<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/NCT03022214</url>
  </required_header>
  <id_info>
    <org_study_id>Bdr2017-1</org_study_id>
    <nct_id>NCT03022214</nct_id>
  </id_info>
  <brief_title>ADAPT: Efficacy of a Dietary Supplement During and After Exercise</brief_title>
  <acronym>ADAPT</acronym>
  <official_title>ADAPT: Efficacy of a Dietary Supplement to Increase Resilience and Inhibit the Oxidative Stress Response During and After Exercise</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aberdeen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aberdeen</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>
      Since 1948, health has been defined as &quot;a state of complete physical, mental and social&#xD;
      well-being, and not merely the absence of disease and infirmity&quot; . However, a growing school&#xD;
      of thought suggests that health represents an ability to be adaptable and flexible in&#xD;
      response to daily stressors. It has been proposed that instead, the view of health should be&#xD;
      &quot;towards the ability to adapt and self-manage in the face of social, physical and emotional&#xD;
      challenges&quot;, which has been termed &quot;resilience&quot;.&#xD;
&#xD;
      The theory of &quot;resilience&quot; relates health to the body's capacity to manage daily stressors&#xD;
      (such as physical activity or oxidative fluctuations) that challenge homeostasis, with the&#xD;
      return to homeostasis resulting from several physiological stress responses. Although this is&#xD;
      an all-encompassing model, and the effects of pathogens and other stress factors are also&#xD;
      relevant, this study will centre on the physiological aspects on this theory, focussing on&#xD;
      the disruption through exercise.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Nrf-2 pathway is the major cellular defence against oxidative and electrophilic stresses.&#xD;
      Briefly, following dissociation from Keap1 (a scaffolding protein which binds Nrf2 and Cul3&#xD;
      ubiquitin ligase for proteasome degradation), Nrf-2 accumulates in the nucleus where it&#xD;
      activates the antioxidant response element (ARE) in the promoter region of many antioxidant&#xD;
      genes, including catalase, glutathione peroxidases (GPX), and superoxide dismutase (SOD). As&#xD;
      such, it is an attractive target for both dietary and pharmacological interventions aiming to&#xD;
      increase resilience to oxidative stress. Most diet-derived bioactive Nrf-2 inducers contain&#xD;
      Michael acceptor groups (an α, β-unsaturated carbonyl moiety). Curcumin, for example,&#xD;
      contains two Michael acceptor groups and is a known activator of Nrf-2. An additional&#xD;
      bioactive with a Michael accepter group is trans-cinnamaldehyde (CA) (a component found in&#xD;
      the stem bark of Cinnamomum cassia), which, like curcumin, is an Nrf-2 activator in a&#xD;
      dose-dependent manner.&#xD;
&#xD;
      Therefore, the purpose of this study will be to assess the effect of bioactive Nrf-2&#xD;
      inducers, based on the presence of an α, β-unsaturated carbonyl moiety, on resilience markers&#xD;
      such as antioxidant enzyme activities and markers of oxidative stress, such as TBARS, to an&#xD;
      exercise challenge. The hypothesis is that specific plant bioactive increase the production&#xD;
      of antioxidant enzyme activities at baseline, and thereby decrease levels of TBARS upon an&#xD;
      exercise challenge. Ultimately, the use of novel resilience markers and signatures could&#xD;
      significantly improve the ability to prove the efficacy by which pro-oxidant dietary&#xD;
      bioactive improve lifelong health, as well as targeting those with lowest resilience as a way&#xD;
      to make best use of limited healthcare resources.&#xD;
&#xD;
      The intervention supplement will consist of a mix of dietary bioactive with an α,&#xD;
      β-unsaturated carbonyl moiety (provided in individual capsules), of which the efficacy to&#xD;
      beneficially affect platelet activity, with and without a H2O2 (Hydrogen Peroxide) challenge,&#xD;
      was recently established: sulforaphane (SUL), green tea extract (epigallocatechin gallate)&#xD;
      (EGCG) and cinnamaldehyde (Cin).&#xD;
&#xD;
      It is intended to use a mix of dietary bioactive for the proposed human intervention study,&#xD;
      as different compounds could affect multiple pathways and therefore, have a broader efficacy.&#xD;
      In addition, bioavailability of compounds may be influenced by presence of other compounds,&#xD;
      as has been suggested in the literature (effect of piperine on EGCG bioavailability).&#xD;
&#xD;
      Bioavailability data for each of these compounds were extracted from the literature and these&#xD;
      have been used, alongside practical considerations, to decide on the dosing strategy. The&#xD;
      desired composition of the supplement mix has been set as follows:&#xD;
&#xD;
        -  SUL: ~ 14mg&#xD;
&#xD;
        -  EGCG: ~ 400mg&#xD;
&#xD;
        -  CIN: ~ 15mg These daily intakes should be sufficient to achieve micromolar quantities in&#xD;
           blood plasma for between 1 and 6 hours after ingestion, and perhaps longer. .&#xD;
&#xD;
      Suitable food ingredients which can be used in the study to achieve these intakes have been&#xD;
      sourced from reputable suppliers. These ingredients will be used to give desired intakes as&#xD;
      follows:&#xD;
&#xD;
        -  EnduraCell broccoli sprout powder (with added myrosinase): 1.5g (sufficient to provide ~&#xD;
           45mg glucoraphanin, the precursor to SUL, which should release approximately ~14mg SUL).&#xD;
&#xD;
        -  Bulk Powders Green tea extract: ~ 900mg (containing approximately 400mg EGCG).&#xD;
&#xD;
        -  Bulk Powders Cinnamon Bark Extract: 0.75g (containing ~15 - 20mg Cin).&#xD;
&#xD;
      Due to envisaged difficulties with palatability, the ingredient mix will be encapsulated.&#xD;
      While one of the ingredients (green tea extract) is available pre-encapsulated from the&#xD;
      supplier, it is preferred to obtain all ingredients as free powder, and encapsulate them into&#xD;
      size 00 capsules at Science in Sport. This will avoid difficulties with placebo blinding, as&#xD;
      the capsules can all be given a similar appearance. Tests indicate that daily doses of&#xD;
      cinnamon bark extract and of green tea extract will be represented by 2 capsules, each&#xD;
      containing 375mg (cinnamon bark extract) and 450mg (green tea extract), while a daily dose of&#xD;
      broccoli sprout powder will be represented by 6 capsules containing 250mg each. Placebo&#xD;
      capsules will be prepared using food grade microcrystalline cellulose. Microbial testing will&#xD;
      be carried out on all supplements.&#xD;
&#xD;
      For presentation to volunteers, the daily capsules will be divided into two servings, one&#xD;
      serving to be taken in the morning with breakfast, and one serving to be taken in the evening&#xD;
      with dinner. Each serving containing 5 capsules, as follows:&#xD;
&#xD;
        -  EnduraCell broccoli sprout powder: 3 capsules&#xD;
&#xD;
        -  Bulk Powders Green tea extract: 1 capsule&#xD;
&#xD;
        -  Bulk Powders Cinnamon Bark Extract: 1 capsule&#xD;
&#xD;
      One serving of the placebo intervention contains:&#xD;
&#xD;
      • Placebo (microcrystalline cellulose): 5 capsules&#xD;
&#xD;
      Volunteers will take 5 servings just prior to the exercise challenge tests as follows:&#xD;
&#xD;
      Day -2: two servings (one in the morning and one in the evening) Day -1: two servings (one in&#xD;
      the morning and one in the evening) Day 0: one serving (one in the morning with the first&#xD;
      meal)&#xD;
&#xD;
      Each serving of capsules will be individually bagged and labelled with a unique identifier.&#xD;
      Volunteers will be instructed to take a serving of capsules twice per day, with a small&#xD;
      volume of water. They will be asked to record the unique identifier of each capsule serving&#xD;
      after consumption, along with the time at which it was consumed. Compliance will be monitored&#xD;
      via this daily supplement log, as well as by measuring plasma SUL metabolites.&#xD;
&#xD;
      Volunteers will be encouraged to minimise, as far as is possible, a high intake of products&#xD;
      rich in sulforaphane (cruciferous vegetables such as Brussels sprouts, broccoli, cabbage,&#xD;
      cauliflower, bok choy, kale, collards, broccoli sprouts, chinese broccoli, broccoli raab,&#xD;
      kohlrabi, mustard, turnip, radish, rocket), epigallocatechin gallate (green tea) and&#xD;
      cinnamaldehyde (cinnamon), during the 2.5 days prior to the challenge test days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 22, 2017</start_date>
  <completion_date type="Actual">August 31, 2018</completion_date>
  <primary_completion_date type="Actual">February 28, 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>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Markers of Oxidative Stress</measure>
    <time_frame>18months</time_frame>
    <description>Plasma TBARS:Plasma TBARS will be measured by HPLC (High Performance Liquid Chromatography).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Antioxidant enzyme activity</measure>
    <time_frame>18months</time_frame>
    <description>Glutathione peroxidase, superoxide dismutase, and acetaldehyde dehydrogenase will be measured in plasma by spectrophotometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Marker of Oxidative Stress</measure>
    <time_frame>18months</time_frame>
    <description>Plasma F2-Isoprostanes: will be measured by ELISA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Markers of Inflammation</measure>
    <time_frame>18months</time_frame>
    <description>Plasma high sensitivity C-Reactive Protein (hs-CRP): Plasma hsCRP will be assessed by automated analysis using KONE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Interleukin-6 (IL-6)</measure>
    <time_frame>18months</time_frame>
    <description>Plasma IL-6 will be assessed by ELISA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Tumour-Necrosis Factor - alpha (TNF-α)</measure>
    <time_frame>18months</time_frame>
    <description>Will be assessed by ELISA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolic risk markers</measure>
    <time_frame>18months</time_frame>
    <description>Plasma insulin: Plasma insulin will be assessed by ELISA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma glucose</measure>
    <time_frame>18months</time_frame>
    <description>Plasma glucose will be assessed by automated analysis using KONE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma non-esterified fatty acids (NEFA)</measure>
    <time_frame>18months</time_frame>
    <description>Will be measured by automated analysis using KONE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Markers of muscle damage</measure>
    <time_frame>18 months</time_frame>
    <description>Plasma Creatine Kinase activity will assessed by spectrophotometer Plasma Lactate dehydrogenase activity will assessed by spectrophotometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Markers of platelet function</measure>
    <time_frame>18 months</time_frame>
    <description>Thrombin generation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Counter Movement Jump</measure>
    <time_frame>18months</time_frame>
    <description>This is a test of lower body strength and will be assessed throughout the study visits using a vertical jump meter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Ratings</measure>
    <time_frame>18months</time_frame>
    <description>Questionnaires to be applied during exercise challenge test days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wellness Questionnaire</measure>
    <time_frame>18months</time_frame>
    <description>To assess lifestyle factors such as fatigue, sleep, and mood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Soreness of quadriceps</measure>
    <time_frame>18months</time_frame>
    <description>Rating of perceived soreness (pre, post, 48hr post) - Volunteers will rate their perceived soreness in their quadriceps on a ten point scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Exhaustion</measure>
    <time_frame>18months</time_frame>
    <description>Ratings of perceived exhaustion (during exercise challenge) - Volunteers will rate their perceived exhaustion using Borg's modified R.P.E scale (10 point).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Dietary Supplementation During Exercise</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 capsules of placebo (microcrystalline cellulose) taken once in the morning with breakfast and once in the evening with dinner for two days prior to the study supervised exercise period and then one dose taken on the morning of the exercise test with the first meal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For presentation to volunteers, the daily capsules will be divided into two servings, one serving to be taken in the morning with breakfast, and one serving to be taken in the evening with dinner. Each serving containing 5 capsules, as follows:&#xD;
EnduraCell broccoli sprout powder: 3 capsules&#xD;
Bulk Powders Green tea extract: 1 capsule&#xD;
Bulk Powders Cinnamon Bark Extract: 1 capsule to be taken for two days prior to the study supervised exercise period and then one dose taken on the morning of the exercise test with the first meal</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Microcrystalline cellulose capsules x 5 morning and night with meals for two days prior to exercise test and 5 capsules taken on the morning of the test with the first meal</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Intervention</intervention_name>
    <description>Daily capsules will be divided into two servings, one serving to be taken in the morning with breakfast, and one serving to be taken in the evening with dinner. Each serving containing 5 capsules, as follows:&#xD;
EnduraCell broccoli sprout powder: 3 capsules&#xD;
Bulk Powders Green tea extract: 1 capsule&#xD;
Bulk Powders Cinnamon Bark Extract: 1 capsule taken for two days prior to exercise test and 5 capsules taken on the morning of the test with the first meal</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy, recreationally active men and women aged 18-25 BMI 18.5-30&#xD;
&#xD;
          -  Healthy, recreationally active men and women aged 50-75 BMI 18.5-30&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Physician diagnosed diabetes or chronic disease including asthma&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Uncontrolled Hypertension&#xD;
&#xD;
          -  Musculo-skeletal problems&#xD;
&#xD;
          -  Use of some dietary supplements (e.g. antioxidants, fish oils, vitamins_&#xD;
&#xD;
          -  Taking of prescription medicines&#xD;
&#xD;
          -  In the 18-25 group, Physical Activity levels below moderate (Moderate = greater than&#xD;
             2.5 and less than 5.0 hrs /week including 0.5-1.5 hr/week moderate to intense&#xD;
             exercise)&#xD;
&#xD;
          -  In the 50-75 group, activity levels below the minimal recommendations for daily&#xD;
             physical activity (less than 30 min/day, 5 days/week)&#xD;
&#xD;
          -  Participation in another research study&#xD;
&#xD;
          -  Not being able to speak or understand English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Baukje De Roos, Msc, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Rowett Institute, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Aberdeen, The Rowett Institute</name>
      <address>
        <city>Aberdeen</city>
        <zip>AB25 2ZD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>December 11, 2018</last_update_submitted>
  <last_update_submitted_qc>December 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dietary supplementation</keyword>
  <keyword>Exercise</keyword>
  <keyword>Increase Resilience</keyword>
  <keyword>Oxidative Stress</keyword>
  <keyword>Efficacy</keyword>
  <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/NCT03022214
org study id: Bdr2017-1
nct id: NCT03022214
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Since 1948, health has been defined as "a state of complete physical, mental and social
      well-being, and not merely the absence of disease and infirmity" . However, a growing school
      of thought suggests that health represents an ability to be adaptable and flexible in
      response to daily stressors. It has been proposed that instead, the view of health should be
      "towards the ability to adapt and self-manage in the face of social, physical and emotional
      challenges", which has been termed "resilience".

      The theory of "resilience" relates health to the body's capacity to manage daily stressors
      (such as physical activity or oxidative fluctuations) that challenge homeostasis, with the
      return to homeostasis resulting from several physiological stress responses. Although this is
      an all-encompassing model, and the effects of pathogens and other stress factors are also
      relevant, this study will centre on the physiological aspects on this theory, focussing on
      the disruption through exercise.
The Nrf-2 pathway is the major cellular defence against oxidative and electrophilic stresses.
      Briefly, following dissociation from Keap1 (a scaffolding protein which binds Nrf2 and Cul3
      ubiquitin ligase for proteasome degradation), Nrf-2 accumulates in the nucleus where it
      activates the antioxidant response element (ARE) in the promoter region of many antioxidant
      genes, including catalase, glutathione peroxidases (GPX), and superoxide dismutase (SOD). As
      such, it is an attractive target for both dietary and pharmacological interventions aiming to
      increase resilience to oxidative stress. Most diet-derived bioactive Nrf-2 inducers contain
      Michael acceptor groups (an α, β-unsaturated carbonyl moiety). Curcumin, for example,
      contains two Michael acceptor groups and is a known activator of Nrf-2. An additional
      bioactive with a Michael accepter group is trans-cinnamaldehyde (CA) (a component found in
      the stem bark of Cinnamomum cassia), which, like curcumin, is an Nrf-2 activator in a
      dose-dependent manner.

      Therefore, the purpose of this study will be to assess the effect of bioactive Nrf-2
      inducers, based on the presence of an α, β-unsaturated carbonyl moiety, on resilience markers
      such as antioxidant enzyme activities and markers of oxidative stress, such as TBARS, to an
      exercise challenge. The hypothesis is that specific plant bioactive increase the production
      of antioxidant enzyme activities at baseline, and thereby decrease levels of TBARS upon an
      exercise challenge. Ultimately, the use of novel resilience markers and signatures could
      significantly improve the ability to prove the efficacy by which pro-oxidant dietary
      bioactive improve lifelong health, as well as targeting those with lowest resilience as a way
      to make best use of limited healthcare resources.

      The intervention supplement will consist of a mix of dietary bioactive with an α,
      β-unsaturated carbonyl moiety (provided in individual capsules), of which the efficacy to
      beneficially affect platelet activity, with and without a H2O2 (Hydrogen Peroxide) challenge,
      was recently established: sulforaphane (SUL), green tea extract (epigallocatechin gallate)
      (EGCG) and cinnamaldehyde (Cin).

      It is intended to use a mix of dietary bioactive for the proposed human intervention study,
      as different compounds could affect multiple pathways and therefore, have a broader efficacy.
      In addition, bioavailability of compounds may be influenced by presence of other compounds,
      as has been suggested in the literature (effect of piperine on EGCG bioavailability).

      Bioavailability data for each of these compounds were extracted from the literature and these
      have been used, alongside practical considerations, to decide on the dosing strategy. The
      desired composition of the supplement mix has been set as follows:

        -  SUL: ~ 14mg

        -  EGCG: ~ 400mg

        -  CIN: ~ 15mg These daily intakes should be sufficient to achieve micromolar quantities in
           blood plasma for between 1 and 6 hours after ingestion, and perhaps longer. .

      Suitable food ingredients which can be used in the study to achieve these intakes have been
      sourced from reputable suppliers. These ingredients will be used to give desired intakes as
      follows:

        -  EnduraCell broccoli sprout powder (with added myrosinase): 1.5g (sufficient to provide ~
           45mg glucoraphanin, the precursor to SUL, which should release approximately ~14mg SUL).

        -  Bulk Powders Green tea extract: ~ 900mg (containing approximately 400mg EGCG).

        -  Bulk Powders Cinnamon Bark Extract: 0.75g (containing ~15 - 20mg Cin).

      Due to envisaged difficulties with palatability, the ingredient mix will be encapsulated.
      While one of the ingredients (green tea extract) is available pre-encapsulated from the
      supplier, it is preferred to obtain all ingredients as free powder, and encapsulate them into
      size 00 capsules at Science in Sport. This will avoid difficulties with placebo blinding, as
      the capsules can all be given a similar appearance. Tests indicate that daily doses of
      cinnamon bark extract and of green tea extract will be represented by 2 capsules, each
      containing 375mg (cinnamon bark extract) and 450mg (green tea extract), while a daily dose of
      broccoli sprout powder will be represented by 6 capsules containing 250mg each. Placebo
      capsules will be prepared using food grade microcrystalline cellulose. Microbial testing will
      be carried out on all supplements.

      For presentation to volunteers, the daily capsules will be divided into two servings, one
      serving to be taken in the morning with breakfast, and one serving to be taken in the evening
      with dinner. Each serving containing 5 capsules, as follows:

        -  EnduraCell broccoli sprout powder: 3 capsules

        -  Bulk Powders Green tea extract: 1 capsule

        -  Bulk Powders Cinnamon Bark Extract: 1 capsule

      One serving of the placebo intervention contains:

      • Placebo (microcrystalline cellulose): 5 capsules

      Volunteers will take 5 servings just prior to the exercise challenge tests as follows:

      Day -2: two servings (one in the morning and one in the evening) Day -1: two servings (one in
      the morning and one in the evening) Day 0: one serving (one in the morning with the first
      meal)

      Each serving of capsules will be individually bagged and labelled with a unique identifier.
      Volunteers will be instructed to take a serving of capsules twice per day, with a small
      volume of water. They will be asked to record the unique identifier of each capsule serving
      after consumption, along with the time at which it was consumed. Compliance will be monitored
      via this daily supplement log, as well as by measuring plasma SUL metabolites.

      Volunteers will be encouraged to minimise, as far as is possible, a high intake of products
      rich in sulforaphane (cruciferous vegetables such as Brussels sprouts, broccoli, cabbage,
      cauliflower, bok choy, kale, collards, broccoli sprouts, chinese broccoli, broccoli raab,
      kohlrabi, mustard, turnip, radish, rocket), epigallocatechin gallate (green tea) and
      cinnamaldehyde (cinnamon), during the 2.5 days prior to the challenge test days.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: Markers of Oxidative Stress
time frame: 18months
description: Plasma TBARS:Plasma TBARS will be measured by HPLC (High Performance Liquid Chromatography).
measure: Antioxidant enzyme activity
time frame: 18months
description: Glutathione peroxidase, superoxide dismutase, and acetaldehyde dehydrogenase will be measured in plasma by spectrophotometer.
measure: Marker of Oxidative Stress
time frame: 18months
description: Plasma F2-Isoprostanes: will be measured by ELISA.
measure: Markers of Inflammation
time frame: 18months
description: Plasma high sensitivity C-Reactive Protein (hs-CRP): Plasma hsCRP will be assessed by automated analysis using KONE.
measure: Plasma Interleukin-6 (IL-6)
time frame: 18months
description: Plasma IL-6 will be assessed by ELISA.
measure: Plasma Tumour-Necrosis Factor - alpha (TNF-α)
time frame: 18months
description: Will be assessed by ELISA.
measure: Metabolic risk markers
time frame: 18months
description: Plasma insulin: Plasma insulin will be assessed by ELISA.
measure: Plasma glucose
time frame: 18months
description: Plasma glucose will be assessed by automated analysis using KONE.
measure: Plasma non-esterified fatty acids (NEFA)
time frame: 18months
description: Will be measured by automated analysis using KONE.
measure: Markers of muscle damage
time frame: 18 months
description: Plasma Creatine Kinase activity will assessed by spectrophotometer Plasma Lactate dehydrogenase activity will assessed by spectrophotometer
measure: Markers of platelet function
time frame: 18 months
description: Thrombin generation
measure: Counter Movement Jump
time frame: 18months
description: This is a test of lower body strength and will be assessed throughout the study visits using a vertical jump meter.
measure: Subjective Ratings
time frame: 18months
description: Questionnaires to be applied during exercise challenge test days
measure: Wellness Questionnaire
time frame: 18months
description: To assess lifestyle factors such as fatigue, sleep, and mood.
measure: Perceived Soreness of quadriceps
time frame: 18months
description: Rating of perceived soreness (pre, post, 48hr post) - Volunteers will rate their perceived soreness in their quadriceps on a ten point scale.
measure: Perceived Exhaustion
time frame: 18months
description: Ratings of perceived exhaustion (during exercise challenge) - Volunteers will rate their perceived exhaustion using Borg's modified R.P.E scale (10 point).
arm group label: Placebo
arm group type: Experimental
description: 5 capsules of placebo (microcrystalline cellulose) taken once in the morning with breakfast and once in the evening with dinner for two days prior to the study supervised exercise period and then one dose taken on the morning of the exercise test with the first meal
arm group label: Intervention
arm group type: Experimental
description: For presentation to volunteers, the daily capsules will be divided into two servings, one serving to be taken in the morning with breakfast, and one serving to be taken in the evening with dinner. Each serving containing 5 capsules, as follows:
EnduraCell broccoli sprout powder: 3 capsules
Bulk Powders Green tea extract: 1 capsule
Bulk Powders Cinnamon Bark Extract: 1 capsule to be taken for two days prior to the study supervised exercise period and then one dose taken on the morning of the exercise test with the first meal
intervention type: Dietary Supplement
intervention name: Placebo
description: Microcrystalline cellulose capsules x 5 morning and night with meals for two days prior to exercise test and 5 capsules taken on the morning of the test with the first meal
arm group label: Placebo
intervention type: Dietary Supplement
intervention name: Intervention
description: Daily capsules will be divided into two servings, one serving to be taken in the morning with breakfast, and one serving to be taken in the evening with dinner. Each serving containing 5 capsules, as follows:
EnduraCell broccoli sprout powder: 3 capsules
Bulk Powders Green tea extract: 1 capsule
Bulk Powders Cinnamon Bark Extract: 1 capsule taken for two days prior to exercise test and 5 capsules taken on the morning of the test with the first meal
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Baukje De Roos, Msc, PhD
role: Principal Investigator
affiliation: The Rowett Institute, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No