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/NCT06006416</url>
    </required_header>
    <id_info>
      <org_study_id>FENGUT</org_study_id>
      <nct_id>NCT06006416</nct_id>
    </id_info>
    <brief_title>Effect of Fenugreek Fibre on Gut Microbiome</brief_title>
    <official_title>Effect of Fenugreek Fibre (Trigonella Foenum-graecum) on the Gut Microbiome in an Adult Population - An Open Label, Self-controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>RDC Clinical Pty Ltd</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>RDC Clinical Pty Ltd</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        A open label, self-controlled trial to evaluate the effect of Fenugreek Fibre (Trigonella&#xD;
        foenum-graecum) on the gut microbiome in generally healthy adults aged 18-65 years old.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 1, 2024</primary_completion_date>
    <phase>Phase 3</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in metagenomic profile of the gut microbiome</measure>
      <time_frame>Week 0, week 4 and week 16</time_frame>
      <description>Change in metagenomic profile of the gut microbiome as measured by 16s rRNA gene sequencing</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in gut function</measure>
      <time_frame>Week 0, week 4 and week 16</time_frame>
      <description>Change in gut function as measured by faecal short change fatty acids testing via faecal sample</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in intestinal permeability</measure>
      <time_frame>Week, 0, week 4, week 8 and week 16</time_frame>
      <description>Change in intestinal permeability as measured by plasma occludin, Muc2 and Endotoxin via blood test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in gut inflammation</measure>
      <time_frame>Week 0, week 4 and week 16</time_frame>
      <description>Change in gut inflammation as measured by faecal calprotectin via faecal sample</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in inflammation</measure>
      <time_frame>Week, 0, week 4, week 8 and week 16</time_frame>
      <description>Change in inflammation as measured by inflammatory markers (IFN-g, TNF-a, il-2, MCP-2, IL-1b, TGF-b, CRP) via blood test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in GLP-1</measure>
      <time_frame>Week, 0, week 4, week 8 and week 16</time_frame>
      <description>Change in GLP-1 as measured by blood test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in GST</measure>
      <time_frame>Week, 0, week 4, week 8 and week 16</time_frame>
      <description>Change in GST as measured by blood test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in glutathione</measure>
      <time_frame>Week, 0, week 4, week 8 and week 16</time_frame>
      <description>Change in glutathione as measured by blood test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in FABP</measure>
      <time_frame>Week, 0, week 4, week 8 and week 16</time_frame>
      <description>Change in FABP as measured by blood test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Homocysteine</measure>
      <time_frame>Week, 0, week 4, week 8 and week 16</time_frame>
      <description>Change in Homocysteine as measured by blood test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in diet</measure>
      <time_frame>Week 0 and Week 16 (completed for 3 consecutive days)</time_frame>
      <description>Change in diet as measured by 24hr Dietary Recall</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in quality of life</measure>
      <time_frame>Week, 0, week 4, week 8 and week 16</time_frame>
      <description>Change in quality of life as measured by the SF-36 questionnaire. Consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in stress state</measure>
      <time_frame>Week, 0, week 4, week 8 and week 16</time_frame>
      <description>Change in stress as measured by the Perceived Stress Scale questionnaire. Consists of 10 items with a score range 0-40. Higher scores indicate higher perceived stress.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in sleep quality</measure>
      <time_frame>Week, 0, week 4, week 8 and week 16</time_frame>
      <description>Change in sleep as measured by the Leeds Sleep Evaluation Questionnaire. Consists of ten questions pertaining to four consecutive aspects of sleep: getting to sleep (GTS), quality of sleep (QOS), awakening from sleep (AFS), and behaviour following wakefulness (BFW). Higher scores indicate better sleep quality.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in safety</measure>
      <time_frame>Week 0, week 4 and week 16</time_frame>
      <description>Change in safety as measured by E/LFT via blood test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Height</measure>
      <time_frame>Week 0, week 4 and week 16</time_frame>
      <description>Height as measured by stadiometer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in weight</measure>
      <time_frame>Week 0, week 4 and week 16</time_frame>
      <description>Change in weight as measured by digital scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in hip and weight circumference</measure>
      <time_frame>Week 0, week 4 and week 16</time_frame>
      <description>Change in hip and weight circumference as measured by tape measure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in blood pressure</measure>
      <time_frame>Week 0, week 4 and week 16</time_frame>
      <description>Change in blood pressure as measured by blood pressure monitor</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Gut Microbiome</condition>
    <arm_group>
      <arm_group_label>Fenugreek Fibre</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Fenugreek Fibre - 2 x 10g powder per day with/in food</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Fenugreek Fibre</intervention_name>
      <description>Daily dose of 2 x 10g per day with/in food</description>
      <arm_group_label>Fenugreek Fibre</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male and females aged 18-65 years old&#xD;
  &#xD;
            -  Generally healthy&#xD;
  &#xD;
            -  Able to provide informed consent&#xD;
  &#xD;
            -  BMI &gt; 25kg/m2&#xD;
  &#xD;
            -  Agree not to participate in another clinical trial while enrolled in this trial&#xD;
  &#xD;
            -  Agree not the change their diet or exercise while enrolled in this trial&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Unstable(1) or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes,&#xD;
               thyroid gland function, lung conditions, chronic asthma and mood disorders or&#xD;
               neurological disorders such as MS)&#xD;
  &#xD;
            -  Current malignancy (excluding BCC) or chemotherapy or radiotherapy treatment for&#xD;
               malignancy within the previous 2 years&#xD;
  &#xD;
            -  Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other&#xD;
               anticoagulation therapy&#xD;
  &#xD;
            -  Acute sickness experienced within the past 2 months&#xD;
  &#xD;
            -  Current use of medications (e.g. antibiotics) or supplements (e.g. pre- and&#xD;
               probiotics) that alter the microbiome or gut health. Any use during the trial will&#xD;
               result in exclusion from the study.&#xD;
  &#xD;
            -  Active smokers and/or nicotine or drug abuse&#xD;
  &#xD;
            -  Chronic alcohol use (&gt;14 alcoholic drinks week)&#xD;
  &#xD;
            -  Allergic to any of the ingredients in the formula&#xD;
  &#xD;
            -  Pregnant(2) or lactating woman&#xD;
  &#xD;
            -  Females of child bearing potential not using a highly effective form of&#xD;
               contraception(3,4) (i.e. methods which result in low failure rate, i.e. less than 1%&#xD;
               per year, when used consistently and correctly like the oral contraception pill, birth&#xD;
               control implant e.g. implanon(3,4))&#xD;
  &#xD;
            -  People medically prescribed medications that would affect the immune and/or the&#xD;
               inflammatory response (e.g. NSAIDs, steroids, antibiotics).&#xD;
  &#xD;
            -  Any condition which in the opinion of the investigator makes the participant&#xD;
               unsuitable for inclusion&#xD;
  &#xD;
            -  Participants who have participated in any other related clinical study during the past&#xD;
               1 month&#xD;
  &#xD;
            -  People with cognitive damage&#xD;
  &#xD;
            -  People who have or have had treatment for cancer, HIV or chronic use of any dose of&#xD;
               steroids (cream, tablet or inhalant) in the past year&#xD;
  &#xD;
          Footnotes&#xD;
  &#xD;
            1. An unstable illness is any illness that is currently not being treated with a stable&#xD;
               dose of medication or is fluctuating in severity. A serious illness is a condition&#xD;
               that carries a risk of mortality, negatively impacts quality of life and daily&#xD;
               function and/or is burdensome in symptoms and/or treatments.&#xD;
  &#xD;
            2. All female participants of child bearing potential will be required to take a urine&#xD;
               pregnancy test prior to entry into the study.&#xD;
  &#xD;
            3. Examples of acceptable forms of highly effective contraception include: Established&#xD;
               use of oral, injected or implanted hormonal methods of contraception; Placement of an&#xD;
               intrauterine device (IUD) or intrauterine system (IUS); Sterilised male partner (with&#xD;
               the appropriate post-vasectomy documentation of the absence of sperm in the&#xD;
               ejaculate); True abstinence: When this is in line with your preferred and usual&#xD;
               lifestyle&#xD;
  &#xD;
            4. Examples of non-acceptable methods of contraception include: Condoms alone or double&#xD;
               barrier; Periodic abstinence (e.g. calendar, ovulation, symptothermal, post&#xD;
               ovulation); Withdrawal; Spermicide (as it is not approved as a method of contraception&#xD;
               in Australia)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Amanda Rao, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>RDC Clinical Pty Ltd</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Amanda Rao, PhD</last_name>
      <phone>+61 414 488 559</phone>
      <email>amanda@rdcglobal.com.au</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>David Briskey, PhD</last_name>
      <phone>+61 421 784 077</phone>
      <email>david@rdcglobal.com.au</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>RDC Global Pty Ltd</name>
        <address>
          <city>Brisbane</city>
          <state>Queensland</state>
          <zip>4006</zip>
          <country>Australia</country>
        </address>
      </facility>
      <contact>
        <last_name>Amanda Rao, PhD</last_name>
        <phone>+61 414 488 559</phone>
        <email>amanda@rdcglobal.com.au</email>
      </contact>
      <contact_backup>
        <last_name>David Briskey, PhD</last_name>
        <phone>+61 421 784 077</phone>
        <email>david@rdcglobal.com.au</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Australia</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06006416
  org study id: FENGUT
  nct id: NCT06006416
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  A open label, self-controlled trial to evaluate the effect of Fenugreek Fibre (Trigonella
        foenum-graecum) on the gut microbiome in generally healthy adults aged 18-65 years old.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in metagenomic profile of the gut microbiome
  time frame: Week 0, week 4 and week 16
  description: Change in metagenomic profile of the gut microbiome as measured by 16s rRNA gene sequencing
  measure: Change in gut function
  time frame: Week 0, week 4 and week 16
  description: Change in gut function as measured by faecal short change fatty acids testing via faecal sample
  measure: Change in intestinal permeability
  time frame: Week, 0, week 4, week 8 and week 16
  description: Change in intestinal permeability as measured by plasma occludin, Muc2 and Endotoxin via blood test
  measure: Change in gut inflammation
  time frame: Week 0, week 4 and week 16
  description: Change in gut inflammation as measured by faecal calprotectin via faecal sample
  measure: Change in inflammation
  time frame: Week, 0, week 4, week 8 and week 16
  description: Change in inflammation as measured by inflammatory markers (IFN-g, TNF-a, il-2, MCP-2, IL-1b, TGF-b, CRP) via blood test
  measure: Change in GLP-1
  time frame: Week, 0, week 4, week 8 and week 16
  description: Change in GLP-1 as measured by blood test
  measure: Change in GST
  time frame: Week, 0, week 4, week 8 and week 16
  description: Change in GST as measured by blood test
  measure: Change in glutathione
  time frame: Week, 0, week 4, week 8 and week 16
  description: Change in glutathione as measured by blood test
  measure: Change in FABP
  time frame: Week, 0, week 4, week 8 and week 16
  description: Change in FABP as measured by blood test
  measure: Change in Homocysteine
  time frame: Week, 0, week 4, week 8 and week 16
  description: Change in Homocysteine as measured by blood test
  measure: Change in diet
  time frame: Week 0 and Week 16 (completed for 3 consecutive days)
  description: Change in diet as measured by 24hr Dietary Recall
  measure: Change in quality of life
  time frame: Week, 0, week 4, week 8 and week 16
  description: Change in quality of life as measured by the SF-36 questionnaire. Consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
  measure: Change in stress state
  time frame: Week, 0, week 4, week 8 and week 16
  description: Change in stress as measured by the Perceived Stress Scale questionnaire. Consists of 10 items with a score range 0-40. Higher scores indicate higher perceived stress.
  measure: Change in sleep quality
  time frame: Week, 0, week 4, week 8 and week 16
  description: Change in sleep as measured by the Leeds Sleep Evaluation Questionnaire. Consists of ten questions pertaining to four consecutive aspects of sleep: getting to sleep (GTS), quality of sleep (QOS), awakening from sleep (AFS), and behaviour following wakefulness (BFW). Higher scores indicate better sleep quality.
  measure: Change in safety
  time frame: Week 0, week 4 and week 16
  description: Change in safety as measured by E/LFT via blood test
  measure: Height
  time frame: Week 0, week 4 and week 16
  description: Height as measured by stadiometer
  measure: Change in weight
  time frame: Week 0, week 4 and week 16
  description: Change in weight as measured by digital scale
  measure: Change in hip and weight circumference
  time frame: Week 0, week 4 and week 16
  description: Change in hip and weight circumference as measured by tape measure
  measure: Change in blood pressure
  time frame: Week 0, week 4 and week 16
  description: Change in blood pressure as measured by blood pressure monitor
  arm group label: Fenugreek Fibre
  arm group type: Experimental
  description: Fenugreek Fibre - 2 x 10g powder per day with/in food
  intervention type: Drug
  intervention name: Fenugreek Fibre
  description: Daily dose of 2 x 10g per day with/in food
  arm group label: Fenugreek Fibre
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Amanda Rao, PhD
  role: Principal Investigator
  affiliation: RDC Clinical Pty Ltd
  last name: Amanda Rao, PhD
  phone: +61 414 488 559
  email: amanda@rdcglobal.com.au
  last name: David Briskey, PhD
  phone: +61 421 784 077
  email: david@rdcglobal.com.au
  facility: 
  contact: 
  contact backup: 
  country: Australia
  responsible party type: Sponsor
  sharing ipd: No