<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/NCT03029975</url>
  </required_header>
  <id_info>
    <org_study_id>16997</org_study_id>
    <nct_id>NCT03029975</nct_id>
  </id_info>
  <brief_title>The Influence of Regular Beef Consumption and Protein Density of the Diet on Training-induced Gains in Muscle Strength and Performance in Healthy Adults</brief_title>
  <official_title>The Influence of Regular Beef Consumption and Protein Density of the Diet on Training-induced Gains in Muscle Strength and Performance in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Illinois at Urbana-Champaign</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cattlemen's Beef Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Illinois at Urbana-Champaign</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>
      Humans lose muscle and strength as they get older. Further, ageing is accompanied by loss in&#xD;
      cognitive function. It is not quite clear why this happens; however, it is known that the&#xD;
      loss of muscle and strength can increase risk for physical and mental health risks and impair&#xD;
      the ability of older people to remain physically independent. Weight lifting and proper&#xD;
      nutrition, particularly eating high quality protein at the proper time and quantity, may help&#xD;
      prevent these losses when a person gets older. To determine if regular beef consumption as&#xD;
      part of a higher protein diet aids the muscle adaptive response to resistance training and&#xD;
      improvements in cognition, seventy healthy individuals will be recruited to lift weights 3&#xD;
      times a week for 10 weeks. One group (n=36) will consume the Recommended Dietary Allowance&#xD;
      (RDA) for protein (0.8g/kg/day), while the other group (n=36) will consume an amount twice&#xD;
      the RDA (1.6g/kg/day), which is in agreement with recommendations from the American College&#xD;
      of Sports Medicine. Participants will have their muscle strength tested and samples of blood&#xD;
      and muscles will be collected before and after training to determine how the muscle adaptive&#xD;
      response to resistance exercise is affected by higher protein intake. In addition,&#xD;
      participants will undergo cognitive assessments at baseline and follow-up to determine the&#xD;
      influence of improving muscle strength on attention and memory. Overall, the investigators&#xD;
      proposed study will use sensitive methodology to determine if providing protein above the RDA&#xD;
      and at optimal times during the day in combination with a weight lifting program can help&#xD;
      make someone stronger and build larger muscles than someone consuming the RDA, as well as&#xD;
      what processes may be responsible for helping the muscles to get bigger and stronger.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">May 17, 2019</completion_date>
  <primary_completion_date type="Actual">May 17, 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>
    <intervention_model_description>This study will consist of two groups: one group will be asked to consume 2x the RDA of protein during the 10 week intervention, while the other group will be asked to consume the RDA for protein. Both groups will receive 10 weeks of the same resistance training intervention.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximal strength of leg muscles</measure>
    <time_frame>Change from baseline to the end of the 10 week diet and resistance training intervention</time_frame>
    <description>Assess maximum strength of legs using an isokinetic dynamometer in combination with 1 repetition maximum testing on leg extension, leg press, and leg curl machines.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Muscle cross-sectional area</measure>
    <time_frame>Change from baseline to the end of the 10 week diet and resistance training intervention</time_frame>
    <description>Using muscle biopsies, the investigators will assess the muscle cross sectional area of the vastus lateralis pre and post intervention.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Aging</condition>
  <arm_group>
    <arm_group_label>RDA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be asked to consume the RDA for protein for a 10 week period while also undergoing progressive resistance training exercise three times a week. Beef protein consumption will be emphasized and participants will consume a beef meal after each training session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2x RDA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be asked to consume the twice the RDA for protein for a 10 week period while also undergoing progressive resistance training exercise three times a week. Beef protein will be emphasized and participants will consume a beef meal after each training session.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Resistance Training Exercise</intervention_name>
    <description>Participants will undergo 10 weeks of progressive resistance exercise training while following their randomly assigned nutritional intervention.</description>
    <arm_group_label>2x RDA</arm_group_label>
    <arm_group_label>RDA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Beef Protein Consumption</intervention_name>
    <description>Following each resistance training sessions, participants will consume either a 3oz or 6oz beef patty (corresponding to the randomly assigned nutritional intervention group). Participants will also be provided with beef protein powder and beef snack bars to help them achieve their assigned protein goals during the intervention period.</description>
    <arm_group_label>2x RDA</arm_group_label>
    <arm_group_label>RDA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non-obese adults: BMI &lt;30 kg/m2&#xD;
&#xD;
          -  Aged between 40-64 years&#xD;
&#xD;
          -  Sedentary&#xD;
&#xD;
          -  Weight-stable for 6 months prior&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergies to beef consumption&#xD;
&#xD;
          -  Phenylketonuria (PKU)&#xD;
&#xD;
          -  BMI &gt;30 kg/m2&#xD;
&#xD;
          -  history of active cardiovascular disease, diabetes mellitus, GI disorders,&#xD;
             musculoskeletal/orthopedic disorders (e.g. osteoarthritis, rheumatoid arthritis,&#xD;
             tendinitis, gout, fibromyalgia, patellar tendinopathy, or chronic low back pain)&#xD;
&#xD;
          -  hypersensitivity or allergy to antibiotics&#xD;
&#xD;
          -  Kidney, urinary, or liver conditions&#xD;
&#xD;
          -  Epilepsy&#xD;
&#xD;
          -  Diagnosed mental illness&#xD;
&#xD;
          -  have bleeding or clotting disorders (or take related medications e.g.. Coumadin/ low&#xD;
             dose Aspirin)&#xD;
&#xD;
          -  High alcohol consumption&#xD;
&#xD;
          -  use tobacco&#xD;
&#xD;
          -  uncontrolled hypertension&#xD;
&#xD;
          -  vegan/vegetarian diets&#xD;
&#xD;
          -  on medications known to affect protein metabolism (i.e. corticosteroids,&#xD;
             androgen/estrogen containing compounds, non-steroidal anti-inflammatories)&#xD;
&#xD;
          -  habitual consumption of high (&gt;1.8 g protein/kg/d) or low (&lt;0.66 g protein/kg/day)&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  supplements that influence protein metabolism (e.g. omega 3 fish oils)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Freer Hall</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>November 12, 2019</last_update_submitted>
  <last_update_submitted_qc>November 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>beef</keyword>
  <keyword>protein</keyword>
  <keyword>resistance training</keyword>
  <keyword>strength</keyword>
  <keyword>performance</keyword>
  <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/NCT03029975
org study id: 16997
nct id: NCT03029975
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Humans lose muscle and strength as they get older. Further, ageing is accompanied by loss in
      cognitive function. It is not quite clear why this happens; however, it is known that the
      loss of muscle and strength can increase risk for physical and mental health risks and impair
      the ability of older people to remain physically independent. Weight lifting and proper
      nutrition, particularly eating high quality protein at the proper time and quantity, may help
      prevent these losses when a person gets older. To determine if regular beef consumption as
      part of a higher protein diet aids the muscle adaptive response to resistance training and
      improvements in cognition, seventy healthy individuals will be recruited to lift weights 3
      times a week for 10 weeks. One group (n=36) will consume the Recommended Dietary Allowance
      (RDA) for protein (0.8g/kg/day), while the other group (n=36) will consume an amount twice
      the RDA (1.6g/kg/day), which is in agreement with recommendations from the American College
      of Sports Medicine. Participants will have their muscle strength tested and samples of blood
      and muscles will be collected before and after training to determine how the muscle adaptive
      response to resistance exercise is affected by higher protein intake. In addition,
      participants will undergo cognitive assessments at baseline and follow-up to determine the
      influence of improving muscle strength on attention and memory. Overall, the investigators
      proposed study will use sensitive methodology to determine if providing protein above the RDA
      and at optimal times during the day in combination with a weight lifting program can help
      make someone stronger and build larger muscles than someone consuming the RDA, as well as
      what processes may be responsible for helping the muscles to get bigger and stronger.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study will consist of two groups: one group will be asked to consume 2x the RDA of protein during the 10 week intervention, while the other group will be asked to consume the RDA for protein. Both groups will receive 10 weeks of the same resistance training intervention.
primary purpose: Basic Science
masking: Double (Investigator, Outcomes Assessor)
measure: Maximal strength of leg muscles
time frame: Change from baseline to the end of the 10 week diet and resistance training intervention
description: Assess maximum strength of legs using an isokinetic dynamometer in combination with 1 repetition maximum testing on leg extension, leg press, and leg curl machines.
measure: Muscle cross-sectional area
time frame: Change from baseline to the end of the 10 week diet and resistance training intervention
description: Using muscle biopsies, the investigators will assess the muscle cross sectional area of the vastus lateralis pre and post intervention.
arm group label: RDA
arm group type: Active Comparator
description: Participants will be asked to consume the RDA for protein for a 10 week period while also undergoing progressive resistance training exercise three times a week. Beef protein consumption will be emphasized and participants will consume a beef meal after each training session.
arm group label: 2x RDA
arm group type: Experimental
description: Participants will be asked to consume the twice the RDA for protein for a 10 week period while also undergoing progressive resistance training exercise three times a week. Beef protein will be emphasized and participants will consume a beef meal after each training session.
intervention type: Behavioral
intervention name: Resistance Training Exercise
description: Participants will undergo 10 weeks of progressive resistance exercise training while following their randomly assigned nutritional intervention.
arm group label: 2x RDA
arm group label: RDA
intervention type: Behavioral
intervention name: Beef Protein Consumption
description: Following each resistance training sessions, participants will consume either a 3oz or 6oz beef patty (corresponding to the randomly assigned nutritional intervention group). Participants will also be provided with beef protein powder and beef snack bars to help them achieve their assigned protein goals during the intervention period.
arm group label: 2x RDA
arm group label: RDA
criteria: 
gender: All
minimum age: 40 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No