Area</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>B-mode ultrasound determined cross-sectional area of the rectus femoris in cm squared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Muscle Thickness</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>B-mode ultrasound determined combined thickness of the vastus lateralis and vastus medius in cm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Aerobic Performance</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>measured as a 5km time trial with a 250m hill segment (8% grade) at 1km and 4km on a treadmill</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Vertical Jump Height</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>measured using vertec</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Vertical Jump Power</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>measured using linear force transducer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Vertical Jump Velocity</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>measured using linear force transducer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Vertical Jump Force</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>measured using linear force transducer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Strength</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>measured as 1 repetition maximum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Insulin</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>measured using clinical analyzer pmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HDL</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>measured using clinical analyzer mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in LDL</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>measured using clinical analyzer mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Triglycerides</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>measured using clinical analyzer mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Aspartate Amino Transferase</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>measured using clinical analyzer U/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Alanine amino Transferase</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>measured using clinical analyzer U/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in HbA1C</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>measured using clinical analyzer mmol/mol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Creatine Kinase</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>measured using clinical analyzer U/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Total Testosterone</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>measured using ELISA ng/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Free Testosterone</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>measured using ELISA ng/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Total Estrogens</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>measured using ELISA pg/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Triiodothyronine</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>measured using ELISA ng/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Thyroxine</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>measured using ELISA ng/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Thyroid Stimulating Hormone</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>measured using ELISA mu/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in C-reactive Protein</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>measured using ELISA mg/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Dehydroepiandrosterone sulfate</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>measured using ELISA ug/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Sex hormone Binding Globulin</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>measured using ELISA nmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Cortisol</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>measured using ELISA ug/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Whole Blood Betahydroxybutyrate</measure>
    <time_frame>about every 3-7 days</time_frame>
    <description>measured using handheld meter mmol/L</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Ketogenic Dieting</condition>
  <arm_group>
    <arm_group_label>Carbohydrate Diet &amp; Placebo &amp; Exercise</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This group receives the carbohydrate-based diet and flavored placebo pre-workout drink. All participate in the exercise intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Carbohydrate Diet &amp; Carbohydrate Supplement(Carb10) &amp; Exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group receives the carbohydrate-based diet and supplemental carbohydrate. Will be compared to Carbohydrate &amp; Placebo for effects of supplement. All participate in the exercise intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ketogenic Diet &amp; Placebo &amp; Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group receives the ketogenic diet and flavored placebo. It is both an experimental (vs. carbohydrate diet &amp; placebo) and placebo control group (vs. ketogenic &amp; supplement). All participate in the exercise intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ketogenic Diet &amp; Carbohydrate Supplement (Carb10) &amp; Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group receives the ketogenic diet and supplemental carbohydrate. All participate in the exercise intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Carbohydrate Supplement (Carb10)</intervention_name>
    <description>2 of 4 arms will be supplemented with carbohydrate pre-workout (Carb10, Compound Solutions, Carlsbad, CA)</description>
    <arm_group_label>Carbohydrate Diet &amp; Carbohydrate Supplement(Carb10) &amp; Exercise</arm_group_label>
    <arm_group_label>Ketogenic Diet &amp; Carbohydrate Supplement (Carb10) &amp; Exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diet</intervention_name>
    <description>2 groups will be on a carbohydrate-based diet (% energy from carbohydrate:fat:protein, 53:24:23) and 2 groups will be on a ketogenic diet (72:5:23)</description>
    <arm_group_label>Ketogenic Diet &amp; Carbohydrate Supplement (Carb10) &amp; Exercise</arm_group_label>
    <arm_group_label>Ketogenic Diet &amp; Placebo &amp; Exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>All groups will participate in a standardized exercise intervention.</description>
    <arm_group_label>Carbohydrate Diet &amp; Carbohydrate Supplement(Carb10) &amp; Exercise</arm_group_label>
    <arm_group_label>Carbohydrate Diet &amp; Placebo &amp; Exercise</arm_group_label>
    <arm_group_label>Ketogenic Diet &amp; Carbohydrate Supplement (Carb10) &amp; Exercise</arm_group_label>
    <arm_group_label>Ketogenic Diet &amp; Placebo &amp; Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  consistently exercising at least 3 days per week for the past 2 years, participating&#xD;
             in both cardiovascular and resistance exercise at least once per week for the past 2&#xD;
             years, reported themselves as healthy, and were willing and able to comply with study&#xD;
             protocols&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  using tobacco of any form, a history of medical events, reporting any supplement or&#xD;
             medication use that may affect study outcomes, regularly consuming &gt; 7 alcoholic&#xD;
             beverages per week, appearing unfit to handle the training program, inability to&#xD;
             complete baseline testing, having a BMI &gt; 35 kg/m2, or becoming &lt; 80% compliant with&#xD;
             training or dietary interventions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jordan Joy, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas Woman's University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Texas Woman's University</name>
      <address>
        <city>Denton</city>
        <state>Texas</state>
        <zip>76204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Volek JS, Freidenreich DJ, Saenz C, Kunces LJ, Creighton BC, Bartley JM, Davitt PM, Munoz CX, Anderson JM, Maresh CM, Lee EC, Schuenke MD, Aerni G, Kraemer WJ, Phinney SD. Metabolic characteristics of keto-adapted ultra-endurance runners. Metabolism. 2016 Mar;65(3):100-10. doi: 10.1016/j.metabol.2015.10.028. Epub 2015 Nov 2.</citation>
    <PMID>26892521</PMID>
  </reference>
  <reference>
    <citation>Wilson JM, Lowery RP, Roberts MD, Sharp MH, Joy JM, Shields KA, Partl JM, Volek JS, D'Agostino DP. Effects of Ketogenic Dieting on Body Composition, Strength, Power, and Hormonal Profiles in Resistance Training Men. J Strength Cond Res. 2020 Dec;34(12):3463-3474. doi: 10.1519/JSC.0000000000001935.</citation>
    <PMID>28399015</PMID>
  </reference>
  <reference>
    <citation>Burke LM, Ross ML, Garvican-Lewis LA, Welvaert M, Heikura IA, Forbes SG, Mirtschin JG, Cato LE, Strobel N, Sharma AP, Hawley JA. Low carbohydrate, high fat diet impairs exercise economy and negates the performance benefit from intensified training in elite race walkers. J Physiol. 2017 May 1;595(9):2785-2807. doi: 10.1113/JP273230. Epub 2017 Feb 14.</citation>
    <PMID>28012184</PMID>
  </reference>
  <reference>
    <citation>Urbain P, Strom L, Morawski L, Wehrle A, Deibert P, Bertz H. Impact of a 6-week non-energy-restricted ketogenic diet on physical fitness, body composition and biochemical parameters in healthy adults. Nutr Metab (Lond). 2017 Feb 20;14:17. doi: 10.1186/s12986-017-0175-5. eCollection 2017.</citation>
    <PMID>28239404</PMID>
  </reference>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>July 12, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>February 16, 2018</last_update_submitted>
  <last_update_submitted_qc>February 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Texas Woman's University</investigator_affiliation>
    <investigator_full_name>Jordan Joy</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>body composition</keyword>
  <keyword>exercise performance</keyword>
  <keyword>keto-adaptation</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/NCT03231514
org study id: 19151
nct id: NCT03231514
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study will examine the performance and body composition effects of ketogenic vs
      carbohydrate-based diets, determine the carbohydrate tolerance ("carbohydrate threshold") for
      active individuals on a ketogenic diet, and then, reexamine the performance and body
      composition effects when the diets are modified with supplemental carbohydrate up to the
      newly defined "ketogenic threshold."
Participants will be recruited from TWU and the Denton area and grouped in a semi-randomized
      fashion that considers dietary preferences. They will then undergo baseline testing, begin
      the diet and training interventions, followed by post-testing (phase 1) and a carbohydrate
      titration period in the ketogenic diet group (phase 2). In the following academic semester,
      the training intervention will be repeated with an adjusted dietary carbohydrate level,
      delivered as a pre-workout supplement, corresponding to Phase 2 (Phase 3).

      Phase 1 will consist of diets at an energy level estimated by the Mifflin St. Jeor equation
      adjusted by 1.625 for exercise. The exercise intervention will be a supervised, periodized
      (daily undulating), 9-week concurrent resistance (3 days/week) and cardiovascular (2
      days/week) exercise program designed to improve body composition and performance variables.
      During phase 2, the ketogenic diet participants will continue exercising with the same
      program while consuming incrementally greater quantities of carbohydrate pre-workout until
      the state of ketosis is lost. Phase 3 will be identical to Phase 1, but diets will be
      modified to include more carbohydrate. As of completing Phase 2, this amount has been
      determined to be 20g of Carb10 (pea starch).
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Semi-randomized, parallel-group, single-blind diet and exercise intervention
primary purpose: Other
masking: Single (Participant)
masking description: Participants are blinded to the pre-workout drink content.
measure: Change in Body Composition
time frame: 0 and 10 weeks
description: Will be measured as fat and lean soft tissue mass in kg by dual x-ray absorptiometry (DXA)
measure: Change in Anaerobic Cardiovascular Performance
time frame: 0 and 10 weeks
description: Will be measured as peak and average power output in Watts during a repeated Wingate sprint test
measure: Change in Body Composition
time frame: 0 and 10 weeks
description: In addition to DXA, body composition will be verified using bioelectric impedance (BIS) estimations of fat-free and fat mass in kg
measure: Change in Body Water
time frame: 0 and 10 weeks
description: BIS determined total, intra-, and extra-cellular fluid in Liters
measure: Change in Cross-sectional Area
time frame: 0 and 10 weeks
description: B-mode ultrasound determined cross-sectional area of the rectus femoris in cm squared
measure: Change in Muscle Thickness
time frame: 0 and 10 weeks
description: B-mode ultrasound determined combined thickness of the vastus lateralis and vastus medius in cm
measure: Change in Aerobic Performance
time frame: 0 and 10 weeks
description: measured as a 5km time trial with a 250m hill segment (8% grade) at 1km and 4km on a treadmill
measure: Change in Vertical Jump Height
time frame: 0 and 10 weeks
description: measured using vertec
measure: Change in Vertical Jump Power
time frame: 0 and 10 weeks
description: measured using linear force transducer
measure: Change in Vertical Jump Velocity
time frame: 0 and 10 weeks
description: measured using linear force transducer
measure: Change in Vertical Jump Force
time frame: 0 and 10 weeks
description: measured using linear force transducer
measure: Change in Strength
time frame: 0 and 10 weeks
description: measured as 1 repetition maximum
measure: Change in Insulin
time frame: 0 and 10 weeks
description: measured using clinical analyzer pmol/L
measure: Change in HDL
time frame: 0 and 10 weeks
description: measured using clinical analyzer mg/dL
measure: Changes in LDL
time frame: 0 and 10 weeks
description: measured using clinical analyzer mg/dL
measure: Changes in Triglycerides
time frame: 0 and 10 weeks
description: measured using clinical analyzer mg/dL
measure: Changes in Aspartate Amino Transferase
time frame: 0 and 10 weeks
description: measured using clinical analyzer U/L
measure: Changes in Alanine amino Transferase
time frame: 0 and 10 weeks
description: measured using clinical analyzer U/L
measure: Changes in HbA1C
time frame: 0 and 10 weeks
description: measured using clinical analyzer mmol/mol
measure: Changes in Creatine Kinase
time frame: 0 and 10 weeks
description: measured using clinical analyzer U/L
measure: Changes in Total Testosterone
time frame: 0 and 10 weeks
description: measured using ELISA ng/dL
measure: Changes in Free Testosterone
time frame: 0 and 10 weeks
description: measured using ELISA ng/dL
measure: Changes in Total Estrogens
time frame: 0 and 10 weeks
description: measured using ELISA pg/mL
measure: Changes in Triiodothyronine
time frame: 0 and 10 weeks
description: measured using ELISA ng/dL
measure: Changes in Thyroxine
time frame: 0 and 10 weeks
description: measured using ELISA ng/dL
measure: Changes in Thyroid Stimulating Hormone
time frame: 0 and 10 weeks
description: measured using ELISA mu/L
measure: changes in C-reactive Protein
time frame: 0 and 10 weeks
description: measured using ELISA mg/L
measure: Changes in Dehydroepiandrosterone sulfate
time frame: 0 and 10 weeks
description: measured using ELISA ug/dL
measure: Changes in Sex hormone Binding Globulin
time frame: 0 and 10 weeks
description: measured using ELISA nmol/L
measure: Changes in Cortisol
time frame: 0 and 10 weeks
description: measured using ELISA ug/dL
measure: Changes in Whole Blood Betahydroxybutyrate
time frame: about every 3-7 days
description: measured using handheld meter mmol/L
arm group label: Carbohydrate Diet & Placebo & Exercise
arm group type: Placebo Comparator
description: This group receives the carbohydrate-based diet and flavored placebo pre-workout drink. All participate in the exercise intervention.
arm group label: Carbohydrate Diet & Carbohydrate Supplement(Carb10) & Exercise
arm group type: Active Comparator
description: This group receives the carbohydrate-based diet and supplemental carbohydrate. Will be compared to Carbohydrate & Placebo for effects of supplement. All participate in the exercise intervention.
arm group label: Ketogenic Diet & Placebo & Exercise
arm group type: Experimental
description: This group receives the ketogenic diet and flavored placebo. It is both an experimental (vs. carbohydrate diet & placebo) and placebo control group (vs. ketogenic & supplement). All participate in the exercise intervention.
arm group label: Ketogenic Diet & Carbohydrate Supplement (Carb10) & Exercise
arm group type: Experimental
description: This group receives the ketogenic diet and supplemental carbohydrate. All participate in the exercise intervention.
intervention type: Dietary Supplement
intervention name: Carbohydrate Supplement (Carb10)
description: 2 of 4 arms will be supplemented with carbohydrate pre-workout (Carb10, Compound Solutions, Carlsbad, CA)
arm group label: Carbohydrate Diet & Carbohydrate Supplement(Carb10) & Exercise
arm group label: Ketogenic Diet & Carbohydrate Supplement (Carb10) & Exercise
intervention type: Other
intervention name: Diet
description: 2 groups will be on a carbohydrate-based diet (% energy from carbohydrate:fat:protein, 53:24:23) and 2 groups will be on a ketogenic diet (72:5:23)
arm group label: Ketogenic Diet & Carbohydrate Supplement (Carb10) & Exercise
arm group label: Ketogenic Diet & Placebo & Exercise
intervention type: Other
intervention name: Exercise
description: All groups will participate in a standardized exercise intervention.
arm group label: Carbohydrate Diet & Carbohydrate Supplement(Carb10) & Exercise
arm group label: Carbohydrate Diet & Placebo & Exercise
arm group label: Ketogenic Diet & Carbohydrate Supplement (Carb10) & Exercise
arm group label: Ketogenic Diet & Placebo & Exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jordan Joy, MS
role: Principal Investigator
affiliation: Texas Woman's University
facility: 
country: United States
citation: Volek JS, Freidenreich DJ, Saenz C, Kunces LJ, Creighton BC, Bartley JM, Davitt PM, Munoz CX, Anderson JM, Maresh CM, Lee EC, Schuenke MD, Aerni G, Kraemer WJ, Phinney SD. Metabolic characteristics of keto-adapted ultra-endurance runners. Metabolism. 2016 Mar;65(3):100-10. doi: 10.1016/j.metabol.2015.10.028. Epub 2015 Nov 2.
PMID: 26892521
citation: Wilson JM, Lowery RP, Roberts MD, Sharp MH, Joy JM, Shields KA, Partl JM, Volek JS, D'Agostino DP. Effects of Ketogenic Dieting on Body Composition, Strength, Power, and Hormonal Profiles in Resistance Training Men. J Strength Cond Res. 2020 Dec;34(12):3463-3474. doi: 10.1519/JSC.0000000000001935.
PMID: 28399015
citation: Burke LM, Ross ML, Garvican-Lewis LA, Welvaert M, Heikura IA, Forbes SG, Mirtschin JG, Cato LE, Strobel N, Sharma AP, Hawley JA. Low carbohydrate, high fat diet impairs exercise economy and negates the performance benefit from intensified training in elite race walkers. J Physiol. 2017 May 1;595(9):2785-2807. doi: 10.1113/JP273230. Epub 2017 Feb 14.
PMID: 28012184
citation: Urbain P, Strom L, Morawski L, Wehrle A, Deibert P, Bertz H. Impact of a 6-week non-energy-restricted ketogenic diet on physical fitness, body composition and biochemical parameters in healthy adults. Nutr Metab (Lond). 2017 Feb 20;14:17. doi: 10.1186/s12986-017-0175-5. eCollection 2017.
PMID: 28239404
responsible party type: Principal Investigator
investigator affiliation: Texas Woman's University
investigator full name: Jordan Joy
investigator title: Principal Investigator
sharing ipd: No