<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/NCT03293004</url>
  </required_header>
  <id_info>
    <org_study_id>1042848</org_study_id>
    <nct_id>NCT03293004</nct_id>
  </id_info>
  <brief_title>Collagen Vitamin C Dose Response Performance</brief_title>
  <acronym>Collagen</acronym>
  <official_title>Effects of Hydrolyzed Collagen and Vitamin C on Collagen Synthesis and Explosive Performance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Davis</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>
      Previous work has shown that gelatin supplementation could increase collagen synthesis in&#xD;
      humans. In this study subjects consume placebo, 5 or 15 g of gelatin with a standard amount&#xD;
      of vitamin C (48 mg) 1 hour before 6 minutes of jump rope exercise. The feeding and exercise&#xD;
      intervention was repeated every 6 hours while the subjects were awake for three days and the&#xD;
      amount of the amino terminal procollagen I peptide (PINP) was determined; a marker of&#xD;
      collagen synthesis, in the blood. Consistent with the hypothesis that gelatin increases&#xD;
      collagen synthesis in humans; the amount of PINP in the 15 g gelatin group was significantly&#xD;
      higher than either the placebo or the 5 g groups. These data conclusively demonstrate that&#xD;
      gelatin supplementation can increase exercise-induced collagen synthesis in humans.&#xD;
      Hydrolyzed collagen has a similar amino acid profile, in particular with high concentrations&#xD;
      of glycine, proline, hydroxyproline, and arginine. Thus the current study aims to precisely&#xD;
      map out the dose response relationship of hydrolyzed collagen and vitamin C on PINP and to&#xD;
      determine the optimal dose to achieve maximal increased in PINP levels.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In preliminary work investigating the physiological determinants of maximal performance in&#xD;
      throwing events, researchers found that the best predictor of elite performance was the rate&#xD;
      of force development (RFD; Force (N) x time (sec)) when performing and isometric squat.&#xD;
      Therefore, it is not surprising that in order to maximize performance, athletes train to&#xD;
      optimize RFD.&#xD;
&#xD;
      RFD is determined by three factors:&#xD;
&#xD;
        1. Neural activation of the muscles&#xD;
&#xD;
        2. Type of motor protein (fast or slow myosin)&#xD;
&#xD;
        3. Force transfer Interestingly, performance in power movements (that are highly dependent&#xD;
           on RFD) like vertical jump is closely related to tendon stiffness and inversely related&#xD;
           to muscle size. This indicates that force transfer, in the form of tendon stiffness,&#xD;
           plays an important role in performance and can explain a large amount of variance in&#xD;
           determining an athlete's ability to rapidly develop force during a dynamic movement.&#xD;
&#xD;
      The stiffness of a tendon is determined by the amount and cross-linking of collagen within&#xD;
      the tissue. Acute exercise is known to increase collagen synthesis as well as the expression&#xD;
      of the primary enzyme involved in collagen cross-linking, lysyl oxidase. The result is a&#xD;
      denser and stiffer tissue after training. Even though the relationship between exercise and&#xD;
      collagen synthesis is known, whether this measure of performance can be improved with&#xD;
      nutritional interventions has not been determined.&#xD;
&#xD;
      A recent study looking at amino acid levels following consumption of increasing doses of&#xD;
      gelatin (derivative of collagen) in human subjects has shown that the key primary and trace&#xD;
      amino acids found in collagen increase in human serum after consuming gelatin. Further, the&#xD;
      peak of these amino acids occurs 60 minutes after consuming the gelatin supplement.&#xD;
      Therefore, consuming a collagen supplement 1 hour before an exercise intervention should&#xD;
      maximize delivery of amino acids to bone and other connective tissues.&#xD;
&#xD;
      To determine whether the gelatin supplement could increase collagen synthesis in humans,&#xD;
      subjects consumed placebo, 5 or 15 g of gelatin with a standard amount of vitamin C (48 mg) 1&#xD;
      hour before 6 minutes of jump rope exercise. The feeding and exercise intervention was&#xD;
      repeated every 6 hours while the subjects were awake for three days and the amount of the&#xD;
      amino terminal procollagen I peptide (PINP) was determined; a marker of collagen synthesis,&#xD;
      in the blood. Consistent with the hypothesis that gelatin increases collagen synthesis in&#xD;
      humans; the amount of PINP in the 15 g gelatin group was significantly higher than either the&#xD;
      placebo or the 5 g groups. These data conclusively demonstrate that gelatin supplementation&#xD;
      can increase exercise-induced collagen synthesis in humans.&#xD;
&#xD;
      Similarly, supplementation with collagen hydrolysate has previously been shown to improve&#xD;
      cartilage function in a randomized clinical trial in patients with osteoarthritis [9].&#xD;
      McAlindon and colleagues showed that consuming 10 g of collagen hydrolysate per day resulted&#xD;
      in an increase in gadolinium enhanced MRI of collagen [9]. This finding suggests that the&#xD;
      hydrolyzed collagen increased cartilage formation. In agreement with this finding, a 24-week&#xD;
      randomized clinical trial in athletes showed that 10 g of GELITA® collagen hydrolysate&#xD;
      significantly decreased knee pain. Mouse studies using C14 labeled hydrolyzed collagen&#xD;
      hydrolysate demonstrated that &gt;95% of the hydrolyzed collagen was absorbed in the first 12&#xD;
      hours after feeding. Interestingly, even though tracer from a separate C14 labeled proline&#xD;
      could be incorporated into skin collagen at the same rate as tracer from hydrolyzed collagen,&#xD;
      tracer from the hydrolyzed collagen was incorporated into the collagen of cartilage and&#xD;
      muscle two-fold more than the tracer from proline. These data suggest that musculoskeletal&#xD;
      collagen synthesis is greater in response to gelatin or hydrolyzed collagen than to the&#xD;
      individual amino acids.&#xD;
&#xD;
      Even though the blood measure of PINP levels likely reflects bone collagen synthesis, using&#xD;
      an engineered ligament model, a similar response has been demonstrated in tendons/ligaments&#xD;
      treated with serum from people 1 hour after supplementation with gelatin. This work has shown&#xD;
      that in the presence of serum isolated from the 5 and 15 grams of gelatin groups a step-wise&#xD;
      increase in the collagen content of the ligaments. From this work, it can be ascertained that&#xD;
      PINP can be used dependably as an indirect marker of collagen synthesis and that the changes&#xD;
      observed in bone (blood levels) reflect what is occurring in other connective tissues as&#xD;
      well.&#xD;
&#xD;
      The current study aims to precisely map out the dose response relationship of hydrolyzed&#xD;
      collagen and vitamin C on PINP and to determine the optimal dose to achieve maximal increased&#xD;
      in PINP levels. Secondly, whether this optimal dose of hydrolyzed collagen and vitamin C,&#xD;
      taken before training is sufficient to improve RFD and performance will be determined. To&#xD;
      achieve this goal, subjects will first consume increasing doses of hydrolyzed collagen (0&#xD;
      (control), 5, 10, 20 and 30 g) alongside a constant amount of vitamin C (50 mg). Once the&#xD;
      optimal dose of hydrolyzed collagen is determined this dose will be administered with&#xD;
      increasing doses of vitamin C (0 (control), 50, 250, 500 mg) to determine the optimal dose of&#xD;
      vitamin C to maximize PINP levels. Both hydrolyzed collagen and vitamin C supplementation&#xD;
      will be given 1 hour before 6 minutes of jump rope exercise.&#xD;
&#xD;
      After the optimal doses of hydrolyzed collagen and vitamin C are determined, the effects of&#xD;
      the optimal dose of hydrolyzed collagen and vitamin C on performance will be assessed.&#xD;
      Subjects will undergo an explosive/power-based exercise training program three days a week&#xD;
      (Monday/Wednesday/Friday) for three weeks. The hydrolyzed collagen and vitamin C will be&#xD;
      ingested 1 hour before each training session. Baseline exercise testing will take place at&#xD;
      week 0, then exercise testing will occur on Friday of each week (week 1, 2 and 3). Subjects&#xD;
      will undergo a series of tests to determine the RFD in the isometric squat, and&#xD;
      countermovement and squat jump height.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 13, 2017</start_date>
  <completion_date type="Actual">May 24, 2018</completion_date>
  <primary_completion_date type="Actual">May 24, 2018</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>
    <intervention_model_description>A double blinded cross over design where subject are randomized to consume all 5 intervention doses.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>All nutritional interventions taste and look similar and are prepared for subjects in opaque bottles</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>PINP Levels</measure>
    <time_frame>9 weeks</time_frame>
    <description>To determine optimal dose of supplemental hydrolyzed collagen and vitamin C required to maximally elevate PINP levels (a marker of collagen synthesis) in healthy athletes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of force development (RFD)</measure>
    <time_frame>3 weeks</time_frame>
    <description>a measure of explosive strength</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Hydrolyzed collagen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First, we aim to determine the optimal amount of hydrolyzed collagen with a constant dose of vitamin C in humans to increase a marker of collagen synthesis (PINP). In a randomized, double-blinded, crossover design subjects consume a nutritional supplement with varying doses of hydrolyzed collagen (control (0 g), 5 10, 20 and 30 g hydrolyzed collagen) with a constant dose of vitamin C (50 mg). Each intervention will be separated by a 6-day wash out. Subjects will be asked to consume the supplement 1 hour before 6-min of jump rope exercise. Following completion of exercise, subjects will remain in the lab in a rested state for the subsequent 4 hours. After 4 hours and 24 hours blood samples will be collected. Blood samples will be used for PINP analysis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vitamin C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Second, we aim to determine the optimal amount of vitamin C with the determined optimal dose of hydrolyzed collagen in humans to increase a marker of collagen synthesis (PINP). In a randomized, double-blinded, crossover design subjects consume a nutritional supplement with varying doses of vitamin C (0 (control), 50, 250 and 500 mg) with an optimized dose of hydrolyzed collagen as determined from the first arm. Each intervention will be separated by a 6-day wash out. Subjects will be asked to consume the supplement 1 hour before 6-min of jump rope exercise. Following completion of exercise, subjects will remain in the lab in a rested state for the subsequent 4 hours. After 4 hours and 24 hours blood samples will be collected. Blood samples will be used for PINP analysis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Optimized Collagen and Vitamin C supplement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The findings from the first 2 arms of the study will be used to inform a training-based study aimed to determine whether exercise together with this optimal dose of hydrolyzed collagen and vitamin C is sufficient to improve rate of force development (RFD) and performance. A gummy food will be developed with the optimized dose of hydrolyzed collagen and vitamin C as well as a placebo. In a randomized, double-blinded, parallel design with subjects undertake a 3 week exercise protocol. The supplement will be ingested 1 hour prior to each exercise session (Monday/Wednesday/Friday). Exercise testing to assess rate of force development (RFD) will take place at the end of each week (Fridays) and these outcomes will be the basis for determining the effects of the nutrition intervention on performance.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gummy Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A gummy food will be developed with the optimized dose of hydrolyzed collagen and vitamin C as well as a placebo. In a randomized, double-blinded, parallel design with subjects undertake a 3 week exercise protocol. The supplement or placebo will be ingested 1 hour prior to each exercise session (Monday/Wednesday/Friday). Exercise testing to assess rate of force development (RFD) will take place at the end of each week (Fridays) and these outcomes will be the basis for determining the effects of the nutrition intervention on performance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Hydrolyzed collagen</intervention_name>
    <description>Escalating dose of Hydrolyzed collagen</description>
    <arm_group_label>Hydrolyzed collagen</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin C</intervention_name>
    <description>Escalating dose of Vitamin C</description>
    <arm_group_label>Vitamin C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Optimized Hydrolyzed Collagen and Vitamin C</intervention_name>
    <description>combination of optimized doses of Hydrolyzed Collagen and Vitamin C</description>
    <arm_group_label>Optimized Collagen and Vitamin C supplement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Gummy Placebo</intervention_name>
    <description>Gummy placebo</description>
    <arm_group_label>Gummy Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Collegiate level male athletes between 18 - 25 years of age&#xD;
&#xD;
          -  Currently registered/participating as an intercollegiate athlete&#xD;
&#xD;
          -  &lt; 3 musculoskeletal injuries in the past year&#xD;
&#xD;
          -  No health or dietary restriction that would be affected by the supplementation&#xD;
             protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of more than 3 musculoskeletal injuries within the past 12 months.&#xD;
&#xD;
          -  Health, dietary restriction or diet that would be affected by the supplementation&#xD;
             protocol.&#xD;
&#xD;
          -  Then initial phases of this study will be performed in males since collagen synthesis&#xD;
             varies significantly throughout the menstrual cycle in females. Since collagen in the&#xD;
             main outcome measure for this study this natural variation would confound the initial&#xD;
             phase of the work. Provided this work proves successful then we will aim to perform&#xD;
             similar studies in females.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Male&#xD;
Then initial phases of this study will be performed in males since collagen synthesis varies significantly throughout the menstrual cycle in females. Since collagen in the main outcome measure for this study this natural variation would confound the initial phase of the work. • Provided this work proves successful then we will aim to perform similar studies in females.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of California Davis</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>August 2018</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>August 17, 2018</last_update_submitted>
  <last_update_submitted_qc>August 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>collagen</keyword>
  <keyword>tendon</keyword>
  <keyword>procollagen type I N-terminal</keyword>
  <keyword>athletes</keyword>
  <keyword>vitamin C</keyword>
  <keyword>hydrolyzed collagen</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamins</mesh_term>
    <mesh_term>Ascorbic Acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03293004
org study id: 1042848
nct id: NCT03293004
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Previous work has shown that gelatin supplementation could increase collagen synthesis in
      humans. In this study subjects consume placebo, 5 or 15 g of gelatin with a standard amount
      of vitamin C (48 mg) 1 hour before 6 minutes of jump rope exercise. The feeding and exercise
      intervention was repeated every 6 hours while the subjects were awake for three days and the
      amount of the amino terminal procollagen I peptide (PINP) was determined; a marker of
      collagen synthesis, in the blood. Consistent with the hypothesis that gelatin increases
      collagen synthesis in humans; the amount of PINP in the 15 g gelatin group was significantly
      higher than either the placebo or the 5 g groups. These data conclusively demonstrate that
      gelatin supplementation can increase exercise-induced collagen synthesis in humans.
      Hydrolyzed collagen has a similar amino acid profile, in particular with high concentrations
      of glycine, proline, hydroxyproline, and arginine. Thus the current study aims to precisely
      map out the dose response relationship of hydrolyzed collagen and vitamin C on PINP and to
      determine the optimal dose to achieve maximal increased in PINP levels.
In preliminary work investigating the physiological determinants of maximal performance in
      throwing events, researchers found that the best predictor of elite performance was the rate
      of force development (RFD; Force (N) x time (sec)) when performing and isometric squat.
      Therefore, it is not surprising that in order to maximize performance, athletes train to
      optimize RFD.

      RFD is determined by three factors:

        1. Neural activation of the muscles

        2. Type of motor protein (fast or slow myosin)

        3. Force transfer Interestingly, performance in power movements (that are highly dependent
           on RFD) like vertical jump is closely related to tendon stiffness and inversely related
           to muscle size. This indicates that force transfer, in the form of tendon stiffness,
           plays an important role in performance and can explain a large amount of variance in
           determining an athlete's ability to rapidly develop force during a dynamic movement.

      The stiffness of a tendon is determined by the amount and cross-linking of collagen within
      the tissue. Acute exercise is known to increase collagen synthesis as well as the expression
      of the primary enzyme involved in collagen cross-linking, lysyl oxidase. The result is a
      denser and stiffer tissue after training. Even though the relationship between exercise and
      collagen synthesis is known, whether this measure of performance can be improved with
      nutritional interventions has not been determined.

      A recent study looking at amino acid levels following consumption of increasing doses of
      gelatin (derivative of collagen) in human subjects has shown that the key primary and trace
      amino acids found in collagen increase in human serum after consuming gelatin. Further, the
      peak of these amino acids occurs 60 minutes after consuming the gelatin supplement.
      Therefore, consuming a collagen supplement 1 hour before an exercise intervention should
      maximize delivery of amino acids to bone and other connective tissues.

      To determine whether the gelatin supplement could increase collagen synthesis in humans,
      subjects consumed placebo, 5 or 15 g of gelatin with a standard amount of vitamin C (48 mg) 1
      hour before 6 minutes of jump rope exercise. The feeding and exercise intervention was
      repeated every 6 hours while the subjects were awake for three days and the amount of the
      amino terminal procollagen I peptide (PINP) was determined; a marker of collagen synthesis,
      in the blood. Consistent with the hypothesis that gelatin increases collagen synthesis in
      humans; the amount of PINP in the 15 g gelatin group was significantly higher than either the
      placebo or the 5 g groups. These data conclusively demonstrate that gelatin supplementation
      can increase exercise-induced collagen synthesis in humans.

      Similarly, supplementation with collagen hydrolysate has previously been shown to improve
      cartilage function in a randomized clinical trial in patients with osteoarthritis [9].
      McAlindon and colleagues showed that consuming 10 g of collagen hydrolysate per day resulted
      in an increase in gadolinium enhanced MRI of collagen [9]. This finding suggests that the
      hydrolyzed collagen increased cartilage formation. In agreement with this finding, a 24-week
      randomized clinical trial in athletes showed that 10 g of GELITA® collagen hydrolysate
      significantly decreased knee pain. Mouse studies using C14 labeled hydrolyzed collagen
      hydrolysate demonstrated that >95% of the hydrolyzed collagen was absorbed in the first 12
      hours after feeding. Interestingly, even though tracer from a separate C14 labeled proline
      could be incorporated into skin collagen at the same rate as tracer from hydrolyzed collagen,
      tracer from the hydrolyzed collagen was incorporated into the collagen of cartilage and
      muscle two-fold more than the tracer from proline. These data suggest that musculoskeletal
      collagen synthesis is greater in response to gelatin or hydrolyzed collagen than to the
      individual amino acids.

      Even though the blood measure of PINP levels likely reflects bone collagen synthesis, using
      an engineered ligament model, a similar response has been demonstrated in tendons/ligaments
      treated with serum from people 1 hour after supplementation with gelatin. This work has shown
      that in the presence of serum isolated from the 5 and 15 grams of gelatin groups a step-wise
      increase in the collagen content of the ligaments. From this work, it can be ascertained that
      PINP can be used dependably as an indirect marker of collagen synthesis and that the changes
      observed in bone (blood levels) reflect what is occurring in other connective tissues as
      well.

      The current study aims to precisely map out the dose response relationship of hydrolyzed
      collagen and vitamin C on PINP and to determine the optimal dose to achieve maximal increased
      in PINP levels. Secondly, whether this optimal dose of hydrolyzed collagen and vitamin C,
      taken before training is sufficient to improve RFD and performance will be determined. To
      achieve this goal, subjects will first consume increasing doses of hydrolyzed collagen (0
      (control), 5, 10, 20 and 30 g) alongside a constant amount of vitamin C (50 mg). Once the
      optimal dose of hydrolyzed collagen is determined this dose will be administered with
      increasing doses of vitamin C (0 (control), 50, 250, 500 mg) to determine the optimal dose of
      vitamin C to maximize PINP levels. Both hydrolyzed collagen and vitamin C supplementation
      will be given 1 hour before 6 minutes of jump rope exercise.

      After the optimal doses of hydrolyzed collagen and vitamin C are determined, the effects of
      the optimal dose of hydrolyzed collagen and vitamin C on performance will be assessed.
      Subjects will undergo an explosive/power-based exercise training program three days a week
      (Monday/Wednesday/Friday) for three weeks. The hydrolyzed collagen and vitamin C will be
      ingested 1 hour before each training session. Baseline exercise testing will take place at
      week 0, then exercise testing will occur on Friday of each week (week 1, 2 and 3). Subjects
      will undergo a series of tests to determine the RFD in the isometric squat, and
      countermovement and squat jump height.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: A double blinded cross over design where subject are randomized to consume all 5 intervention doses.
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: All nutritional interventions taste and look similar and are prepared for subjects in opaque bottles
measure: PINP Levels
time frame: 9 weeks
description: To determine optimal dose of supplemental hydrolyzed collagen and vitamin C required to maximally elevate PINP levels (a marker of collagen synthesis) in healthy athletes.
measure: Rate of force development (RFD)
time frame: 3 weeks
description: a measure of explosive strength
arm group label: Hydrolyzed collagen
arm group type: Experimental
description: First, we aim to determine the optimal amount of hydrolyzed collagen with a constant dose of vitamin C in humans to increase a marker of collagen synthesis (PINP). In a randomized, double-blinded, crossover design subjects consume a nutritional supplement with varying doses of hydrolyzed collagen (control (0 g), 5 10, 20 and 30 g hydrolyzed collagen) with a constant dose of vitamin C (50 mg). Each intervention will be separated by a 6-day wash out. Subjects will be asked to consume the supplement 1 hour before 6-min of jump rope exercise. Following completion of exercise, subjects will remain in the lab in a rested state for the subsequent 4 hours. After 4 hours and 24 hours blood samples will be collected. Blood samples will be used for PINP analysis.
arm group label: Vitamin C
arm group type: Experimental
description: Second, we aim to determine the optimal amount of vitamin C with the determined optimal dose of hydrolyzed collagen in humans to increase a marker of collagen synthesis (PINP). In a randomized, double-blinded, crossover design subjects consume a nutritional supplement with varying doses of vitamin C (0 (control), 50, 250 and 500 mg) with an optimized dose of hydrolyzed collagen as determined from the first arm. Each intervention will be separated by a 6-day wash out. Subjects will be asked to consume the supplement 1 hour before 6-min of jump rope exercise. Following completion of exercise, subjects will remain in the lab in a rested state for the subsequent 4 hours. After 4 hours and 24 hours blood samples will be collected. Blood samples will be used for PINP analysis.
arm group label: Optimized Collagen and Vitamin C supplement
arm group type: Experimental
description: The findings from the first 2 arms of the study will be used to inform a training-based study aimed to determine whether exercise together with this optimal dose of hydrolyzed collagen and vitamin C is sufficient to improve rate of force development (RFD) and performance. A gummy food will be developed with the optimized dose of hydrolyzed collagen and vitamin C as well as a placebo. In a randomized, double-blinded, parallel design with subjects undertake a 3 week exercise protocol. The supplement will be ingested 1 hour prior to each exercise session (Monday/Wednesday/Friday). Exercise testing to assess rate of force development (RFD) will take place at the end of each week (Fridays) and these outcomes will be the basis for determining the effects of the nutrition intervention on performance.
arm group label: Gummy Placebo
arm group type: Placebo Comparator
description: A gummy food will be developed with the optimized dose of hydrolyzed collagen and vitamin C as well as a placebo. In a randomized, double-blinded, parallel design with subjects undertake a 3 week exercise protocol. The supplement or placebo will be ingested 1 hour prior to each exercise session (Monday/Wednesday/Friday). Exercise testing to assess rate of force development (RFD) will take place at the end of each week (Fridays) and these outcomes will be the basis for determining the effects of the nutrition intervention on performance.
intervention type: Dietary Supplement
intervention name: Hydrolyzed collagen
description: Escalating dose of Hydrolyzed collagen
arm group label: Hydrolyzed collagen
intervention type: Dietary Supplement
intervention name: Vitamin C
description: Escalating dose of Vitamin C
arm group label: Vitamin C
intervention type: Dietary Supplement
intervention name: Optimized Hydrolyzed Collagen and Vitamin C
description: combination of optimized doses of Hydrolyzed Collagen and Vitamin C
arm group label: Optimized Collagen and Vitamin C supplement
intervention type: Dietary Supplement
intervention name: Gummy Placebo
description: Gummy placebo
arm group label: Gummy Placebo
criteria: 
gender: Male
gender based: Yes
gender description: Male
Then initial phases of this study will be performed in males since collagen synthesis varies significantly throughout the menstrual cycle in females. Since collagen in the main outcome measure for this study this natural variation would confound the initial phase of the work. • Provided this work proves successful then we will aim to perform similar studies in females.
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Vitamins
mesh term: Ascorbic Acid
sharing ipd: No