<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/NCT03297151</url>
  </required_header>
  <id_info>
    <org_study_id>FHIHAPN3.3RX</org_study_id>
    <secondary_id>TC20130001</secondary_id>
    <nct_id>NCT03297151</nct_id>
  </id_info>
  <brief_title>Protein Supplementation and Recovery of Muscle Function</brief_title>
  <official_title>The Effect of Milk Derived Protein Supplementation on Muscle Recovery Following Resistance Exercise</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Limerick</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Limerick</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>
      The focus is performance nutrition. Resistance exercise can induce low level muscle damage in&#xD;
      conjunction with impaired contractile function. Milk-derived proteins contain, or induce,&#xD;
      bioactive properties that assist muscle recovery and restore/improve muscle function. The aim&#xD;
      of the research is the recovery of muscle function following resistance exercise.&#xD;
&#xD;
      In this study, the investigators propose to undertake a comparison of the ingestion of two&#xD;
      milk-derived protein-based recovery drinks on muscle function after resistance exercise&#xD;
      compares to an isonitrogenous, non-essential amino acid control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Design: A block randomised design of 3 groups of resistance-exercise trained (RET) men&#xD;
&#xD;
      Participants: 24 young, healthy, resistance exercise trained, males aged 18 - 35 years.&#xD;
&#xD;
      Recovery drinks; CONTROL - an isonitrogenous, non-essential amino acid solution; PROTEIN - a&#xD;
      milk-based whey protein concentrate (WPC), WPC-80; HYDROLYSATE - a hydrolysed derivative of&#xD;
      WPC-80.&#xD;
&#xD;
      Day 1, Pre-screening consisting of:&#xD;
&#xD;
        -  medical history and examination by a clinician&#xD;
&#xD;
        -  blood sample to be evaluated for health-related contraindications&#xD;
&#xD;
        -  body composition measurement by dual energy x-ray absorptiometry (DXA) to determine&#xD;
           whole body and segmental lean tissue mass;&#xD;
&#xD;
        -  exercise training log (6 month recall);&#xD;
&#xD;
        -  dietary consultation;&#xD;
&#xD;
        -  habitual physical activity level assessed by European Physical Activity Questionaire&#xD;
           (EPAQ)-2&#xD;
&#xD;
      Day 2 - 8: Participants will be &quot;free-living&quot; during this time. Participants will record&#xD;
      dietary intake under the guidance of a qualified dietitian and sports nutritionist.&#xD;
&#xD;
      Day 9 and 10: Participants will complete two familiarisation sessions to the resistance&#xD;
      exercise and muscle function testing procedures.&#xD;
&#xD;
      A single blood sample (5ml) will be drawn following o/n fast on each day. On day 2&#xD;
      participants will drink a metered dose of deuterated water (around 200ml) containing&#xD;
      deuterium. A saliva sample will be taken before and after consuming this bolus.&#xD;
&#xD;
      Day 11-17. During this experimental phase diet is prescribed and provided. The diet is based&#xD;
      on habitual food intake standardized to body mass.&#xD;
&#xD;
      Day 11: O/n fasted blood, saliva and 1st micro-biopsy of muscle obtained; Muscle function&#xD;
      measured prior to and upon completion of a prescribed bout of resistance exercise training&#xD;
      (RET); The recovery drink (0.33 g protein/kg body mass) is ingested; 3 hours following&#xD;
      completion of RET a 2nd micro-biopsy of muscle is obtained.&#xD;
&#xD;
      Day 12: O/n fasted blood and saliva is obtained Muscle function measured and recovery drink&#xD;
      (0.33 g protein/kg body mass) consumed.&#xD;
&#xD;
      Day 13: O/n fasted blood and saliva is obtained Muscle function measured followed by the 2nd&#xD;
      RET bout and recovery drink (0.33 g protein/kg body mass) consumed.&#xD;
&#xD;
      Day 14: O/n fasted blood and saliva is obtained Muscle function measured and recovery drink&#xD;
      (0.33 g protein/kg body mass) consumed.&#xD;
&#xD;
      Day 15: O/n fasted blood and saliva is obtained Muscle function measured followed by the 3rd&#xD;
      RET bout and recovery drink (0.33 g protein/kg body mass) consumed.&#xD;
&#xD;
      Day 16 O/n fasted blood, saliva and 3rd micro-biopsy of muscle obtained Muscle function&#xD;
      measured and recovery drink (0.33 g protein/kg body mass) consumed.&#xD;
&#xD;
      Day 17: O/n fasted blood and saliva is obtained Muscle function measured&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2017</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2017</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>Factorial Assignment</intervention_model>
    <intervention_model_description>Block randomised, between group study</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Double blind (participant and investigator)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Muscle Contractile Function</measure>
    <time_frame>Day 9, 10, 11, 12, 13, 14, 15, 16 and 17</time_frame>
    <description>Maximal Voluntary Contract (MVC) of Knee Extensor Muscle measured by laboratory-based ergometry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Muscle Protein Synthesis</measure>
    <time_frame>Day 11 and 16</time_frame>
    <description>The fractional rate of muscle protein synthesis (MPS) measured by deuterium incorporation into skeletal muscle sampled by microbiopsy</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Resistance Training</condition>
  <condition>Muscle Damage</condition>
  <arm_group>
    <arm_group_label>CONTROL</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Intervention: Dietary Supplement: Non-essential amino acids A group of subjects ingesting a liquid beverage (per kilogram body mass: 0.33g non-essential amino acids dissolved in water ) prior to completion of a prescribed resistance exercise training (RET) session.&#xD;
Muscle Contractile Function to be conducted prior to and following the RET session by laboratory-based ergometry.&#xD;
Muscle Protein Synthesis induced by RET to be measured by deuterium incorporation in to skeletal muscle sampled by microbiopsy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PROTEIN</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention: Dietary Supplement: Whey Protein Concentrate A group of subjects ingesting a liquid beverage (per kilogram body mass: 0.33g of Whey Protein Concentrate dissolved in water ) prior to completion of a prescribed resistance exercise training (RET) session.&#xD;
Muscle Contractile Function to be conducted prior to and following the RET session by laboratory-based ergometry. Muscle Protein Synthesis induced by RET to be measured by deuterium incorporation in to skeletal muscle sampled by microbiopsy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HYDROLYSATE</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention: Dietary Supplement: Whey Protein Hydrolysate A group of subjects ingesting a liquid beverage (per kilogram body mass: 0.33g of Whey Protein Hydrolysate dissolved in water ) prior to completion of a prescribed resistance exercise training (RET) session.&#xD;
Muscle Contractile Function to be conducted prior to and following the RET session by laboratory-based ergometry. Muscle Protein Synthesis induced by RET to be measured by deuterium incorporation in to skeletal muscle sampled by microbiopsy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>CONTROL</intervention_name>
    <description>Food grade mixture of non-essential amino acids in powdered form, flavoured and instantised to be dissolved in water.&#xD;
Supplied by Carbery Food Ingredients Limited, Ballineen, Ireland. Product Reference Number 10955</description>
    <arm_group_label>CONTROL</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Whey Protein Concentrate</intervention_name>
    <description>Whey protein concentrate in powdered form, flavoured and instantised to be dissolved in water.&#xD;
Supplied by Carbery Food Ingredients Limited, Ballineen, Ireland. Trade name of product is Carbelac80 Instant Product Reference Number 10431</description>
    <arm_group_label>PROTEIN</arm_group_label>
    <other_name>Carbelac80 Instant</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Whey Protein Hydrolysate</intervention_name>
    <description>Whey protein concentrate hydrolysate (degree of hydrolysate 27%) in powdered form, flavoured and instantised to be dissolved in water.&#xD;
Supplied by Carbery Food Ingredients Limited, Ballineen, Ireland. Product Reference Number 10468</description>
    <arm_group_label>HYDROLYSATE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  risk&#xD;
&#xD;
          -  no known current illness or physically active&#xD;
&#xD;
          -  resistance-exercise trained&#xD;
&#xD;
          -  no known intolerance to milk-based products&#xD;
&#xD;
          -  no known blood born disease or medication that would adversely affect participation&#xD;
&#xD;
          -  no adverse risk to venepuncture&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • recent musculoskeletal injury&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philip M Jakeman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Limerick</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Philip M Jakeman, PhD</last_name>
    <phone>+35361202800</phone>
    <phone_ext>2800</phone_ext>
    <email>phil.jakeman@ul.ie</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mary Clarke-Moloney, BSc</last_name>
    <phone>+35361204230</phone>
    <phone_ext>4230</phone_ext>
    <email>Mary.ClarkMoloney@ul.ie</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Limerick</name>
      <address>
        <city>Limerick</city>
        <state>Co Limerick</state>
        <country>Ireland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Philip Jakeman, PhD</last_name>
      <phone>+35361202800</phone>
      <email>phil.jakeman@ul.ie</email>
    </contact>
    <contact_backup>
      <last_name>Dick Fitzgerald, PhD</last_name>
      <phone>+35361202598</phone>
      <email>dick.fitzgerald@ul.ie</email>
    </contact_backup>
    <investigator>
      <last_name>Philip Jakeman, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Dick Fitzgerald, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Ireland</country>
  </location_countries>
  <link>
    <url>http://FHI.ie</url>
    <description>Food For Health Ireland National Technology Centre</description>
  </link>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>September 25, 2017</last_update_submitted>
  <last_update_submitted_qc>September 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Limerick</investigator_affiliation>
    <investigator_full_name>Phil Jakeman</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Resistance Training</keyword>
  <keyword>Muscle Function</keyword>
  <keyword>Protein Synthesis</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 9, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/51/NCT03297151/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 9, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/51/NCT03297151/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03297151
org study id: FHIHAPN3.3RX
secondary id: TC20130001
nct id: NCT03297151
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The focus is performance nutrition. Resistance exercise can induce low level muscle damage in
      conjunction with impaired contractile function. Milk-derived proteins contain, or induce,
      bioactive properties that assist muscle recovery and restore/improve muscle function. The aim
      of the research is the recovery of muscle function following resistance exercise.

      In this study, the investigators propose to undertake a comparison of the ingestion of two
      milk-derived protein-based recovery drinks on muscle function after resistance exercise
      compares to an isonitrogenous, non-essential amino acid control.
Study Design: A block randomised design of 3 groups of resistance-exercise trained (RET) men

      Participants: 24 young, healthy, resistance exercise trained, males aged 18 - 35 years.

      Recovery drinks; CONTROL - an isonitrogenous, non-essential amino acid solution; PROTEIN - a
      milk-based whey protein concentrate (WPC), WPC-80; HYDROLYSATE - a hydrolysed derivative of
      WPC-80.

      Day 1, Pre-screening consisting of:

        -  medical history and examination by a clinician

        -  blood sample to be evaluated for health-related contraindications

        -  body composition measurement by dual energy x-ray absorptiometry (DXA) to determine
           whole body and segmental lean tissue mass;

        -  exercise training log (6 month recall);

        -  dietary consultation;

        -  habitual physical activity level assessed by European Physical Activity Questionaire
           (EPAQ)-2

      Day 2 - 8: Participants will be "free-living" during this time. Participants will record
      dietary intake under the guidance of a qualified dietitian and sports nutritionist.

      Day 9 and 10: Participants will complete two familiarisation sessions to the resistance
      exercise and muscle function testing procedures.

      A single blood sample (5ml) will be drawn following o/n fast on each day. On day 2
      participants will drink a metered dose of deuterated water (around 200ml) containing
      deuterium. A saliva sample will be taken before and after consuming this bolus.

      Day 11-17. During this experimental phase diet is prescribed and provided. The diet is based
      on habitual food intake standardized to body mass.

      Day 11: O/n fasted blood, saliva and 1st micro-biopsy of muscle obtained; Muscle function
      measured prior to and upon completion of a prescribed bout of resistance exercise training
      (RET); The recovery drink (0.33 g protein/kg body mass) is ingested; 3 hours following
      completion of RET a 2nd micro-biopsy of muscle is obtained.

      Day 12: O/n fasted blood and saliva is obtained Muscle function measured and recovery drink
      (0.33 g protein/kg body mass) consumed.

      Day 13: O/n fasted blood and saliva is obtained Muscle function measured followed by the 2nd
      RET bout and recovery drink (0.33 g protein/kg body mass) consumed.

      Day 14: O/n fasted blood and saliva is obtained Muscle function measured and recovery drink
      (0.33 g protein/kg body mass) consumed.

      Day 15: O/n fasted blood and saliva is obtained Muscle function measured followed by the 3rd
      RET bout and recovery drink (0.33 g protein/kg body mass) consumed.

      Day 16 O/n fasted blood, saliva and 3rd micro-biopsy of muscle obtained Muscle function
      measured and recovery drink (0.33 g protein/kg body mass) consumed.

      Day 17: O/n fasted blood and saliva is obtained Muscle function measured
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: Block randomised, between group study
primary purpose: Basic Science
masking: Double (Participant, Investigator)
masking description: Double blind (participant and investigator)
measure: Change in Muscle Contractile Function
time frame: Day 9, 10, 11, 12, 13, 14, 15, 16 and 17
description: Maximal Voluntary Contract (MVC) of Knee Extensor Muscle measured by laboratory-based ergometry
measure: Change in Muscle Protein Synthesis
time frame: Day 11 and 16
description: The fractional rate of muscle protein synthesis (MPS) measured by deuterium incorporation into skeletal muscle sampled by microbiopsy
arm group label: CONTROL
arm group type: Sham Comparator
description: Intervention: Dietary Supplement: Non-essential amino acids A group of subjects ingesting a liquid beverage (per kilogram body mass: 0.33g non-essential amino acids dissolved in water ) prior to completion of a prescribed resistance exercise training (RET) session.
Muscle Contractile Function to be conducted prior to and following the RET session by laboratory-based ergometry.
Muscle Protein Synthesis induced by RET to be measured by deuterium incorporation in to skeletal muscle sampled by microbiopsy.
arm group label: PROTEIN
arm group type: Active Comparator
description: Intervention: Dietary Supplement: Whey Protein Concentrate A group of subjects ingesting a liquid beverage (per kilogram body mass: 0.33g of Whey Protein Concentrate dissolved in water ) prior to completion of a prescribed resistance exercise training (RET) session.
Muscle Contractile Function to be conducted prior to and following the RET session by laboratory-based ergometry. Muscle Protein Synthesis induced by RET to be measured by deuterium incorporation in to skeletal muscle sampled by microbiopsy.
arm group label: HYDROLYSATE
arm group type: Active Comparator
description: Intervention: Dietary Supplement: Whey Protein Hydrolysate A group of subjects ingesting a liquid beverage (per kilogram body mass: 0.33g of Whey Protein Hydrolysate dissolved in water ) prior to completion of a prescribed resistance exercise training (RET) session.
Muscle Contractile Function to be conducted prior to and following the RET session by laboratory-based ergometry. Muscle Protein Synthesis induced by RET to be measured by deuterium incorporation in to skeletal muscle sampled by microbiopsy.
intervention type: Dietary Supplement
intervention name: CONTROL
description: Food grade mixture of non-essential amino acids in powdered form, flavoured and instantised to be dissolved in water.
Supplied by Carbery Food Ingredients Limited, Ballineen, Ireland. Product Reference Number 10955
arm group label: CONTROL
intervention type: Dietary Supplement
intervention name: Whey Protein Concentrate
description: Whey protein concentrate in powdered form, flavoured and instantised to be dissolved in water.
Supplied by Carbery Food Ingredients Limited, Ballineen, Ireland. Trade name of product is Carbelac80 Instant Product Reference Number 10431
arm group label: PROTEIN
other name: Carbelac80 Instant
intervention type: Dietary Supplement
intervention name: Whey Protein Hydrolysate
description: Whey protein concentrate hydrolysate (degree of hydrolysate 27%) in powdered form, flavoured and instantised to be dissolved in water.
Supplied by Carbery Food Ingredients Limited, Ballineen, Ireland. Product Reference Number 10468
arm group label: HYDROLYSATE
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Philip M Jakeman, PhD
role: Principal Investigator
affiliation: University of Limerick
last name: Philip M Jakeman, PhD
phone: +35361202800
phone ext: 2800
email: phil.jakeman@ul.ie
last name: Mary Clarke-Moloney, BSc
phone: +35361204230
phone ext: 4230
email: Mary.ClarkMoloney@ul.ie
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Ireland
url: http://FHI.ie
description: Food For Health Ireland National Technology Centre
responsible party type: Principal Investigator
investigator affiliation: University of Limerick
investigator full name: Phil Jakeman
investigator title: Principal Investigator
sharing ipd: No
provided document: 
provided document: 