<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/NCT03263065</url>
  </required_header>
  <id_info>
    <org_study_id>NOPAL</org_study_id>
    <nct_id>NCT03263065</nct_id>
  </id_info>
  <brief_title>A Study of the Effect of Bran, Psyllium and Nopal on Intestinal Water Content Using Magnetic Resonance Imaging</brief_title>
  <acronym>NOPAL</acronym>
  <official_title>A Pilot Participant-blind Study of the Effect of Bran, Psyllium and Nopal on Intestinal Water Content Using Magnetic Resonance Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nottingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nottingham</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will compare 3 food products (bran, psyllium and nopal) on intestinal water&#xD;
      content measured via MRI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND AND RATIONALE&#xD;
&#xD;
      The role of dietary fibre in human health is a topic of both debate and research.&#xD;
      Interpreting evidence is complicated by changes in the definition of fibre. In the UK the&#xD;
      Scientific Advisory Committee for Nutrition has recently proposed a definition of &quot;all&#xD;
      carbohydrates that are neither digested nor absorbed in the small intestine and have a degree&#xD;
      of polymerisation of three or more monomeric units, plus lignin&quot;. They have also called for&#xD;
      further research into the physiological effects of fibre of the gastrointestinal (GI) tract.&#xD;
&#xD;
      The Nottingham GI MRI group has been at the forefront of elucidating the effects of poorly&#xD;
      digested carbohydrates on gastrointestinal physiology. The investigators have published&#xD;
      techniques to measure free water in the small bowel and assessment of the physical form of&#xD;
      chyme in the colon using MR relaxometry. This includes the demonstration that fructose&#xD;
      ingestion on its own leads to increased free water in the small bowel compared to&#xD;
      co-ingestion with glucose.&#xD;
&#xD;
      Bran is often confused with dietary fibre. Although it contains fibre, the term actually&#xD;
      refers to the outer husk of seeds and grains. It has been shown to accelerate oro-caecal&#xD;
      transit (OCT) with scintigraphy. Bran can also be shown to increase small bowel water&#xD;
      content, possibly by mechanical stimulation, one of the most powerful stimuli for small&#xD;
      intestinal secretion, which may be a mechanism to prevent blockage. In the past bran's high&#xD;
      fibre content led to the hypothesis that its effect derived from holding water in the lumen&#xD;
      but a comparison study of 17 different fibres found an inverse relationship between their&#xD;
      water-holding properties and effect on faecal weight, with bran holding the least water but&#xD;
      inducing the largest weight changes. Rather, weight change appeared to relate to the amount&#xD;
      of undigested fibre present in the faeces and the associated changes in bacterial numbers,&#xD;
      which account for most of dry stool weight.&#xD;
&#xD;
      In contrast, psyllium husk contains a fibre that binds water effectively. On this basis it&#xD;
      has been used as a laxative for thousands of years. In fact, there is little evidence that&#xD;
      psyllium accelerates whole gut transit time as might be expected of a laxative. Work within&#xD;
      the investigating group has shown that psyllium increases water in both the small bowel and&#xD;
      the faeces, leading to softer, looser stool.&#xD;
&#xD;
      Nopal is a Mexican dietary product derived from cactus. It contains a different mix of fibre,&#xD;
      2/3rds of which is insoluble like bran fibre and 1/3rd soluble like psyllium. It is the&#xD;
      subject of several health claims. The investigating group has recently been awarded a grant&#xD;
      by the Newton Fund, through the Medical Research council, to study its effects on gut&#xD;
      function. The aim of the Newton Fund is to stimulate collaborative research with&#xD;
      middle-income countries such as Mexico. Part of the project plan is to invite a Mexican&#xD;
      radiologist, Dr Alfonso Gil-Valadez, to Nottingham to learn about the MRI techniques used by&#xD;
      our group.&#xD;
&#xD;
      TRIAL OBJECTIVES AND PURPOSE&#xD;
&#xD;
      Purpose&#xD;
&#xD;
      The purpose of the study is to gather pilot data on the effect of Nopal on intestinal water&#xD;
      content, in comparison to bran and psyllium.&#xD;
&#xD;
      Objective&#xD;
&#xD;
      The primary objective is to gather pilot data on the change from baseline in small bowel&#xD;
      water content in healthy volunteers after a meal containing nopal, in comparison to meals&#xD;
      containing psyllium or bran.&#xD;
&#xD;
      Secondary Objectives&#xD;
&#xD;
      Secondary objectives will be to gather pilot data on the effects of the fibre-containing&#xD;
      meals on the physical form of colonic chyme, colonic volume and breath markers of&#xD;
      fermentation.&#xD;
&#xD;
      Hypotheses&#xD;
&#xD;
      The test meals will lead to differences in post-prandial water in the small bowel.&#xD;
&#xD;
      The test meals will lead to differences in the post-prandial volume and physical composition&#xD;
      of chyme in the colon.&#xD;
&#xD;
      The test meals will not lead to change in breath markers of fermentation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 18, 2018</start_date>
  <completion_date type="Actual">November 1, 2018</completion_date>
  <primary_completion_date type="Actual">October 1, 2018</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>Crossover Assignment</intervention_model>
    <intervention_model_description>This will be a three-period, three-treatment crossover trial with blinding of data analysis</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Data analysis will be blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from the baseline in T1 relaxation time (ms) of the chyme in the ascending colon</measure>
    <time_frame>baseline, immediately post ingestion, 1, 2, 3 and 4 hours post ingestion</time_frame>
    <description>measured by MRI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from the baseline in small bowel water content (mL)</measure>
    <time_frame>baseline, immediately post ingestion, 1, 2, 3 and 4 hours post ingestion</time_frame>
    <description>measured by MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from the baseline in colonic volume in mL</measure>
    <time_frame>baseline, immediately post ingestion, 1, 2, 3 and 4 hours post ingestion</time_frame>
    <description>measured by MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from the baseline of breath hydrogen and methane (ppm)</measure>
    <time_frame>baseline, immediately post ingestion, 1, 2, 3 and 4 hours post ingestion</time_frame>
    <description>measured using GastroCHeck</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Constipation</condition>
  <condition>Diet Modification</condition>
  <arm_group>
    <arm_group_label>Nopal added to test meal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>test meal including nopal powder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Psyllium added to test meal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>test meal including psyllium powder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bran added to test meal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>test meal including bran powder</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Bran</intervention_name>
    <description>220g rice pudding meal with raspberry jam with added bran flakes</description>
    <arm_group_label>Bran added to test meal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nopal</intervention_name>
    <description>220g rice pudding meal with raspberry jam with added nopal flakes</description>
    <arm_group_label>Nopal added to test meal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Psyllium</intervention_name>
    <description>220g rice pudding meal with raspberry jam with added psyllium flakes</description>
    <arm_group_label>Psyllium added to test meal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 or older&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy declared by candidate&#xD;
&#xD;
          -  History declared by the candidate of pre-existing gastrointestinal disorder that may&#xD;
             affect bowel function&#xD;
&#xD;
          -  A positive diagnosis of irritable bowel syndrome based on the Rome IV criteria&#xD;
             questionnaire&#xD;
&#xD;
          -  Reported history of previous resection of the oesophagus, stomach or intestine&#xD;
             (excluding appendix)&#xD;
&#xD;
          -  Intestinal stoma&#xD;
&#xD;
          -  Any medical condition making participation potentially compromising participation in&#xD;
             the study e.g. diabetes mellitus, respiratory disease limiting ability to lie in the&#xD;
             scanner, known allergy to one of the food products&#xD;
&#xD;
          -  Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of&#xD;
             metallic foreign body in eye(s) and penetrating eye injury&#xD;
&#xD;
          -  Will not agree to dietary restrictions required in 24 hours before each MRI study day&#xD;
&#xD;
          -  Unable to stop drugs known to alter GI motility including mebeverine, opiates,&#xD;
             monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel&#xD;
             antagonists for the duration of the study (Selective serotonin reuptake inhibitors and&#xD;
             low dose tricyclic antidepressants will be recorded but will not be an exclusion&#xD;
             criteria)&#xD;
&#xD;
          -  Inability to lie flat or exceed scanner limits of weight &lt;120kg&#xD;
&#xD;
          -  Poor understanding of English language&#xD;
&#xD;
          -  Participation in night shift work the week prior to the study day. Night work is&#xD;
             defined as working between midnight and 6.00 AM&#xD;
&#xD;
          -  Participation in any medical trials for the past 3 months&#xD;
&#xD;
          -  Anyone who in the opinion of the investigator is unlikely to be able to comply with&#xD;
             the protocol e.g. cognitive dysfunction, chaotic lifestyle related to substance abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robin Spiller, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Nottingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Nottingham</name>
      <address>
        <city>Nottingham</city>
        <state>Nottinghamshire</state>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>April 16, 2019</last_update_submitted>
  <last_update_submitted_qc>April 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nopal</keyword>
  <keyword>Bran</keyword>
  <keyword>Psyllium</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constipation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psyllium</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/NCT03263065
org study id: NOPAL
nct id: NCT03263065
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study will compare 3 food products (bran, psyllium and nopal) on intestinal water
      content measured via MRI.
BACKGROUND AND RATIONALE

      The role of dietary fibre in human health is a topic of both debate and research.
      Interpreting evidence is complicated by changes in the definition of fibre. In the UK the
      Scientific Advisory Committee for Nutrition has recently proposed a definition of "all
      carbohydrates that are neither digested nor absorbed in the small intestine and have a degree
      of polymerisation of three or more monomeric units, plus lignin". They have also called for
      further research into the physiological effects of fibre of the gastrointestinal (GI) tract.

      The Nottingham GI MRI group has been at the forefront of elucidating the effects of poorly
      digested carbohydrates on gastrointestinal physiology. The investigators have published
      techniques to measure free water in the small bowel and assessment of the physical form of
      chyme in the colon using MR relaxometry. This includes the demonstration that fructose
      ingestion on its own leads to increased free water in the small bowel compared to
      co-ingestion with glucose.

      Bran is often confused with dietary fibre. Although it contains fibre, the term actually
      refers to the outer husk of seeds and grains. It has been shown to accelerate oro-caecal
      transit (OCT) with scintigraphy. Bran can also be shown to increase small bowel water
      content, possibly by mechanical stimulation, one of the most powerful stimuli for small
      intestinal secretion, which may be a mechanism to prevent blockage. In the past bran's high
      fibre content led to the hypothesis that its effect derived from holding water in the lumen
      but a comparison study of 17 different fibres found an inverse relationship between their
      water-holding properties and effect on faecal weight, with bran holding the least water but
      inducing the largest weight changes. Rather, weight change appeared to relate to the amount
      of undigested fibre present in the faeces and the associated changes in bacterial numbers,
      which account for most of dry stool weight.

      In contrast, psyllium husk contains a fibre that binds water effectively. On this basis it
      has been used as a laxative for thousands of years. In fact, there is little evidence that
      psyllium accelerates whole gut transit time as might be expected of a laxative. Work within
      the investigating group has shown that psyllium increases water in both the small bowel and
      the faeces, leading to softer, looser stool.

      Nopal is a Mexican dietary product derived from cactus. It contains a different mix of fibre,
      2/3rds of which is insoluble like bran fibre and 1/3rd soluble like psyllium. It is the
      subject of several health claims. The investigating group has recently been awarded a grant
      by the Newton Fund, through the Medical Research council, to study its effects on gut
      function. The aim of the Newton Fund is to stimulate collaborative research with
      middle-income countries such as Mexico. Part of the project plan is to invite a Mexican
      radiologist, Dr Alfonso Gil-Valadez, to Nottingham to learn about the MRI techniques used by
      our group.

      TRIAL OBJECTIVES AND PURPOSE

      Purpose

      The purpose of the study is to gather pilot data on the effect of Nopal on intestinal water
      content, in comparison to bran and psyllium.

      Objective

      The primary objective is to gather pilot data on the change from baseline in small bowel
      water content in healthy volunteers after a meal containing nopal, in comparison to meals
      containing psyllium or bran.

      Secondary Objectives

      Secondary objectives will be to gather pilot data on the effects of the fibre-containing
      meals on the physical form of colonic chyme, colonic volume and breath markers of
      fermentation.

      Hypotheses

      The test meals will lead to differences in post-prandial water in the small bowel.

      The test meals will lead to differences in the post-prandial volume and physical composition
      of chyme in the colon.

      The test meals will not lead to change in breath markers of fermentation.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: This will be a three-period, three-treatment crossover trial with blinding of data analysis
primary purpose: Basic Science
masking: Single (Outcomes Assessor)
masking description: Data analysis will be blinded
measure: Change from the baseline in T1 relaxation time (ms) of the chyme in the ascending colon
time frame: baseline, immediately post ingestion, 1, 2, 3 and 4 hours post ingestion
description: measured by MRI
measure: Change from the baseline in small bowel water content (mL)
time frame: baseline, immediately post ingestion, 1, 2, 3 and 4 hours post ingestion
description: measured by MRI
measure: Change from the baseline in colonic volume in mL
time frame: baseline, immediately post ingestion, 1, 2, 3 and 4 hours post ingestion
description: measured by MRI
measure: Change from the baseline of breath hydrogen and methane (ppm)
time frame: baseline, immediately post ingestion, 1, 2, 3 and 4 hours post ingestion
description: measured using GastroCHeck
arm group label: Nopal added to test meal
arm group type: Experimental
description: test meal including nopal powder
arm group label: Psyllium added to test meal
arm group type: Experimental
description: test meal including psyllium powder
arm group label: Bran added to test meal
arm group type: Experimental
description: test meal including bran powder
intervention type: Dietary Supplement
intervention name: Bran
description: 220g rice pudding meal with raspberry jam with added bran flakes
arm group label: Bran added to test meal
intervention type: Dietary Supplement
intervention name: Nopal
description: 220g rice pudding meal with raspberry jam with added nopal flakes
arm group label: Nopal added to test meal
intervention type: Dietary Supplement
intervention name: Psyllium
description: 220g rice pudding meal with raspberry jam with added psyllium flakes
arm group label: Psyllium added to test meal
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Robin Spiller, PhD
role: Study Chair
affiliation: University of Nottingham
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Constipation
mesh term: Psyllium
sharing ipd: No