<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/NCT01692860</url>
  </required_header>
  <id_info>
    <org_study_id>1109011319</org_study_id>
    <nct_id>NCT01692860</nct_id>
  </id_info>
  <brief_title>Effects of Milk Protein Concentrate on Overall Health During Weight Loss in Overweight/Obese Adults</brief_title>
  <acronym>S28</acronym>
  <official_title>Effects of Milk Protein Concentrate on Blood Pressure, Inflammation, Muscle Health During Weight Loss in Overweight/Obese Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Purdue University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Purdue University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      . The purpose of this study is to examine the effects of eating a larger amount of&#xD;
      dairy-based protein on risk factors for metabolic syndrome&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Currently, over 47 million adults in the United States are known to have metabolic syndrome.&#xD;
      Metabolic syndrome is comprised of a cluster of conditions including obesity, elevated&#xD;
      cholesterol, high blood sugar, and high blood pressure. People with metabolic syndrome have&#xD;
      an increased risk for the development of chronic diseases such as cardiovascular disease and&#xD;
      diabetes. Recent studies have shown that a build-up of fat in the muscle of overweight and&#xD;
      obese people may partially explain the link between metabolic syndrome and the development of&#xD;
      chronic diseases. There is evidence to suggest that diets with a higher amount of protein can&#xD;
      improve some aspects of metabolic syndrome, including the build-up of fat in muscle. The&#xD;
      purpose of this study is to examine the effects of eating a larger amount of dairy-based&#xD;
      protein on risk factors for metabolic syndrome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">September 2014</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>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>weight loss</measure>
    <time_frame>20 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Sarcopenia</condition>
  <condition>Metabolic Disease</condition>
  <condition>High Blood Pressure</condition>
  <arm_group>
    <arm_group_label>High protein consumption</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention, energy restriction. This arm has a dietary protein intake of 1.5g/kg/d</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal protein consumption</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intervention, energy restriction. This arm has a dietary protein intake of .8g/kg/d</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Energy Restriction</intervention_name>
    <description>Subjects consume 750 kcal/d of energy below their need</description>
    <arm_group_label>High protein consumption</arm_group_label>
    <arm_group_label>Normal protein consumption</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        BMI: 25-38 ,male or female; age 35-65 y; weight stable (± 3 kg) during last 3 months; no&#xD;
        acute illness; not diabetic, pregnant or lactating; not currently (or within last 3 months)&#xD;
        following an exercise or weight loss program; non-smoking; not taking BP medication; not&#xD;
        lactose intolerant,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects will be excluded if baseline protein intake is less than 0.6 or greater than 1.6&#xD;
        g•kg-1•d-1 Subjects will also be excluded if they have any chronic or acute condition which&#xD;
        will increase risk of illness or injury during study participation as determined by our&#xD;
        study physician such as high BP, high fasting glucose, metabolic syndrome, etc.&#xD;
      </textblock>
    </criteria>
    <gender>All</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>Wayne W Campbell, Ph. D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Purdue University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Purdue University - Stone Hall 700 W State St</name>
      <address>
        <city>W Lafayette</city>
        <state>Indiana</state>
        <zip>47907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>November 3, 2015</last_update_submitted>
  <last_update_submitted_qc>November 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 4, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Purdue University</investigator_affiliation>
    <investigator_full_name>Wayne Campbell</investigator_full_name>
    <investigator_title>Wayne Campbell, Ph.D.</investigator_title>
  </responsible_party>
  <keyword>the impact of a higher dairy-based protein diet in</keyword>
  <keyword>combination with energy restriction on muscle health,</keyword>
  <keyword>metabolic health (including blood pressure) in overweight</keyword>
  <keyword>and obese, middle aged adults</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcopenia</mesh_term>
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Metabolic Diseases</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <!-- 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/NCT01692860
org study id: 1109011319
nct id: NCT01692860
lead sponsor: 
has dmc: No
. The purpose of this study is to examine the effects of eating a larger amount of
      dairy-based protein on risk factors for metabolic syndrome
Currently, over 47 million adults in the United States are known to have metabolic syndrome.
      Metabolic syndrome is comprised of a cluster of conditions including obesity, elevated
      cholesterol, high blood sugar, and high blood pressure. People with metabolic syndrome have
      an increased risk for the development of chronic diseases such as cardiovascular disease and
      diabetes. Recent studies have shown that a build-up of fat in the muscle of overweight and
      obese people may partially explain the link between metabolic syndrome and the development of
      chronic diseases. There is evidence to suggest that diets with a higher amount of protein can
      improve some aspects of metabolic syndrome, including the build-up of fat in muscle. The
      purpose of this study is to examine the effects of eating a larger amount of dairy-based
      protein on risk factors for metabolic syndrome.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: weight loss
time frame: 20 weeks
arm group label: High protein consumption
arm group type: Experimental
description: Intervention, energy restriction. This arm has a dietary protein intake of 1.5g/kg/d
arm group label: Normal protein consumption
arm group type: Placebo Comparator
description: Intervention, energy restriction. This arm has a dietary protein intake of .8g/kg/d
intervention type: Other
intervention name: Energy Restriction
description: Subjects consume 750 kcal/d of energy below their need
arm group label: High protein consumption
arm group label: Normal protein consumption
criteria: 
gender: All
minimum age: 35 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Wayne W Campbell, Ph. D.
role: Principal Investigator
affiliation: Purdue University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Purdue University
investigator full name: Wayne Campbell
investigator title: Wayne Campbell, Ph.D.
mesh term: Sarcopenia
mesh term: Hypertension
mesh term: Overweight
mesh term: Metabolic Diseases
mesh term: Weight Loss