xml: <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/NCT06002672</url>
    </required_header>
    <id_info>
      <org_study_id>Plant_Food_2021</org_study_id>
      <nct_id>NCT06002672</nct_id>
    </id_info>
    <brief_title>Effects of Saline Eustress in Plant Food (ESEPF)</brief_title>
    <acronym>ESEPF</acronym>
    <official_title>Analysis of the Potential Health Effects of Saline Eustress in Plant Food</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Palermo</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Palermo</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 aim of the project is to study if supplementation with eustress plant food like lettuce&#xD;
        grown in mild salinity condition affects health in a healthy population.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Salinity can affect the levels of bioactive compounds in leafy vegetables. The aim of the&#xD;
        project is to verify the impact, if any, of the changing of bioactive compounds in the&#xD;
        physiology of the study population. The participants will be randomly assigned to the control&#xD;
        group that will eat 100 gr of untreated (control) lettuce and the intervention group that&#xD;
        will consume 100gr of eustress lettuce. Blood samples and urine samples will be collected at&#xD;
        time zero (start) after 12 days. Each subject will be subjected to two venous blood samples&#xD;
        taken at the beginning of the observation and at the end. The samples obtained will be&#xD;
        transported in certified containers for the safe transport of biological samples, and,&#xD;
        subsequently, processed by the experimenters at the laboratories of the Molecular Biology&#xD;
        section of the University of Palermo. Serum and plasma will be obtained from each blood&#xD;
        sample. All information thus obtained will be recorded in a database in which each person&#xD;
        will be identified with a numerical code, in order to comply with current privacy&#xD;
        regulations. Body weight, Barefoot standing height, Body mass index, Body composition will be&#xD;
        measured in the different groups of study. Samples will be analyzed and compared for glucose,&#xD;
        insulin, albumin, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, AST,&#xD;
        ALT, GGT, ALP, Ferritin, free Iron, transferrin, total proteins, magnesium, calcium, insulin,&#xD;
        osteocalcin, calcitonin, parathyroid hormone, c terminal peptide of collagen (CTX), Vitamin&#xD;
        D, Phosphate, Potassium.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 1, 2021</start_date>
    <completion_date type="Actual">June 28, 2021</completion_date>
    <primary_completion_date type="Actual">April 1, 2021</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>control vs intervention</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>Two groups that consumed lettuce. No differences in shape, size, colours of lettuce</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>anthropometric measurement</measure>
      <time_frame>12 days</time_frame>
      <description>weight in kilograms, height in meters will be aggregated to arrive at one reported value (weight and height will be combined to report BMI in kg/m^2).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Bone metabolism markers</measure>
      <time_frame>12 days</time_frame>
      <description>Parathyroid hormone (PTH) (ng/ml), calcitonin (ng/ml) will be assessed at baseline and after 12 days.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Vitamin D</measure>
      <time_frame>12 days</time_frame>
      <description>Vitamin D (microgram/L) will be assessed at baseline and after 12 days.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>blood markers</measure>
      <time_frame>12 days</time_frame>
      <description>Calcium (mg/dL), Phosphate (mg/dL) will be assessed at baseline and after 12 days.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Potassium</measure>
      <time_frame>12 days</time_frame>
      <description>Potassium (mmol/L) will be assessed at baseline and after 12 days.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Bone remodelling markers</measure>
      <time_frame>12 days</time_frame>
      <description>markers of bone resorption CTX (μg/L) and bone formation osteocalcin (μg/L) will be assessed in serum at baseline and after 12 days.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Iron</measure>
      <time_frame>12 days</time_frame>
      <description>iron (μg/dL) will be assessed in serum at baseline and after 12 days.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Ferritin</measure>
      <time_frame>12 days</time_frame>
      <description>ferritin (ng/dL) will be assessed in serum at baseline and after 12 days.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>transferrin</measure>
      <time_frame>12 days</time_frame>
      <description>transferrin (mg/dL) will be assessed in serum at baseline and after 12 days.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>% saturation of transferrin</measure>
      <time_frame>12 days</time_frame>
      <description>% saturation of transferrin will be will be assessed in serum at baseline and after 12 days.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>markers of lipid metabolism</measure>
      <time_frame>12 days</time_frame>
      <description>triglycerides , HDL, LDL, cholesterol (in mg/dL) will be measured in serum will be assessed at baseline and after 12 days.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Insulin</measure>
      <time_frame>12 days</time_frame>
      <description>insulin (mUI/L) will be measured in serum will be assessed at baseline and after 12 days.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Glucose</measure>
      <time_frame>12 days</time_frame>
      <description>Glucose (mg/dL) will be measured in serum will be assessed at baseline and after 12 days.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>markers of hepatic metabolism</measure>
      <time_frame>12 days</time_frame>
      <description>Aspartate transaminase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Gamma-Glutamyl Transferase (GGT) in U/l will be assessed in serum at baseline and after 12 days.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Total protein (TP) and Albumin</measure>
      <time_frame>12 days</time_frame>
      <description>Total protein (TP) and Albumin in g/L will be assessed in serum at baseline and after 12 days.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>body composition</measure>
      <time_frame>12 days</time_frame>
      <description>lean mass as percent of body weight and fat mass as percent of body weight will be will be assessed at baseline and after 12 days</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">60</enrollment>
    <condition>Healthy Diet</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>group that consumed control lettuce</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>group that consumed eustress lettuce</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Placebo comparator: Control group. To the control group was assigned lettuce without any change in salinity but with the same characteristic of eustress lettuce (soil, water, harvesting time).</intervention_name>
      <description>Lettuce without any eustress was assigned to each participant belonging to the control group which ate 100gr every day for 12 day</description>
      <arm_group_label>Control</arm_group_label>
      <other_name>control lettuce</other_name>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Experimental: Eustress group. To the intervention Eustress group was assigned the eustress lettuce.</intervention_name>
      <description>100gr of eustress lettuce were assigned to each participant belonging to the intervention group which ate 100 grams every day for a total of 12 days</description>
      <arm_group_label>Intervention</arm_group_label>
      <other_name>Eustress Intervention group</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Italian&#xD;
  &#xD;
            -  age: 18-65 years&#xD;
  &#xD;
            -  currently injury free&#xD;
  &#xD;
            -  Body mass index between 18.5 and 28 kg/m2&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Use of vitamins and minerals supplements,&#xD;
  &#xD;
            -  use of medications&#xD;
  &#xD;
            -  Presence of metabolic or chronic disease&#xD;
  &#xD;
            -  Pregnancy, breastfeeding condition,&#xD;
  &#xD;
            -  smokers&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sara Baldassano</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Palermo</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>NABbio, STEBICEF department</name>
        <address>
          <city>Palermo</city>
          <zip>90128</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Palermo</investigator_affiliation>
      <investigator_full_name>Sara Baldassano</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06002672
  org study id: Plant_Food_2021
  nct id: NCT06002672
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the project is to study if supplementation with eustress plant food like lettuce
        grown in mild salinity condition affects health in a healthy population.
  Salinity can affect the levels of bioactive compounds in leafy vegetables. The aim of the
        project is to verify the impact, if any, of the changing of bioactive compounds in the
        physiology of the study population. The participants will be randomly assigned to the control
        group that will eat 100 gr of untreated (control) lettuce and the intervention group that
        will consume 100gr of eustress lettuce. Blood samples and urine samples will be collected at
        time zero (start) after 12 days. Each subject will be subjected to two venous blood samples
        taken at the beginning of the observation and at the end. The samples obtained will be
        transported in certified containers for the safe transport of biological samples, and,
        subsequently, processed by the experimenters at the laboratories of the Molecular Biology
        section of the University of Palermo. Serum and plasma will be obtained from each blood
        sample. All information thus obtained will be recorded in a database in which each person
        will be identified with a numerical code, in order to comply with current privacy
        regulations. Body weight, Barefoot standing height, Body mass index, Body composition will be
        measured in the different groups of study. Samples will be analyzed and compared for glucose,
        insulin, albumin, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, AST,
        ALT, GGT, ALP, Ferritin, free Iron, transferrin, total proteins, magnesium, calcium, insulin,
        osteocalcin, calcitonin, parathyroid hormone, c terminal peptide of collagen (CTX), Vitamin
        D, Phosphate, Potassium.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: control vs intervention
  primary purpose: Prevention
  masking: Double (Participant, Investigator)
  masking description: Two groups that consumed lettuce. No differences in shape, size, colours of lettuce
  measure: anthropometric measurement
  time frame: 12 days
  description: weight in kilograms, height in meters will be aggregated to arrive at one reported value (weight and height will be combined to report BMI in kg/m^2).
  measure: Bone metabolism markers
  time frame: 12 days
  description: Parathyroid hormone (PTH) (ng/ml), calcitonin (ng/ml) will be assessed at baseline and after 12 days.
  measure: Vitamin D
  time frame: 12 days
  description: Vitamin D (microgram/L) will be assessed at baseline and after 12 days.
  measure: blood markers
  time frame: 12 days
  description: Calcium (mg/dL), Phosphate (mg/dL) will be assessed at baseline and after 12 days.
  measure: Potassium
  time frame: 12 days
  description: Potassium (mmol/L) will be assessed at baseline and after 12 days.
  measure: Bone remodelling markers
  time frame: 12 days
  description: markers of bone resorption CTX (μg/L) and bone formation osteocalcin (μg/L) will be assessed in serum at baseline and after 12 days.
  measure: Iron
  time frame: 12 days
  description: iron (μg/dL) will be assessed in serum at baseline and after 12 days.
  measure: Ferritin
  time frame: 12 days
  description: ferritin (ng/dL) will be assessed in serum at baseline and after 12 days.
  measure: transferrin
  time frame: 12 days
  description: transferrin (mg/dL) will be assessed in serum at baseline and after 12 days.
  measure: % saturation of transferrin
  time frame: 12 days
  description: % saturation of transferrin will be will be assessed in serum at baseline and after 12 days.
  measure: markers of lipid metabolism
  time frame: 12 days
  description: triglycerides , HDL, LDL, cholesterol (in mg/dL) will be measured in serum will be assessed at baseline and after 12 days.
  measure: Insulin
  time frame: 12 days
  description: insulin (mUI/L) will be measured in serum will be assessed at baseline and after 12 days.
  measure: Glucose
  time frame: 12 days
  description: Glucose (mg/dL) will be measured in serum will be assessed at baseline and after 12 days.
  measure: markers of hepatic metabolism
  time frame: 12 days
  description: Aspartate transaminase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Gamma-Glutamyl Transferase (GGT) in U/l will be assessed in serum at baseline and after 12 days.
  measure: Total protein (TP) and Albumin
  time frame: 12 days
  description: Total protein (TP) and Albumin in g/L will be assessed in serum at baseline and after 12 days.
  measure: body composition
  time frame: 12 days
  description: lean mass as percent of body weight and fat mass as percent of body weight will be will be assessed at baseline and after 12 days
  arm group label: Control
  arm group type: Placebo Comparator
  description: group that consumed control lettuce
  arm group label: Intervention
  arm group type: Active Comparator
  description: group that consumed eustress lettuce
  intervention type: Dietary Supplement
  intervention name: Placebo comparator: Control group. To the control group was assigned lettuce without any change in salinity but with the same characteristic of eustress lettuce (soil, water, harvesting time).
  description: Lettuce without any eustress was assigned to each participant belonging to the control group which ate 100gr every day for 12 day
  arm group label: Control
  other name: control lettuce
  intervention type: Dietary Supplement
  intervention name: Experimental: Eustress group. To the intervention Eustress group was assigned the eustress lettuce.
  description: 100gr of eustress lettuce were assigned to each participant belonging to the intervention group which ate 100 grams every day for a total of 12 days
  arm group label: Intervention
  other name: Eustress Intervention group
  criteria: 
  gender: All
  gender based: Yes
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Sara Baldassano
  role: Principal Investigator
  affiliation: University of Palermo
  facility: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: University of Palermo
  investigator full name: Sara Baldassano
  investigator title: Professor
  sharing ipd: No