<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/NCT03262376</url>
  </required_header>
  <id_info>
    <org_study_id>IIT15073</org_study_id>
    <nct_id>NCT03262376</nct_id>
  </id_info>
  <brief_title>Minerals and Botanicals for Acute Stress</brief_title>
  <official_title>Acute Effect of Minerals and Botanicals in Combination or Isolation on Cognitive Performance, Neural Activity, and Subjective and Cortisol Response to Acute Stress</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Leeds</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Leeds</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>
      The objective of this acute intervention study is to examine the potential of minerals&#xD;
      combined with botanicals to demonstrate unique and synergistic effects on oscillatory brain&#xD;
      activity, cognitive performance, and stress reduction (endocrine, sympathetic, and subjective&#xD;
      parameters) under conditions of acute stress in moderately stressed individuals&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Botanicals in isolation or combined, will be administered with a mineral and vitamin complex&#xD;
      to moderately stressed, healthy adults in a parallel groups fashion in this randomised&#xD;
      placebo controlled trial. Oscillatory brain activity (EEG) during rest and performance on&#xD;
      cognitive tasks of attention will be examined after treatment intake under conditions of&#xD;
      acute laboratory stress. The effects of treatments on stress responses (cardiovascular,&#xD;
      subjective and cortisol responses) will also be assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 4, 2017</start_date>
  <completion_date type="Actual">December 12, 2018</completion_date>
  <primary_completion_date type="Actual">December 12, 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>Parallel Assignment</intervention_model>
    <intervention_model_description>The study conforms to a double blind, quasi-randomised (randomisation will be balanced across condition based on age and sex), placebo controlled, parallel group design comprising 4 treatment conditions</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>This study is double-blinded. The supplement manufacturer will independently create codes for the 4 treatment conditions. The study statistician will use the treatment codes generated to allocate participants to treatments. Researchers and participants will be blind treatment allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Oscillatory brain activity during the rested state and attentional processing (EEG; Biosemi Active2, 64-channel, DC amplifier, 24-bit resolution system)</measure>
    <time_frame>30 minute period, approximately 65 minutes post treatment intake</time_frame>
    <description>The effect of treatment on oscillatory brain activity during the rested state and during attentional task processing after stress exposure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective stress (Stress &amp; Arousal Checklist; Mackay et al., 1978)</measure>
    <time_frame>Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake</time_frame>
    <description>The effect of treatment on subjective stress responses to stress induction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective mood (Profile of Mood States [MCNair et al., 1971] &amp; Bond Visual analogue scales, 1974)</measure>
    <time_frame>Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake</time_frame>
    <description>The effect of treatment on subjective mood responses to stress induction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective anxiety (Spielberger State Trait Anxiety Inventory, 1983)</measure>
    <time_frame>Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake</time_frame>
    <description>The effect of treatment on subjective anxiety responses to stress induction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive performance (Digit attention switching &amp; threat vs neutral dot probe task)</measure>
    <time_frame>20 minute period (comprising two distinct tasks) approximately 75 minutes post treatment intake</time_frame>
    <description>The effect of treatment on reaction time and accuracy performance on two cognitive tasks of attention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake</time_frame>
    <description>The effect of treatment on blood pressure responses to stress induction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake</time_frame>
    <description>The effect of treatment on heart rate variability before and after stress induction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Salivary cortisol</measure>
    <time_frame>Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake</time_frame>
    <description>The effect of treatment on salivary cortisol responses to stress induction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event related potentials (EEG; Biosemi Active2, 64-channel, DC amplifier, 24-bit resolution system)</measure>
    <time_frame>20 minute period (comprising two distinct tasks) approximately 75 minutes post treatment intake</time_frame>
    <description>The effect of treatment on event related potentials during execution of attentional processing</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Stress</condition>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>Mineral + vits + botanical A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mineral and vitamin complex combined with Botanical A</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mineral + vits + botanical B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mineral and vitamin complex combined with Botanical B</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mineral+vits +botanical A+Botanical B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mineral and vitamin complex combined with Botanical A and Botanical B</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Cellulose crystalline placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Minerals + Vitamins</intervention_name>
    <description>A mineral and vitamin tablet</description>
    <arm_group_label>Mineral + vits + botanical A</arm_group_label>
    <arm_group_label>Mineral + vits + botanical B</arm_group_label>
    <arm_group_label>Mineral+vits +botanical A+Botanical B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Botanical A</intervention_name>
    <description>Botanical extract administered in capsule form</description>
    <arm_group_label>Mineral + vits + botanical A</arm_group_label>
    <arm_group_label>Mineral+vits +botanical A+Botanical B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Botanical B</intervention_name>
    <description>Botanical extract administered in capsule form</description>
    <arm_group_label>Mineral + vits + botanical B</arm_group_label>
    <arm_group_label>Mineral+vits +botanical A+Botanical B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Cellulose crystalline tablet</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults capable of giving informed consent&#xD;
&#xD;
          -  Male and Female&#xD;
&#xD;
          -  ≥18 - ≤50 years of age (premenopausal if female)&#xD;
&#xD;
          -  Effective contraception taken in females&#xD;
&#xD;
          -  Women in luteal menstrual phase&#xD;
&#xD;
          -  Body mass index (BMI) ≥18 and ≤30 kg/m2&#xD;
&#xD;
          -  Normal vision or corrected to normal&#xD;
&#xD;
          -  Moderately stressed (subjective report)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No known intolerance to minerals, vitamins or botanicals&#xD;
&#xD;
          -  Intake of prescribed medication except contraceptives&#xD;
&#xD;
          -  Intake of any regular medication/supplements&#xD;
&#xD;
          -  History of significant hypertensive, hepatic, renal, pulmonary, gastro-intestinal,&#xD;
             endocrinological, neurologic, haematological, psychiatric (inc. mood disorders),&#xD;
             cardiac or allergic disease which is clinically relevant to the study&#xD;
&#xD;
          -  Hypertension (self-report or resting blood pressure &gt;160/95 mmHg)&#xD;
&#xD;
          -  Diabetes (T1 or T2)&#xD;
&#xD;
          -  Smoking more than occasional cigarettes (&gt;5/day)&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
&#xD;
          -  Previous participation in a stress study involving the Trier Social Stress Test&#xD;
&#xD;
          -  Night-working/shift work&#xD;
&#xD;
          -  Recreational drug use&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Louise Dye, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Leeds</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Human Appetite Research Unit, University of Leeds</name>
      <address>
        <city>Leeds</city>
        <state>West Yorkshire</state>
        <zip>LS29JT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>January 4, 2019</last_update_submitted>
  <last_update_submitted_qc>January 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Leeds</investigator_affiliation>
    <investigator_full_name>Prof Louise Dye</investigator_full_name>
    <investigator_title>Professor of Nutrition and Behaviour</investigator_title>
  </responsible_party>
  <keyword>Stress</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Cortisol</keyword>
  <keyword>Vitamins</keyword>
  <keyword>Botanicals</keyword>
  <keyword>Minerals</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamins</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/NCT03262376
org study id: IIT15073
nct id: NCT03262376
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this acute intervention study is to examine the potential of minerals
      combined with botanicals to demonstrate unique and synergistic effects on oscillatory brain
      activity, cognitive performance, and stress reduction (endocrine, sympathetic, and subjective
      parameters) under conditions of acute stress in moderately stressed individuals
Botanicals in isolation or combined, will be administered with a mineral and vitamin complex
      to moderately stressed, healthy adults in a parallel groups fashion in this randomised
      placebo controlled trial. Oscillatory brain activity (EEG) during rest and performance on
      cognitive tasks of attention will be examined after treatment intake under conditions of
      acute laboratory stress. The effects of treatments on stress responses (cardiovascular,
      subjective and cortisol responses) will also be assessed.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The study conforms to a double blind, quasi-randomised (randomisation will be balanced across condition based on age and sex), placebo controlled, parallel group design comprising 4 treatment conditions
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: This study is double-blinded. The supplement manufacturer will independently create codes for the 4 treatment conditions. The study statistician will use the treatment codes generated to allocate participants to treatments. Researchers and participants will be blind treatment allocation.
measure: Oscillatory brain activity during the rested state and attentional processing (EEG; Biosemi Active2, 64-channel, DC amplifier, 24-bit resolution system)
time frame: 30 minute period, approximately 65 minutes post treatment intake
description: The effect of treatment on oscillatory brain activity during the rested state and during attentional task processing after stress exposure
measure: Subjective stress (Stress & Arousal Checklist; Mackay et al., 1978)
time frame: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake
description: The effect of treatment on subjective stress responses to stress induction
measure: Subjective mood (Profile of Mood States [MCNair et al., 1971] & Bond Visual analogue scales, 1974)
time frame: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake
description: The effect of treatment on subjective mood responses to stress induction
measure: Subjective anxiety (Spielberger State Trait Anxiety Inventory, 1983)
time frame: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake
description: The effect of treatment on subjective anxiety responses to stress induction
measure: Cognitive performance (Digit attention switching & threat vs neutral dot probe task)
time frame: 20 minute period (comprising two distinct tasks) approximately 75 minutes post treatment intake
description: The effect of treatment on reaction time and accuracy performance on two cognitive tasks of attention
measure: Blood pressure
time frame: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake
description: The effect of treatment on blood pressure responses to stress induction
measure: Heart rate
time frame: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake
description: The effect of treatment on heart rate variability before and after stress induction
measure: Salivary cortisol
time frame: Acute responses to stress induction from pre-treatment intake to approximately 8 hours post-treatment intake
description: The effect of treatment on salivary cortisol responses to stress induction
measure: Event related potentials (EEG; Biosemi Active2, 64-channel, DC amplifier, 24-bit resolution system)
time frame: 20 minute period (comprising two distinct tasks) approximately 75 minutes post treatment intake
description: The effect of treatment on event related potentials during execution of attentional processing
arm group label: Mineral + vits + botanical A
arm group type: Experimental
description: Mineral and vitamin complex combined with Botanical A
arm group label: Mineral + vits + botanical B
arm group type: Experimental
description: Mineral and vitamin complex combined with Botanical B
arm group label: Mineral+vits +botanical A+Botanical B
arm group type: Experimental
description: Mineral and vitamin complex combined with Botanical A and Botanical B
arm group label: Placebo
arm group type: Placebo Comparator
description: Cellulose crystalline placebo
intervention type: Dietary Supplement
intervention name: Minerals + Vitamins
description: A mineral and vitamin tablet
arm group label: Mineral + vits + botanical A
arm group label: Mineral + vits + botanical B
arm group label: Mineral+vits +botanical A+Botanical B
intervention type: Dietary Supplement
intervention name: Botanical A
description: Botanical extract administered in capsule form
arm group label: Mineral + vits + botanical A
arm group label: Mineral+vits +botanical A+Botanical B
intervention type: Dietary Supplement
intervention name: Botanical B
description: Botanical extract administered in capsule form
arm group label: Mineral + vits + botanical B
arm group label: Mineral+vits +botanical A+Botanical B
intervention type: Other
intervention name: Placebo
description: Cellulose crystalline tablet
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Louise Dye, PhD
role: Principal Investigator
affiliation: University of Leeds
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Leeds
investigator full name: Prof Louise Dye
investigator title: Professor of Nutrition and Behaviour
mesh term: Vitamins
sharing ipd: No