<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/NCT02999256</url>
  </required_header>
  <id_info>
    <org_study_id>LMS/PGT/UH/02336_</org_study_id>
    <nct_id>NCT02999256</nct_id>
  </id_info>
  <brief_title>Effect of Cherry Juice on Fat Oxidation and Cardio-metabolic Markers</brief_title>
  <official_title>The Effect of Tart Cherry Juice Supplementation on Fat Oxidation, Body Composition and Cardio-Metabolic Markers With Cycling Exercise</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Hertfordshire</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Hertfordshire</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present study examined the effect of Montmorency tart cherry juice and FATMAX (intensity&#xD;
      eliciting maximal fat oxidation) exercise on fat oxidation rates, body composition and&#xD;
      blood-based cardio-metabolic markers. Participants received both Montmorency tart cherry&#xD;
      juice and placebo in a random counterbalanced order for 20 days. Outcome variables were&#xD;
      measured immediately pre- and post-supplementation and 10 days after the onset of&#xD;
      supplementation. It was hypothesised that Montmorency tart cherry juice would increase fat&#xD;
      oxidation during exercise, reduce body fat percentage and improve cardio-metabolic markers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aims: (1) Examine whether tart cherry juice supplementation with cycling exercise augments&#xD;
      fat oxidation rate and therefore plays a role in weight management in healthy active human&#xD;
      participants. (2) To extrapolate findings from this study to future biomedical health and&#xD;
      disease research.&#xD;
&#xD;
      Methods: Random counterbalanced, within-group, double-blind study design. Participants were&#xD;
      randomly allocated into consuming either cherry juice first or placebo. Eleven recreationally&#xD;
      active male and female participants were recruited. Participants consumed 30ml Montmorency&#xD;
      tart cherry juice concentrate mixed with 100ml water, twice daily for 20 days. Participants&#xD;
      underwent a 14 day washout period between trials. All participants were instructed to keep to&#xD;
      their habitual intake of polyphenols and anthocyanins. Twenty-four hours before each exercise&#xD;
      testing session, participants consumed similar meals at the same times. Diet adherence was&#xD;
      monitored through food diaries.&#xD;
&#xD;
      Participants attended each testing session following an overnight fast, with the testing&#xD;
      being completed at the same time in the morning to avoid circadian variation. Preliminary&#xD;
      testing was conducted to ascertain VO2max and individual FATMAX, 4 days before the one hour&#xD;
      pre-supplementation exercise test. VO2max was re-assessed 4 days before the one hour&#xD;
      post-supplementation exercise test to determine if any changes in training status affected&#xD;
      results.&#xD;
&#xD;
      Testing will occur at baseline, 10 days after the onset of supplementation and after 20 days&#xD;
      supplementation. Exercise protocol consisted of 60min cycling at pre-determined individual&#xD;
      FATMAX. Continuous gas analysis and heart rate were monitored throughout. Substrate oxidation&#xD;
      rates and energy expenditure were calculated using stoichiometric equations (Jeukendrup and&#xD;
      Wallis, 2005). During each testing session blood pressure and body composition (impedance)&#xD;
      measurements were taken at baseline and pre-exercise during all testing sessions. Resting&#xD;
      metabolic rate (indirect calorimetry) was assessed at baseline and pre-exercise during all&#xD;
      testing sessions.&#xD;
&#xD;
      Serum blood samples were obtained from participants at the following time points: baseline,&#xD;
      pre-exercise and post-exercise for one hour submaximal exercise tests, in both trials. The&#xD;
      following markers were analysed: Glucose, Lactate, Triglycerides, HDL, Total Cholesterol and&#xD;
      Total Antioxidant Status.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Fat Oxidation (grams/min)</measure>
    <time_frame>Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Lipid Profile (Total Cholesterol, HDL, Triglycerides, LDL) (mmol/L)</measure>
    <time_frame>Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Serum Glucose (mmol/L)</measure>
    <time_frame>Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Fat Percentage (%)</measure>
    <time_frame>Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Mass (kg)</measure>
    <time_frame>Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fat Mass (kg)</measure>
    <time_frame>Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fat Free Mass (kg)</measure>
    <time_frame>Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Total Antioxidant Status (mmol/L)</measure>
    <time_frame>Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Healthy</condition>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>130ml serving twice daily (immediately before breakfast and dinner) for 20 days.&#xD;
Placebo composition: Water (100ml), Cherry Squash Concentrate (30ml), Citric Acid (1.5g), Maltodextrin (24.75g), Black Food Colouring (2ml).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Montmorency Tart Cherry Juice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>130ml serving twice daily (immediately before breakfast and dinner) for 20 days.&#xD;
MTCJ Composition: 100ml water and 30ml Montmorency tart cherry concentrate (Cherry Active, Sunbury, UK).</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Montmorency Tart Cherry Juice</intervention_name>
    <arm_group_label>Montmorency Tart Cherry Juice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18-45&#xD;
&#xD;
          -  Male and Female&#xD;
&#xD;
          -  Non-smokers&#xD;
&#xD;
          -  Recreationally active (minimum 150 minutes physical activity per week)&#xD;
&#xD;
          -  Injury free at all times of testing.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Aged &lt;18 years old, &gt;45 years old&#xD;
&#xD;
          -  Current or previous history of gastrointestinal, cardiovascular or renal disease&#xD;
&#xD;
          -  Current or previous history of injury that may be exacerbated with the exercise&#xD;
             protocol used&#xD;
&#xD;
          -  Allergy to maltodextrin or specific fruit products (especially cherries) and those&#xD;
             currently taking medication (such as steroids, NSAIDs, antibiotics) or currently using&#xD;
             any nutritional supplement.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>December 16, 2016</last_update_submitted>
  <last_update_submitted_qc>December 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Hertfordshire</investigator_affiliation>
    <investigator_full_name>Terun Desai</investigator_full_name>
    <investigator_title>PhD Student</investigator_title>
  </responsible_party>
  <keyword>Tart Cherry Juice</keyword>
  <keyword>Fat Oxidation</keyword>
  <keyword>Lipid Profile</keyword>
  <keyword>Anthocyanins</keyword>
  <keyword>Exercise</keyword>
  <keyword>Calorie Restrictive Mimetic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</mesh_term>
  </condition_browse>
  <!-- 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/NCT02999256
org study id: LMS/PGT/UH/02336_
nct id: NCT02999256
lead sponsor: 
has dmc: No
The present study examined the effect of Montmorency tart cherry juice and FATMAX (intensity
      eliciting maximal fat oxidation) exercise on fat oxidation rates, body composition and
      blood-based cardio-metabolic markers. Participants received both Montmorency tart cherry
      juice and placebo in a random counterbalanced order for 20 days. Outcome variables were
      measured immediately pre- and post-supplementation and 10 days after the onset of
      supplementation. It was hypothesised that Montmorency tart cherry juice would increase fat
      oxidation during exercise, reduce body fat percentage and improve cardio-metabolic markers.
Aims: (1) Examine whether tart cherry juice supplementation with cycling exercise augments
      fat oxidation rate and therefore plays a role in weight management in healthy active human
      participants. (2) To extrapolate findings from this study to future biomedical health and
      disease research.

      Methods: Random counterbalanced, within-group, double-blind study design. Participants were
      randomly allocated into consuming either cherry juice first or placebo. Eleven recreationally
      active male and female participants were recruited. Participants consumed 30ml Montmorency
      tart cherry juice concentrate mixed with 100ml water, twice daily for 20 days. Participants
      underwent a 14 day washout period between trials. All participants were instructed to keep to
      their habitual intake of polyphenols and anthocyanins. Twenty-four hours before each exercise
      testing session, participants consumed similar meals at the same times. Diet adherence was
      monitored through food diaries.

      Participants attended each testing session following an overnight fast, with the testing
      being completed at the same time in the morning to avoid circadian variation. Preliminary
      testing was conducted to ascertain VO2max and individual FATMAX, 4 days before the one hour
      pre-supplementation exercise test. VO2max was re-assessed 4 days before the one hour
      post-supplementation exercise test to determine if any changes in training status affected
      results.

      Testing will occur at baseline, 10 days after the onset of supplementation and after 20 days
      supplementation. Exercise protocol consisted of 60min cycling at pre-determined individual
      FATMAX. Continuous gas analysis and heart rate were monitored throughout. Substrate oxidation
      rates and energy expenditure were calculated using stoichiometric equations (Jeukendrup and
      Wallis, 2005). During each testing session blood pressure and body composition (impedance)
      measurements were taken at baseline and pre-exercise during all testing sessions. Resting
      metabolic rate (indirect calorimetry) was assessed at baseline and pre-exercise during all
      testing sessions.

      Serum blood samples were obtained from participants at the following time points: baseline,
      pre-exercise and post-exercise for one hour submaximal exercise tests, in both trials. The
      following markers were analysed: Glucose, Lactate, Triglycerides, HDL, Total Cholesterol and
      Total Antioxidant Status.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Change in Fat Oxidation (grams/min)
time frame: Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
measure: Change in Lipid Profile (Total Cholesterol, HDL, Triglycerides, LDL) (mmol/L)
time frame: Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
measure: Change in Serum Glucose (mmol/L)
time frame: Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
measure: Change in Body Fat Percentage (%)
time frame: Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
measure: Change in Body Mass (kg)
time frame: Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
measure: Change in Fat Mass (kg)
time frame: Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
measure: Change in Fat Free Mass (kg)
time frame: Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
measure: Change in Total Antioxidant Status (mmol/L)
time frame: Pre-, Mid- (10 days) and Post- (21 days) after onset of Supplementation in both Arms
arm group label: Placebo
arm group type: Placebo Comparator
description: 130ml serving twice daily (immediately before breakfast and dinner) for 20 days.
Placebo composition: Water (100ml), Cherry Squash Concentrate (30ml), Citric Acid (1.5g), Maltodextrin (24.75g), Black Food Colouring (2ml).
arm group label: Montmorency Tart Cherry Juice
arm group type: Experimental
description: 130ml serving twice daily (immediately before breakfast and dinner) for 20 days.
MTCJ Composition: 100ml water and 30ml Montmorency tart cherry concentrate (Cherry Active, Sunbury, UK).
intervention type: Dietary Supplement
intervention name: Montmorency Tart Cherry Juice
arm group label: Montmorency Tart Cherry Juice
intervention type: Other
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: University of Hertfordshire
investigator full name: Terun Desai
investigator title: PhD Student
mesh term: Metabolic Syndrome