<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/NCT03020511</url>
  </required_header>
  <id_info>
    <org_study_id>ACPM19</org_study_id>
    <nct_id>NCT03020511</nct_id>
  </id_info>
  <brief_title>Effects of Ancient Grains-based Diet in a Closed Community</brief_title>
  <official_title>Effects of Ancient Grains-based Diet in a Closed Community</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recently it has been reported that a consistent percentage of the general population consider&#xD;
      themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though&#xD;
      they do not have celiac disease or wheat allergy. This clinical condition has been named&#xD;
      Non-Celiac Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the&#xD;
      term 'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat&#xD;
      causes the symptoms in NCGS patients, and the investigators also showed that these patients&#xD;
      had a high frequency of coexistent multiple food hypersensitivity. It is also believed that&#xD;
      this condition is worldwide increasing, due to the evolution of wheat breeding (i.e.&#xD;
      consumption of wheats with high gluten content), and that &quot;ancient&quot; wheat flour varieties are&#xD;
      better tolerated by NCWS patients than the &quot;modern&quot; ones. This effect could be related to a&#xD;
      lower immunogenic stimulation of the ancient wheat than the modern ones. The aim of the study&#xD;
      is to evaluate the effect of a diet based on ancient grains in a &quot;closed&quot; community (i.e.&#xD;
      nuns from enclosed religious order) as regard to 1) main haematochemical parameters and&#xD;
      vitamins, 2) intestinal microbiota (bacterial flora), and 3) cytokines production from&#xD;
      peripheral blood mononuclear cells (PBMC), before and after the diet period (30 days) with&#xD;
      ancient grains.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recently it has been reported that a consistent percentage of the general population consider&#xD;
      themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though&#xD;
      they do not have celiac disease or wheat allergy. This clinical condition has been named&#xD;
      Non-Celiac Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the&#xD;
      term 'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat&#xD;
      causes the symptoms in NCGS patients, and the investigators also showed that these patients&#xD;
      had a high frequency of coexistent multiple food hypersensitivity. Therefore, NCWS&#xD;
      pathogenesis has been attributed to very different mechanisms: innate or adaptive immunity,&#xD;
      non IgE-mediated food allergy, amylase/trypsine inhibitors pro-inflammatory effects,&#xD;
      incomplete digestion and/or absorption of fermentable oligosaccharides and disaccharides,&#xD;
      monosaccharides and polyols, and, finally, psychological effect. The clinical picture of NCWS&#xD;
      is characterized by combined gastrointestinal (bloating, abdominal pain, diarrhea and/or&#xD;
      constipation, nausea, epigastric pain, gastroesophageal reflux, aphthous stomatitis) and&#xD;
      extra-intestinal and/or systemic manifestations (headache, depression, anxiety, 'foggy mind,'&#xD;
      tiredness, dermatitis or skin rash, fibromyalgia-like joint/muscle pain, leg or arm numbness,&#xD;
      and anemia). It is also believed that this condition is worldwide increasing, due to the&#xD;
      evolution of wheat breeding (i.e. consumption of wheats with high gluten content), and that&#xD;
      &quot;ancient&quot; wheat flour varieties are better tolerated by NCWS patients than the &quot;modern&quot; ones.&#xD;
      More in details, it has been demonstrated that in patients with NCWS foods containing modern&#xD;
      (i.e. &quot;Manitoba&quot;) wheat flour varieties may trigger immunological mechanisms of inflammation&#xD;
      (i.e. CXCL10 secretion) and may alter intestinal permeability; on the contrary, these effects&#xD;
      was not observed with wheat flour from ancient (i.e. &quot;Kamut&quot; or &quot;Senatore Cappelli&quot;)&#xD;
      varieties. Therefore, the aim of the study is to evaluate the effect of a diet based on&#xD;
      ancient grains (i.e. a mixture of &quot;Tumminia&quot;, &quot;Perciasacchi&quot;, &quot;Senatore-Cappelli&quot; and&#xD;
      &quot;Margherito&quot; grains) in a &quot;closed&quot; community (i.e. nuns from enclosed religious order) as&#xD;
      regard to: 1) main haematochemical parameters and vitamins (serum creatinine, serum&#xD;
      glutamic-oxaloacetic transaminase, serum glutamic-pyruvic transaminase, hemoglobin, serum&#xD;
      iron, serum ferritin, blood glucose, serum sodium, total cholesterol, glycated hemoglobin,&#xD;
      vitamin B12, and vitamin D), 2) intestinal microbiota (bacterial flora), and 3) cytokines&#xD;
      production from peripheral blood mononuclear cells (PBMC), before and after the diet period&#xD;
      (30 days) with ancient grains.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Laboratory Values evaluation</measure>
    <time_frame>Change from baseline at 30 days</time_frame>
    <description>Laboratory Values evaluation at baseline and after a 30 days challenge with ancient grains-based diet.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intestinal microbiota (bacterial flora) by feces samples examination</measure>
    <time_frame>Change from baseline at 30 days</time_frame>
    <description>Evaluation of modifications of intestinal microbiota (bacterial flora) by feces samples examination, before and after a 30 days challenge with ancient grains-based diet.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokines production from PBMC</measure>
    <time_frame>Cytokines production from PBMC after the diet period (30 days) with ancient grains</time_frame>
    <description>Evaluation of modifications in cytokines production from PBMC, before and after the diet period (30 days) with ancient grains.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Gluten Sensitivity</condition>
  <arm_group>
    <arm_group_label>Ancient wheat flours</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>We prospectively will survey 30 nuns from the &quot;Congregazione delle Suore Collegine della Santa Famiglia&quot;, Palermo, Italy. The subjects will be recruited between January 2017 and June 2017 and will be examined before and after the diet period (30 days) with ancient grains, undergoing clinical evaluation and blood and feces samples collection. Ancient wheat flours will be administered in open label for 30 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ancient wheat flours</intervention_name>
    <description>Ancient wheat flours will be administered in open label for 30 days</description>
    <arm_group_label>Ancient wheat flours</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Nuns from the &quot;Congregazione delle Suore Collegine della Santa Famiglia&quot;, Palermo,&#xD;
             Italy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  N/A&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antonio Carroccio, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Palermo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Congregazione delle Suore Collegine della Santa Famiglia</name>
      <address>
        <city>Palermo</city>
        <zip>90135</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>Carroccio A, Mansueto P, Iacono G, Soresi M, D'Alcamo A, Cavataio F, Brusca I, Florena AM, Ambrosiano G, Seidita A, Pirrone G, Rini GB. Non-celiac wheat sensitivity diagnosed by double-blind placebo-controlled challenge: exploring a new clinical entity. Am J Gastroenterol. 2012 Dec;107(12):1898-906; quiz 1907. doi: 10.1038/ajg.2012.236. Epub 2012 Jul 24.</citation>
    <PMID>22825366</PMID>
  </results_reference>
  <results_reference>
    <citation>Mansueto P, Seidita A, D'Alcamo A, Carroccio A. Non-celiac gluten sensitivity: literature review. J Am Coll Nutr. 2014;33(1):39-54. doi: 10.1080/07315724.2014.869996.</citation>
    <PMID>24533607</PMID>
  </results_reference>
  <results_reference>
    <citation>Carroccio A, Rini G, Mansueto P. Non-celiac wheat sensitivity is a more appropriate label than non-celiac gluten sensitivity. Gastroenterology. 2014 Jan;146(1):320-1. doi: 10.1053/j.gastro.2013.08.061. Epub 2013 Nov 22. No abstract available.</citation>
    <PMID>24275240</PMID>
  </results_reference>
  <results_reference>
    <citation>Carroccio A, D'Alcamo A, Mansueto P. Nonceliac wheat sensitivity in the context of multiple food hypersensitivity: new data from confocal endomicroscopy. Gastroenterology. 2015 Mar;148(3):666-7. doi: 10.1053/j.gastro.2014.11.047. Epub 2015 Jan 24. No abstract available.</citation>
    <PMID>25625764</PMID>
  </results_reference>
  <results_reference>
    <citation>Carroccio A, Soresi M, D'Alcamo A, Sciume C, Iacono G, Geraci G, Brusca I, Seidita A, Adragna F, Carta M, Mansueto P. Risk of low bone mineral density and low body mass index in patients with non-celiac wheat-sensitivity: a prospective observation study. BMC Med. 2014 Nov 28;12:230. doi: 10.1186/s12916-014-0230-2.</citation>
    <PMID>25430806</PMID>
  </results_reference>
  <results_reference>
    <citation>Mansueto P, Seidita A, D'Alcamo A, Carroccio A. Role of FODMAPs in Patients With Irritable Bowel Syndrome. Nutr Clin Pract. 2015 Oct;30(5):665-82. doi: 10.1177/0884533615569886. Epub 2015 Feb 18.</citation>
    <PMID>25694210</PMID>
  </results_reference>
  <results_reference>
    <citation>Valerii MC, Ricci C, Spisni E, Di Silvestro R, De Fazio L, Cavazza E, Lanzini A, Campieri M, Dalpiaz A, Pavan B, Volta U, Dinelli G. Responses of peripheral blood mononucleated cells from non-celiac gluten sensitive patients to various cereal sources. Food Chem. 2015 Jun 1;176:167-74. doi: 10.1016/j.foodchem.2014.12.061. Epub 2014 Dec 23.</citation>
    <PMID>25624220</PMID>
  </results_reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>December 30, 2016</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>July 9, 2017</last_update_submitted>
  <last_update_submitted_qc>July 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Palermo</investigator_affiliation>
    <investigator_full_name>Pasquale Mansueto</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Modern grains</keyword>
  <keyword>ancient grains</keyword>
  <keyword>immunologic response</keyword>
  <keyword>microbiota</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_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/NCT03020511
org study id: ACPM19
nct id: NCT03020511
lead sponsor: 
has dmc: No
Recently it has been reported that a consistent percentage of the general population consider
      themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though
      they do not have celiac disease or wheat allergy. This clinical condition has been named
      Non-Celiac Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the
      term 'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat
      causes the symptoms in NCGS patients, and the investigators also showed that these patients
      had a high frequency of coexistent multiple food hypersensitivity. It is also believed that
      this condition is worldwide increasing, due to the evolution of wheat breeding (i.e.
      consumption of wheats with high gluten content), and that "ancient" wheat flour varieties are
      better tolerated by NCWS patients than the "modern" ones. This effect could be related to a
      lower immunogenic stimulation of the ancient wheat than the modern ones. The aim of the study
      is to evaluate the effect of a diet based on ancient grains in a "closed" community (i.e.
      nuns from enclosed religious order) as regard to 1) main haematochemical parameters and
      vitamins, 2) intestinal microbiota (bacterial flora), and 3) cytokines production from
      peripheral blood mononuclear cells (PBMC), before and after the diet period (30 days) with
      ancient grains.
Recently it has been reported that a consistent percentage of the general population consider
      themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though
      they do not have celiac disease or wheat allergy. This clinical condition has been named
      Non-Celiac Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the
      term 'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat
      causes the symptoms in NCGS patients, and the investigators also showed that these patients
      had a high frequency of coexistent multiple food hypersensitivity. Therefore, NCWS
      pathogenesis has been attributed to very different mechanisms: innate or adaptive immunity,
      non IgE-mediated food allergy, amylase/trypsine inhibitors pro-inflammatory effects,
      incomplete digestion and/or absorption of fermentable oligosaccharides and disaccharides,
      monosaccharides and polyols, and, finally, psychological effect. The clinical picture of NCWS
      is characterized by combined gastrointestinal (bloating, abdominal pain, diarrhea and/or
      constipation, nausea, epigastric pain, gastroesophageal reflux, aphthous stomatitis) and
      extra-intestinal and/or systemic manifestations (headache, depression, anxiety, 'foggy mind,'
      tiredness, dermatitis or skin rash, fibromyalgia-like joint/muscle pain, leg or arm numbness,
      and anemia). It is also believed that this condition is worldwide increasing, due to the
      evolution of wheat breeding (i.e. consumption of wheats with high gluten content), and that
      "ancient" wheat flour varieties are better tolerated by NCWS patients than the "modern" ones.
      More in details, it has been demonstrated that in patients with NCWS foods containing modern
      (i.e. "Manitoba") wheat flour varieties may trigger immunological mechanisms of inflammation
      (i.e. CXCL10 secretion) and may alter intestinal permeability; on the contrary, these effects
      was not observed with wheat flour from ancient (i.e. "Kamut" or "Senatore Cappelli")
      varieties. Therefore, the aim of the study is to evaluate the effect of a diet based on
      ancient grains (i.e. a mixture of "Tumminia", "Perciasacchi", "Senatore-Cappelli" and
      "Margherito" grains) in a "closed" community (i.e. nuns from enclosed religious order) as
      regard to: 1) main haematochemical parameters and vitamins (serum creatinine, serum
      glutamic-oxaloacetic transaminase, serum glutamic-pyruvic transaminase, hemoglobin, serum
      iron, serum ferritin, blood glucose, serum sodium, total cholesterol, glycated hemoglobin,
      vitamin B12, and vitamin D), 2) intestinal microbiota (bacterial flora), and 3) cytokines
      production from peripheral blood mononuclear cells (PBMC), before and after the diet period
      (30 days) with ancient grains.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Laboratory Values evaluation
time frame: Change from baseline at 30 days
description: Laboratory Values evaluation at baseline and after a 30 days challenge with ancient grains-based diet.
measure: Intestinal microbiota (bacterial flora) by feces samples examination
time frame: Change from baseline at 30 days
description: Evaluation of modifications of intestinal microbiota (bacterial flora) by feces samples examination, before and after a 30 days challenge with ancient grains-based diet.
measure: Cytokines production from PBMC
time frame: Cytokines production from PBMC after the diet period (30 days) with ancient grains
description: Evaluation of modifications in cytokines production from PBMC, before and after the diet period (30 days) with ancient grains.
arm group label: Ancient wheat flours
arm group type: Other
description: We prospectively will survey 30 nuns from the "Congregazione delle Suore Collegine della Santa Famiglia", Palermo, Italy. The subjects will be recruited between January 2017 and June 2017 and will be examined before and after the diet period (30 days) with ancient grains, undergoing clinical evaluation and blood and feces samples collection. Ancient wheat flours will be administered in open label for 30 days
intervention type: Other
intervention name: Ancient wheat flours
description: Ancient wheat flours will be administered in open label for 30 days
arm group label: Ancient wheat flours
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Antonio Carroccio, PhD
role: Study Director
affiliation: University of Palermo
facility: 
country: Italy
citation: Carroccio A, Mansueto P, Iacono G, Soresi M, D'Alcamo A, Cavataio F, Brusca I, Florena AM, Ambrosiano G, Seidita A, Pirrone G, Rini GB. Non-celiac wheat sensitivity diagnosed by double-blind placebo-controlled challenge: exploring a new clinical entity. Am J Gastroenterol. 2012 Dec;107(12):1898-906; quiz 1907. doi: 10.1038/ajg.2012.236. Epub 2012 Jul 24.
PMID: 22825366
citation: Mansueto P, Seidita A, D'Alcamo A, Carroccio A. Non-celiac gluten sensitivity: literature review. J Am Coll Nutr. 2014;33(1):39-54. doi: 10.1080/07315724.2014.869996.
PMID: 24533607
citation: Carroccio A, Rini G, Mansueto P. Non-celiac wheat sensitivity is a more appropriate label than non-celiac gluten sensitivity. Gastroenterology. 2014 Jan;146(1):320-1. doi: 10.1053/j.gastro.2013.08.061. Epub 2013 Nov 22. No abstract available.
PMID: 24275240
citation: Carroccio A, D'Alcamo A, Mansueto P. Nonceliac wheat sensitivity in the context of multiple food hypersensitivity: new data from confocal endomicroscopy. Gastroenterology. 2015 Mar;148(3):666-7. doi: 10.1053/j.gastro.2014.11.047. Epub 2015 Jan 24. No abstract available.
PMID: 25625764
citation: Carroccio A, Soresi M, D'Alcamo A, Sciume C, Iacono G, Geraci G, Brusca I, Seidita A, Adragna F, Carta M, Mansueto P. Risk of low bone mineral density and low body mass index in patients with non-celiac wheat-sensitivity: a prospective observation study. BMC Med. 2014 Nov 28;12:230. doi: 10.1186/s12916-014-0230-2.
PMID: 25430806
citation: Mansueto P, Seidita A, D'Alcamo A, Carroccio A. Role of FODMAPs in Patients With Irritable Bowel Syndrome. Nutr Clin Pract. 2015 Oct;30(5):665-82. doi: 10.1177/0884533615569886. Epub 2015 Feb 18.
PMID: 25694210
citation: Valerii MC, Ricci C, Spisni E, Di Silvestro R, De Fazio L, Cavazza E, Lanzini A, Campieri M, Dalpiaz A, Pavan B, Volta U, Dinelli G. Responses of peripheral blood mononucleated cells from non-celiac gluten sensitive patients to various cereal sources. Food Chem. 2015 Jun 1;176:167-74. doi: 10.1016/j.foodchem.2014.12.061. Epub 2014 Dec 23.
PMID: 25624220
responsible party type: Principal Investigator
investigator affiliation: University of Palermo
investigator full name: Pasquale Mansueto
investigator title: MD
mesh term: Hypersensitivity
sharing ipd: No