<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/NCT04437758</url>
  </required_header>
  <id_info>
    <org_study_id>PEP-1704</org_study_id>
    <nct_id>NCT04437758</nct_id>
  </id_info>
  <brief_title>Effects of Hydrolyzed Collagen and Vitamin C on Explosive Performance</brief_title>
  <official_title>Effects of Hydrolyzed Collagen and Vitamin C on Explosive Performance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PepsiCo Global R&amp;D</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PepsiCo Global R&amp;D</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>
      Determine whether supplementation with a combined dose of 20 g of hydrolyzed collagen and 50&#xD;
      mg vitamin C, along with a power training exercise program, increases rate of force&#xD;
      development (RFD) and performance in athletes&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 22, 2019</start_date>
  <completion_date type="Actual">February 5, 2020</completion_date>
  <primary_completion_date type="Actual">February 5, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Sealed opaque packets coded by Sponsor's Product Development</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Maximal rate of force development (RFD) of isometric squat (MIS)</measure>
    <time_frame>% change from baseline to week 1, week 2 and week 3</time_frame>
    <description>Force (N) over time (msec) for the maximum slope of the first 20% of the movement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Counter-movement jump (CMJ) rate of force development (RFD)</measure>
    <time_frame>% change from baseline to week 1, week 2 and week 3</time_frame>
    <description>CMJ jump performance N/s/kg</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Squat jump height rate of force development (RFD)</measure>
    <time_frame>% change from baseline to week 1, week 2 and week 3</time_frame>
    <description>Squat jump height performance RFD/kg</description>
  </primary_outcome>
  <other_outcome>
    <measure>Maximum peak force of maximal isometric squat (MIS)</measure>
    <time_frame>% change from baseline to week 1, week 2 and week 3</time_frame>
    <description>Peak force (N)</description>
  </other_outcome>
  <other_outcome>
    <measure>Counter-movement jump (CMJ) net eccentric impulse</measure>
    <time_frame>% change from baseline to week 1, week 2 and week 3</time_frame>
    <description>Jump performance max N/s/kg (Note: Eccentric is the drop down part of the CMJ)</description>
  </other_outcome>
  <other_outcome>
    <measure>Counter-movement jump (CMJ) net concentric impulse</measure>
    <time_frame>% change from baseline to week 1, week 2 and week 3</time_frame>
    <description>Jump performance max N/s/kg (Note: Concentric is the movement upwards of the CMJ)</description>
  </other_outcome>
  <other_outcome>
    <measure>Leg stiffness assessment</measure>
    <time_frame>% change from baseline to week 1, week 2 and week 3</time_frame>
    <description>Tendon stiffness mean per kg (N/m/kg)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Collagen Synthesis</condition>
  <condition>Rate of Force (RFD) Development</condition>
  <arm_group>
    <arm_group_label>Hydrolyzed collagen and Vitamin C powder mix</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 g hydrolyzed collagen + 50 mg vitamin C (ascorbic acid) pre-packed powder diluted in 250 ml (8 oz) of water</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Maltodextrin powder</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>20 g maltodextrin pre-packed powder diluted in 250 ml (8 oz) of water</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Collagen and Vitamin C powder mix nutritional intervention</intervention_name>
    <description>20 g collagen + 50 mg vitamin C daily, 60 min prior to exercise</description>
    <arm_group_label>Hydrolyzed collagen and Vitamin C powder mix</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Maltodextrin placebo powder</intervention_name>
    <description>20 g maltodextrin placebo daily, 60 min prior to exercise</description>
    <arm_group_label>Maltodextrin powder</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Maximum power training exercise</intervention_name>
    <description>Explosive/power-based exercise training program 3 times/week at home consisting of drop jumps, box jumps, weighted jump squats loaded in a progressive manner weekly for 3 weeks. At baseline and at the end of each of the 3 weeks, measures of explosive performance are assessed in the lab (maximal isometric squat, counter-movement jump and squat jump)</description>
    <arm_group_label>Hydrolyzed collagen and Vitamin C powder mix</arm_group_label>
    <arm_group_label>Maltodextrin powder</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male athletes between 18-30 years of age&#xD;
&#xD;
          2. Currently participating in sport&#xD;
&#xD;
          3. &lt;3 musculoskeletal injuries in the past year&#xD;
&#xD;
          4. No health or dietary restriction that would be affected by the supplementation&#xD;
             protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of more than 3 musculoskeletal injuries within the past 12 months&#xD;
&#xD;
          2. Health, dietary restriction or diet that would be affected by the supplementation&#xD;
             protocol&#xD;
&#xD;
          3. Willing to eat similar dietary pattern the day before baseline testing and each&#xD;
             exercise testing/intervention day&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Collagen synthesis varies significantly throughout the menstrual cycle in females. This natural variation would confound the study. Provided this work proves successful, we will aim to perform similar studies in females.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Keith Baar, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Davis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UC Davis Functional Molecular Biology Laboratory and Human Performance Laboratory</name>
      <address>
        <city>Davis</city>
        <state>California</state>
        <zip>95616</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 16, 2020</last_update_submitted>
  <last_update_submitted_qc>June 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>exercise</keyword>
  <keyword>performance</keyword>
  <keyword>athletes</keyword>
  <!-- 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/NCT04437758
org study id: PEP-1704
nct id: NCT04437758
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Determine whether supplementation with a combined dose of 20 g of hydrolyzed collagen and 50
      mg vitamin C, along with a power training exercise program, increases rate of force
      development (RFD) and performance in athletes
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Sealed opaque packets coded by Sponsor's Product Development
measure: Maximal rate of force development (RFD) of isometric squat (MIS)
time frame: % change from baseline to week 1, week 2 and week 3
description: Force (N) over time (msec) for the maximum slope of the first 20% of the movement
measure: Counter-movement jump (CMJ) rate of force development (RFD)
time frame: % change from baseline to week 1, week 2 and week 3
description: CMJ jump performance N/s/kg
measure: Squat jump height rate of force development (RFD)
time frame: % change from baseline to week 1, week 2 and week 3
description: Squat jump height performance RFD/kg
measure: Maximum peak force of maximal isometric squat (MIS)
time frame: % change from baseline to week 1, week 2 and week 3
description: Peak force (N)
measure: Counter-movement jump (CMJ) net eccentric impulse
time frame: % change from baseline to week 1, week 2 and week 3
description: Jump performance max N/s/kg (Note: Eccentric is the drop down part of the CMJ)
measure: Counter-movement jump (CMJ) net concentric impulse
time frame: % change from baseline to week 1, week 2 and week 3
description: Jump performance max N/s/kg (Note: Concentric is the movement upwards of the CMJ)
measure: Leg stiffness assessment
time frame: % change from baseline to week 1, week 2 and week 3
description: Tendon stiffness mean per kg (N/m/kg)
arm group label: Hydrolyzed collagen and Vitamin C powder mix
arm group type: Experimental
description: 20 g hydrolyzed collagen + 50 mg vitamin C (ascorbic acid) pre-packed powder diluted in 250 ml (8 oz) of water
arm group label: Maltodextrin powder
arm group type: Placebo Comparator
description: 20 g maltodextrin pre-packed powder diluted in 250 ml (8 oz) of water
intervention type: Dietary Supplement
intervention name: Collagen and Vitamin C powder mix nutritional intervention
description: 20 g collagen + 50 mg vitamin C daily, 60 min prior to exercise
arm group label: Hydrolyzed collagen and Vitamin C powder mix
intervention type: Other
intervention name: Maltodextrin placebo powder
description: 20 g maltodextrin placebo daily, 60 min prior to exercise
arm group label: Maltodextrin powder
intervention type: Other
intervention name: Maximum power training exercise
description: Explosive/power-based exercise training program 3 times/week at home consisting of drop jumps, box jumps, weighted jump squats loaded in a progressive manner weekly for 3 weeks. At baseline and at the end of each of the 3 weeks, measures of explosive performance are assessed in the lab (maximal isometric squat, counter-movement jump and squat jump)
arm group label: Hydrolyzed collagen and Vitamin C powder mix
arm group label: Maltodextrin powder
criteria: 
gender: Male
gender based: Yes
gender description: Collagen synthesis varies significantly throughout the menstrual cycle in females. This natural variation would confound the study. Provided this work proves successful, we will aim to perform similar studies in females.
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Keith Baar, PhD
role: Principal Investigator
affiliation: University of California, Davis
facility: 
country: United States
responsible party type: Sponsor