<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/NCT02968888</url>
  </required_header>
  <id_info>
    <org_study_id>Tine acute</org_study_id>
    <nct_id>NCT02968888</nct_id>
  </id_info>
  <brief_title>Anabolic Effects of Whey and Casein After Strength Training in Young and Elderly</brief_title>
  <official_title>Effects of Whey and Casein Supplementation on Acute Anabolic Responses in Muscle After Strength Training in Young and Elderly</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian School of Sport Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tine</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Research Council of Norway</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Arkansas Children's Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Norwegian School of Sport Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to investigate the acute anabolic effects of native whey, whey&#xD;
      protein concentrate 80 (WPC-80) and milk after a bout of strength training in young and&#xD;
      elderly. The investigators hypothesize that native whey will give a greater stimulation of&#xD;
      muscle protein synthesis and intracellular anabolic signaling than WPC-80, and that WPC-80&#xD;
      will give a stronger stimulus than milk.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Increasing or maintaining muscle mass is of great importance for populations ranging from&#xD;
      athletes to patients and elderly. Resistance exercise and protein ingestion are two of the&#xD;
      most potent stimulators of muscle protein synthesis. Both the physical characteristic of&#xD;
      proteins (e.g. different digestion rates of whey and casein) and the amino acid composition,&#xD;
      affects the potential of a certain protein to stimulate muscle protein synthesis. Given its&#xD;
      superior ability to rapidly increase blood leucine concentrations to high levels, whey is&#xD;
      often considered the most potent protein source to stimulate muscle protein synthesis. Native&#xD;
      whey protein is produced by filtration of unprocessed milk. Consequently, native whey has&#xD;
      different characteristics than WPC-80, which is exposed to heating and acidification. Because&#xD;
      of the direct filtration of unprocessed milk, native whey is a more intact protein compared&#xD;
      with WPC-80. Of special interest is the higher amounts of the highly anabolic amino acid&#xD;
      leucine in native whey.&#xD;
&#xD;
      The higher levels of leucine can be of great interest for elderly individuals as some studies&#xD;
      in elderly has shown an anabolic resistance to the effects of protein feeding and strength&#xD;
      training. By increasing levels of leucine one might overcome this anabolic resistance in the&#xD;
      elderly.&#xD;
&#xD;
      The aim of this double-blinded, randomized, partial cross-over study is to compare the acute&#xD;
      fractional protein synthesis and intracellular signaling response to a bout of strength&#xD;
      training and intake of 20 grams of protein from either native whey, whey protein concentrate&#xD;
      80 or milk, in young and old individuals. Furthermore, the investigators wil investigate&#xD;
      fractional protein breakdown, markers of protein breakdown, amino acid concentrations in&#xD;
      blood.&#xD;
&#xD;
      The investigators hypothesize that native whey will induce a greater anabolic response than&#xD;
      whey protein concentrate 80, and that whey protein concentrate 80 will give a stronger&#xD;
      anabolic response than milk.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">April 2015</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mixed muscle fractional synthetic rate</measure>
    <time_frame>Three to one hours prior to a bout of strength training and protein consumption</time_frame>
    <description>A continous infusion of a stable isotope (phe D5) is used to measure incorporation of tracer into muscle (biopsies from m. vastus lateralis)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mixed muscle fractional synthetic rate</measure>
    <time_frame>One to five hours after a bout of strength training and protein consumption</time_frame>
    <description>A continous infusion of a stable isotope (phe D5) is used to measure incorporation of tracer into muscle (biopsies from m. vastus lateralis)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mixed muscle fractional synthetic rate</measure>
    <time_frame>From three to five hours after a bout of strength training and protein consumption</time_frame>
    <description>Two boluses of tracer (phe13C6 and phe15N) was used to measure incorporation of tracer into muscle (biopsies from m. vastus lateralis)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mixed muscle fractional breakdown rate</measure>
    <time_frame>From three to five hours after a bout of strength training and protein consumption</time_frame>
    <description>Two boluses of tracer (phe13C6 and phe15N) was used to measure the dilution of tracer in muscle (biopsies from m. vastus lateralis)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ratio of phosphorylated to total ribosomal protein S6 kinase beta-1(P70S6K) change from baseline</measure>
    <time_frame>30 min before, 1, 2.5 and 5 hours after training and protein intake</time_frame>
    <description>Biopsies from m. Vastus Lateralis was analyzed by western blot</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phosphorylation of phosphorylated to total eukaryotic elongation factor 2 (eEF-2) change from baseline</measure>
    <time_frame>30 min before, 1, 2.5 and 5 hours after training and protein intake</time_frame>
    <description>Biopsies from m. Vastus Lateralis was analyzed by western blot</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phosphorylation of phosphorylated to total eukaryotic translation initiation factor 4E-binding protein 1 (4EBP-1) change from baseline</measure>
    <time_frame>30 min before, 1, 2.5 and 5 hours after training and protein intake</time_frame>
    <description>Biopsies from m. Vastus Lateralis was analyzed by western blot</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intracellular translocation of forkhead box O3 (FOXO3a) change from baseline</measure>
    <time_frame>30 min before, 1, 2.5 and 5 hours after training and protein intake</time_frame>
    <description>Biopsies from m. Vastus Lateralis was analyzed by western blot</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intracellular translocation of muscle RING-finger protein-1 (Murf-1) change from baseline</measure>
    <time_frame>30 min before, 1, 2.5 and 5 hours after training and protein intake</time_frame>
    <description>Biopsies from m. Vastus Lateralis was analyzed by western blot</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intracellular translocation of Atrogin1 change from baseline</measure>
    <time_frame>30 min before, 1, 2.5 and 5 hours after training and protein intake</time_frame>
    <description>Biopsies from m. Vastus Lateralis was analyzed by western blot</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ubiquitin</measure>
    <time_frame>30 min before, 1, 2.5 and 5 hours after training and protein intake</time_frame>
    <description>Biopsies from m. Vastus Lateralis was analyzed by western blot</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma amino acid concentration</measure>
    <time_frame>180 and 60 min before, and 45, 60, 75, 120, 160, 180, 200, 220 and 300 min after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle force generating capacity change from baseline</measure>
    <time_frame>15 min before, 15 and 300 min after, and 24 hours after training and protein intake</time_frame>
    <description>Measured as unilateral isometric knee extension force (Nm) with 90° in the hip and knee joints.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma glucose</measure>
    <time_frame>180 and 60 min before, and 45, 60, 75, 120, 160, 180, 200, 220 and 300 min after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma insulin</measure>
    <time_frame>180 and 60 min before, and 45, 60, 75, 120, 160, 180, 200, 220 and 300 min after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum urea</measure>
    <time_frame>180 and 60 min before, and 60, 10, 180 and 300 min after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum ureic acid</measure>
    <time_frame>180 and 60 min before, and 60, 10, 180 and 300 min after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum creatine kinase</measure>
    <time_frame>180 and 60 min before, and 60, 10, 180 and 300 min after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in ATP-binding cassette transporter (ABCA1) messenger ribonucleic acid (mRNA)</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in ABCA1 mRNA</measure>
    <time_frame>5 hous after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in BRCA1-A complex subunit Abraxas (ABRA1) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in ABRA1 mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in alfa-actin (ACTA1) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in ACTA1 mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in C-C motif chemokine 2 (CCL2) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in CCL2 mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in C-C motif chemokine 3 (CCL3) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in CCL3 mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in C-C motif chemokine 5 (CCL5) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in CCL5 mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in C-C motif chemokine 8 (CCL8) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in CCL8 mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in platelet glycoprotein 4 (CD36) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in CD36 mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cholesterol 25-hydroxylase (CH25H) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in CH25H mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in granulocyte colony-stimulating factor (CSF3) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in CSF3 mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in C-X-C motif chemokine 16 (CXCL16) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in CXCL16 mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in F-box only protein 32 (FBXO32) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in FBXO32 mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in growth-regulated alpha protein (CXCL1) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in CXCL1 mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in matrix metalloproteinase-9 (MMP9) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in MMP9 mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in forkhead box protein O1 (FOXO1) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in FOXO1 mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in forkhead box protein O3 (FOXO3A) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in FOXO3A mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hepatocyte growth factor (HGF) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HGF mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in insulin-like growth factor I (IGF1) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in IGF1 mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in interleukin-10 (IL10) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in IL10 mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in interleukin-17D (IL17D) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in IL17D mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in interleukin-1B (IL1B) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in IL1B mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in interleukin-1 receptor antagonist protein (IL1RN) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in IL1RN mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in interleukin-6 (IL6) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in IL6 mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in interleukin-8 (IL8) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in IL8 mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in transcription factor jun-B (JUNB) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in JUNB mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in kit ligand (KITLG) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in KITLG mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in myostatin (MSTN) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in MSTN mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in myosin-1 (MYH1) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in MYH1 mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in myosin-2 (MYH2) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in MYH2 mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in myosin-7 (MYH7) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in MYH7 mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in oxysterols receptor LXR-alpha (NR1H3) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in NR1H3 mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in nuclear receptor subfamily 4 group A member 3 (NR4A3) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in NR4A3 mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PPARGC1A) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PPARGC1A mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in prostaglandin G/H synthase 2 (PTGS2) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PTGS2 mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in proton-coupled amino acid transporter 1 (SLC36A1) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SLC36A1 mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in sodium-coupled neutral amino acid transporter 2 (SLC38A2) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SLC38A2 mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 4F2 cell-surface antigen heavy chain (SLC3A2) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SLC3A2 mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in large neutral amino acids transporter small subunit 1 (SLC7A5) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SLC7A5 mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in toll-like receptor 2 (TLR2) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in TLR2 mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in tumor necrosis factor (TNF) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in TNF mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in E3 ubiquitin-protein ligase TRIM63 (TRIM63) mRNA</measure>
    <time_frame>1 hour after training and protein intake</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in E3 ubiquitin-protein ligase TRIM63 (TRIM63) mRNA</measure>
    <time_frame>5 hours after training and protein intake</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Healthy</condition>
  <condition>Young</condition>
  <condition>Elderly</condition>
  <arm_group>
    <arm_group_label>Milk</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants performed a bout of strength training and consumed 20g of milk protein</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Whey protein concentrate 80</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants performed a bout of strength training and consumed 20g of whey protein concentrate 80</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Native whey</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants performed a bout of strength training and consumed 20g of native whey</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Strength training</intervention_name>
    <arm_group_label>Milk</arm_group_label>
    <arm_group_label>Native whey</arm_group_label>
    <arm_group_label>Whey protein concentrate 80</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Milk 1%</intervention_name>
    <arm_group_label>Milk</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Whey protein concentrate 80</intervention_name>
    <arm_group_label>Whey protein concentrate 80</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Native whey</intervention_name>
    <arm_group_label>Native whey</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy in the sense that they can conduct training and testing&#xD;
&#xD;
          -  Able to understand Norwegian language written and oral&#xD;
&#xD;
          -  Between 18 and 45, or above 70 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diseases or injuries contraindicating participation&#xD;
&#xD;
          -  Use of dietary supplements (e.g. proteins, vitamins and creatine)&#xD;
&#xD;
          -  Lactose intolerance&#xD;
&#xD;
          -  Allergy to milk&#xD;
&#xD;
          -  Allergy towards local anesthetics (xylocain)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Norwegian School of Sport Sciences</name>
      <address>
        <city>Oslo</city>
        <zip>0863</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>November 10, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>April 9, 2018</last_update_submitted>
  <last_update_submitted_qc>April 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Norwegian School of Sport Sciences</investigator_affiliation>
    <investigator_full_name>Havard Hamarsland</investigator_full_name>
    <investigator_title>PhD student</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02968888
org study id: Tine acute
nct id: NCT02968888
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The aim of this study is to investigate the acute anabolic effects of native whey, whey
      protein concentrate 80 (WPC-80) and milk after a bout of strength training in young and
      elderly. The investigators hypothesize that native whey will give a greater stimulation of
      muscle protein synthesis and intracellular anabolic signaling than WPC-80, and that WPC-80
      will give a stronger stimulus than milk.
Increasing or maintaining muscle mass is of great importance for populations ranging from
      athletes to patients and elderly. Resistance exercise and protein ingestion are two of the
      most potent stimulators of muscle protein synthesis. Both the physical characteristic of
      proteins (e.g. different digestion rates of whey and casein) and the amino acid composition,
      affects the potential of a certain protein to stimulate muscle protein synthesis. Given its
      superior ability to rapidly increase blood leucine concentrations to high levels, whey is
      often considered the most potent protein source to stimulate muscle protein synthesis. Native
      whey protein is produced by filtration of unprocessed milk. Consequently, native whey has
      different characteristics than WPC-80, which is exposed to heating and acidification. Because
      of the direct filtration of unprocessed milk, native whey is a more intact protein compared
      with WPC-80. Of special interest is the higher amounts of the highly anabolic amino acid
      leucine in native whey.

      The higher levels of leucine can be of great interest for elderly individuals as some studies
      in elderly has shown an anabolic resistance to the effects of protein feeding and strength
      training. By increasing levels of leucine one might overcome this anabolic resistance in the
      elderly.

      The aim of this double-blinded, randomized, partial cross-over study is to compare the acute
      fractional protein synthesis and intracellular signaling response to a bout of strength
      training and intake of 20 grams of protein from either native whey, whey protein concentrate
      80 or milk, in young and old individuals. Furthermore, the investigators wil investigate
      fractional protein breakdown, markers of protein breakdown, amino acid concentrations in
      blood.

      The investigators hypothesize that native whey will induce a greater anabolic response than
      whey protein concentrate 80, and that whey protein concentrate 80 will give a stronger
      anabolic response than milk.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Mixed muscle fractional synthetic rate
time frame: Three to one hours prior to a bout of strength training and protein consumption
description: A continous infusion of a stable isotope (phe D5) is used to measure incorporation of tracer into muscle (biopsies from m. vastus lateralis)
measure: Mixed muscle fractional synthetic rate
time frame: One to five hours after a bout of strength training and protein consumption
description: A continous infusion of a stable isotope (phe D5) is used to measure incorporation of tracer into muscle (biopsies from m. vastus lateralis)
measure: Mixed muscle fractional synthetic rate
time frame: From three to five hours after a bout of strength training and protein consumption
description: Two boluses of tracer (phe13C6 and phe15N) was used to measure incorporation of tracer into muscle (biopsies from m. vastus lateralis)
measure: Mixed muscle fractional breakdown rate
time frame: From three to five hours after a bout of strength training and protein consumption
description: Two boluses of tracer (phe13C6 and phe15N) was used to measure the dilution of tracer in muscle (biopsies from m. vastus lateralis)
measure: Ratio of phosphorylated to total ribosomal protein S6 kinase beta-1(P70S6K) change from baseline
time frame: 30 min before, 1, 2.5 and 5 hours after training and protein intake
description: Biopsies from m. Vastus Lateralis was analyzed by western blot
measure: Phosphorylation of phosphorylated to total eukaryotic elongation factor 2 (eEF-2) change from baseline
time frame: 30 min before, 1, 2.5 and 5 hours after training and protein intake
description: Biopsies from m. Vastus Lateralis was analyzed by western blot
measure: Phosphorylation of phosphorylated to total eukaryotic translation initiation factor 4E-binding protein 1 (4EBP-1) change from baseline
time frame: 30 min before, 1, 2.5 and 5 hours after training and protein intake
description: Biopsies from m. Vastus Lateralis was analyzed by western blot
measure: Intracellular translocation of forkhead box O3 (FOXO3a) change from baseline
time frame: 30 min before, 1, 2.5 and 5 hours after training and protein intake
description: Biopsies from m. Vastus Lateralis was analyzed by western blot
measure: Intracellular translocation of muscle RING-finger protein-1 (Murf-1) change from baseline
time frame: 30 min before, 1, 2.5 and 5 hours after training and protein intake
description: Biopsies from m. Vastus Lateralis was analyzed by western blot
measure: Intracellular translocation of Atrogin1 change from baseline
time frame: 30 min before, 1, 2.5 and 5 hours after training and protein intake
description: Biopsies from m. Vastus Lateralis was analyzed by western blot
measure: Ubiquitin
time frame: 30 min before, 1, 2.5 and 5 hours after training and protein intake
description: Biopsies from m. Vastus Lateralis was analyzed by western blot
measure: Plasma amino acid concentration
time frame: 180 and 60 min before, and 45, 60, 75, 120, 160, 180, 200, 220 and 300 min after training and protein intake
measure: Muscle force generating capacity change from baseline
time frame: 15 min before, 15 and 300 min after, and 24 hours after training and protein intake
description: Measured as unilateral isometric knee extension force (Nm) with 90° in the hip and knee joints.
measure: Plasma glucose
time frame: 180 and 60 min before, and 45, 60, 75, 120, 160, 180, 200, 220 and 300 min after training and protein intake
measure: Plasma insulin
time frame: 180 and 60 min before, and 45, 60, 75, 120, 160, 180, 200, 220 and 300 min after training and protein intake
measure: Serum urea
time frame: 180 and 60 min before, and 60, 10, 180 and 300 min after training and protein intake
measure: Serum ureic acid
time frame: 180 and 60 min before, and 60, 10, 180 and 300 min after training and protein intake
measure: Serum creatine kinase
time frame: 180 and 60 min before, and 60, 10, 180 and 300 min after training and protein intake
measure: Change in ATP-binding cassette transporter (ABCA1) messenger ribonucleic acid (mRNA)
time frame: 1 hour after training and protein intake
measure: Change in ABCA1 mRNA
time frame: 5 hous after training and protein intake
measure: Change in BRCA1-A complex subunit Abraxas (ABRA1) mRNA
time frame: 1 hour after training and protein intake
measure: Change in ABRA1 mRNA
time frame: 5 hours after training and protein intake
measure: Change in alfa-actin (ACTA1) mRNA
time frame: 1 hour after training and protein intake
measure: Change in ACTA1 mRNA
time frame: 5 hours after training and protein intake
measure: Change in C-C motif chemokine 2 (CCL2) mRNA
time frame: 1 hour after training and protein intake
measure: Change in CCL2 mRNA
time frame: 5 hours after training and protein intake
measure: Change in C-C motif chemokine 3 (CCL3) mRNA
time frame: 1 hour after training and protein intake
measure: Change in CCL3 mRNA
time frame: 5 hours after training and protein intake
measure: Change in C-C motif chemokine 5 (CCL5) mRNA
time frame: 1 hour after training and protein intake
measure: Change in CCL5 mRNA
time frame: 5 hours after training and protein intake
measure: Change in C-C motif chemokine 8 (CCL8) mRNA
time frame: 1 hour after training and protein intake
measure: Change in CCL8 mRNA
time frame: 5 hours after training and protein intake
measure: Change in platelet glycoprotein 4 (CD36) mRNA
time frame: 1 hour after training and protein intake
measure: Change in CD36 mRNA
time frame: 5 hours after training and protein intake
measure: Change in cholesterol 25-hydroxylase (CH25H) mRNA
time frame: 1 hour after training and protein intake
measure: Change in CH25H mRNA
time frame: 5 hours after training and protein intake
measure: Change in granulocyte colony-stimulating factor (CSF3) mRNA
time frame: 1 hour after training and protein intake
measure: Change in CSF3 mRNA
time frame: 5 hours after training and protein intake
measure: Change in C-X-C motif chemokine 16 (CXCL16) mRNA
time frame: 1 hour after training and protein intake
measure: Change in CXCL16 mRNA
time frame: 5 hours after training and protein intake
measure: Change in F-box only protein 32 (FBXO32) mRNA
time frame: 1 hour after training and protein intake
measure: Change in FBXO32 mRNA
time frame: 5 hours after training and protein intake
measure: Change in growth-regulated alpha protein (CXCL1) mRNA
time frame: 1 hour after training and protein intake
measure: Change in CXCL1 mRNA
time frame: 5 hours after training and protein intake
measure: Change in matrix metalloproteinase-9 (MMP9) mRNA
time frame: 1 hour after training and protein intake
measure: Change in MMP9 mRNA
time frame: 5 hours after training and protein intake
measure: Change in forkhead box protein O1 (FOXO1) mRNA
time frame: 1 hour after training and protein intake
measure: Change in FOXO1 mRNA
time frame: 5 hours after training and protein intake
measure: Change in forkhead box protein O3 (FOXO3A) mRNA
time frame: 1 hour after training and protein intake
measure: Change in FOXO3A mRNA
time frame: 5 hours after training and protein intake
measure: Change in hepatocyte growth factor (HGF) mRNA
time frame: 1 hour after training and protein intake
measure: Change in HGF mRNA
time frame: 5 hours after training and protein intake
measure: Change in insulin-like growth factor I (IGF1) mRNA
time frame: 1 hour after training and protein intake
measure: Change in IGF1 mRNA
time frame: 5 hours after training and protein intake
measure: Change in interleukin-10 (IL10) mRNA
time frame: 1 hour after training and protein intake
measure: Change in IL10 mRNA
time frame: 5 hours after training and protein intake
measure: Change in interleukin-17D (IL17D) mRNA
time frame: 1 hour after training and protein intake
measure: Change in IL17D mRNA
time frame: 5 hours after training and protein intake
measure: Change in interleukin-1B (IL1B) mRNA
time frame: 1 hour after training and protein intake
measure: Change in IL1B mRNA
time frame: 5 hours after training and protein intake
measure: Change in interleukin-1 receptor antagonist protein (IL1RN) mRNA
time frame: 1 hour after training and protein intake
measure: Change in IL1RN mRNA
time frame: 5 hours after training and protein intake
measure: Change in interleukin-6 (IL6) mRNA
time frame: 1 hour after training and protein intake
measure: Change in IL6 mRNA
time frame: 5 hours after training and protein intake
measure: Change in interleukin-8 (IL8) mRNA
time frame: 1 hour after training and protein intake
measure: Change in IL8 mRNA
time frame: 5 hours after training and protein intake
measure: Change in transcription factor jun-B (JUNB) mRNA
time frame: 1 hour after training and protein intake
measure: Change in JUNB mRNA
time frame: 5 hours after training and protein intake
measure: Change in kit ligand (KITLG) mRNA
time frame: 1 hour after training and protein intake
measure: Change in KITLG mRNA
time frame: 5 hours after training and protein intake
measure: Change in myostatin (MSTN) mRNA
time frame: 1 hour after training and protein intake
measure: Change in MSTN mRNA
time frame: 5 hours after training and protein intake
measure: Change in myosin-1 (MYH1) mRNA
time frame: 1 hour after training and protein intake
measure: Change in MYH1 mRNA
time frame: 5 hours after training and protein intake
measure: Change in myosin-2 (MYH2) mRNA
time frame: 1 hour after training and protein intake
measure: Change in MYH2 mRNA
time frame: 5 hours after training and protein intake
measure: Change in myosin-7 (MYH7) mRNA
time frame: 1 hour after training and protein intake
measure: Change in MYH7 mRNA
time frame: 5 hours after training and protein intake
measure: Change in oxysterols receptor LXR-alpha (NR1H3) mRNA
time frame: 1 hour after training and protein intake
measure: Change in NR1H3 mRNA
time frame: 5 hours after training and protein intake
measure: Change in nuclear receptor subfamily 4 group A member 3 (NR4A3) mRNA
time frame: 1 hour after training and protein intake
measure: Change in NR4A3 mRNA
time frame: 5 hours after training and protein intake
measure: Change in peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PPARGC1A) mRNA
time frame: 1 hour after training and protein intake
measure: Change in PPARGC1A mRNA
time frame: 5 hours after training and protein intake
measure: Change in prostaglandin G/H synthase 2 (PTGS2) mRNA
time frame: 1 hour after training and protein intake
measure: Change in PTGS2 mRNA
time frame: 5 hours after training and protein intake
measure: Change in proton-coupled amino acid transporter 1 (SLC36A1) mRNA
time frame: 1 hour after training and protein intake
measure: Change in SLC36A1 mRNA
time frame: 5 hours after training and protein intake
measure: Change in sodium-coupled neutral amino acid transporter 2 (SLC38A2) mRNA
time frame: 1 hour after training and protein intake
measure: Change in SLC38A2 mRNA
time frame: 5 hours after training and protein intake
measure: Change in 4F2 cell-surface antigen heavy chain (SLC3A2) mRNA
time frame: 1 hour after training and protein intake
measure: Change in SLC3A2 mRNA
time frame: 5 hours after training and protein intake
measure: Change in large neutral amino acids transporter small subunit 1 (SLC7A5) mRNA
time frame: 1 hour after training and protein intake
measure: Change in SLC7A5 mRNA
time frame: 5 hours after training and protein intake
measure: Change in toll-like receptor 2 (TLR2) mRNA
time frame: 1 hour after training and protein intake
measure: Change in TLR2 mRNA
time frame: 5 hours after training and protein intake
measure: Change in tumor necrosis factor (TNF) mRNA
time frame: 1 hour after training and protein intake
measure: Change in TNF mRNA
time frame: 5 hours after training and protein intake
measure: Change in E3 ubiquitin-protein ligase TRIM63 (TRIM63) mRNA
time frame: 1 hour after training and protein intake
measure: Change in E3 ubiquitin-protein ligase TRIM63 (TRIM63) mRNA
time frame: 5 hours after training and protein intake
arm group label: Milk
arm group type: Placebo Comparator
description: Participants performed a bout of strength training and consumed 20g of milk protein
arm group label: Whey protein concentrate 80
arm group type: Experimental
description: Participants performed a bout of strength training and consumed 20g of whey protein concentrate 80
arm group label: Native whey
arm group type: Experimental
description: Participants performed a bout of strength training and consumed 20g of native whey
intervention type: Other
intervention name: Strength training
arm group label: Milk
arm group label: Native whey
arm group label: Whey protein concentrate 80
intervention type: Dietary Supplement
intervention name: Milk 1%
arm group label: Milk
intervention type: Dietary Supplement
intervention name: Whey protein concentrate 80
arm group label: Whey protein concentrate 80
intervention type: Dietary Supplement
intervention name: Native whey
arm group label: Native whey
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Norwegian School of Sport Sciences
investigator full name: Havard Hamarsland
investigator title: PhD student
sharing ipd: Undecided