<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/NCT03299972</url>
  </required_header>
  <id_info>
    <org_study_id>P59723</org_study_id>
    <nct_id>NCT03299972</nct_id>
  </id_info>
  <brief_title>Multidisciplinary Research Into the Effects of Resistance Exercise and Whey Protein Supplementation in Healthy Older Men</brief_title>
  <official_title>Effects of 12 Weeks Resistance Exercise and Whey Protein Supplementation on Energy Metabolism, Appetite, Body Composition and Biomarkers Related to Sarcopenia and Metabolic Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Coventry University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospitals Coventry and Warwickshire NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Coventry 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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this randomised, double-blind, placebo-controlled, parallel groups trial is to&#xD;
      investigate the effects of 12 weeks resistance exercise and whey protein supplementation on&#xD;
      energy metabolism, markers of appetite, inflammation and hormonal response and body&#xD;
      composition and strength and functional performance.&#xD;
&#xD;
      Generally healthy, retired men aged 60-80 years will be recruited (n = 52 in total, n = 13&#xD;
      per group). Participants will be randomised to either: a) control group, b) whey protein&#xD;
      supplement group, c) resistance exercise + control group or d) resistance exercise + whey&#xD;
      protein supplementation group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      With demographics indicating that the world's population aged &gt;60 years will increase from&#xD;
      600 million reported in 2000, to &gt;2 billion by 2050, there is an increasing interest in&#xD;
      health issues related to ageing. One area of particular interest is sarcopenia, defined as&#xD;
      the progressive loss of muscle mass, strength and physical function as a consequence of&#xD;
      ageing. Sarcopenia has been associated with an increase in cardiovascular disease, poor&#xD;
      metabolic and cognitive function, reduced quality of life and early mortality. Studies have&#xD;
      reported beneficial effects of both resistance exercise and increasing protein intake&#xD;
      independently and in combination on markers of sarcopenia (mostly increases in muscle mass,&#xD;
      strength and physical function). However, little is known about the effects of combined&#xD;
      intervention on energy metabolism, appetite and cognitive and endocrine function. This&#xD;
      randomised, double-blind, placebo-controlled, parallel groups trial will investigate these,&#xD;
      alongside assessing the effects of combined intervention on total lean tissue mass, muscular&#xD;
      strength and functional performance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 27, 2017</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in components of 24-h energy expenditure and its components (kcal/d)</measure>
    <time_frame>0 to 12 weeks</time_frame>
    <description>Measured by whole-room calorimetry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in body composition (kg)</measure>
    <time_frame>0 to 12 weeks</time_frame>
    <description>Fat-free mass, fat mass, skeletal muscle mass measured by bio-electrical impedance analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in 24-h substrate oxidation (g/d)</measure>
    <time_frame>0 to 12 weeks</time_frame>
    <description>Measured by whole-room calorimetry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biochemical: Appetite hormones</measure>
    <time_frame>0 to 12 weeks</time_frame>
    <description>Ghrelin, leptin, and PYY</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemical: Insulin Resistance (HOMAR-IR)</measure>
    <time_frame>0 to 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Salivary:Diurnal Cortisol</measure>
    <time_frame>0 to 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemical: Inflammtion</measure>
    <time_frame>0 to 12 weeks</time_frame>
    <description>Tumor necrosis factor alpha (TNF-α), C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-10 (IL-10), Annexin A1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interstitial Glucose</measure>
    <time_frame>0 to 12 weeks</time_frame>
    <description>24 Hour Continuous Glucose Monitoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemical: Insulin-Like Growth Factor 1 (IGF-1)</measure>
    <time_frame>0 to 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Isotonic Strength (kg) - Leg press and leg extension</measure>
    <time_frame>0 to 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Physical Performance Battery (SPPB)</measure>
    <time_frame>0 to 12 weeks</time_frame>
    <description>Balance, Gait speed and time to sit and stand from a chair 5 times</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Function - Cambridge Cognition Neuropsychological Testing Battery</measure>
    <time_frame>0 to 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Handgrip strength (kg)</measure>
    <time_frame>0 to 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemical: Myostatin</measure>
    <time_frame>0 to 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Habitual Physical Activity</measure>
    <time_frame>0 to 12 weeks</time_frame>
    <description>Accelerometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endurance (Six Minute Walk Test)</measure>
    <time_frame>0 to 12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Sarcopenia</condition>
  <condition>Muscle Atrophy</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Whey Protein</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Resistance Exercise + Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Resistance Exercise + Whey Protein</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Whey Protein</intervention_name>
    <description>25 g whey protein supplementation twice daily (breakfast and lunch)</description>
    <arm_group_label>Resistance Exercise + Whey Protein</arm_group_label>
    <arm_group_label>Whey Protein</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>23.75 g maltodextrin twice daily (breakfast and lunch)</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Resistance Exercise + Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Resistance Exercise</intervention_name>
    <description>60 minutes of resistance exercise twice a week</description>
    <arm_group_label>Resistance Exercise + Control</arm_group_label>
    <arm_group_label>Resistance Exercise + Whey Protein</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Retired Men aged 60-80 years&#xD;
&#xD;
          -  Body Mass Index 18.5-30 kg/m2&#xD;
&#xD;
          -  Not participated in resistance exercise within the last 6 months&#xD;
&#xD;
          -  Free from musculoskeletal injury&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Retired Men aged &lt;60 or &gt;80 years&#xD;
&#xD;
          -  Current smokers, or ex-smokers ceasing &lt;6 months ago&#xD;
&#xD;
          -  Body Mass Index &lt;18.5 and &gt;30 kg/m2&#xD;
&#xD;
          -  Currently participating in resistance exercise regularly (within last 6 months)&#xD;
&#xD;
          -  Not weight stable and/or looking to start a weight loss programme&#xD;
&#xD;
          -  Individuals participating in another research project (within the last 6 months)&#xD;
             involving dietary and/or exercise intervention&#xD;
&#xD;
          -  Existing or past medical history of vascular disease, cancer, diabetes, neurological,&#xD;
             kidney, pulmonary, digestive (Coeliac disease), thyroidal disease, osteoporosis or&#xD;
             history of falls&#xD;
&#xD;
          -  Currently taking protein/amino acid supplements regularly&#xD;
&#xD;
          -  Currently prescribed non-steroidal anti-inflammatory medication, hormone replacement&#xD;
             therapy (HRT), diabetic medication, beta-blockers, statins&#xD;
&#xD;
          -  Uncontrolled blood pressure (Blood pressure &gt;160/100 mmHg)&#xD;
&#xD;
          -  Self-reported lactose intolerant or allergic to wheat or potatoes&#xD;
&#xD;
          -  Individuals with a pacemaker&#xD;
&#xD;
          -  Neuromuscular disorders or injuries&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Derek Renshaw, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Coventry University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>John Hattersley, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University Hosptials Coventry and Warwickshire NHS Trust</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael Duncan, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Coventry University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Corbin Griffen, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Coventry University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Coventry University</name>
      <address>
        <city>Coventry</city>
        <state>West Midlands</state>
        <zip>CV1 5FB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>July 24, 2019</last_update_submitted>
  <last_update_submitted_qc>July 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Coventry University</investigator_affiliation>
    <investigator_full_name>Corbin Griffen</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>Sarcopenia</keyword>
  <keyword>Resistance exercise</keyword>
  <keyword>Protein</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcopenia</mesh_term>
    <mesh_term>Muscular Atrophy</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/NCT03299972
org study id: P59723
nct id: NCT03299972
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
The aim of this randomised, double-blind, placebo-controlled, parallel groups trial is to
      investigate the effects of 12 weeks resistance exercise and whey protein supplementation on
      energy metabolism, markers of appetite, inflammation and hormonal response and body
      composition and strength and functional performance.

      Generally healthy, retired men aged 60-80 years will be recruited (n = 52 in total, n = 13
      per group). Participants will be randomised to either: a) control group, b) whey protein
      supplement group, c) resistance exercise + control group or d) resistance exercise + whey
      protein supplementation group.
With demographics indicating that the world's population aged >60 years will increase from
      600 million reported in 2000, to >2 billion by 2050, there is an increasing interest in
      health issues related to ageing. One area of particular interest is sarcopenia, defined as
      the progressive loss of muscle mass, strength and physical function as a consequence of
      ageing. Sarcopenia has been associated with an increase in cardiovascular disease, poor
      metabolic and cognitive function, reduced quality of life and early mortality. Studies have
      reported beneficial effects of both resistance exercise and increasing protein intake
      independently and in combination on markers of sarcopenia (mostly increases in muscle mass,
      strength and physical function). However, little is known about the effects of combined
      intervention on energy metabolism, appetite and cognitive and endocrine function. This
      randomised, double-blind, placebo-controlled, parallel groups trial will investigate these,
      alongside assessing the effects of combined intervention on total lean tissue mass, muscular
      strength and functional performance.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Changes in components of 24-h energy expenditure and its components (kcal/d)
time frame: 0 to 12 weeks
description: Measured by whole-room calorimetry
measure: Changes in body composition (kg)
time frame: 0 to 12 weeks
description: Fat-free mass, fat mass, skeletal muscle mass measured by bio-electrical impedance analysis
measure: Changes in 24-h substrate oxidation (g/d)
time frame: 0 to 12 weeks
description: Measured by whole-room calorimetry
measure: Biochemical: Appetite hormones
time frame: 0 to 12 weeks
description: Ghrelin, leptin, and PYY
measure: Biochemical: Insulin Resistance (HOMAR-IR)
time frame: 0 to 12 weeks
measure: Salivary:Diurnal Cortisol
time frame: 0 to 12 weeks
measure: Biochemical: Inflammtion
time frame: 0 to 12 weeks
description: Tumor necrosis factor alpha (TNF-α), C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-10 (IL-10), Annexin A1
measure: Interstitial Glucose
time frame: 0 to 12 weeks
description: 24 Hour Continuous Glucose Monitoring
measure: Biochemical: Insulin-Like Growth Factor 1 (IGF-1)
time frame: 0 to 12 weeks
measure: Isotonic Strength (kg) - Leg press and leg extension
time frame: 0 to 12 weeks
measure: Short Physical Performance Battery (SPPB)
time frame: 0 to 12 weeks
description: Balance, Gait speed and time to sit and stand from a chair 5 times
measure: Cognitive Function - Cambridge Cognition Neuropsychological Testing Battery
time frame: 0 to 12 weeks
measure: Handgrip strength (kg)
time frame: 0 to 12 weeks
measure: Biochemical: Myostatin
time frame: 0 to 12 weeks
measure: Habitual Physical Activity
time frame: 0 to 12 weeks
description: Accelerometer
measure: Endurance (Six Minute Walk Test)
time frame: 0 to 12 weeks
arm group label: Control
arm group type: Placebo Comparator
arm group label: Whey Protein
arm group type: Experimental
arm group label: Resistance Exercise + Control
arm group type: Experimental
arm group label: Resistance Exercise + Whey Protein
arm group type: Experimental
intervention type: Dietary Supplement
intervention name: Whey Protein
description: 25 g whey protein supplementation twice daily (breakfast and lunch)
arm group label: Resistance Exercise + Whey Protein
arm group label: Whey Protein
intervention type: Dietary Supplement
intervention name: Control
description: 23.75 g maltodextrin twice daily (breakfast and lunch)
arm group label: Control
arm group label: Resistance Exercise + Control
intervention type: Other
intervention name: Resistance Exercise
description: 60 minutes of resistance exercise twice a week
arm group label: Resistance Exercise + Control
arm group label: Resistance Exercise + Whey Protein
criteria: 
gender: Male
minimum age: 60 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Derek Renshaw, PhD
role: Study Director
affiliation: Coventry University
last name: John Hattersley, PhD
role: Study Director
affiliation: University Hosptials Coventry and Warwickshire NHS Trust
last name: Michael Duncan, PhD
role: Study Director
affiliation: Coventry University
last name: Corbin Griffen, MSc
role: Principal Investigator
affiliation: Coventry University
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Coventry University
investigator full name: Corbin Griffen
investigator title: Principle Investigator
mesh term: Sarcopenia
mesh term: Muscular Atrophy
sharing ipd: No