<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/NCT03254537</url>
  </required_header>
  <id_info>
    <org_study_id>NUHEALTH-CS01-ORGANIC</org_study_id>
    <nct_id>NCT03254537</nct_id>
  </id_info>
  <brief_title>Effect of Mediterranean Diets Based on Organic and Conventional Foods</brief_title>
  <official_title>Effect of Mediterranean Diets Based on Organic and Conventional Foods on Health Related Physiological Parameters in Urine and Blood/Plasma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Newcastle University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Sheepdrove Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Newcastle University</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>
      Results from a small number of human cohort studies are also available and indicate that&#xD;
      there are positive associations between organic food consumption and reduced risk/incidence&#xD;
      of certain acute diseases (e.g. pre-eclampsia, hypospadias) and obesity/overweight.&#xD;
&#xD;
      Results from animal dietary intervention studies suggest that (i) switching to organic food&#xD;
      consumption results in significant changes in hormonal balances and an increase in immune&#xD;
      system responsiveness and (ii) differences in pesticide residue, cadmium, protein and&#xD;
      antioxidant concentrations between organic and conventional foods are major drivers for&#xD;
      hormonal balances and immune system parameters in animals.&#xD;
&#xD;
      However, there is virtually no published data from (i) long-term cohort studies focusing on&#xD;
      chronic diseases (e.g. cardiovascular disease, diabetes, cancer and neurodegenerative&#xD;
      conditions) and (ii) controlled human dietary intervention studies comparing effects of&#xD;
      organic and conventional diets. It is therefore currently not possible to assess whether and&#xD;
      estimate to what extent organic food consumption may affect human health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The most recent systematic literature reviews and meta-analyses have indicated significant&#xD;
      and nutritionally-relevant composition differences between organic and conventional foods&#xD;
      (crops, meat and dairy products). Specifically, these systematic reviews reported that:&#xD;
&#xD;
      organic crops have 17% higher antioxidant activity and between 18% and 69% higher&#xD;
      concentrations of a range of individual antioxidants; increased intakes of polyphenolics and&#xD;
      antioxidants has been linked to a reduced risk of certain chronic diseases such as&#xD;
      cardiovascular and neurodegenerative diseases and certain cancers.&#xD;
&#xD;
      conventional crops have 48% higher levels of the toxic metal cadmium, and are 4-times more&#xD;
      likely to contain detectable pesticide residues; there are general recommendations to&#xD;
      minimise the intake of pesticides and cadmium to avoid potential negative health impacts.&#xD;
&#xD;
      conventional crops also have 15%, 10%, 30%, and 87% higher concentrations of protein,&#xD;
      nitrogen, nitrate, nitrite, respectively; increased intakes of these compounds have been&#xD;
      linked to both positive and negative health impacts.&#xD;
&#xD;
      organic meat, milk and dairy products have approximately 50% higher concentrations of&#xD;
      nutritionally-desirable omega-3 fatty acids; intakes of very long chain omega-3 fatty acids&#xD;
      in Western diets and there are EFSA recommendation to at least double their intake.&#xD;
&#xD;
      organic milk has 70% lower concentrations of iodine and slightly lower concentrations of&#xD;
      Selenium, which is nutritionally undesirables especially in the UK where (a) the Se content&#xD;
      of cereals has decreased (due to reduced import of cereals grown on Se-rich soil (b) Iodine&#xD;
      fortified table salt is not widely available and used and the iodine supply relies more on&#xD;
      mineral fortification of animal, and especially dairy feeds.&#xD;
&#xD;
      Results from a small number of human cohort studies are also available and indicate that&#xD;
      there are positive associations between organic food consumption and reduced risk/incidence&#xD;
      of certain acute diseases (e.g. pre-eclampsia, hypospadias) and obesity/overweight .&#xD;
&#xD;
      Results from animal dietary intervention studies suggest that (i) switching to organic food&#xD;
      consumption results in significant changes in hormonal balances and an increase in immune&#xD;
      system responsiveness and (ii) differences in pesticide residue, cadmium, protein and&#xD;
      antioxidant concentrations between organic and conventional foods are major drivers for&#xD;
      hormonal balances and immune system parameters in animals.&#xD;
&#xD;
      However, there is virtually no published data from (i) long-term cohort studies focusing on&#xD;
      chronic diseases (e.g. cardiovascular disease, diabetes, cancer and neurodegenerative&#xD;
      conditions) and (ii) controlled human dietary intervention studies comparing effects of&#xD;
      organic and conventional diets. It is therefore currently not possible to assess whether and&#xD;
      estimate to what extent organic food consumption may affect human health.&#xD;
&#xD;
      The overall aim of the study is to get a quantitative understanding of (a) the uptake (and&#xD;
      therefore potential to affect health) of food composition components (pesticide residues,&#xD;
      toxic metals such as cadmium, antioxidants) that differ between organic and conventional&#xD;
      foods and (b) the effect of organic vs conventional food consumption on selected&#xD;
      physiological parameters in plasma linked to health.&#xD;
&#xD;
      This information will be essential to (a) carry out accurate statistical power analyses&#xD;
      (based on uptake [=estimated from blood and urine concentrations] rather than food&#xD;
      composition data) and (b) optimise designs for longer-term dietary intervention studies,&#xD;
      designed to identify impacts of organic food consumption on health related physiological&#xD;
      markers in humans and mechanisms for potential health impacts.&#xD;
&#xD;
      The main objectives of the proposed study are to:&#xD;
&#xD;
        1. Carry out a human dietary intervention study comparing the effects of switching to&#xD;
           Mediterranean diets based on organic and conventional foods on concentrations of&#xD;
           pesticides, toxic metals, mineral nutrients (e.g. Fe, Cu, Se, I) and antioxidants, and&#xD;
           antioxidant activity and selected health-related markers in urine and blood.&#xD;
&#xD;
        2. Quantify concentrations of pesticide residue, mineral, toxic metal and antioxidants in&#xD;
           both organic and conventional food samples consumed during the intervention period&#xD;
&#xD;
        3. Carry out both univariate and redundancy analyses to both quantify effects of different&#xD;
           diets on urine and blood composition and to identify the most important food composition&#xD;
           drivers for differences in urine/blood composition and health markers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">August 1, 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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>IL-6 in Plasma measured using ELISA</measure>
    <time_frame>Change from baseline 2 weeks post supplementation and 4 weeks post supplementation</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>IL-6 in WBC measured using ELISA</measure>
    <time_frame>Change from baseline 2 weeks post supplementation and 4 weeks post supplementation</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>DNA damage in WBC measured using Western Blot</measure>
    <time_frame>Change from baseline 2 weeks post supplementation and 4 weeks post supplementation</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Total antioxidant activity in plasma measured using PENTRA</measure>
    <time_frame>Change from baseline 2 weeks post supplementation and 4 weeks post supplementation</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Phenols in plasma measured using GCMS</measure>
    <time_frame>Change from baseline 2 weeks post supplementation and 4 weeks post supplementation</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Carotenoids in plasma measured using GCMS</measure>
    <time_frame>Change from baseline 2 weeks post supplementation and 4 weeks post supplementation</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pesticides in urine and plasma measured using ICPMS</measure>
    <time_frame>Change from baseline 2 weeks post supplementation and 4 weeks post supplementation</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Isoprostanes in urine measured using ICPMS</measure>
    <time_frame>Change from baseline 2 weeks post supplementation and 4 weeks post supplementation</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>toxic metals in urine and plasma (Cd, Pb, Hg, Al) measured using ICPMS</measure>
    <time_frame>Change from baseline 2 weeks post supplementation and 4 weeks post supplementation</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>minerals in plasma (including Cu, Fe, Mn, Mg, Ca, I, Se) measured using ICPMS</measure>
    <time_frame>Change from baseline 2 weeks post supplementation and 4 weeks post supplementation</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">27</enrollment>
  <condition>Health Status</condition>
  <arm_group>
    <arm_group_label>Mediterranean Organic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Mediterranean conventional</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Mediterranean Organic</intervention_name>
    <description>Traditional Mediterranean diet comprised of organic ingredients</description>
    <arm_group_label>Mediterranean Organic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Mediterranean conventional</intervention_name>
    <description>Traditional Mediterranean diet comprised of conventional ingredients</description>
    <arm_group_label>Mediterranean conventional</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Healthy adults No medications No known illness&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Any known illness Using prescribed medication Using over the counter vitamin or mineral&#xD;
        supplements Allergy to any food&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Levidopa Field Station</name>
      <address>
        <city>Sivas</city>
        <state>Sivas Festos</state>
        <zip>GR 70200</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NU-Food Research Facility</name>
      <address>
        <city>Newcastle upon Tyne</city>
        <state>Tyne and Wear</state>
        <zip>NE1 7RU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>June 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>August 17, 2017</last_update_submitted>
  <last_update_submitted_qc>August 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03254537
org study id: NUHEALTH-CS01-ORGANIC
nct id: NCT03254537
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Results from a small number of human cohort studies are also available and indicate that
      there are positive associations between organic food consumption and reduced risk/incidence
      of certain acute diseases (e.g. pre-eclampsia, hypospadias) and obesity/overweight.

      Results from animal dietary intervention studies suggest that (i) switching to organic food
      consumption results in significant changes in hormonal balances and an increase in immune
      system responsiveness and (ii) differences in pesticide residue, cadmium, protein and
      antioxidant concentrations between organic and conventional foods are major drivers for
      hormonal balances and immune system parameters in animals.

      However, there is virtually no published data from (i) long-term cohort studies focusing on
      chronic diseases (e.g. cardiovascular disease, diabetes, cancer and neurodegenerative
      conditions) and (ii) controlled human dietary intervention studies comparing effects of
      organic and conventional diets. It is therefore currently not possible to assess whether and
      estimate to what extent organic food consumption may affect human health.
The most recent systematic literature reviews and meta-analyses have indicated significant
      and nutritionally-relevant composition differences between organic and conventional foods
      (crops, meat and dairy products). Specifically, these systematic reviews reported that:

      organic crops have 17% higher antioxidant activity and between 18% and 69% higher
      concentrations of a range of individual antioxidants; increased intakes of polyphenolics and
      antioxidants has been linked to a reduced risk of certain chronic diseases such as
      cardiovascular and neurodegenerative diseases and certain cancers.

      conventional crops have 48% higher levels of the toxic metal cadmium, and are 4-times more
      likely to contain detectable pesticide residues; there are general recommendations to
      minimise the intake of pesticides and cadmium to avoid potential negative health impacts.

      conventional crops also have 15%, 10%, 30%, and 87% higher concentrations of protein,
      nitrogen, nitrate, nitrite, respectively; increased intakes of these compounds have been
      linked to both positive and negative health impacts.

      organic meat, milk and dairy products have approximately 50% higher concentrations of
      nutritionally-desirable omega-3 fatty acids; intakes of very long chain omega-3 fatty acids
      in Western diets and there are EFSA recommendation to at least double their intake.

      organic milk has 70% lower concentrations of iodine and slightly lower concentrations of
      Selenium, which is nutritionally undesirables especially in the UK where (a) the Se content
      of cereals has decreased (due to reduced import of cereals grown on Se-rich soil (b) Iodine
      fortified table salt is not widely available and used and the iodine supply relies more on
      mineral fortification of animal, and especially dairy feeds.

      Results from a small number of human cohort studies are also available and indicate that
      there are positive associations between organic food consumption and reduced risk/incidence
      of certain acute diseases (e.g. pre-eclampsia, hypospadias) and obesity/overweight .

      Results from animal dietary intervention studies suggest that (i) switching to organic food
      consumption results in significant changes in hormonal balances and an increase in immune
      system responsiveness and (ii) differences in pesticide residue, cadmium, protein and
      antioxidant concentrations between organic and conventional foods are major drivers for
      hormonal balances and immune system parameters in animals.

      However, there is virtually no published data from (i) long-term cohort studies focusing on
      chronic diseases (e.g. cardiovascular disease, diabetes, cancer and neurodegenerative
      conditions) and (ii) controlled human dietary intervention studies comparing effects of
      organic and conventional diets. It is therefore currently not possible to assess whether and
      estimate to what extent organic food consumption may affect human health.

      The overall aim of the study is to get a quantitative understanding of (a) the uptake (and
      therefore potential to affect health) of food composition components (pesticide residues,
      toxic metals such as cadmium, antioxidants) that differ between organic and conventional
      foods and (b) the effect of organic vs conventional food consumption on selected
      physiological parameters in plasma linked to health.

      This information will be essential to (a) carry out accurate statistical power analyses
      (based on uptake [=estimated from blood and urine concentrations] rather than food
      composition data) and (b) optimise designs for longer-term dietary intervention studies,
      designed to identify impacts of organic food consumption on health related physiological
      markers in humans and mechanisms for potential health impacts.

      The main objectives of the proposed study are to:

        1. Carry out a human dietary intervention study comparing the effects of switching to
           Mediterranean diets based on organic and conventional foods on concentrations of
           pesticides, toxic metals, mineral nutrients (e.g. Fe, Cu, Se, I) and antioxidants, and
           antioxidant activity and selected health-related markers in urine and blood.

        2. Quantify concentrations of pesticide residue, mineral, toxic metal and antioxidants in
           both organic and conventional food samples consumed during the intervention period

        3. Carry out both univariate and redundancy analyses to both quantify effects of different
           diets on urine and blood composition and to identify the most important food composition
           drivers for differences in urine/blood composition and health markers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: IL-6 in Plasma measured using ELISA
time frame: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
measure: IL-6 in WBC measured using ELISA
time frame: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
measure: DNA damage in WBC measured using Western Blot
time frame: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
measure: Total antioxidant activity in plasma measured using PENTRA
time frame: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
measure: Phenols in plasma measured using GCMS
time frame: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
measure: Carotenoids in plasma measured using GCMS
time frame: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
measure: Pesticides in urine and plasma measured using ICPMS
time frame: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
measure: Isoprostanes in urine measured using ICPMS
time frame: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
measure: toxic metals in urine and plasma (Cd, Pb, Hg, Al) measured using ICPMS
time frame: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
measure: minerals in plasma (including Cu, Fe, Mn, Mg, Ca, I, Se) measured using ICPMS
time frame: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
arm group label: Mediterranean Organic
arm group type: Experimental
arm group label: Mediterranean conventional
arm group type: Experimental
intervention type: Dietary Supplement
intervention name: Mediterranean Organic
description: Traditional Mediterranean diet comprised of organic ingredients
arm group label: Mediterranean Organic
intervention type: Dietary Supplement
intervention name: Mediterranean conventional
description: Traditional Mediterranean diet comprised of conventional ingredients
arm group label: Mediterranean conventional
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: Greece
country: United Kingdom
responsible party type: Sponsor
sharing ipd: Undecided