<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/NCT03014141</url>
  </required_header>
  <id_info>
    <org_study_id>2015-12-10-OAT</org_study_id>
    <nct_id>NCT03014141</nct_id>
  </id_info>
  <brief_title>Effect of Oat Bran on Bowel Function and Appetite</brief_title>
  <acronym>OATGUT</acronym>
  <official_title>The Effect of Oat Bran on Bowel Function and Appetite. A Randomized, Double-blind, Placebo-controlled, Cross-over Intervention Study in Healthy Humans.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DSM Nutritional Products, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>DSM Nutritional Products, Inc.</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 consumption of oat bran fiber also has a significant bulking effect in humans. However,&#xD;
      besides fecal bulk, dietary fiber can promote gut health in other ways. Therefore, the&#xD;
      purpose of this study is to investigate the effects of oat bran (rich in oat beta-glucan)&#xD;
      supplementation on bowel function and appetite.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a randomized, double-blind, placebo-controlled crossover study it involves a&#xD;
      total of 8 visits with a 14 day run-in period for total study duration of 84 days. A washout&#xD;
      period of 2 weeks will occur in between the 2, 28 day treatment periods. The effects of an&#xD;
      oat bran beverage for breakfast on bowel function will be tested after 2 week and 4 weeks of&#xD;
      intake.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study supply issues&#xD;
  </why_stopped>
  <start_date type="Anticipated">June 2018</start_date>
  <completion_date type="Anticipated">March 2019</completion_date>
  <primary_completion_date type="Anticipated">December 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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Whole gut transit time</measure>
    <time_frame>4 weeks</time_frame>
    <description>Whole gut transit time is the time required for the passage of 80% of radio-opaque markers (ROM) which are detected by x-ray in the fecal samples collected over the next 5 days after swallowing the ROM.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Whole gut transit time</measure>
    <time_frame>2 weeks</time_frame>
    <description>Whole gut transit time is the time required for the passage of 80% of radio-opaque markers (ROM) which are detected by x-ray in the fecal samples collected over the next 5 days after swallowing the ROM.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stool frequency</measure>
    <time_frame>2 weeks and 4 weeks</time_frame>
    <description>using a bowel movement diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fecal output</measure>
    <time_frame>2 weeks and 4 weeks</time_frame>
    <description>Fecal out is the weight of the fecal samples collected over the 5 days preceding the 2 week and 4 week time point</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent fecal moisture</measure>
    <time_frame>2 weeks and 4 weeks</time_frame>
    <description>Fecal moisture is determined by freeze drying fecal samples and calculating the percent moisture in the fecal sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bristol Stool Score</measure>
    <time_frame>2 weeks and 4 weeks</time_frame>
    <description>using Bristol Stool Chart</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fecal pH</measure>
    <time_frame>2 weeks and 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective measures of bowel comfort</measure>
    <time_frame>2 weeks and 4 weeks</time_frame>
    <description>Gastrointestinal Quality of life questionnaires (GIQLI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gut microbiota</measure>
    <time_frame>2 weeks and 4 weeks</time_frame>
    <description>Using 16S ribosomal RNA sequencing techniques</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fecal short chain fatty acids</measure>
    <time_frame>2 weeks and 4 weeks</time_frame>
    <description>Using gas chromatography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fecal total bile acids</measure>
    <time_frame>2 weeks and 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fecal enzymes</measure>
    <time_frame>2 weeks and 4 weeks</time_frame>
    <description>fecal beta-glucoronidase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fecal ammonia</measure>
    <time_frame>2 weeks and 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intestinal gas production</measure>
    <time_frame>2 weeks and 4 weeks</time_frame>
    <description>using breath hydrogen production</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appetite</measure>
    <time_frame>2 weeks and 4 weeks</time_frame>
    <description>Appetite will be measured via visual analogue score (VAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ad libitum energy intake</measure>
    <time_frame>2 weeks and 4 weeks</time_frame>
    <description>Ad libitum energy intake is measured by serving the subject an excess of food</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Gastrointestinal Disorder, Functional</condition>
  <arm_group>
    <arm_group_label>Oat bran (Oatwell 28)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A beverage containing 11 gram (3 gram of oat beta-glucan) of Oat bran (Oatwell 28) will be consumed before breakfast</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Maltodextrin</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A beverage containing 11 gram of maltodextrin will be consumed before breakfast.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Oat bran (Oatwell 28)</intervention_name>
    <description>11 g oat bran containing 3.1 gram oat beta-glucan</description>
    <arm_group_label>Oat bran (Oatwell 28)</arm_group_label>
    <other_name>Oat bran oat beta-glucan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Maltodextrin</intervention_name>
    <description>11 g of Maltodextrin</description>
    <arm_group_label>Maltodextrin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male or female between the ages of 18-60 years&#xD;
&#xD;
          -  Subject has a body mass index of ≥18.5 and ≤30 kg/m2 at screening visit.&#xD;
&#xD;
          -  Subject is willing to stick to their normal habitual diet excluding the consumption of&#xD;
             any unusual high energy-rich or fat-rich meals or prolonged fasting, etc. through the&#xD;
             study period.&#xD;
&#xD;
          -  Subject is willing to maintain their habitual physical activity patterns throughout&#xD;
             the study period.&#xD;
&#xD;
          -  Subject has been weight stable within the last 6 months.&#xD;
&#xD;
          -  Subject has no health conditions that would prevent him or her from fulfilling the&#xD;
             study requirements as judged by the investigator on the basis of medical history and&#xD;
             routine laboratory test results.&#xD;
&#xD;
          -  Low fiber consumer (≤14 g per day)&#xD;
&#xD;
          -  Subject is willing to follow study procedures and dietary restrictions (ex: stick to&#xD;
             habitual diet, refrain from consuming alcohol 24 hours prior to test days).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of a gastrointestinal disorder&#xD;
&#xD;
          -  Lactose intolerant&#xD;
&#xD;
          -  High fiber consumer (≥15 g per day)&#xD;
&#xD;
          -  Use of pre-and probiotics in the past 90 days&#xD;
&#xD;
          -  High protein consumer (i.e. vegetarians or those who follow diets high in protein such&#xD;
             as paleo)&#xD;
&#xD;
          -  History of psychological illness or conditions that may interfere with subjects&#xD;
             ability to understand study directions&#xD;
&#xD;
          -  Use of antibiotics or signs of active systemic infection in the last 6 months.&#xD;
&#xD;
          -  Subjects who are on hypo/hypercaloric diet aiming for weight loss or weight gain&#xD;
&#xD;
          -  History or presence of cancer in the prior 2 years (except for non-melanoma skin&#xD;
             cancer).&#xD;
&#xD;
          -  Currently pregnant, lactating or planning to be pregnant during the study period&#xD;
&#xD;
          -  Regular use of dietary supplements (ex: fish oil, riboflavin, etc.), 90 days prior to&#xD;
             study inclusion&#xD;
&#xD;
          -  Exposure to any non-registered drug product within the last 30 days prior to screening&#xD;
             visit&#xD;
&#xD;
          -  History of or strong potential for alcohol or substance abuse (within 12 months of&#xD;
             screening visit). Alcohol abuse is defined as &gt;60g (men)/40g (women) pure alcohol per&#xD;
             day (1.5 L/ 1 l beer resp. 0.75l/0.5l wine).&#xD;
&#xD;
          -  Allergy or sensitivity to oat bran or any meals or snacks provided&#xD;
&#xD;
          -  Current smoker or use of tobacco products in the past 90 days&#xD;
&#xD;
          -  Concurrent or recent participation (30 days) in a dietary intervention trial&#xD;
&#xD;
          -  Anything in the judgment of the investigator would interfere with the subject's&#xD;
             ability to comply with the study (protocol), which might confound the interpretation&#xD;
             of the study results, or put the subject at undue risk.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joanne Slavin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <reference>
    <citation>Grabitske HA, Slavin JL. Low-digestible carbohydrates in practice. J Am Diet Assoc. 2008 Oct;108(10):1677-81. doi: 10.1016/j.jada.2008.07.010.</citation>
    <PMID>18926133</PMID>
  </reference>
  <reference>
    <citation>Stewart ML, Nikhanj SD, Timm DA, Thomas W, Slavin JL. Evaluation of the effect of four fibers on laxation, gastrointestinal tolerance and serum markers in healthy humans. Ann Nutr Metab. 2010;56(2):91-8. doi: 10.1159/000275962. Epub 2010 Jan 19.</citation>
    <PMID>20090313</PMID>
  </reference>
  <reference>
    <citation>Chen HL, Haack VS, Janecky CW, Vollendorf NW, Marlett JA. Mechanisms by which wheat bran and oat bran increase stool weight in humans. Am J Clin Nutr. 1998 Sep;68(3):711-9. doi: 10.1093/ajcn/68.3.711.</citation>
    <PMID>9734752</PMID>
  </reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>August 9, 2018</last_update_submitted>
  <last_update_submitted_qc>August 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastrointestinal Diseases</mesh_term>
    <mesh_term>Digestive System Diseases</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/NCT03014141
org study id: 2015-12-10-OAT
nct id: NCT03014141
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The consumption of oat bran fiber also has a significant bulking effect in humans. However,
      besides fecal bulk, dietary fiber can promote gut health in other ways. Therefore, the
      purpose of this study is to investigate the effects of oat bran (rich in oat beta-glucan)
      supplementation on bowel function and appetite.
The study is a randomized, double-blind, placebo-controlled crossover study it involves a
      total of 8 visits with a 14 day run-in period for total study duration of 84 days. A washout
      period of 2 weeks will occur in between the 2, 28 day treatment periods. The effects of an
      oat bran beverage for breakfast on bowel function will be tested after 2 week and 4 weeks of
      intake.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Whole gut transit time
time frame: 4 weeks
description: Whole gut transit time is the time required for the passage of 80% of radio-opaque markers (ROM) which are detected by x-ray in the fecal samples collected over the next 5 days after swallowing the ROM.
measure: Whole gut transit time
time frame: 2 weeks
description: Whole gut transit time is the time required for the passage of 80% of radio-opaque markers (ROM) which are detected by x-ray in the fecal samples collected over the next 5 days after swallowing the ROM.
measure: Stool frequency
time frame: 2 weeks and 4 weeks
description: using a bowel movement diary
measure: Fecal output
time frame: 2 weeks and 4 weeks
description: Fecal out is the weight of the fecal samples collected over the 5 days preceding the 2 week and 4 week time point
measure: Percent fecal moisture
time frame: 2 weeks and 4 weeks
description: Fecal moisture is determined by freeze drying fecal samples and calculating the percent moisture in the fecal sample
measure: Bristol Stool Score
time frame: 2 weeks and 4 weeks
description: using Bristol Stool Chart
measure: Fecal pH
time frame: 2 weeks and 4 weeks
measure: Subjective measures of bowel comfort
time frame: 2 weeks and 4 weeks
description: Gastrointestinal Quality of life questionnaires (GIQLI)
measure: Gut microbiota
time frame: 2 weeks and 4 weeks
description: Using 16S ribosomal RNA sequencing techniques
measure: Fecal short chain fatty acids
time frame: 2 weeks and 4 weeks
description: Using gas chromatography
measure: Fecal total bile acids
time frame: 2 weeks and 4 weeks
measure: Fecal enzymes
time frame: 2 weeks and 4 weeks
description: fecal beta-glucoronidase
measure: Fecal ammonia
time frame: 2 weeks and 4 weeks
measure: Intestinal gas production
time frame: 2 weeks and 4 weeks
description: using breath hydrogen production
measure: Appetite
time frame: 2 weeks and 4 weeks
description: Appetite will be measured via visual analogue score (VAS)
measure: Ad libitum energy intake
time frame: 2 weeks and 4 weeks
description: Ad libitum energy intake is measured by serving the subject an excess of food
arm group label: Oat bran (Oatwell 28)
arm group type: Active Comparator
description: A beverage containing 11 gram (3 gram of oat beta-glucan) of Oat bran (Oatwell 28) will be consumed before breakfast
arm group label: Maltodextrin
arm group type: Placebo Comparator
description: A beverage containing 11 gram of maltodextrin will be consumed before breakfast.
intervention type: Other
intervention name: Oat bran (Oatwell 28)
description: 11 g oat bran containing 3.1 gram oat beta-glucan
arm group label: Oat bran (Oatwell 28)
other name: Oat bran oat beta-glucan
intervention type: Other
intervention name: Maltodextrin
description: 11 g of Maltodextrin
arm group label: Maltodextrin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Joanne Slavin, PhD
role: Principal Investigator
affiliation: University of Minnesota
citation: Grabitske HA, Slavin JL. Low-digestible carbohydrates in practice. J Am Diet Assoc. 2008 Oct;108(10):1677-81. doi: 10.1016/j.jada.2008.07.010.
PMID: 18926133
citation: Stewart ML, Nikhanj SD, Timm DA, Thomas W, Slavin JL. Evaluation of the effect of four fibers on laxation, gastrointestinal tolerance and serum markers in healthy humans. Ann Nutr Metab. 2010;56(2):91-8. doi: 10.1159/000275962. Epub 2010 Jan 19.
PMID: 20090313
citation: Chen HL, Haack VS, Janecky CW, Vollendorf NW, Marlett JA. Mechanisms by which wheat bran and oat bran increase stool weight in humans. Am J Clin Nutr. 1998 Sep;68(3):711-9. doi: 10.1093/ajcn/68.3.711.
PMID: 9734752
responsible party type: Sponsor
mesh term: Gastrointestinal Diseases
mesh term: Digestive System Diseases
sharing ipd: No