<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/NCT04465851</url>
  </required_header>
  <id_info>
    <org_study_id>ETH1718-0907</org_study_id>
    <nct_id>NCT04465851</nct_id>
  </id_info>
  <brief_title>Effect of Ferrous iROn and cUrcumin sTatus on Inflammatory and Neurotrophic markErs</brief_title>
  <acronym>Fe-ROUTINE</acronym>
  <official_title>The Effect of HydroCurc™ Curcumin and Ferrous Iron Supplementation on Iron Status and Inflammatory and Neurotrophic Marker Levels in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Westminster</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gencor Pacific Group</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Westminster</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>
      INTRODUCTION: Iron is a vital nutrient for many physiological processes including DNA&#xD;
      production, oxygen transport and neuronal processes. However, several factors limit iron&#xD;
      absorption including: limited bioavailability of iron (dietary or supplementation sources),&#xD;
      can be subject to dietary iron inhibitors (e.g. calcium). Excess iron can cause cellular&#xD;
      oxidative stress in the body.&#xD;
&#xD;
      Curcumin is an active component found in turmeric, known for its anti-oxidant and&#xD;
      anti-inflammatory properties. Co-administration of iron and curcumin may influence iron,&#xD;
      inflammatory status and/or neurotrophic markers in the body.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intervention study with five parallel treatment groups in a randomised, double-blind,&#xD;
      placebo-controlled design.&#xD;
&#xD;
      Study population: Healthy Participants (Male or Female) will receive daily supplements&#xD;
      (active or equivalent placebos) for 6 weeks (42 days)&#xD;
&#xD;
      Biological samples (blood and urine samples) are collected at baseline visit (day 1),&#xD;
      mid-point (day 21) and end-point (day 42). In addition, pertinent questionnaires (Visual&#xD;
      Analogue Scale-Fatigue [VAS-F] and oral iron supplement questionnaire will be collected at&#xD;
      the aforementioned time points.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 18, 2018</start_date>
  <completion_date type="Actual">January 31, 2020</completion_date>
  <primary_completion_date type="Actual">November 11, 2019</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>Allocation: Randomisation (block) Intervention Model: Parallel, Randomised placebo-controlled design Masking: Double-blind</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Participants (and supplements) will be coded and randomly allocated (applied randomly by software [gender balanced[) to treatment arms to eliminate order effects and maintain research staff blinding.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation</measure>
    <time_frame>Change in Interleukin 6, Interleukin 10 and Interleukin 1 beta (ELISA) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)</time_frame>
    <description>Marker: Interleukin 6 (pg/mL), Interleukin 10 (pg/mL), Interleukin 1 beta (pg/mL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation</measure>
    <time_frame>Change in Tumour Necrosis Factor alpha (ELISA) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)</time_frame>
    <description>Tumour Necrosis Factor alpha (pg/mL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation</measure>
    <time_frame>Change in C-Reactive Protein (immunoassay) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)</time_frame>
    <description>Marker: C-Reactive Protein (g/L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated lipid peroxidation</measure>
    <time_frame>Change in thiobarbituric acid reactive substances (ELISA) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)</time_frame>
    <description>Marker: thiobarbituric acid reactive substances (μM)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated acute iron absorption</measure>
    <time_frame>Change in serum iron (colorimetric analyser) from 0 and 180 minutes following supplementation</time_frame>
    <description>Marker: serum iron (μmol/L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated acute iron absorption</measure>
    <time_frame>Change in total iron binding capacity (colorimetric analyser) from 0 and 180 minutes following supplementation</time_frame>
    <description>Marker: total iron binding capacity (μmol/L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status</measure>
    <time_frame>Change in serum iron (colorimetric analyser) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)</time_frame>
    <description>Marker: serum iron (μmol/L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status</measure>
    <time_frame>Change in total iron binding capacity (colorimetric analyser) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)</time_frame>
    <description>Marker: total iron binding capacity (μmol/L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status</measure>
    <time_frame>Change in ferritin (immunoassay) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)</time_frame>
    <description>Marker: Ferritin (ng/mL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status</measure>
    <time_frame>Change in haemoglobin (whole blood analyser) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)</time_frame>
    <description>Marker: Haemoglobin (g/dL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status</measure>
    <time_frame>Change in red blood cells (whole blood analyser) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)</time_frame>
    <description>Marker: Red blood cells (M/μL)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated neurotrophic levels</measure>
    <time_frame>Change in BDNF (ELISA) from baseline to endpoint from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)</time_frame>
    <description>Marker: Brain derived neurotrophic factor (BDNF) (ng/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated gastrointestinal effects</measure>
    <time_frame>Change in reported subjective gastrointestinal effects from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)</time_frame>
    <description>Subjective analysis including: Oral Iron Supplement Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated perception of fatigue</measure>
    <time_frame>Change in VAS-F from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)</time_frame>
    <description>Subjective analysis including: Visual Analogue Scale for Fatigue (VAS-F). Scores range from 0 to 100 (the higher the score the greater the level of fatigue)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated perception of fatigue</measure>
    <time_frame>Change in FSS from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)</time_frame>
    <description>Subjective analysis including: Fatigue Severity Scale (FSS). The total score of all answers indicates level of fatigue (a total score above ≥ 36 indicates fatigue).</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">155</enrollment>
  <condition>Iron Deficiency (Without Anemia)</condition>
  <arm_group>
    <arm_group_label>FS65_Curc</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ferrous Sulphate (65 mg/day elemental iron) and Curcumin 500 mg/day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FS65_Plac</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Ferrous Sulphate (65 mg/day elemental iron) and Placebo (Curcumin placebo [cellulose])</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FS0_Plac</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo (Ferrous Sulphate placebo [cellulose]) and Placebo (Curcumin placebo [cellulose])</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FS18_Plac</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Ferrous Sulphate (18 mg/day elemental iron) and Placebo (Curcumin placebo [cellulose])</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FS18_Curc</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ferrous Sulphate (18 mg/day elemental iron) and Curcumin 500 mg/day</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Ferrous Sulphate 65 mg</intervention_name>
    <description>Oral ferrous salt supplement Ferrous Sulphate 200 mg (equiv. 65 mg elemental iron content)&#xD;
Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach)&#xD;
At the mid-point visit day (day 21) and the finally at the end-point (day 42) compliance will be verified by counting capsules</description>
    <arm_group_label>FS65_Curc</arm_group_label>
    <arm_group_label>FS65_Plac</arm_group_label>
    <other_name>Ferrous Sulfate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Curcumin</intervention_name>
    <description>HydroCurc™ 500 mg formulated curcumin&#xD;
At the mid-point visit day (day 21) and the finally at the end-point (day 42) compliance will be verified by counting capsules&#xD;
Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach)</description>
    <arm_group_label>FS18_Curc</arm_group_label>
    <arm_group_label>FS65_Curc</arm_group_label>
    <other_name>Turmeric</other_name>
    <other_name>Curcuma longa</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo (Ferrous Sulphate)</intervention_name>
    <description>Microcrystalline cellulose&#xD;
Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach)</description>
    <arm_group_label>FS0_Plac</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo (Curcumin)</intervention_name>
    <description>Microcrystalline cellulose&#xD;
Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach)</description>
    <arm_group_label>FS0_Plac</arm_group_label>
    <arm_group_label>FS18_Plac</arm_group_label>
    <arm_group_label>FS65_Plac</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Ferrous Sulphate 18mg</intervention_name>
    <description>Oral ferrous salt supplement&#xD;
Ferrous Sulphate 55 mg (equiv. 18 mg elemental iron content)&#xD;
Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach)&#xD;
At the mid-point visit day (day 21) and the finally at the end-point (day 42) compliance will be verified by counting capsules</description>
    <arm_group_label>FS18_Curc</arm_group_label>
    <arm_group_label>FS18_Plac</arm_group_label>
    <other_name>Ferrous Sulfate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males &amp; Females (18-40 years of age)&#xD;
&#xD;
          -  Healthy subjects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt;18 years or &gt;40 years&#xD;
&#xD;
          -  Dieters&#xD;
&#xD;
          -  Consumption of &gt;21 serving of alcohol/week&#xD;
&#xD;
          -  Any allergies/health issues related to items being ingested&#xD;
&#xD;
          -  Any serious illnesses or those on medication&#xD;
&#xD;
          -  Any pregnant or lactating women&#xD;
&#xD;
          -  Any women who are trying to conceive&#xD;
&#xD;
          -  Any women taking contraceptive medication&#xD;
&#xD;
          -  Any gastrointestinal disorders&#xD;
&#xD;
          -  Any chronic menstrual disorders&#xD;
&#xD;
          -  Any subjects who have undergone the menopause or undergoing the perimenopause&#xD;
             transition&#xD;
&#xD;
          -  Any eating disorders&#xD;
&#xD;
          -  Any depression/mental disorders&#xD;
&#xD;
          -  Any abnormal blood pressure levels&#xD;
&#xD;
          -  Those with deficient/excess/abnormal iron levels according to United Kingdom (UK)&#xD;
             guidelines &amp;/or haemochromatosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Male or Female</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Westminster</name>
      <address>
        <city>London</city>
        <zip>W1W 6UW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>July 6, 2020</last_update_submitted>
  <last_update_submitted_qc>July 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Westminster</investigator_affiliation>
    <investigator_full_name>Mohammed Gulrez Zariwala</investigator_full_name>
    <investigator_title>Reader in Translational Physiology</investigator_title>
  </responsible_party>
  <keyword>nutraceutical</keyword>
  <keyword>anti-oxidant</keyword>
  <keyword>oxidative status</keyword>
  <keyword>ferrous sulphate</keyword>
  <keyword>curcumin</keyword>
  <keyword>inflammatory status</keyword>
  <keyword>turmeric</keyword>
  <keyword>gastrointestinal</keyword>
  <keyword>fatigue</keyword>
  <keyword>iron</keyword>
  <keyword>Hydrocurc</keyword>
  <keyword>supplement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iron Deficiencies</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Curcumin</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/NCT04465851
org study id: ETH1718-0907
nct id: NCT04465851
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
INTRODUCTION: Iron is a vital nutrient for many physiological processes including DNA
      production, oxygen transport and neuronal processes. However, several factors limit iron
      absorption including: limited bioavailability of iron (dietary or supplementation sources),
      can be subject to dietary iron inhibitors (e.g. calcium). Excess iron can cause cellular
      oxidative stress in the body.

      Curcumin is an active component found in turmeric, known for its anti-oxidant and
      anti-inflammatory properties. Co-administration of iron and curcumin may influence iron,
      inflammatory status and/or neurotrophic markers in the body.
Intervention study with five parallel treatment groups in a randomised, double-blind,
      placebo-controlled design.

      Study population: Healthy Participants (Male or Female) will receive daily supplements
      (active or equivalent placebos) for 6 weeks (42 days)

      Biological samples (blood and urine samples) are collected at baseline visit (day 1),
      mid-point (day 21) and end-point (day 42). In addition, pertinent questionnaires (Visual
      Analogue Scale-Fatigue [VAS-F] and oral iron supplement questionnaire will be collected at
      the aforementioned time points.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Allocation: Randomisation (block) Intervention Model: Parallel, Randomised placebo-controlled design Masking: Double-blind
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Participants (and supplements) will be coded and randomly allocated (applied randomly by software [gender balanced[) to treatment arms to eliminate order effects and maintain research staff blinding.
measure: To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation
time frame: Change in Interleukin 6, Interleukin 10 and Interleukin 1 beta (ELISA) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
description: Marker: Interleukin 6 (pg/mL), Interleukin 10 (pg/mL), Interleukin 1 beta (pg/mL)
measure: To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation
time frame: Change in Tumour Necrosis Factor alpha (ELISA) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
description: Tumour Necrosis Factor alpha (pg/mL)
measure: To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated inflammation
time frame: Change in C-Reactive Protein (immunoassay) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
description: Marker: C-Reactive Protein (g/L)
measure: To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated lipid peroxidation
time frame: Change in thiobarbituric acid reactive substances (ELISA) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
description: Marker: thiobarbituric acid reactive substances (μM)
measure: To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated acute iron absorption
time frame: Change in serum iron (colorimetric analyser) from 0 and 180 minutes following supplementation
description: Marker: serum iron (μmol/L)
measure: To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated acute iron absorption
time frame: Change in total iron binding capacity (colorimetric analyser) from 0 and 180 minutes following supplementation
description: Marker: total iron binding capacity (μmol/L)
measure: To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status
time frame: Change in serum iron (colorimetric analyser) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
description: Marker: serum iron (μmol/L)
measure: To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status
time frame: Change in total iron binding capacity (colorimetric analyser) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
description: Marker: total iron binding capacity (μmol/L)
measure: To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status
time frame: Change in ferritin (immunoassay) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
description: Marker: Ferritin (ng/mL)
measure: To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status
time frame: Change in haemoglobin (whole blood analyser) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
description: Marker: Haemoglobin (g/dL)
measure: To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated iron status
time frame: Change in red blood cells (whole blood analyser) from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
description: Marker: Red blood cells (M/μL)
measure: To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated neurotrophic levels
time frame: Change in BDNF (ELISA) from baseline to endpoint from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
description: Marker: Brain derived neurotrophic factor (BDNF) (ng/mL)
measure: To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated gastrointestinal effects
time frame: Change in reported subjective gastrointestinal effects from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
description: Subjective analysis including: Oral Iron Supplement Questionnaire
measure: To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated perception of fatigue
time frame: Change in VAS-F from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
description: Subjective analysis including: Visual Analogue Scale for Fatigue (VAS-F). Scores range from 0 to 100 (the higher the score the greater the level of fatigue)
measure: To assess the influence of HydroCurc™ administration on ferrous iron supplementation associated perception of fatigue
time frame: Change in FSS from day 1 compared to day 21 (baseline to midpoint), day 1 compared to day 42 (baseline to endpoint) and day 21 compared to day 42 (midpoint to endpoint)
description: Subjective analysis including: Fatigue Severity Scale (FSS). The total score of all answers indicates level of fatigue (a total score above ≥ 36 indicates fatigue).
arm group label: FS65_Curc
arm group type: Active Comparator
description: Ferrous Sulphate (65 mg/day elemental iron) and Curcumin 500 mg/day
arm group label: FS65_Plac
arm group type: Placebo Comparator
description: Ferrous Sulphate (65 mg/day elemental iron) and Placebo (Curcumin placebo [cellulose])
arm group label: FS0_Plac
arm group type: Placebo Comparator
description: Placebo (Ferrous Sulphate placebo [cellulose]) and Placebo (Curcumin placebo [cellulose])
arm group label: FS18_Plac
arm group type: Placebo Comparator
description: Ferrous Sulphate (18 mg/day elemental iron) and Placebo (Curcumin placebo [cellulose])
arm group label: FS18_Curc
arm group type: Active Comparator
description: Ferrous Sulphate (18 mg/day elemental iron) and Curcumin 500 mg/day
intervention type: Dietary Supplement
intervention name: Ferrous Sulphate 65 mg
description: Oral ferrous salt supplement Ferrous Sulphate 200 mg (equiv. 65 mg elemental iron content)
Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach)
At the mid-point visit day (day 21) and the finally at the end-point (day 42) compliance will be verified by counting capsules
arm group label: FS65_Curc
arm group label: FS65_Plac
other name: Ferrous Sulfate
intervention type: Dietary Supplement
intervention name: Curcumin
description: HydroCurc™ 500 mg formulated curcumin
At the mid-point visit day (day 21) and the finally at the end-point (day 42) compliance will be verified by counting capsules
Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach)
arm group label: FS18_Curc
arm group label: FS65_Curc
other name: Turmeric
other name: Curcuma longa
intervention type: Other
intervention name: Placebo (Ferrous Sulphate)
description: Microcrystalline cellulose
Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach)
arm group label: FS0_Plac
intervention type: Other
intervention name: Placebo (Curcumin)
description: Microcrystalline cellulose
Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach)
arm group label: FS0_Plac
arm group label: FS18_Plac
arm group label: FS65_Plac
intervention type: Dietary Supplement
intervention name: Ferrous Sulphate 18mg
description: Oral ferrous salt supplement
Ferrous Sulphate 55 mg (equiv. 18 mg elemental iron content)
Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach)
At the mid-point visit day (day 21) and the finally at the end-point (day 42) compliance will be verified by counting capsules
arm group label: FS18_Curc
arm group label: FS18_Plac
other name: Ferrous Sulfate
criteria: 
gender: All
gender based: Yes
gender description: Male or Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Westminster
investigator full name: Mohammed Gulrez Zariwala
investigator title: Reader in Translational Physiology
mesh term: Iron Deficiencies
mesh term: Curcumin
sharing ipd: No