<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/NCT04424537</url>
  </required_header>
  <id_info>
    <org_study_id>2019-0701</org_study_id>
    <secondary_id>A534245</secondary_id>
    <secondary_id>SMPH/MEDICINE/ENDOCRINOL</secondary_id>
    <secondary_id>Protocol Version 3/1/2021</secondary_id>
    <nct_id>NCT04424537</nct_id>
  </id_info>
  <brief_title>SOAR-2: Intervening in Obesity Through Reduction of Dietary Branched Chain Amino Acids</brief_title>
  <acronym>SOAR-2</acronym>
  <official_title>The Metabolic Response to Reduced Branched-chain Amino Acids in Humans 2</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>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>
      One of the primary risk factors for the development of diabetes is obesity. While even&#xD;
      moderate weight loss achieved by dieting can lead to improvements in metabolic health,&#xD;
      reduced-calorie diets are notoriously difficult to sustain. Over the past decade, a number of&#xD;
      groups have shown that low protein diets are associated with metabolic health in both rodents&#xD;
      and humans. In particular, specific building blocks of protein- the branched chain amino&#xD;
      acids (BCAAs) leucine, isoleucine, and valine - are associated with insulin resistance and&#xD;
      diabetes in humans. Blood levels of the BCAAs decrease in humans fed a low protein diet, and&#xD;
      we recently showed that reducing either dietary BCAAs or protein rapidly restored normal body&#xD;
      composition and insulin sensitivity to diet-induced obese mice without reducing calorie&#xD;
      intake.&#xD;
&#xD;
      Current study will test the metabolic role of dietary BCAAs in humans by completing an&#xD;
      adequately powered, randomized controlled study. A total of 132 subjects stratified by gender&#xD;
      will be randomized to one of three groups: 1) Control; 2) Low Protein; 3) Low BCAA. Subjects&#xD;
      in each group will replace two meals a day (and 2/3rds of their baseline dietary protein)&#xD;
      with meal replacement beverages based on either complete protein powder or a BCAA-free&#xD;
      medical food for two months. Primary outcomes will be weight and fasting blood glucose&#xD;
      levels. A number of secondary outcomes will also be assessed and blood, adipose, and fecal&#xD;
      samples will be collected for integrated transcriptional and metabolomic pathway analysis to&#xD;
      identify and compare the metabolic pathways affected by low protein and low BCAA diets.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Withdrawn due to lack of funding&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 2024</start_date>
  <completion_date type="Anticipated">January 2028</completion_date>
  <primary_completion_date type="Anticipated">January 2028</primary_completion_date>
  <phase>Early Phase 1</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>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in weight</measure>
    <time_frame>Baseline, 30 (±7)days, 60(-3 to +7)days, 134(+7) days</time_frame>
    <description>Change in participant weight</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in fasting blood glucose level</measure>
    <time_frame>Baseline, 30 (±7)days, 60(-3 to +7)days, 134(+7) days</time_frame>
    <description>Change in the participant's fasting blood glucose level</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the body composition (adipose mass) as measured by DXA/BIS</measure>
    <time_frame>Baseline, 60(-3 to +7)days</time_frame>
    <description>Dual energy X-ray absorptiometry (DXA) is a standard technique for the determination of body composition. DXA results will be used to calculate fat and lean mass composition. Total body Bioelectrical Impedance Spectroscopy (BIS) is a minimal risk procedure which enhances DXA as it permits the determination of intracellular water.BIS is used to calculate fat and fat-free mass composition. A formula will be used to combine BIS fat-free mass composition and DXA lean mass composition corrected by limb length, which allows a surrogate measurement of muscle mass.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Insulin sensitivity</measure>
    <time_frame>Baseline, 30 (±7)days, 60(-3 to +7)days, 134(+7) days</time_frame>
    <description>Insulin resistance will be measured by HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) method. Insulin resistance reveals the dynamics between the participant's baseline (fasting) blood sugar and the responsive insulin levels.&#xD;
HOMA-IR healthy range: 1.0 (0.5-1.4), less than 1.0 means participant is insulin-sensitive which is optimal, above 1.9 indicates early insulin resistance, above 2.9 indicates significant insulin resistance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fibroblast growth factor 21 (FGF21) levels</measure>
    <time_frame>Baseline, 30 (±7)days, 60(-3 to +7)days</time_frame>
    <description>Fibroblast growth factor 21 (FGF21) is a hormone which regulate insulin signalling in response to nutritional status. Levels of FGF21 induced in response to low protein diet and fasting will be measured using enzyme-linked immunosorbent assay(ELISA) assay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Energy expenditure as measured by resting metabolic rate</measure>
    <time_frame>Baseline, 60(-3 to +7)days</time_frame>
    <description>Energy expenditure will be calculated from resting metabolic rate. Resting metabolic rate is the energy required by the body to perform the most basic functions when body is at rest.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Muscle function as measured by jump maximal height</measure>
    <time_frame>Baseline, 60(-3 to +7)days</time_frame>
    <description>Jumping mechanography will be used to quantify muscle function. Jumping mechanography involves 3 supervised jumps on a force measurement platform. Analysis will be conducted on variables associated with the highest achieved jump height of the 3 trials.&#xD;
In Jumping mechanography, participants perform two-leg maximal countermovement jumps on a force plate (Leonardo, Novotec, Pforzheim, Germany). Maximal jump height(meter) will be calculated using Leonardo software.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Muscle function as measured by jump velocity</measure>
    <time_frame>Baseline, 60(-3 to +7)days</time_frame>
    <description>Jumping mechanography will be used to quantify muscle function. Jumping mechanography involves 3 supervised jumps on a force measurement platform.Analysis will be conducted on variables associated with the highest achieved jump height of the 3 trials.&#xD;
In Jumping mechanography, participants perform two-leg maximal counter-movement jumps on a force plate (Leonardo, Novotec, Pforzheim, Germany). Jump velocity [meter/sec] will be calculated using Leonardo software.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Muscle function as measured by relative power of jump</measure>
    <time_frame>Baseline, 60(-3 to +7)days</time_frame>
    <description>Jumping mechanography will be used to quantify muscle function. Jumping mechanography involves 3 supervised jumps on a force measurement platform.Analysis will be conducted on variables associated with the highest achieved jump height of the 3 trials.&#xD;
In Jumping mechanography, participants perform two-leg maximal countermovement jumps on a force plate (Leonardo, Novotec, Pforzheim, Germany). Relative power of jump [Watt/kg] will be calculated using Leonardo software.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Obesity</condition>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A control group will consume 2 meal replacement beverages(MRBs) made with whey protein&#xD;
The control diet group will be provided with a protein powder which will provide all Amino Acids. Diets will be provided in unmarked containers, to ensure subjects will be blinded to the dietary group assignment.&#xD;
No overall calorie reduction will be implemented for any group.&#xD;
All subjects will receive recipes developed by clinical nutritionist in the study team. Theses recipes will maximize palatability and match energy density across all diets and total protein content.&#xD;
The subjects will be able to use multiple different recipes over the course of the study to prevent taste fatigue and dropout. Each subject is anticipated to replace 2 meals per day with a beverage.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low protein(LP) diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will consume 2 meal replacement beverages(MRBs) containing low protein (goal to reduce total protein by 2/3rds).&#xD;
LP diet group will be provided with a protein powder which will provide all Amino Acids. Diets will be provided in unmarked containers, to ensure subjects will be blinded to the dietary group assignment.&#xD;
No overall calorie reduction will be implemented for any group.&#xD;
All subjects will receive recipes developed by clinical nutritionist in the study team. Theses recipes will maximize palatability and match energy density across all diets and total protein content.&#xD;
The subjects will be able to use multiple different recipes over the course of the study to prevent taste fatigue and dropout. Each subject is anticipated to replace 2 meals per day with a beverage.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low branched-chain amino acids (BCAA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The group on low-BCAA diet will consume 2 meal replacement beverages (MRBs) per day made with BCAD2 (branched chain amino acid) powder (lacking BCAAs).&#xD;
BCAD2 powder(Mead Johnson) is a fortified medical food powder that does not contain the BCAAs isoleucine, leucine, or valine, but provides all other essential and nonessential AAs, carbohydrates, fat, vitamins, and minerals.&#xD;
No overall calorie reduction will be implemented for any group.&#xD;
All subjects will receive recipes developed by clinical nutritionist in the study team. Theses recipes will maximize palatability and match energy density across all diets and total protein content.&#xD;
The subjects will be able to use multiple different recipes over the course of the study to prevent taste fatigue and dropout. Each subject is anticipated to replace 2 meals per day with a beverage.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Control diet</intervention_name>
    <description>Meal replacement beverages made with whey protein</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Low branched-chain amino acids(BCAA) diet</intervention_name>
    <description>meal replacement beverages (MRBs) made with BCAD2 powder (lacking BCAAs).</description>
    <arm_group_label>Low branched-chain amino acids (BCAA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Low protein diet</intervention_name>
    <description>meal replacement beverages(MRBs) containing low protein</description>
    <arm_group_label>Low protein(LP) diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI between 28 - 40 (overweight to obese)&#xD;
&#xD;
          -  Baseline protein intake within normal adult ranges (15.1%-20.8% of calories from&#xD;
             protein)&#xD;
&#xD;
          -  Able and willing to give written informed consent&#xD;
&#xD;
          -  Stable weight (within 5 lbs. for at least 3 months)&#xD;
&#xD;
          -  Not taking (or willing to cease taking) vitamin/mineral supplements, unless prescribed&#xD;
             for a specific medical disorder&#xD;
&#xD;
          -  Not planning to begin a new exercise or diet program&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of prescription medications for diabetes or weight-loss&#xD;
&#xD;
          -  Diabetes - fasting glucose level of greater than 125 mg/dL and/or hemoglobin A1C(&#xD;
             HbA1c or A1C) above 6.4%&#xD;
&#xD;
          -  Use of and unwillingness to discontinue weight loss beverage or meal plans (e.g.&#xD;
             SlimFast or Jenny Craig)&#xD;
&#xD;
          -  Low baseline albumin or pre-albumin levels (below normal reference range)&#xD;
&#xD;
          -  Significant anemia (Hemoglobin &lt; 11 g/dL)&#xD;
&#xD;
          -  Known bleeding disorder or platelet dysfunction&#xD;
&#xD;
          -  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;
          -  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;
          -  Planned smoking cessation or attempt at smoking cessation during study period&#xD;
&#xD;
          -  Inability to tolerate meal replacement beverages due to palatability&#xD;
&#xD;
          -  Bariatric surgery, gastric banding or liposuction&#xD;
&#xD;
          -  Current or past (within 1 year) use of illicit drugs&#xD;
&#xD;
          -  Use of and unwillingness to cease taking vitamin/mineral supplements and other over&#xD;
             the counter supplements (e.g.,cinnamon, protein powders) that are known to affect&#xD;
             weight and/or glucose tolerance, unless prescribed for a specific medical disorder&#xD;
&#xD;
          -  Allergy to racemethionine&#xD;
&#xD;
          -  Lactose intolerance&#xD;
&#xD;
          -  Pregnancy or plans to conceive within 4 months of visit 1&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dawn B Davis, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, 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>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>August 2, 2022</last_update_submitted>
  <last_update_submitted_qc>August 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Calorie restriction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</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/NCT04424537
org study id: 2019-0701
secondary id: A534245
secondary id: SMPH/MEDICINE/ENDOCRINOL
secondary id: Protocol Version 3/1/2021
nct id: NCT04424537
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
One of the primary risk factors for the development of diabetes is obesity. While even
      moderate weight loss achieved by dieting can lead to improvements in metabolic health,
      reduced-calorie diets are notoriously difficult to sustain. Over the past decade, a number of
      groups have shown that low protein diets are associated with metabolic health in both rodents
      and humans. In particular, specific building blocks of protein- the branched chain amino
      acids (BCAAs) leucine, isoleucine, and valine - are associated with insulin resistance and
      diabetes in humans. Blood levels of the BCAAs decrease in humans fed a low protein diet, and
      we recently showed that reducing either dietary BCAAs or protein rapidly restored normal body
      composition and insulin sensitivity to diet-induced obese mice without reducing calorie
      intake.

      Current study will test the metabolic role of dietary BCAAs in humans by completing an
      adequately powered, randomized controlled study. A total of 132 subjects stratified by gender
      will be randomized to one of three groups: 1) Control; 2) Low Protein; 3) Low BCAA. Subjects
      in each group will replace two meals a day (and 2/3rds of their baseline dietary protein)
      with meal replacement beverages based on either complete protein powder or a BCAA-free
      medical food for two months. Primary outcomes will be weight and fasting blood glucose
      levels. A number of secondary outcomes will also be assessed and blood, adipose, and fecal
      samples will be collected for integrated transcriptional and metabolomic pathway analysis to
      identify and compare the metabolic pathways affected by low protein and low BCAA diets.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Change in weight
time frame: Baseline, 30 (±7)days, 60(-3 to +7)days, 134(+7) days
description: Change in participant weight
measure: Change in fasting blood glucose level
time frame: Baseline, 30 (±7)days, 60(-3 to +7)days, 134(+7) days
description: Change in the participant's fasting blood glucose level
measure: Change in the body composition (adipose mass) as measured by DXA/BIS
time frame: Baseline, 60(-3 to +7)days
description: Dual energy X-ray absorptiometry (DXA) is a standard technique for the determination of body composition. DXA results will be used to calculate fat and lean mass composition. Total body Bioelectrical Impedance Spectroscopy (BIS) is a minimal risk procedure which enhances DXA as it permits the determination of intracellular water.BIS is used to calculate fat and fat-free mass composition. A formula will be used to combine BIS fat-free mass composition and DXA lean mass composition corrected by limb length, which allows a surrogate measurement of muscle mass.
measure: Change in Insulin sensitivity
time frame: Baseline, 30 (±7)days, 60(-3 to +7)days, 134(+7) days
description: Insulin resistance will be measured by HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) method. Insulin resistance reveals the dynamics between the participant's baseline (fasting) blood sugar and the responsive insulin levels.
HOMA-IR healthy range: 1.0 (0.5-1.4), less than 1.0 means participant is insulin-sensitive which is optimal, above 1.9 indicates early insulin resistance, above 2.9 indicates significant insulin resistance.
measure: Change in Fibroblast growth factor 21 (FGF21) levels
time frame: Baseline, 30 (±7)days, 60(-3 to +7)days
description: Fibroblast growth factor 21 (FGF21) is a hormone which regulate insulin signalling in response to nutritional status. Levels of FGF21 induced in response to low protein diet and fasting will be measured using enzyme-linked immunosorbent assay(ELISA) assay.
measure: Change in Energy expenditure as measured by resting metabolic rate
time frame: Baseline, 60(-3 to +7)days
description: Energy expenditure will be calculated from resting metabolic rate. Resting metabolic rate is the energy required by the body to perform the most basic functions when body is at rest.
measure: Change in Muscle function as measured by jump maximal height
time frame: Baseline, 60(-3 to +7)days
description: Jumping mechanography will be used to quantify muscle function. Jumping mechanography involves 3 supervised jumps on a force measurement platform. Analysis will be conducted on variables associated with the highest achieved jump height of the 3 trials.
In Jumping mechanography, participants perform two-leg maximal countermovement jumps on a force plate (Leonardo, Novotec, Pforzheim, Germany). Maximal jump height(meter) will be calculated using Leonardo software.
measure: Change in Muscle function as measured by jump velocity
time frame: Baseline, 60(-3 to +7)days
description: Jumping mechanography will be used to quantify muscle function. Jumping mechanography involves 3 supervised jumps on a force measurement platform.Analysis will be conducted on variables associated with the highest achieved jump height of the 3 trials.
In Jumping mechanography, participants perform two-leg maximal counter-movement jumps on a force plate (Leonardo, Novotec, Pforzheim, Germany). Jump velocity [meter/sec] will be calculated using Leonardo software.
measure: Change in Muscle function as measured by relative power of jump
time frame: Baseline, 60(-3 to +7)days
description: Jumping mechanography will be used to quantify muscle function. Jumping mechanography involves 3 supervised jumps on a force measurement platform.Analysis will be conducted on variables associated with the highest achieved jump height of the 3 trials.
In Jumping mechanography, participants perform two-leg maximal countermovement jumps on a force plate (Leonardo, Novotec, Pforzheim, Germany). Relative power of jump [Watt/kg] will be calculated using Leonardo software.
arm group label: Control
arm group type: Placebo Comparator
description: A control group will consume 2 meal replacement beverages(MRBs) made with whey protein
The control diet group will be provided with a protein powder which will provide all Amino Acids. Diets will be provided in unmarked containers, to ensure subjects will be blinded to the dietary group assignment.
No overall calorie reduction will be implemented for any group.
All subjects will receive recipes developed by clinical nutritionist in the study team. Theses recipes will maximize palatability and match energy density across all diets and total protein content.
The subjects will be able to use multiple different recipes over the course of the study to prevent taste fatigue and dropout. Each subject is anticipated to replace 2 meals per day with a beverage.
arm group label: Low protein(LP) diet
arm group type: Active Comparator
description: This group will consume 2 meal replacement beverages(MRBs) containing low protein (goal to reduce total protein by 2/3rds).
LP diet group will be provided with a protein powder which will provide all Amino Acids. Diets will be provided in unmarked containers, to ensure subjects will be blinded to the dietary group assignment.
No overall calorie reduction will be implemented for any group.
All subjects will receive recipes developed by clinical nutritionist in the study team. Theses recipes will maximize palatability and match energy density across all diets and total protein content.
The subjects will be able to use multiple different recipes over the course of the study to prevent taste fatigue and dropout. Each subject is anticipated to replace 2 meals per day with a beverage.
arm group label: Low branched-chain amino acids (BCAA)
arm group type: Experimental
description: The group on low-BCAA diet will consume 2 meal replacement beverages (MRBs) per day made with BCAD2 (branched chain amino acid) powder (lacking BCAAs).
BCAD2 powder(Mead Johnson) is a fortified medical food powder that does not contain the BCAAs isoleucine, leucine, or valine, but provides all other essential and nonessential AAs, carbohydrates, fat, vitamins, and minerals.
No overall calorie reduction will be implemented for any group.
All subjects will receive recipes developed by clinical nutritionist in the study team. Theses recipes will maximize palatability and match energy density across all diets and total protein content.
The subjects will be able to use multiple different recipes over the course of the study to prevent taste fatigue and dropout. Each subject is anticipated to replace 2 meals per day with a beverage.
intervention type: Dietary Supplement
intervention name: Control diet
description: Meal replacement beverages made with whey protein
arm group label: Control
intervention type: Dietary Supplement
intervention name: Low branched-chain amino acids(BCAA) diet
description: meal replacement beverages (MRBs) made with BCAD2 powder (lacking BCAAs).
arm group label: Low branched-chain amino acids (BCAA)
intervention type: Dietary Supplement
intervention name: Low protein diet
description: meal replacement beverages(MRBs) containing low protein
arm group label: Low protein(LP) diet
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dawn B Davis, MD, PhD
role: Principal Investigator
affiliation: University of Wisconsin, Madison
facility: 
country: United States
responsible party type: Sponsor
mesh term: Obesity
sharing ipd: No