<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/NCT02190136</url>
  </required_header>
  <id_info>
    <org_study_id>Yoga-0610-52</org_study_id>
    <nct_id>NCT02190136</nct_id>
  </id_info>
  <brief_title>Yoga Improves Aerobic Fitness, Glycemia and Mood State and Reduces Abdominal Obesity</brief_title>
  <acronym>PRISE</acronym>
  <official_title>Yoga Improves Aerobic Fitness, Glycemia and Mood State and Reduces Abdominal Obesity in Overweight Women: The PRISE Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Skidmore College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Skidmore College</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Stretching and flexibility exercise such as yoga and functional resistance exercise are two&#xD;
      forms of exercise that are growing in popularity. However, they have not been scientifically&#xD;
      tested to demonstrate their ability to improve body composition, fitness, heart and metabolic&#xD;
      health, and mood state in overweight/obese women. The investigators hypothesize that during&#xD;
      an 11 week intervention, both forms of exercise will improve body composition, heart and&#xD;
      metabolic health and mood state.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was a 11 week protein-rich whole food diet and exercise training intervention in&#xD;
      middle aged overweight/obese women. Subjects were randomized into 3 groups: Protein-rich&#xD;
      whole food only consumed as 20-25 grams per serving 4-6 per day (P); protein and resistance&#xD;
      exercise training (R); and protein and stretching/yoga exercise training (S). All outcomes,&#xD;
      including the primary outcomes of body composition and cardiometabolic biomarkers were&#xD;
      measured at baseline (week 0) and post-intervention (week 12) in all study subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2006</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">January 2008</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total and Regional Body Composition</measure>
    <time_frame>baseline and 11 weeks</time_frame>
    <description>Total and regional body composition was assessed by dual energy xray absorptiometry (DXA) at baseline and 11 weeks in all subjects</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Aerobic Fitness</measure>
    <time_frame>baseline and 11 weeks</time_frame>
    <description>VO2 max was assessed in each subject at baseline and 11 weeks</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Plasma Biomarkers</measure>
    <time_frame>baseline and 11 weeks</time_frame>
    <description>Insulin, glucose, and leptin was assessed in each subject at baseline and 11 weeks</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Obesity</condition>
  <condition>Insulin Resistance</condition>
  <arm_group>
    <arm_group_label>Protein whole foods</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ingestion of 20-25 grams per serving consumed 4-6 times per day; 1 within an hour of waking in the morning and the other 2.5-3 hours apart during the day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Protein Resistance Exercise Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ingestion of 4-6 protein-rich meals per day and 3 times per week of resistance functional training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Protein Stretching/Yoga Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ingestion of Protein-rich diet 4-6 meals/day and stretching/yoga training 3 times per week</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Protein whole foods</intervention_name>
    <description>Protein-rich whole foods consumed at 20-30 grams of protein at each of 4-6 meals per day</description>
    <arm_group_label>Protein Resistance Exercise Training</arm_group_label>
    <arm_group_label>Protein Stretching/Yoga Training</arm_group_label>
    <arm_group_label>Protein whole foods</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Protein Resistance Exercise Training</intervention_name>
    <description>Protein rich whole foods diet and resistance training 3 times per week for 11 weeks</description>
    <arm_group_label>Protein Resistance Exercise Training</arm_group_label>
    <arm_group_label>Protein whole foods</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Protein Stretching/Yoga Training</intervention_name>
    <description>Protein-rich whole foods diet of 20-30 grams of protein at each of 4-6 meals per day with stretching/yoga training 3 times per week for 11 weeks</description>
    <arm_group_label>Protein Stretching/Yoga Training</arm_group_label>
    <arm_group_label>Protein whole foods</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  obese or overweight women&#xD;
&#xD;
          -  between ages 25-60 and&#xD;
&#xD;
          -  otherwise healthy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  smokers,&#xD;
&#xD;
          -  habitual exercisers&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul J Arciero, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Skidmore College</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Human Nutrition and Metabolism Laboratory</name>
      <address>
        <city>Saratoga Springs</city>
        <state>New York</state>
        <zip>12866</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>July 11, 2014</last_update_submitted>
  <last_update_submitted_qc>July 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Skidmore College</investigator_affiliation>
    <investigator_full_name>Paul Arciero</investigator_full_name>
    <investigator_title>Professor, Health and Exercise Sciences Department</investigator_title>
  </responsible_party>
  <keyword>obesity</keyword>
  <keyword>protein-rich whole foods diet</keyword>
  <keyword>aerobic fitness</keyword>
  <keyword>resistance training</keyword>
  <keyword>stretching/yoga training</keyword>
  <keyword>glycemia</keyword>
  <keyword>mood state</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Insulin Resistance</mesh_term>
    <mesh_term>Obesity, Abdominal</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/NCT02190136
org study id: Yoga-0610-52
nct id: NCT02190136
lead sponsor: 
has dmc: No
Stretching and flexibility exercise such as yoga and functional resistance exercise are two
      forms of exercise that are growing in popularity. However, they have not been scientifically
      tested to demonstrate their ability to improve body composition, fitness, heart and metabolic
      health, and mood state in overweight/obese women. The investigators hypothesize that during
      an 11 week intervention, both forms of exercise will improve body composition, heart and
      metabolic health and mood state.
This study was a 11 week protein-rich whole food diet and exercise training intervention in
      middle aged overweight/obese women. Subjects were randomized into 3 groups: Protein-rich
      whole food only consumed as 20-25 grams per serving 4-6 per day (P); protein and resistance
      exercise training (R); and protein and stretching/yoga exercise training (S). All outcomes,
      including the primary outcomes of body composition and cardiometabolic biomarkers were
      measured at baseline (week 0) and post-intervention (week 12) in all study subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Total and Regional Body Composition
time frame: baseline and 11 weeks
description: Total and regional body composition was assessed by dual energy xray absorptiometry (DXA) at baseline and 11 weeks in all subjects
measure: Aerobic Fitness
time frame: baseline and 11 weeks
description: VO2 max was assessed in each subject at baseline and 11 weeks
measure: Plasma Biomarkers
time frame: baseline and 11 weeks
description: Insulin, glucose, and leptin was assessed in each subject at baseline and 11 weeks
arm group label: Protein whole foods
arm group type: Active Comparator
description: Ingestion of 20-25 grams per serving consumed 4-6 times per day; 1 within an hour of waking in the morning and the other 2.5-3 hours apart during the day.
arm group label: Protein Resistance Exercise Training
arm group type: Experimental
description: Ingestion of 4-6 protein-rich meals per day and 3 times per week of resistance functional training.
arm group label: Protein Stretching/Yoga Training
arm group type: Experimental
description: Ingestion of Protein-rich diet 4-6 meals/day and stretching/yoga training 3 times per week
intervention type: Other
intervention name: Protein whole foods
description: Protein-rich whole foods consumed at 20-30 grams of protein at each of 4-6 meals per day
arm group label: Protein Resistance Exercise Training
arm group label: Protein Stretching/Yoga Training
arm group label: Protein whole foods
intervention type: Other
intervention name: Protein Resistance Exercise Training
description: Protein rich whole foods diet and resistance training 3 times per week for 11 weeks
arm group label: Protein Resistance Exercise Training
arm group label: Protein whole foods
intervention type: Other
intervention name: Protein Stretching/Yoga Training
description: Protein-rich whole foods diet of 20-30 grams of protein at each of 4-6 meals per day with stretching/yoga training 3 times per week for 11 weeks
arm group label: Protein Stretching/Yoga Training
arm group label: Protein whole foods
criteria: 
gender: Female
minimum age: 25 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Paul J Arciero, PhD
role: Principal Investigator
affiliation: Skidmore College
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Skidmore College
investigator full name: Paul Arciero
investigator title: Professor, Health and Exercise Sciences Department
mesh term: Obesity
mesh term: Insulin Resistance
mesh term: Obesity, Abdominal