<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/NCT03239717</url>
  </required_header>
  <id_info>
    <org_study_id>2017-0099</org_study_id>
    <secondary_id>Protocol Version 2/23/2021</secondary_id>
    <secondary_id>A534245</secondary_id>
    <secondary_id>SMPH\MEDICINE\ENDOCRINOL</secondary_id>
    <nct_id>NCT03239717</nct_id>
  </id_info>
  <brief_title>The Metabolic Response to Reduced Branched-chain Amino Acids in Humans</brief_title>
  <acronym>SOAR</acronym>
  <official_title>The Metabolic Response to Reduced Branched-chain Amino Acids in Humans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Wisconsin, Madison</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>
      Branched-chain amino acids (BCAAs) are essential nutrients that the body obtains from&#xD;
      proteins found in food, especially meat, diary products, and legumes. Data from rodent&#xD;
      studies suggest that reduction of dietary BCAAs will promote fat mass loss and improved&#xD;
      control of blood glucose. The purpose of this study is to test if reduction of dietary BCAAs&#xD;
      without reducing calorie intake will lead to similar metabolic benefits in humans. Here the&#xD;
      investigators test the feasibility of reducing dietary BCAAs using BCAA-free meal replacement&#xD;
      beverages for two months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study, which will be completed over three months, involves replacing two meals a day&#xD;
      with meal replacement beverages for two months, with a one month follow-up visit. These&#xD;
      beverages will be made up by subjects using either a complete protein powder or BCAD2, a&#xD;
      BCAA-free medical food. Participants will complete food diaries at baseline and at one month&#xD;
      intervals during the study, and compliance will be assessed via food diaries, weekly&#xD;
      telephone contact, and measuring returned food powder.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 28, 2017</start_date>
  <completion_date type="Actual">July 16, 2021</completion_date>
  <primary_completion_date type="Actual">July 16, 2021</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>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction of BCAA intake</measure>
    <time_frame>3 months</time_frame>
    <description>The principle outcome of this study is to determine if replacing 2/3rds of the subjects baseline protein intake with BCAA-free meal replacement beverages are a feasible method of selectively reducing BCAA consumption. Our principle outcome is to reduce BCAA intake by 50% or more in the Experimental Arm (BCAD2) of the study as compared to baseline intake.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>3 months</time_frame>
    <description>Weight in kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat mass</measure>
    <time_frame>3 months</time_frame>
    <description>Fat mass in kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI</measure>
    <time_frame>3 months</time_frame>
    <description>Weight in kg and height in meters will be combined to report BMI in kg/m^2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resting metabolic rate</measure>
    <time_frame>3 months</time_frame>
    <description>Resting metabolic rate in kcal/hour</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting blood glucose</measure>
    <time_frame>3 months</time_frame>
    <description>Fasting blood glucose in mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin</measure>
    <time_frame>3 months</time_frame>
    <description>Insulin in ng/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1c</measure>
    <time_frame>3 months</time_frame>
    <description>HbA1c in mmol/mol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose tolerance</measure>
    <time_frame>3 months</time_frame>
    <description>Area under the curve in mg/dL/min</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Diabetes</condition>
  <condition>Obesity</condition>
  <condition>Insulin Resistance</condition>
  <arm_group>
    <arm_group_label>Whey protein powder</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants in the Placebo Arm will replace two-thirds of participants dietary protein intake with meal replacement beverages utilizing a complete protein powder.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the Experimental Arm will replace two-thirds of participants dietary protein intake with BCAD2 (Mead Johnson), a BCAA-free medical food.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Whey protein powder</intervention_name>
    <description>Participants in the Control Arm will replace two-thirds of participants dietary protein intake with a commercially available whey protein powder.</description>
    <arm_group_label>Whey protein powder</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>BCAD2</intervention_name>
    <description>Participants in the Experimental Arm will replace two-thirds of participants dietary protein intake with BCAD2 (Mead Johnson), a BCAA-free medical food.</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male between the age of 35 - 65&#xD;
&#xD;
          2. BMI between 28 - 35 (mildly obese/overweight)&#xD;
&#xD;
          3. Fasting glucose level of 101 - 125 mg/dL&#xD;
&#xD;
          4. Able and willing to give written informed consent&#xD;
&#xD;
          5. Stable weight (within 5 lbs. for at least 3 months)&#xD;
&#xD;
          6. Not taking (or willing to cease taking) over the counter vitamin/mineral supplements&#xD;
&#xD;
          7. Not planning to begin an exercise or diet program&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Female&#xD;
&#xD;
          2. Outside required age range of 35 - 65&#xD;
&#xD;
          3. BMI not within range of 28 - 35&#xD;
&#xD;
          4. Fasting glucose not within range of 101 - 125 mg/dL&#xD;
&#xD;
          5. Use of prescription medications for diabetes or weight-loss&#xD;
&#xD;
          6. Use of and unwillingness to discontinue over the counter supplements (e.g. cinnamon,&#xD;
             chromium, protein powders) or weight loss beverage or meal plans (e.g. SlimFast or&#xD;
             Jenny Craig).&#xD;
&#xD;
          7. Low baseline albumin or pre-albumin levels (below normal reference range)&#xD;
&#xD;
          8. Significant anemia (Hemoglobin &lt; 11 g/dL)&#xD;
&#xD;
          9. Known bleeding disorder or platelet dysfunction&#xD;
&#xD;
         10. Already eating a low protein diet (less than 14% total caloric intake from protein),&#xD;
             as calculated from food diaries provided by subjects&#xD;
&#xD;
         11. Participating in intensive exercise training program (high to moderate intensity&#xD;
             exercise greater than 210 minutes per week) or planning to start new exercise program&#xD;
             during study period.&#xD;
&#xD;
         12. Significant co-morbidities (including kidney disease, liver disease, GI disease,&#xD;
             cardiovascular disease, respiratory disease, malnutrition, substance abuse,&#xD;
             psychiatric disease, or a diagnosed eating disorder).&#xD;
&#xD;
         13. Planned smoking cessation or attempt at smoking cessation during study period&#xD;
&#xD;
         14. Inability to tolerate meal replacement beverages due to palatability&#xD;
&#xD;
         15. Recent weight loss (&gt; 5 lbs within 3 months).&#xD;
&#xD;
         16. Bariatric surgery, gastric banding or liposuction&#xD;
&#xD;
         17. Current or past (within 1 year) use of illicit drugs&#xD;
&#xD;
         18. Claustrophobia&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dudley W Lamming, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UW-Madison</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dawn B Davis, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UW-Madison</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Wisconsin-Madison School of Medicine and Public Health</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53726</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Fontana L, Cummings NE, Arriola Apelo SI, Neuman JC, Kasza I, Schmidt BA, Cava E, Spelta F, Tosti V, Syed FA, Baar EL, Veronese N, Cottrell SE, Fenske RJ, Bertozzi B, Brar HK, Pietka T, Bullock AD, Figenshau RS, Andriole GL, Merrins MJ, Alexander CM, Kimple ME, Lamming DW. Decreased Consumption of Branched-Chain Amino Acids Improves Metabolic Health. Cell Rep. 2016 Jul 12;16(2):520-530. doi: 10.1016/j.celrep.2016.05.092. Epub 2016 Jun 23.</citation>
    <PMID>27346343</PMID>
  </reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>May 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>July 28, 2021</last_update_submitted>
  <last_update_submitted_qc>July 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2021</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>Insulin Resistance</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/NCT03239717
org study id: 2017-0099
secondary id: Protocol Version 2/23/2021
secondary id: A534245
secondary id: SMPH\MEDICINE\ENDOCRINOL
nct id: NCT03239717
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Branched-chain amino acids (BCAAs) are essential nutrients that the body obtains from
      proteins found in food, especially meat, diary products, and legumes. Data from rodent
      studies suggest that reduction of dietary BCAAs will promote fat mass loss and improved
      control of blood glucose. The purpose of this study is to test if reduction of dietary BCAAs
      without reducing calorie intake will lead to similar metabolic benefits in humans. Here the
      investigators test the feasibility of reducing dietary BCAAs using BCAA-free meal replacement
      beverages for two months.
This study, which will be completed over three months, involves replacing two meals a day
      with meal replacement beverages for two months, with a one month follow-up visit. These
      beverages will be made up by subjects using either a complete protein powder or BCAD2, a
      BCAA-free medical food. Participants will complete food diaries at baseline and at one month
      intervals during the study, and compliance will be assessed via food diaries, weekly
      telephone contact, and measuring returned food powder.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Reduction of BCAA intake
time frame: 3 months
description: The principle outcome of this study is to determine if replacing 2/3rds of the subjects baseline protein intake with BCAA-free meal replacement beverages are a feasible method of selectively reducing BCAA consumption. Our principle outcome is to reduce BCAA intake by 50% or more in the Experimental Arm (BCAD2) of the study as compared to baseline intake.
measure: Weight
time frame: 3 months
description: Weight in kg
measure: Fat mass
time frame: 3 months
description: Fat mass in kg
measure: BMI
time frame: 3 months
description: Weight in kg and height in meters will be combined to report BMI in kg/m^2
measure: Resting metabolic rate
time frame: 3 months
description: Resting metabolic rate in kcal/hour
measure: Fasting blood glucose
time frame: 3 months
description: Fasting blood glucose in mg/dL
measure: Insulin
time frame: 3 months
description: Insulin in ng/dL
measure: HbA1c
time frame: 3 months
description: HbA1c in mmol/mol
measure: Glucose tolerance
time frame: 3 months
description: Area under the curve in mg/dL/min
arm group label: Whey protein powder
arm group type: Placebo Comparator
description: Participants in the Placebo Arm will replace two-thirds of participants dietary protein intake with meal replacement beverages utilizing a complete protein powder.
arm group label: Experimental
arm group type: Experimental
description: Participants in the Experimental Arm will replace two-thirds of participants dietary protein intake with BCAD2 (Mead Johnson), a BCAA-free medical food.
intervention type: Other
intervention name: Whey protein powder
description: Participants in the Control Arm will replace two-thirds of participants dietary protein intake with a commercially available whey protein powder.
arm group label: Whey protein powder
intervention type: Other
intervention name: BCAD2
description: Participants in the Experimental Arm will replace two-thirds of participants dietary protein intake with BCAD2 (Mead Johnson), a BCAA-free medical food.
arm group label: Experimental
criteria: 
gender: Male
minimum age: 35 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dudley W Lamming, PhD
role: Principal Investigator
affiliation: UW-Madison
last name: Dawn B Davis, MD, PhD
role: Principal Investigator
affiliation: UW-Madison
facility: 
country: United States
citation: Fontana L, Cummings NE, Arriola Apelo SI, Neuman JC, Kasza I, Schmidt BA, Cava E, Spelta F, Tosti V, Syed FA, Baar EL, Veronese N, Cottrell SE, Fenske RJ, Bertozzi B, Brar HK, Pietka T, Bullock AD, Figenshau RS, Andriole GL, Merrins MJ, Alexander CM, Kimple ME, Lamming DW. Decreased Consumption of Branched-Chain Amino Acids Improves Metabolic Health. Cell Rep. 2016 Jul 12;16(2):520-530. doi: 10.1016/j.celrep.2016.05.092. Epub 2016 Jun 23.
PMID: 27346343
responsible party type: Sponsor
mesh term: Insulin Resistance
sharing ipd: No