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/NCT06032104</url>
    </required_header>
    <id_info>
      <org_study_id>2012455</org_study_id>
      <nct_id>NCT06032104</nct_id>
    </id_info>
    <brief_title>Feasibility and Colorectal Benefits of Pulses Supplementation</brief_title>
    <official_title>Feasibility of Pulses Supplementation in Healthy Adults: A Feeding Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, Davis</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of California, Davis</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Beans are a forgotten staple food that shows promise in improving health. The goal of this&#xD;
        study is to look at how bean supplementation affects metabolic and bowel health. In the&#xD;
        long-term, the investigators believe this research will lead to a better understanding of the&#xD;
        impact of beans on bowel health. The investigators also hope that this research study will&#xD;
        help us understand ways to improve human diet and prevent colon cancer in the future.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Investigators are seeking adults planning for a standard of care colonoscopies (part of the&#xD;
        participant's usual care). As part of this feeding study, a participant will be randomly&#xD;
        assigned to either two weeks of a bean smoothie that the investigators will provide (Bush's&#xD;
        Best Cannellini Beans) in addition to the participant's usual diet or continue with&#xD;
        participant's usual diet without the bean smoothie (including the food and drink guidelines&#xD;
        for the colonoscopy) 2 weeks before the participant colonoscopy. Then, one month after&#xD;
        colonoscopy, the participant will switch to the diet he was not assigned in the beginning for&#xD;
        two weeks.&#xD;
  &#xD;
        Participants' involvement in this research will also include three brief research visits plus&#xD;
        a research visit at the time of their scheduled standard-of-care colonoscopy (the research&#xD;
        visit will be 30-60 minutes in length, scheduled at close to 2-4 weeks before colonoscopy,&#xD;
        day of the colonoscopy, as well as 4-10 and 6-12 weeks after colonoscopy, depending on the&#xD;
        participant availability). The investigators expect about 25 people aged 35-75 to participate&#xD;
        in this research.&#xD;
  &#xD;
        Participation in this study will involve collecting breath tests, fecal (stool) samples, 8&#xD;
        Teaspoons of blood, clinical data, and participant questionnaire data. At the time of&#xD;
        colonoscopy, the investigators will also obtain some cells using a swab of the participant's&#xD;
        bowel and remnant (leftover or discarded) tissue from an intestine biopsy obtained as part of&#xD;
        the participant's clinical care. Participants will be asked to sign a separate HIPAA&#xD;
        authorization form to allow the investigators to collect information from participant's&#xD;
        medical records. This information will become part of the research data.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2025</primary_completion_date>
    <phase>Phase 1</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>The randomized clinical trial has a cross-over design. The 20 participants will be randomized to a 14-day bean intervention versus usual care pre-colonoscopy with a cross-over design to intervention vs. usual care after one month of washout post-colonoscopy. The 14-day bean intervention will be preceded by a 3-day ramp-up, acclimation, phase of beans feeding starting at one 1/2 cup of beans for day 1, followed by two 1/2 cups/day for days 2 and 3, then the full dose of three 1/2 cups/day for 14 days afterwards. Participants will be randomized 1:1 using a stratified randomization design. The randomization strata will be sex and presence/absence of metabolic syndrome factors with 1:1 ratio. Investigators anticipate a 20% dropout; therefore, investigators will recruit 25 participants to complete procedures on 20.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Compliance with the bean smoothie intervention</measure>
      <time_frame>2-4 weeks prior to colonoscopy, till 6-12 weeks after colonoscopy</time_frame>
      <description>Mean percentage completion of bean smoothie intervention and mean percentage with positive breath test over 2 weeks</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Tolerance to the bean smoothie intervention</measure>
      <time_frame>2-4 weeks prior to colonoscopy, till 6-12 weeks after colonoscopy</time_frame>
      <description>Compare the mean change in individual gastrointestinal symptoms and scores between paired baseline- and post- bean smoothie intervention vs. usual care. Patient-Reported Outcomes Measurement Information System (PROMIS) survey T sore range is 1-100, normal average T score is 50 (Standard deviation of 10).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Effect of the bean smoothie intervention on serum biomarkers of health</measure>
      <time_frame>2-4 weeks prior to colonoscopy, till 6-12 weeks after colonoscopy</time_frame>
      <description>Compare the percent with abnormal complete metabolic panel or complete blood count between paired baseline- and post- bean smoothie intervention vs. usual care</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in fecal abundance of microbiome genes with bean smoothie intervention</measure>
      <time_frame>2-4 weeks prior to colonoscopy, till 6-12 weeks after colonoscopy</time_frame>
      <description>Fecal microbiome assessment using 16s/metagenomics assay. Investigators will compare the change in paired baseline- and post- bean smoothie intervention vs. usual diet</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline in the fecal and serum metabolome with bean smoothie intervention</measure>
      <time_frame>2-4 weeks prior to colonoscopy, till 6-12 weeks after colonoscopy</time_frame>
      <description>Fecal and serum metabolomic assessment using an untargeted metabolomics assay. Investigators will compare the change in paired baseline- and post- bean smoothie intervention vs. usual diet</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Impact of bean intervention on colonic tissue RNA markers of health</measure>
      <time_frame>2-4 weeks prior to colonoscopy till colonoscopy</time_frame>
      <description>Compare colonic tissue RNA-seq assay between participants randomized to bean intervention vs usual care before the colonoscopy</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in body composition</measure>
      <time_frame>2-4 weeks prior to colonoscopy, till 6-12 weeks after colonoscopy</time_frame>
      <description>Body fat and muscle percentage measured using bio impedance analysis (BIA). Investigators will compare the change in paired baseline- and post- bean smoothie intervention vs. usual diet</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in body mass index (BMI)</measure>
      <time_frame>2-4 weeks prior to colonoscopy, till 6-12 weeks after colonoscopy</time_frame>
      <description>BMI measured using standard techniques. Investigators will compare the change in paired baseline- and post- bean smoothie intervention vs. usual diet</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in waist circumference</measure>
      <time_frame>2-4 weeks prior to colonoscopy, till 6-12 weeks after colonoscopy</time_frame>
      <description>Waist circumference measured using standard techniques. Investigators will compare the change in paired baseline- and post- bean smoothie intervention vs. usual diet</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in median liver fat and stiffness values</measure>
      <time_frame>2-4 weeks prior to colonoscopy, till 6-12 weeks after colonoscopy</time_frame>
      <description>Using FibroScan. Investigators will compare the change in paired baseline- and post- bean smoothie intervention vs. usual diet</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Reported change from baseline in fitness level</measure>
      <time_frame>2-4 weeks prior to colonoscopy, till 6-12 weeks after colonoscopy</time_frame>
      <description>Investigators will compare the mean change in Abadie Perceived Physical Fitness Scale between paired baseline- and post- bean smoothie intervention vs. usual care. Perceived Physical Fitness Scale score range is 12-60, normal mean score is 42.46</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Reported change from baseline in and exercise per week</measure>
      <time_frame>2-4 weeks prior to colonoscopy, till 6-12 weeks after colonoscopy</time_frame>
      <description>Investigators will use the modified Leisure-Time Exercise Questionnaire to compare the mean change in average weekly exercise (minutes of exercise per week) between paired baseline- and post- bean smoothie intervention vs. usual care</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Colorectal Polyp</condition>
    <condition>Obesity</condition>
    <arm_group>
      <arm_group_label>Bean smoothie then usual diet</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants first receive 2 weeks of adding bean smoothie to usual diet before colonoscopy. After a washout period of 4 weeks after colonoscopy, they receive usual diet for 2 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual diet then bean smoothie</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants first receive 2 weeks of usual diet before colonoscopy. After a washout period of 4 weeks after colonoscopy, they then add bean smoothie to usual diet for 2 weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Bush's Best Cannellini Beans</intervention_name>
      <description>0.5 cup of Bush's Best Cannellini Beans, three times per day before meals blended into a smoothie. If interested and depending on tolerance, participants will also have the opportunity to gradually increase the bean smoothie to a maximum of 1 cup three times per day before meals during the last week of the two-week bean smoothie intervention.</description>
      <arm_group_label>Bean smoothie then usual diet</arm_group_label>
      <arm_group_label>Usual diet then bean smoothie</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Usual diet</intervention_name>
      <description>Usual diet without adding the bean smoothie</description>
      <arm_group_label>Bean smoothie then usual diet</arm_group_label>
      <arm_group_label>Usual diet then bean smoothie</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  35-75 years-old&#xD;
  &#xD;
            -  Overweight or obesity (body mass index ≥ 25 kg/m2)&#xD;
  &#xD;
            -  Planned for a standard of care colonoscopy for colon cancer screening&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Intolerance to a bean or high bean consumer based on a screening survey&#xD;
  &#xD;
            -  Pregnancy or actively planning to get pregnant&#xD;
  &#xD;
            -  Any active gastrointestinal disease resulting in disturbed gut function or&#xD;
               malabsorption (e.g., chronic diarrhea or inflammatory bowel disease)&#xD;
  &#xD;
            -  Current or history of any malignancy or suspected or confirmed inherited colorectal&#xD;
               cancer&#xD;
  &#xD;
            -  Chronic use of opioids, anti-inflammatory drugs, antibiotics, prebiotics, or&#xD;
               probiotics within 1 month of study endpoints&#xD;
  &#xD;
            -  History of a significant systemic condition (e.g., heart disease, chronic kidney&#xD;
               disease, liver dysfunction or immune suppression), or abnormal laboratory markers&#xD;
               (e.g., abnormal liver enzymes, creatinine, clotting factors or low platelets count).&#xD;
               The severity of the intolerance to fiber/ the medical conditions/lab markers and&#xD;
               eligibility will be defined after the careful interview of the patient/review of the&#xD;
               medical records by Dr. Hussan)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>35 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hisham Hussan, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>UC Davis</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hisham Hussan, MD</last_name>
      <phone>(916) 734-8246</phone>
      <email>hhussan@ucdavis.edu</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- 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/NCT06032104
  org study id: 2012455
  nct id: NCT06032104
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Beans are a forgotten staple food that shows promise in improving health. The goal of this
        study is to look at how bean supplementation affects metabolic and bowel health. In the
        long-term, the investigators believe this research will lead to a better understanding of the
        impact of beans on bowel health. The investigators also hope that this research study will
        help us understand ways to improve human diet and prevent colon cancer in the future.
  Investigators are seeking adults planning for a standard of care colonoscopies (part of the
        participant's usual care). As part of this feeding study, a participant will be randomly
        assigned to either two weeks of a bean smoothie that the investigators will provide (Bush's
        Best Cannellini Beans) in addition to the participant's usual diet or continue with
        participant's usual diet without the bean smoothie (including the food and drink guidelines
        for the colonoscopy) 2 weeks before the participant colonoscopy. Then, one month after
        colonoscopy, the participant will switch to the diet he was not assigned in the beginning for
        two weeks.
  
        Participants' involvement in this research will also include three brief research visits plus
        a research visit at the time of their scheduled standard-of-care colonoscopy (the research
        visit will be 30-60 minutes in length, scheduled at close to 2-4 weeks before colonoscopy,
        day of the colonoscopy, as well as 4-10 and 6-12 weeks after colonoscopy, depending on the
        participant availability). The investigators expect about 25 people aged 35-75 to participate
        in this research.
  
        Participation in this study will involve collecting breath tests, fecal (stool) samples, 8
        Teaspoons of blood, clinical data, and participant questionnaire data. At the time of
        colonoscopy, the investigators will also obtain some cells using a swab of the participant's
        bowel and remnant (leftover or discarded) tissue from an intestine biopsy obtained as part of
        the participant's clinical care. Participants will be asked to sign a separate HIPAA
        authorization form to allow the investigators to collect information from participant's
        medical records. This information will become part of the research data.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: The randomized clinical trial has a cross-over design. The 20 participants will be randomized to a 14-day bean intervention versus usual care pre-colonoscopy with a cross-over design to intervention vs. usual care after one month of washout post-colonoscopy. The 14-day bean intervention will be preceded by a 3-day ramp-up, acclimation, phase of beans feeding starting at one 1/2 cup of beans for day 1, followed by two 1/2 cups/day for days 2 and 3, then the full dose of three 1/2 cups/day for 14 days afterwards. Participants will be randomized 1:1 using a stratified randomization design. The randomization strata will be sex and presence/absence of metabolic syndrome factors with 1:1 ratio. Investigators anticipate a 20% dropout; therefore, investigators will recruit 25 participants to complete procedures on 20.
  primary purpose: Other
  masking: Single (Outcomes Assessor)
  measure: Compliance with the bean smoothie intervention
  time frame: 2-4 weeks prior to colonoscopy, till 6-12 weeks after colonoscopy
  description: Mean percentage completion of bean smoothie intervention and mean percentage with positive breath test over 2 weeks
  measure: Tolerance to the bean smoothie intervention
  time frame: 2-4 weeks prior to colonoscopy, till 6-12 weeks after colonoscopy
  description: Compare the mean change in individual gastrointestinal symptoms and scores between paired baseline- and post- bean smoothie intervention vs. usual care. Patient-Reported Outcomes Measurement Information System (PROMIS) survey T sore range is 1-100, normal average T score is 50 (Standard deviation of 10).
  measure: Effect of the bean smoothie intervention on serum biomarkers of health
  time frame: 2-4 weeks prior to colonoscopy, till 6-12 weeks after colonoscopy
  description: Compare the percent with abnormal complete metabolic panel or complete blood count between paired baseline- and post- bean smoothie intervention vs. usual care
  measure: Change in fecal abundance of microbiome genes with bean smoothie intervention
  time frame: 2-4 weeks prior to colonoscopy, till 6-12 weeks after colonoscopy
  description: Fecal microbiome assessment using 16s/metagenomics assay. Investigators will compare the change in paired baseline- and post- bean smoothie intervention vs. usual diet
  measure: Change from baseline in the fecal and serum metabolome with bean smoothie intervention
  time frame: 2-4 weeks prior to colonoscopy, till 6-12 weeks after colonoscopy
  description: Fecal and serum metabolomic assessment using an untargeted metabolomics assay. Investigators will compare the change in paired baseline- and post- bean smoothie intervention vs. usual diet
  measure: Impact of bean intervention on colonic tissue RNA markers of health
  time frame: 2-4 weeks prior to colonoscopy till colonoscopy
  description: Compare colonic tissue RNA-seq assay between participants randomized to bean intervention vs usual care before the colonoscopy
  measure: Change from baseline in body composition
  time frame: 2-4 weeks prior to colonoscopy, till 6-12 weeks after colonoscopy
  description: Body fat and muscle percentage measured using bio impedance analysis (BIA). Investigators will compare the change in paired baseline- and post- bean smoothie intervention vs. usual diet
  measure: Change from baseline in body mass index (BMI)
  time frame: 2-4 weeks prior to colonoscopy, till 6-12 weeks after colonoscopy
  description: BMI measured using standard techniques. Investigators will compare the change in paired baseline- and post- bean smoothie intervention vs. usual diet
  measure: Change from baseline in waist circumference
  time frame: 2-4 weeks prior to colonoscopy, till 6-12 weeks after colonoscopy
  description: Waist circumference measured using standard techniques. Investigators will compare the change in paired baseline- and post- bean smoothie intervention vs. usual diet
  measure: Change from baseline in median liver fat and stiffness values
  time frame: 2-4 weeks prior to colonoscopy, till 6-12 weeks after colonoscopy
  description: Using FibroScan. Investigators will compare the change in paired baseline- and post- bean smoothie intervention vs. usual diet
  measure: Reported change from baseline in fitness level
  time frame: 2-4 weeks prior to colonoscopy, till 6-12 weeks after colonoscopy
  description: Investigators will compare the mean change in Abadie Perceived Physical Fitness Scale between paired baseline- and post- bean smoothie intervention vs. usual care. Perceived Physical Fitness Scale score range is 12-60, normal mean score is 42.46
  measure: Reported change from baseline in and exercise per week
  time frame: 2-4 weeks prior to colonoscopy, till 6-12 weeks after colonoscopy
  description: Investigators will use the modified Leisure-Time Exercise Questionnaire to compare the mean change in average weekly exercise (minutes of exercise per week) between paired baseline- and post- bean smoothie intervention vs. usual care
  arm group label: Bean smoothie then usual diet
  arm group type: Experimental
  description: Participants first receive 2 weeks of adding bean smoothie to usual diet before colonoscopy. After a washout period of 4 weeks after colonoscopy, they receive usual diet for 2 weeks
  arm group label: Usual diet then bean smoothie
  arm group type: Experimental
  description: Participants first receive 2 weeks of usual diet before colonoscopy. After a washout period of 4 weeks after colonoscopy, they then add bean smoothie to usual diet for 2 weeks
  intervention type: Dietary Supplement
  intervention name: Bush's Best Cannellini Beans
  description: 0.5 cup of Bush's Best Cannellini Beans, three times per day before meals blended into a smoothie. If interested and depending on tolerance, participants will also have the opportunity to gradually increase the bean smoothie to a maximum of 1 cup three times per day before meals during the last week of the two-week bean smoothie intervention.
  arm group label: Bean smoothie then usual diet
  arm group label: Usual diet then bean smoothie
  intervention type: Dietary Supplement
  intervention name: Usual diet
  description: Usual diet without adding the bean smoothie
  arm group label: Bean smoothie then usual diet
  arm group label: Usual diet then bean smoothie
  criteria: 
  gender: All
  minimum age: 35 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Hisham Hussan, MD
  role: Principal Investigator
  affiliation: UC Davis
  last name: Hisham Hussan, MD
  phone: (916) 734-8246
  email: hhussan@ucdavis.edu
  responsible party type: Sponsor