<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/NCT03753321</url>
  </required_header>
  <id_info>
    <org_study_id>WHEY vs SOY PROTEIN - UTH</org_study_id>
    <nct_id>NCT03753321</nct_id>
  </id_info>
  <brief_title>Whey and Soy Protein Supplementation in Football Players</brief_title>
  <official_title>Comparison of the Effect of Whey and Soy Protein Supplementation on Muscle Damage Markers and Performance After a Speed Endurance Training Protocol in Football Players</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Thessaly</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Thessaly</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      In a constant effort to find ways to make a quicker recovery between demanding workouts and&#xD;
      football matches, this study is the first to investigate the benefits of protein&#xD;
      supplementation, and compares two types of proteins, an animal-derived (whey) and a&#xD;
      plant-derived (soy) protein, after an exercise-induced muscle injury caused by a speed&#xD;
      endurance training protocol. Soy protein could be a cheaper and more environment-friendly&#xD;
      alternative for athletes involved in high-velocity strength training.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized, three-trial (placebo vs. whey protein isolate vs. soy protein isolate&#xD;
      consumption), cross-over, double-blind design.&#xD;
&#xD;
        1. Baseline performance testing: Initially, volunteers will participate in a performance&#xD;
           testing procedure at University facilities. These measurements include:&#xD;
&#xD;
           A) measurement of descriptor variables: a) body composition (DXA), b) VO2max, c) Yo-Yo&#xD;
           intermittent endurance level 2 (Yo-Yo IE2), d) Yo-Yo intermittent recovery test level 2&#xD;
           (Yo-Yo IR2), e) technical skill level, f) daily dietary intake profile (over a 7-day&#xD;
           period), g) gabitual physical activity level (over a 7-day period) and h) resting&#xD;
           mtabolic rate (RMR).&#xD;
&#xD;
           B) Measurement of dependent variables: a) isokinetic strength (concentric, eccentric)&#xD;
           and maximal voluntary isometric contraction (MVIC) of knee extensors and flexors of both&#xD;
           lower limbs, b) counter movement jump height (CMJ), c) repeated sprint ability (RSA), d)&#xD;
           speed (10 and 30 m), e) delayed onset of muscle soreness (DOMS), f) blood sampling for&#xD;
           measurement of lactate concentration, creatine kinase activity (CK) and inflammatory&#xD;
           markers [i.e.Glutathione (GSH), total antioxidant capacity (TAC) and protein carbonyls&#xD;
           (PC)].&#xD;
&#xD;
        2. A 1-week adaptive period: based on a dietary analysis, participants will be given a&#xD;
           dietary plan [taking into account the resting metabolic rate (RMR) and total daily&#xD;
           physical activity related energy expenditure], providing a standard protein intake of&#xD;
           0.8-1 g protein/kg/day over the 1-week adaptive period. This protein intake is accepted&#xD;
           as the average and population-safe protein intake during periods of very low physical&#xD;
           activity and/or exercise levels. RMR, daily dietary intake and physical activity will be&#xD;
           measured before the adaptive period. Familiarization with the training protocol will&#xD;
           take place during this phase.&#xD;
&#xD;
        3. Participants will randomly participate in three trials including: whey protein (WP), soy&#xD;
           protein (SP) and placebo (PL) supplementation:&#xD;
&#xD;
             -  A 7-day pre-loading phase: A 7-day pre-loading phase will be applied prior to each&#xD;
                trial, during which volunteers will receive the respective supplement (placebo,&#xD;
                whey protein or soy protein). In WP and SP trials, participants will consume daily&#xD;
                the appropriate amount of protein to reach a total protein intake of 1.5 g&#xD;
                protein/kg body weight (BW).&#xD;
&#xD;
             -  On the 7th day (end of pre-loading phase), participants will repeat performance&#xD;
                testing (assessment of all dependent variables according to baseline testing) and&#xD;
                blood sampling.&#xD;
&#xD;
             -  On the 8th day, participants will perform the speed-endurance production training&#xD;
                (SEPT) session 1 (1st trial). During training, participants internal (heart rate)&#xD;
                and external load (total distance, speed zones, acceleration and decelerations,&#xD;
                impacts) will be continuously monitored using heart rate monitors and global&#xD;
                positioning system (GPS) instrumentation.&#xD;
&#xD;
             -  Immediately after the training protocol: Determination of blood lactate&#xD;
                concentration (3-4 minutes post-training) and assessment of MVIC (1 hour, 2 hours&#xD;
                and 3 hours post-training).&#xD;
&#xD;
             -  1-Day post-training (9th day; 24 hours post-training): Blood sampling (for the&#xD;
                determination of CK, GSH, TAC and PC) and measurement of dependent variables (i.e.&#xD;
                isokinetic strength, MVIC, Speed, RSA, CMJ and DOMS).&#xD;
&#xD;
             -  2-Days post-training (10th day; 48 hours post-training): Blood sampling (for the&#xD;
                determination of CK, GSH, TAC and PC) and assessment of DOMS. Thereafter, the SEPT&#xD;
                session 2 will take place during which the particpants' internal and external load&#xD;
                will be continuously monitored (as described in SEPT session 1).&#xD;
&#xD;
        4. Wash-out period: 2-week without any activity or supplementation.&#xD;
&#xD;
        5. 2nd trial: repeat of stages 3 and 4.&#xD;
&#xD;
        6. 3rd trial: repeat of stage 3.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 8, 2018</start_date>
  <completion_date type="Actual">February 20, 2019</completion_date>
  <primary_completion_date type="Actual">January 20, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in field activity during the speed-endurance production training (SEPT)</measure>
    <time_frame>Throughout the SEPT sessions in all trials</time_frame>
    <description>Field activity will be continuously recorded during both SEPT sessions using global positioning system (GPS) technology</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in heart rate during the speed-endurance production training (SEPT)</measure>
    <time_frame>Throughout the SEPT sessions in all trials</time_frame>
    <description>Heart rate will be continuously recorded during both SEPT sessions using heart rate monitors.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in creatine kinase in plasma</measure>
    <time_frame>Baseline; Post-loading (Day 7); 24 hours (Day 9) and 48 hours (Day 10) following SEPT session 1.</time_frame>
    <description>Concentration of creatine kinase will be measured in plasma</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in repeated sprint ability (RSA)</measure>
    <time_frame>Baseline; Post-loading (Day 7); 24 hours (Day 9) following SEPT session 1</time_frame>
    <description>5 x 30 m sprints will be performed with 25 seconds rest in-between</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in countermovement jump (jump height in centimeters)</measure>
    <time_frame>Baseline; Post-loading (Day 7); 24 hours (Day 9) following SEPT session 1</time_frame>
    <description>Countermovement jump will be assessed on a contact platform</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in isokinetic strength of lower limbs</measure>
    <time_frame>Baseline; Post-loading (Day 7); 24 hours (Day 9) following SEPT session 1</time_frame>
    <description>Isokinetic strength will be assessed on an isokinetic dynamometer for both knee extensors and knee flexors at 60 degrees.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in maximal voluntary isometric contraction (MVIC) of lower limbs</measure>
    <time_frame>Baseline; Post-loading (Day 7); 1, 2 and 3 hours post-SEPT session 1; 24 hours (Day 9) and 48 hours (Day 10) following SEPT session 1.</time_frame>
    <description>MVIC will be assessed on an isokinetic dynamometer for knee extensors at 90 degrees and knee flexors at 30 degrees</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in delayed onset of muscle soreness</measure>
    <time_frame>Baseline; Post-loading (Day 7); 24 hours (Day 9) and 48 hours (Day 10) following SEPT session 1.</time_frame>
    <description>Muscle soreness will assessed during palpation of the muscle belly and the distal region of relaxed vastus medialis, vastus lateralis and rectus femoris following three repetitions of of a full squat. Subjects will rate their DOMS on a visual analogue scale (0-10). A score of O indicates no sign or symptom of DOMS, a score of 10 indicated severe signs and symptoms of delayed onset muscle soreness (DOMS). These signs and symptoms include dull, diffuse pain and tenderness; stiffness; swelling; and decreased strength of the exercised muscle.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in total antioxidant capacity in plasma</measure>
    <time_frame>Baseline; Post-loading (Day 7); 24 hours (Day 9) and 48 hours (Day 10) following SEPT session 1.</time_frame>
    <description>Total antioxidant capacity will be measured in plasma</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in protein carbonyl levels in plasma</measure>
    <time_frame>Baseline; Post-loading (Day 7); 24 hours (Day 9) and 48 hours (Day 10) following SEPT session 1.</time_frame>
    <description>Protein carbonyl levels will be measured in plasma</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in GSH levels in red blood cell lysate</measure>
    <time_frame>Baseline; Post-loading (Day 7); 24 hours (Day 9) and 48 hours (Day 10) following SEPT session 1.</time_frame>
    <description>GSH will be measured in red blood cell lysate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in sprint time</measure>
    <time_frame>Baseline; Post-loading (Day 7); 24 hours (Day 9) following SEPT session 1</time_frame>
    <description>Sprint time will be assessed over a 10m and 30m distance using light cells.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dietary intake</measure>
    <time_frame>Over a 7-day period at baseline.</time_frame>
    <description>Dietary intake will be assessed using 7-day diet recalls.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of blood lactate</measure>
    <time_frame>Pre- and Post-SEPT session 1 (Day 8), Pre- and Post-SEPT session 2 (Day 10)</time_frame>
    <description>Blood lactate will be measured using an automatic analyzer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in habitual physical activity</measure>
    <time_frame>Over a 7-day period at baseline</time_frame>
    <description>Physical activity will be measured using 3-axial accelerometers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in resting metabolic rate (RMR)</measure>
    <time_frame>At baseline.</time_frame>
    <description>RMR will be measured using open-circuit indirect calorimeter with a ventilated hood system, after an overnight fast.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body composition</measure>
    <time_frame>At baseline.</time_frame>
    <description>Body composition will be assessed using dual-energy X-ray absorptiometry (DXA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in maximal oxygen uptake</measure>
    <time_frame>At baseline.</time_frame>
    <description>Maximal oxygen uptake (VO2max) will be measured during a graded exercise testing on a treadmill, by using open-circuit spirometry with an automated online pulmonary gas exchange system, via breath-by-breath analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in soccer-specific conditioning.</measure>
    <time_frame>At baseline.</time_frame>
    <description>Soccer-specific conditioning will be assessed using the the Yo-Yo intermittent endurance level 2 test (Yo-Yo IE2) and the Yo-Yo intermittent recovery level 2 test (Yo-Yo IR2).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Skeletal Muscle Damage</condition>
  <condition>Muscle Damage</condition>
  <condition>Athletic Performance</condition>
  <arm_group>
    <arm_group_label>Whey protein</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Whey protein isolate supplementation (7 day pre-loading phase and 3 day training phase). The protein dose will be individually adjusted to reach a total protein intake of 1.5 g protein/kg body mass/day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Soy protein</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Soy protein isolate supplementation (7 day pre-loading phase and 3 day training phase). The protein dose will be individually adjusted to reach a total protein intake of 1.5 g protein/kg body mass/day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (maltodextrin)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Isoenergetic, maltodextrin (7 day pre-loading phase and 3 day training phase)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Whey protein</intervention_name>
    <description>Whey protein isolate supplementation, individually adjusted to reach a total protein intake of 1.5 g/kg body weight/day for 10 days (7 days pre-loading and 3 days during trials 1 and 2)</description>
    <arm_group_label>Whey protein</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Soy protein</intervention_name>
    <description>Soy protein isolate supplementation, individually adjusted to reach a total protein intake of 1.5 g/kg body weight/day for 10 days (7 days pre-loading and 3 days during trials 1 and 2)</description>
    <arm_group_label>Soy protein</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo (maltodextrin)</intervention_name>
    <description>Isoenergetic placebo (maltodextrin) for 10 days (7 days pre-loading and 3 days during trials 1 and 2</description>
    <arm_group_label>Placebo (maltodextrin)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Playing at a competitive level (top three divisions) for ≥3 years&#xD;
&#xD;
          -  Free of any recent history of illnesses, musculoskeletal problems and metabolic&#xD;
             diseases&#xD;
&#xD;
          -  No use of supplements and medications (for ≤6 months prior to the study)&#xD;
&#xD;
          -  Non-smokers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A known milk intolerance or allergy&#xD;
&#xD;
          -  A recent febrile illness&#xD;
&#xD;
          -  History of muscle lesion&#xD;
&#xD;
          -  Lower limb trauma&#xD;
&#xD;
          -  Metabolic diseases.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Savvas Kritikos, MScc</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION &amp; SPORTS SCIENCES</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Exercise Biochemistry Laboratory, School of Physical Education &amp; Sports Sciences, University of Thessaly</name>
      <address>
        <city>Tríkala</city>
        <zip>42100</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>October 12, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>November 23, 2020</last_update_submitted>
  <last_update_submitted_qc>November 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Thessaly</investigator_affiliation>
    <investigator_full_name>Ioannis G. Fatouros</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT03753321
org study id: WHEY vs SOY PROTEIN - UTH
nct id: NCT03753321
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In a constant effort to find ways to make a quicker recovery between demanding workouts and
      football matches, this study is the first to investigate the benefits of protein
      supplementation, and compares two types of proteins, an animal-derived (whey) and a
      plant-derived (soy) protein, after an exercise-induced muscle injury caused by a speed
      endurance training protocol. Soy protein could be a cheaper and more environment-friendly
      alternative for athletes involved in high-velocity strength training.
A randomized, three-trial (placebo vs. whey protein isolate vs. soy protein isolate
      consumption), cross-over, double-blind design.

        1. Baseline performance testing: Initially, volunteers will participate in a performance
           testing procedure at University facilities. These measurements include:

           A) measurement of descriptor variables: a) body composition (DXA), b) VO2max, c) Yo-Yo
           intermittent endurance level 2 (Yo-Yo IE2), d) Yo-Yo intermittent recovery test level 2
           (Yo-Yo IR2), e) technical skill level, f) daily dietary intake profile (over a 7-day
           period), g) gabitual physical activity level (over a 7-day period) and h) resting
           mtabolic rate (RMR).

           B) Measurement of dependent variables: a) isokinetic strength (concentric, eccentric)
           and maximal voluntary isometric contraction (MVIC) of knee extensors and flexors of both
           lower limbs, b) counter movement jump height (CMJ), c) repeated sprint ability (RSA), d)
           speed (10 and 30 m), e) delayed onset of muscle soreness (DOMS), f) blood sampling for
           measurement of lactate concentration, creatine kinase activity (CK) and inflammatory
           markers [i.e.Glutathione (GSH), total antioxidant capacity (TAC) and protein carbonyls
           (PC)].

        2. A 1-week adaptive period: based on a dietary analysis, participants will be given a
           dietary plan [taking into account the resting metabolic rate (RMR) and total daily
           physical activity related energy expenditure], providing a standard protein intake of
           0.8-1 g protein/kg/day over the 1-week adaptive period. This protein intake is accepted
           as the average and population-safe protein intake during periods of very low physical
           activity and/or exercise levels. RMR, daily dietary intake and physical activity will be
           measured before the adaptive period. Familiarization with the training protocol will
           take place during this phase.

        3. Participants will randomly participate in three trials including: whey protein (WP), soy
           protein (SP) and placebo (PL) supplementation:

             -  A 7-day pre-loading phase: A 7-day pre-loading phase will be applied prior to each
                trial, during which volunteers will receive the respective supplement (placebo,
                whey protein or soy protein). In WP and SP trials, participants will consume daily
                the appropriate amount of protein to reach a total protein intake of 1.5 g
                protein/kg body weight (BW).

             -  On the 7th day (end of pre-loading phase), participants will repeat performance
                testing (assessment of all dependent variables according to baseline testing) and
                blood sampling.

             -  On the 8th day, participants will perform the speed-endurance production training
                (SEPT) session 1 (1st trial). During training, participants internal (heart rate)
                and external load (total distance, speed zones, acceleration and decelerations,
                impacts) will be continuously monitored using heart rate monitors and global
                positioning system (GPS) instrumentation.

             -  Immediately after the training protocol: Determination of blood lactate
                concentration (3-4 minutes post-training) and assessment of MVIC (1 hour, 2 hours
                and 3 hours post-training).

             -  1-Day post-training (9th day; 24 hours post-training): Blood sampling (for the
                determination of CK, GSH, TAC and PC) and measurement of dependent variables (i.e.
                isokinetic strength, MVIC, Speed, RSA, CMJ and DOMS).

             -  2-Days post-training (10th day; 48 hours post-training): Blood sampling (for the
                determination of CK, GSH, TAC and PC) and assessment of DOMS. Thereafter, the SEPT
                session 2 will take place during which the particpants' internal and external load
                will be continuously monitored (as described in SEPT session 1).

        4. Wash-out period: 2-week without any activity or supplementation.

        5. 2nd trial: repeat of stages 3 and 4.

        6. 3rd trial: repeat of stage 3.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Change in field activity during the speed-endurance production training (SEPT)
time frame: Throughout the SEPT sessions in all trials
description: Field activity will be continuously recorded during both SEPT sessions using global positioning system (GPS) technology
measure: Change in heart rate during the speed-endurance production training (SEPT)
time frame: Throughout the SEPT sessions in all trials
description: Heart rate will be continuously recorded during both SEPT sessions using heart rate monitors.
measure: Change in creatine kinase in plasma
time frame: Baseline; Post-loading (Day 7); 24 hours (Day 9) and 48 hours (Day 10) following SEPT session 1.
description: Concentration of creatine kinase will be measured in plasma
measure: Change in repeated sprint ability (RSA)
time frame: Baseline; Post-loading (Day 7); 24 hours (Day 9) following SEPT session 1
description: 5 x 30 m sprints will be performed with 25 seconds rest in-between
measure: Change in countermovement jump (jump height in centimeters)
time frame: Baseline; Post-loading (Day 7); 24 hours (Day 9) following SEPT session 1
description: Countermovement jump will be assessed on a contact platform
measure: Change in isokinetic strength of lower limbs
time frame: Baseline; Post-loading (Day 7); 24 hours (Day 9) following SEPT session 1
description: Isokinetic strength will be assessed on an isokinetic dynamometer for both knee extensors and knee flexors at 60 degrees.
measure: Change in maximal voluntary isometric contraction (MVIC) of lower limbs
time frame: Baseline; Post-loading (Day 7); 1, 2 and 3 hours post-SEPT session 1; 24 hours (Day 9) and 48 hours (Day 10) following SEPT session 1.
description: MVIC will be assessed on an isokinetic dynamometer for knee extensors at 90 degrees and knee flexors at 30 degrees
measure: Change in delayed onset of muscle soreness
time frame: Baseline; Post-loading (Day 7); 24 hours (Day 9) and 48 hours (Day 10) following SEPT session 1.
description: Muscle soreness will assessed during palpation of the muscle belly and the distal region of relaxed vastus medialis, vastus lateralis and rectus femoris following three repetitions of of a full squat. Subjects will rate their DOMS on a visual analogue scale (0-10). A score of O indicates no sign or symptom of DOMS, a score of 10 indicated severe signs and symptoms of delayed onset muscle soreness (DOMS). These signs and symptoms include dull, diffuse pain and tenderness; stiffness; swelling; and decreased strength of the exercised muscle.
measure: Change in total antioxidant capacity in plasma
time frame: Baseline; Post-loading (Day 7); 24 hours (Day 9) and 48 hours (Day 10) following SEPT session 1.
description: Total antioxidant capacity will be measured in plasma
measure: Change in protein carbonyl levels in plasma
time frame: Baseline; Post-loading (Day 7); 24 hours (Day 9) and 48 hours (Day 10) following SEPT session 1.
description: Protein carbonyl levels will be measured in plasma
measure: Change in GSH levels in red blood cell lysate
time frame: Baseline; Post-loading (Day 7); 24 hours (Day 9) and 48 hours (Day 10) following SEPT session 1.
description: GSH will be measured in red blood cell lysate
measure: Change in sprint time
time frame: Baseline; Post-loading (Day 7); 24 hours (Day 9) following SEPT session 1
description: Sprint time will be assessed over a 10m and 30m distance using light cells.
measure: Dietary intake
time frame: Over a 7-day period at baseline.
description: Dietary intake will be assessed using 7-day diet recalls.
measure: Concentration of blood lactate
time frame: Pre- and Post-SEPT session 1 (Day 8), Pre- and Post-SEPT session 2 (Day 10)
description: Blood lactate will be measured using an automatic analyzer
measure: Change in habitual physical activity
time frame: Over a 7-day period at baseline
description: Physical activity will be measured using 3-axial accelerometers
measure: Change in resting metabolic rate (RMR)
time frame: At baseline.
description: RMR will be measured using open-circuit indirect calorimeter with a ventilated hood system, after an overnight fast.
measure: Change in body composition
time frame: At baseline.
description: Body composition will be assessed using dual-energy X-ray absorptiometry (DXA).
measure: Change in maximal oxygen uptake
time frame: At baseline.
description: Maximal oxygen uptake (VO2max) will be measured during a graded exercise testing on a treadmill, by using open-circuit spirometry with an automated online pulmonary gas exchange system, via breath-by-breath analysis.
measure: Change in soccer-specific conditioning.
time frame: At baseline.
description: Soccer-specific conditioning will be assessed using the the Yo-Yo intermittent endurance level 2 test (Yo-Yo IE2) and the Yo-Yo intermittent recovery level 2 test (Yo-Yo IR2).
arm group label: Whey protein
arm group type: Experimental
description: Whey protein isolate supplementation (7 day pre-loading phase and 3 day training phase). The protein dose will be individually adjusted to reach a total protein intake of 1.5 g protein/kg body mass/day.
arm group label: Soy protein
arm group type: Experimental
description: Soy protein isolate supplementation (7 day pre-loading phase and 3 day training phase). The protein dose will be individually adjusted to reach a total protein intake of 1.5 g protein/kg body mass/day.
arm group label: Placebo (maltodextrin)
arm group type: Placebo Comparator
description: Isoenergetic, maltodextrin (7 day pre-loading phase and 3 day training phase)
intervention type: Dietary Supplement
intervention name: Whey protein
description: Whey protein isolate supplementation, individually adjusted to reach a total protein intake of 1.5 g/kg body weight/day for 10 days (7 days pre-loading and 3 days during trials 1 and 2)
arm group label: Whey protein
intervention type: Dietary Supplement
intervention name: Soy protein
description: Soy protein isolate supplementation, individually adjusted to reach a total protein intake of 1.5 g/kg body weight/day for 10 days (7 days pre-loading and 3 days during trials 1 and 2)
arm group label: Soy protein
intervention type: Dietary Supplement
intervention name: Placebo (maltodextrin)
description: Isoenergetic placebo (maltodextrin) for 10 days (7 days pre-loading and 3 days during trials 1 and 2
arm group label: Placebo (maltodextrin)
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Savvas Kritikos, MScc
role: Principal Investigator
affiliation: UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES
facility: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: University of Thessaly
investigator full name: Ioannis G. Fatouros
investigator title: Professor