<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/NCT03003442</url>
  </required_header>
  <id_info>
    <org_study_id>18769</org_study_id>
    <nct_id>NCT03003442</nct_id>
  </id_info>
  <brief_title>Effects of Supradyn® Energy 3RDA on Fatigue/Stress, Substrate Metabolism During Exercise and Demanding Cognitive Tasks</brief_title>
  <official_title>Investigation of the Acute and Chronic Effects of Supradyn® Energy 3RDA on Ratings of 'Fatigue/Stress', Substrate Metabolism and Blood Biomarkers of Recovery, as a Consequence of Exercise and Metabolically Demanding Cognitive Tasks</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northumbria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Northumbria University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigation of the acute and chronic effects of Supradyn® Energy 3RDA on subjective ratings&#xD;
      of 'fatigue/stress', substrate metabolism and blood biomarkers of recovery, as a consequence&#xD;
      of exercise and metabolically demanding cognitive tasks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Supplementation with vitamins and minerals has been shown to enhance energy production,&#xD;
      metabolism, and mood state. It is thought that they may also aid recovery from challenging&#xD;
      physical and psychological tasks following both acute and chronic supplementation. The&#xD;
      present study will investigate the effects of a multivitamin/mineral supplement (Supradyn®&#xD;
      Energy 3RDA) following a single intake and following daily intake for 4-weeks on subjective&#xD;
      ratings of 'fatigue/stress', metabolism and blood biomarkers of cell damage following both&#xD;
      exercise and demanding cognitive tasks, in healthy young male and female volunteers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2016</start_date>
  <completion_date type="Actual">October 18, 2017</completion_date>
  <primary_completion_date type="Actual">October 16, 2017</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>Other</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acute treatment effects on energy expenditure/metabolism during physical stress</measure>
    <time_frame>Measures taken following acute treatment during exercise (45 minutes post acute treatment)</time_frame>
    <description>ICa (Indirect Calorimetry) data obtained to determine energy expenditure, fat and carbohydrate oxidation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acute treatment effects on energy expenditure/metabolism during mental stress</measure>
    <time_frame>Measures taken following acute treatment during cognitive task performance (135 minutes post acute treatment)</time_frame>
    <description>ICa (Indirect Calorimetry) data obtained to determine energy expenditure, fat and carbohydrate oxidation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Chronic treatment effects on energy expenditure/metabolism during physical stress</measure>
    <time_frame>Measures taken following 28 days' chronic treatment, during exercise performance</time_frame>
    <description>ICa (Indirect Calorimetry) data obtained to determine energy expenditure, fat and carbohydrate oxidation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Chronic treatment effects on energy expenditure/metabolism during mental stress</measure>
    <time_frame>Measures taken following 28 days' chronic treatment, during cognitive task performance</time_frame>
    <description>ICa (Indirect Calorimetry) data obtained to determine energy expenditure, fat and carbohydrate oxidation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acute treatment effects on subjective arousal/stress/fatigue ratings as assessed by visual analogue scales during physical stress</measure>
    <time_frame>Following acute treatment, measures taken before, after and every 10 minutes during 30 minute exercise period</time_frame>
    <description>Subjective ratings of arousal (concentration, mental stamina/physical stamina) stress and fatigue (mentally tired/physically tired) visual analogue scales (scored along 100mm line)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acute treatment effects on subjective arousal/stress/fatigue ratings as assessed by visual analogue scales during mental stress.</measure>
    <time_frame>Following acute treatment, measures taken before, after and every 10 minutes during 30 minute cognitive task period</time_frame>
    <description>Subjective ratings of arousal (concentration, mental stamina/physical stamina) stress and fatigue (mentally tired/physically tired) visual analogue scales (scored along 100mm line)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Chronic (28 days) treatment effects on subjective arousal/stress/fatigue ratings as assessed by visual analogue scales, during physical stress</measure>
    <time_frame>Following 28 days' treatment, measures taken before, after and every 10 minutes during 30 minute exercise period</time_frame>
    <description>Subjective ratings of arousal (concentration, mental stamina/physical stamina) stress and fatigue (mentally tired/physically tired) visual analogue scales (scored along 100mm line)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Chronic (28 days) treatment effects on subjective arousal/stress/fatigue ratings as assessed by visual analogue scales, during mental stress</measure>
    <time_frame>Following 28 days treatment, measures taken before, after and every 10 minutes during 30 minute cognitive task period</time_frame>
    <description>Subjective ratings of arousal (concentration, mental stamina/physical stamina) stress and fatigue (mentally tired/physically tired) visual analogue scales (scored along 100mm line)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acute treatment effects on recovery biomarkers</measure>
    <time_frame>Following acute treatment, taken at baseline and following exercise (75 minutes post-dose) and cognitive task performance (165 minutes post-dose). Then at 24h and 48hours post-exercise.</time_frame>
    <description>Measuring levels of Interleukin-6, F2 isoprostanes, protein carbonyls, C-reactive protein, glutathione peroxidase, taken to assess recovery from exercise</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Chronic (28 days) treatment effects on recovery biomarkers</measure>
    <time_frame>Following 28 days treatment, taken at baseline, following exercise and cognitive task performance. Then at 24h and 48hours post-exercise.</time_frame>
    <description>Measuring levels of Interleukin-6, F2 isoprostanes, protein carbonyls, C-reactive protein, glutathione peroxidase, taken to assess recovery from exercise</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acute treatment effects on vitamin/mineral/homocysteine levels</measure>
    <time_frame>Measured at baseline, then following acute treatment, after exercise (75 minutes post-dose)</time_frame>
    <description>Measuring levels of Ferritin, vitamin B12, homocysteine, creatinine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chronic (28 days) treatment effects on vitamin/mineral/homocysteine levels</measure>
    <time_frame>Following chronic (28 days) treatment, measured after exercise</time_frame>
    <description>Measuring levels of Ferritin, vitamin B12, homocysteine, creatinine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute treatment effects on cognitive performance</measure>
    <time_frame>Following acute treatment, measured 135 minutes post dose</time_frame>
    <description>Tasks include serial 3s, serial 7s and RVIP (Rapid Visual Information Processing), repeated 3 times</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chronic (28 days) treatment effects on cognitive performance</measure>
    <time_frame>Following chronic (28 days) treatment</time_frame>
    <description>Tasks include serial 3s, serial 7s and RVIP (Rapid Visual Information Processing), repeated 3 times</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">91</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Supradyn® Energy 3RDA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Supradyn® Energy 3RDA, 1 multivitamin/mineral tablet administered by mouth daily for 28 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo, 1 tablet administered by mouth daily for 28 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Supradyn® Energy 3RDA</intervention_name>
    <description>Multivitamin/mineral containing co-Q10</description>
    <arm_group_label>Supradyn® Energy 3RDA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects are physically active (i.e. exercise at least 2 times per week)&#xD;
&#xD;
          -  Subjects are able to run non-stop on a treadmill at a moderate pace for 30mins&#xD;
&#xD;
          -  Subjects agree to abstain throughout the trial from all dietary vitamin and mineral&#xD;
             supplements&#xD;
&#xD;
          -  Subjects are, in the opinion of the investigator, willing to participate in all&#xD;
             scheduled visits and to adhere to all study procedures&#xD;
&#xD;
          -  Subjects accept to refrain from alcohol intake 24 hours and to fast for a minimum of&#xD;
             10 hours before the study visits&#xD;
&#xD;
          -  Subjects do not have a current diagnosis of a significant medical condition which may&#xD;
             interfere with the subject's ability to perform assessments and successfully completes&#xD;
             training&#xD;
&#xD;
          -  Subjects provide a personally signed and dated informed consent indicating that the&#xD;
             subject has been informed of all pertinent aspects of the trial and understood and&#xD;
             accepts these&#xD;
&#xD;
          -  Have a bank account (required for payment)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smokers (smoking within the last 3 months)&#xD;
&#xD;
          -  Blood pressure &gt;140/90mmHg&#xD;
&#xD;
          -  Excessive use of caffeine (&gt; 500 mg caffeine per day) from all dietary sources&#xD;
&#xD;
          -  Current intake of pharmaceuticals (excluding contraception)&#xD;
&#xD;
          -  Have a recent history of (within 12 months of screening visit) or strong potential for&#xD;
             alcohol or substance abuse. Alcohol abuse is defined as more than 60g (men) / 40g&#xD;
             (women) pure alcohol per day (7 / 5.5 units)&#xD;
&#xD;
          -  A history of neurological or psychiatric diseases excluding anxiety or depression&#xD;
&#xD;
          -  Current diagnosis of depression or anxiety&#xD;
&#xD;
          -  A history of significant head trauma&#xD;
&#xD;
          -  Have sleep disturbances and/or are taking sleep aid medication&#xD;
&#xD;
          -  Have learning difficulties or dyslexia&#xD;
&#xD;
          -  Have visual impairment that cannot be corrected with glasses or contact lenses&#xD;
&#xD;
          -  Have frequent migraines that require medication (more than or equal to 1 per month)&#xD;
&#xD;
          -  Have disorders of the blood (e.g. anemia, hemophilia, thrombocytosis)&#xD;
&#xD;
          -  Have a heart disorder or a history of vascular illness&#xD;
&#xD;
          -  Have a respiratory disorder that is induced by exercise or requires regular medication&#xD;
             (Note: participants with asthma who only take their medication occasionally/as&#xD;
             required are eligible for this study)&#xD;
&#xD;
          -  Have type I or type II diabetes&#xD;
&#xD;
          -  Have a history of renal or hepatic disease, or other severe diseases of the&#xD;
             gastrointestinal tract (e.g. iron accumulation, iron utilization disorders,&#xD;
             hypercalcaemia, hypercalciuria), that are likely to interfere with&#xD;
             metabolism/absorption/secretion of the product under investigation&#xD;
&#xD;
          -  Are pregnant, trying to get pregnant or breast feeding&#xD;
&#xD;
          -  Have any health condition that would prevent fulfillment of the study requirements&#xD;
&#xD;
          -  Any condition which may interfere with the subjects ability to perform assessments&#xD;
&#xD;
          -  Are employed in a job that includes night shift work&#xD;
&#xD;
          -  Participation in another clinical trial within 30 days prior to screening&#xD;
&#xD;
          -  Have habitually supplemented with vitamins or minerals, within the last month (defined&#xD;
             as more than 3 consecutive days or 4 days in total)&#xD;
&#xD;
          -  BMI above 30 kg/m2&#xD;
&#xD;
          -  Any history of hypersensitivity to the investigational product or its active or&#xD;
             inactive constituents or any food allergy or intolerance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Crystal Haskell-Ramsay, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northumbria University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northumbria University</name>
      <address>
        <city>Newcastle upon Tyne</city>
        <state>Tyne &amp; Wear</state>
        <zip>NE1 8ST</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>March 12, 2018</last_update_submitted>
  <last_update_submitted_qc>March 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multivitamin/mineral</keyword>
  <keyword>Exercise</keyword>
  <keyword>Fatigue</keyword>
  <keyword>Stress</keyword>
  <keyword>Arousal</keyword>
  <keyword>Energy expenditure</keyword>
  <keyword>Recovery biomarkers</keyword>
  <keyword>Cognition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue</mesh_term>
  </condition_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/NCT03003442
org study id: 18769
nct id: NCT03003442
lead sponsor: 
collaborator: 
has dmc: No
Investigation of the acute and chronic effects of Supradyn® Energy 3RDA on subjective ratings
      of 'fatigue/stress', substrate metabolism and blood biomarkers of recovery, as a consequence
      of exercise and metabolically demanding cognitive tasks.
Supplementation with vitamins and minerals has been shown to enhance energy production,
      metabolism, and mood state. It is thought that they may also aid recovery from challenging
      physical and psychological tasks following both acute and chronic supplementation. The
      present study will investigate the effects of a multivitamin/mineral supplement (Supradyn®
      Energy 3RDA) following a single intake and following daily intake for 4-weeks on subjective
      ratings of 'fatigue/stress', metabolism and blood biomarkers of cell damage following both
      exercise and demanding cognitive tasks, in healthy young male and female volunteers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Acute treatment effects on energy expenditure/metabolism during physical stress
time frame: Measures taken following acute treatment during exercise (45 minutes post acute treatment)
description: ICa (Indirect Calorimetry) data obtained to determine energy expenditure, fat and carbohydrate oxidation
measure: Acute treatment effects on energy expenditure/metabolism during mental stress
time frame: Measures taken following acute treatment during cognitive task performance (135 minutes post acute treatment)
description: ICa (Indirect Calorimetry) data obtained to determine energy expenditure, fat and carbohydrate oxidation
measure: Chronic treatment effects on energy expenditure/metabolism during physical stress
time frame: Measures taken following 28 days' chronic treatment, during exercise performance
description: ICa (Indirect Calorimetry) data obtained to determine energy expenditure, fat and carbohydrate oxidation
measure: Chronic treatment effects on energy expenditure/metabolism during mental stress
time frame: Measures taken following 28 days' chronic treatment, during cognitive task performance
description: ICa (Indirect Calorimetry) data obtained to determine energy expenditure, fat and carbohydrate oxidation
measure: Acute treatment effects on subjective arousal/stress/fatigue ratings as assessed by visual analogue scales during physical stress
time frame: Following acute treatment, measures taken before, after and every 10 minutes during 30 minute exercise period
description: Subjective ratings of arousal (concentration, mental stamina/physical stamina) stress and fatigue (mentally tired/physically tired) visual analogue scales (scored along 100mm line)
measure: Acute treatment effects on subjective arousal/stress/fatigue ratings as assessed by visual analogue scales during mental stress.
time frame: Following acute treatment, measures taken before, after and every 10 minutes during 30 minute cognitive task period
description: Subjective ratings of arousal (concentration, mental stamina/physical stamina) stress and fatigue (mentally tired/physically tired) visual analogue scales (scored along 100mm line)
measure: Chronic (28 days) treatment effects on subjective arousal/stress/fatigue ratings as assessed by visual analogue scales, during physical stress
time frame: Following 28 days' treatment, measures taken before, after and every 10 minutes during 30 minute exercise period
description: Subjective ratings of arousal (concentration, mental stamina/physical stamina) stress and fatigue (mentally tired/physically tired) visual analogue scales (scored along 100mm line)
measure: Chronic (28 days) treatment effects on subjective arousal/stress/fatigue ratings as assessed by visual analogue scales, during mental stress
time frame: Following 28 days treatment, measures taken before, after and every 10 minutes during 30 minute cognitive task period
description: Subjective ratings of arousal (concentration, mental stamina/physical stamina) stress and fatigue (mentally tired/physically tired) visual analogue scales (scored along 100mm line)
measure: Acute treatment effects on recovery biomarkers
time frame: Following acute treatment, taken at baseline and following exercise (75 minutes post-dose) and cognitive task performance (165 minutes post-dose). Then at 24h and 48hours post-exercise.
description: Measuring levels of Interleukin-6, F2 isoprostanes, protein carbonyls, C-reactive protein, glutathione peroxidase, taken to assess recovery from exercise
measure: Chronic (28 days) treatment effects on recovery biomarkers
time frame: Following 28 days treatment, taken at baseline, following exercise and cognitive task performance. Then at 24h and 48hours post-exercise.
description: Measuring levels of Interleukin-6, F2 isoprostanes, protein carbonyls, C-reactive protein, glutathione peroxidase, taken to assess recovery from exercise
measure: Acute treatment effects on vitamin/mineral/homocysteine levels
time frame: Measured at baseline, then following acute treatment, after exercise (75 minutes post-dose)
description: Measuring levels of Ferritin, vitamin B12, homocysteine, creatinine
measure: Chronic (28 days) treatment effects on vitamin/mineral/homocysteine levels
time frame: Following chronic (28 days) treatment, measured after exercise
description: Measuring levels of Ferritin, vitamin B12, homocysteine, creatinine
measure: Acute treatment effects on cognitive performance
time frame: Following acute treatment, measured 135 minutes post dose
description: Tasks include serial 3s, serial 7s and RVIP (Rapid Visual Information Processing), repeated 3 times
measure: Chronic (28 days) treatment effects on cognitive performance
time frame: Following chronic (28 days) treatment
description: Tasks include serial 3s, serial 7s and RVIP (Rapid Visual Information Processing), repeated 3 times
arm group label: Supradyn® Energy 3RDA
arm group type: Experimental
description: Supradyn® Energy 3RDA, 1 multivitamin/mineral tablet administered by mouth daily for 28 days
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo, 1 tablet administered by mouth daily for 28 days
intervention type: Dietary Supplement
intervention name: Supradyn® Energy 3RDA
description: Multivitamin/mineral containing co-Q10
arm group label: Supradyn® Energy 3RDA
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Crystal Haskell-Ramsay, Dr
role: Principal Investigator
affiliation: Northumbria University
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Fatigue
sharing ipd: No