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/NCT05971017</url>
    </required_header>
    <id_info>
      <org_study_id>Weed2023</org_study_id>
      <nct_id>NCT05971017</nct_id>
    </id_info>
    <brief_title>Health Effects of Biostimulated Lettuce in Human</brief_title>
    <acronym>NUTRIWEED23</acronym>
    <official_title>Evaluation of Potential Health Effects of Biostimulated Lettuce for Human Population</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 the influence of biostimulate crops on a healthy&#xD;
        population in order to assess influence on hematological parameters and specific metabolism&#xD;
        (glucose, lipid, iron, bone) and gut and lipid hormones. Secondary outcome will be to find&#xD;
        out micronutrient presence in urine and serum. The use of biostimulation in modern&#xD;
        agriculture has rapidly expanded in recent years, owing to their beneficial effects on crop&#xD;
        yield and product quality, which have come under the scope of intensive research.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The aim of the project is to study the influence of biostimulated crops on a healthy&#xD;
        population in order to assess influence on hematological parameters and specific metabolism&#xD;
        (glucose, lipid, iron, bone) and gut and lipid hormones. Secondary outcome will be to find&#xD;
        out micronutrient presence in urine and serum in order to evaluate vegetables as carrier. The&#xD;
        use of biostimulation in modern agriculture has rapidly expanded in recent years, owing to&#xD;
        their beneficial effects on crop yield and product quality, which have come under the scope&#xD;
        of intensive research.&#xD;
  &#xD;
        The present project aims to investigate the benefits of biostimulated lettuce in a cohort of&#xD;
        healthy individuals. For biostimulation are used organic and inorganic compounds or&#xD;
        microorganisms that when applied to plants can enhance plants' growth, yield, and tolerance&#xD;
        to stress. Participants will be fed with differently biostimulated lettuces to study the&#xD;
        influence on hematological parameters.&#xD;
  &#xD;
        The healthy group will eat 100 gr of Lettuce and 100 gr of biostimulated lettuce and will be&#xD;
        collect plasma and urine samples after 15 days. Each subject will be subjected to two venous&#xD;
        blood samples taken at the beginning of the observation and at the end. The samples obtained&#xD;
        will be transported in certified containers for the safe transport of biological samples,&#xD;
        and, subsequently, processed by the experimenters at the laboratories of the Molecular&#xD;
        Biology section of the University of Palermo. Serum and plasma will be obtained from each&#xD;
        blood sample. All information thus obtained will be recorded in a database in which each&#xD;
        person 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;
        albumin, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, uric acid,&#xD;
        creatinine, AST, ALT, γ-GT, ALP, bilirubin, Ferritin, free Iron, transferrin, total proteins,&#xD;
        Magnesium, Calcium, insulin, osteocalcin, hematocrit, hs-CRP, TSH, FT3, FT4. Bone metabolism&#xD;
        (Osteocalcin, parathyroid hormone, CTX, Calcitonin), Vitamin D Calcium, Phosphate, Potassium,&#xD;
        gastric hormones ( GIP, GLP1, GLP2, ghrelin, glucagon, PYY, CCK, leptin, resistin).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 1, 2023</start_date>
    <completion_date type="Actual">July 9, 2023</completion_date>
    <primary_completion_date type="Actual">May 2, 2023</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 group, biostimulated group</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Two groups that consumed lettuce. No differences in shape, size, colours of lettuce</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>hepatic metabolism</measure>
      <time_frame>15 days</time_frame>
      <description>AST (aspartate transaminase) and ALT (Alanine aminotransferase) will be measured in serum will be assessed at baseline and after 15 days</description>
    </primary_outcome>
    <primary_outcome>
      <measure>iron metabolism</measure>
      <time_frame>15 days</time_frame>
      <description>ferritin, transferrin, % saturation of transferrin will be measured in serum will be assessed at baseline and after 15 days</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Lipid metabolism</measure>
      <time_frame>15 days</time_frame>
      <description>triglycerides, HDL, LDL, cholesterol will be measured in serum will be assessed at baseline and after 15 days</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Glucose metabolism</measure>
      <time_frame>15 days</time_frame>
      <description>insulin, glucose will be measured in serum will be assessed at baseline and after 15 days</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Gastrointestinal peptides and lipid hormones</measure>
      <time_frame>15 days</time_frame>
      <description>Plasma concentrations of Gastrointestinal peptides (GLP-1, GLP-2, GIP, PYY, Ghrelin) and lipid hormones (leptin, resistin, adiponectin) will be assessed at baseline and after and after 15 days.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Serum bone remodelling markers</measure>
      <time_frame>15 days</time_frame>
      <description>PTH, calcitonin, Vitamin D, Calcium, Phosphate, Potassium will be assessed at baseline and after and after 15 days.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Serum bone matabolism markers</measure>
      <time_frame>15 days</time_frame>
      <description>bone resorption CTX and bone formation osteocalcin will be assessed at baseline and after 15 days.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>body mass index (BMI)</measure>
      <time_frame>15 days</time_frame>
      <description>Weight (Kg) Height (m) BMI (kg/m2)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>body composition</measure>
      <time_frame>15 days</time_frame>
      <description>lean mass as percent of body weight and fat mass as percent of body weight will be assessed at baseline and after 15 days</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">100</enrollment>
    <condition>Nutrition, Healthy</condition>
    <condition>Dietary Deficiency</condition>
    <condition>Bone Resorption</condition>
    <condition>Glucose Metabolism Disorders</condition>
    <condition>Lipid Metabolism Disorder</condition>
    <condition>Hepatic Steatosis</condition>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>To the control group was assigned lettuce without any biostimulation but with the same characteristic of biostimulated lettuce (soil, water, harvesting time)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Biostimulated Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>experimental: Biostimulated group: To the intervention group was assigned the biostimulated lettuce.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Control Group</intervention_name>
      <description>Lettuce without any biostimulation was assigned to each participant belonging to the control group which ate 100gr every day for 15 days</description>
      <arm_group_label>Control group</arm_group_label>
      <other_name>Placebo Comparator</other_name>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Biostimulated group</intervention_name>
      <description>Intervention biostimulated group 100gr of biostimulated lettuce were assigned to each participant belonging to the intervention group which ate 100 grams every day for a total of 15 days</description>
      <arm_group_label>Biostimulated Group</arm_group_label>
      <other_name>Intervention group</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Inclusion Criteria:&#xD;
  &#xD;
                 -  Caucasian&#xD;
  &#xD;
                 -  age: 18-90 years&#xD;
  &#xD;
                 -  currently injury free&#xD;
  &#xD;
                 -  Body mass index between 18.5 and 28 kg/m2&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  bone fracture within the previous year&#xD;
  &#xD;
            -  use of medication or suffering from any condition known to affect bone, lipid,&#xD;
               glucose, iron metabolism&#xD;
  &#xD;
            -  pregnancy&#xD;
  &#xD;
            -  breastfeeding&#xD;
  &#xD;
            -  current smokers&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sara Baldassano Professor, PhD</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>
    <link>
      <url>https://www.mdpi.com/2073-4395/12/6/1361</url>
      <description>Plant-Derived Biostimulated Differentially Modulate Primary and Secondary Metabolites and Improve the Yield Potential of Red and Green Lettuce Cultivars</description>
    </link>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 30, 2023</last_update_submitted>
    <last_update_submitted_qc>July 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 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>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bone Resorption</mesh_term>
      <mesh_term>Fatty Liver</mesh_term>
      <mesh_term>Metabolic Diseases</mesh_term>
      <mesh_term>Glucose Metabolism Disorders</mesh_term>
      <mesh_term>Lipid Metabolism Disorders</mesh_term>
      <mesh_term>Malnutrition</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Because is forbidden by the Italian Low</ipd_description>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>July 12, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/17/NCT05971017/Prot_SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT05971017
  org study id: Weed2023
  nct id: NCT05971017
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the project is to study the influence of biostimulate crops on a healthy
        population in order to assess influence on hematological parameters and specific metabolism
        (glucose, lipid, iron, bone) and gut and lipid hormones. Secondary outcome will be to find
        out micronutrient presence in urine and serum. The use of biostimulation in modern
        agriculture has rapidly expanded in recent years, owing to their beneficial effects on crop
        yield and product quality, which have come under the scope of intensive research.
  The aim of the project is to study the influence of biostimulated crops on a healthy
        population in order to assess influence on hematological parameters and specific metabolism
        (glucose, lipid, iron, bone) and gut and lipid hormones. Secondary outcome will be to find
        out micronutrient presence in urine and serum in order to evaluate vegetables as carrier. The
        use of biostimulation in modern agriculture has rapidly expanded in recent years, owing to
        their beneficial effects on crop yield and product quality, which have come under the scope
        of intensive research.
  
        The present project aims to investigate the benefits of biostimulated lettuce in a cohort of
        healthy individuals. For biostimulation are used organic and inorganic compounds or
        microorganisms that when applied to plants can enhance plants' growth, yield, and tolerance
        to stress. Participants will be fed with differently biostimulated lettuces to study the
        influence on hematological parameters.
  
        The healthy group will eat 100 gr of Lettuce and 100 gr of biostimulated lettuce and will be
        collect plasma and urine samples after 15 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,
        albumin, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, uric acid,
        creatinine, AST, ALT, γ-GT, ALP, bilirubin, Ferritin, free Iron, transferrin, total proteins,
        Magnesium, Calcium, insulin, osteocalcin, hematocrit, hs-CRP, TSH, FT3, FT4. Bone metabolism
        (Osteocalcin, parathyroid hormone, CTX, Calcitonin), Vitamin D Calcium, Phosphate, Potassium,
        gastric hormones ( GIP, GLP1, GLP2, ghrelin, glucagon, PYY, CCK, leptin, resistin).
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: control group, biostimulated group
  primary purpose: Prevention
  masking: Single (Participant)
  masking description: Two groups that consumed lettuce. No differences in shape, size, colours of lettuce
  measure: hepatic metabolism
  time frame: 15 days
  description: AST (aspartate transaminase) and ALT (Alanine aminotransferase) will be measured in serum will be assessed at baseline and after 15 days
  measure: iron metabolism
  time frame: 15 days
  description: ferritin, transferrin, % saturation of transferrin will be measured in serum will be assessed at baseline and after 15 days
  measure: Lipid metabolism
  time frame: 15 days
  description: triglycerides, HDL, LDL, cholesterol will be measured in serum will be assessed at baseline and after 15 days
  measure: Glucose metabolism
  time frame: 15 days
  description: insulin, glucose will be measured in serum will be assessed at baseline and after 15 days
  measure: Gastrointestinal peptides and lipid hormones
  time frame: 15 days
  description: Plasma concentrations of Gastrointestinal peptides (GLP-1, GLP-2, GIP, PYY, Ghrelin) and lipid hormones (leptin, resistin, adiponectin) will be assessed at baseline and after and after 15 days.
  measure: Serum bone remodelling markers
  time frame: 15 days
  description: PTH, calcitonin, Vitamin D, Calcium, Phosphate, Potassium will be assessed at baseline and after and after 15 days.
  measure: Serum bone matabolism markers
  time frame: 15 days
  description: bone resorption CTX and bone formation osteocalcin will be assessed at baseline and after 15 days.
  measure: body mass index (BMI)
  time frame: 15 days
  description: Weight (Kg) Height (m) BMI (kg/m2)
  measure: body composition
  time frame: 15 days
  description: lean mass as percent of body weight and fat mass as percent of body weight will be assessed at baseline and after 15 days
  arm group label: Control group
  arm group type: Placebo Comparator
  description: To the control group was assigned lettuce without any biostimulation but with the same characteristic of biostimulated lettuce (soil, water, harvesting time)
  arm group label: Biostimulated Group
  arm group type: Experimental
  description: experimental: Biostimulated group: To the intervention group was assigned the biostimulated lettuce.
  intervention type: Dietary Supplement
  intervention name: Control Group
  description: Lettuce without any biostimulation was assigned to each participant belonging to the control group which ate 100gr every day for 15 days
  arm group label: Control group
  other name: Placebo Comparator
  intervention type: Dietary Supplement
  intervention name: Biostimulated group
  description: Intervention biostimulated group 100gr of biostimulated lettuce were assigned to each participant belonging to the intervention group which ate 100 grams every day for a total of 15 days
  arm group label: Biostimulated Group
  other name: Intervention group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Sara Baldassano Professor, PhD
  role: Principal Investigator
  affiliation: University of Palermo
  facility: 
  country: Italy
  url: https://www.mdpi.com/2073-4395/12/6/1361
  description: Plant-Derived Biostimulated Differentially Modulate Primary and Secondary Metabolites and Improve the Yield Potential of Red and Green Lettuce Cultivars
  responsible party type: Principal Investigator
  investigator affiliation: University of Palermo
  investigator full name: Sara Baldassano
  investigator title: PROFESSOR
  mesh term: Bone Resorption
  mesh term: Fatty Liver
  mesh term: Metabolic Diseases
  mesh term: Glucose Metabolism Disorders
  mesh term: Lipid Metabolism Disorders
  mesh term: Malnutrition
  sharing ipd: No
  ipd description: Because is forbidden by the Italian Low
  provided document: 