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/NCT05971524</url>
    </required_header>
    <id_info>
      <org_study_id>NL83061.018.22</org_study_id>
      <nct_id>NCT05971524</nct_id>
    </id_info>
    <brief_title>Effect of Oral 6-bromotryptophan on Safety, Pharmacokinetics and Efficacy in Metabolic Syndrome Individuals</brief_title>
    <acronym>BROMO</acronym>
    <official_title>Effect of 4 Weeks of Oral 6-bromotryptophan on Safety, Pharmacokinetics and Efficacy in Metabolic Syndrome Individuals (2022)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Nordin Hanssen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</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>
        Safety, pharmacokinetics and efficacy of a novel endogenous plasma metabolite,&#xD;
        6-bromotryptophan, will be established in metabolic syndrome/ insulin resistant participants.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Rationale:&#xD;
  &#xD;
        A newly identified endogenous plasma microbiome-derived tryptophan metabolite,&#xD;
        6-bromotryptophan (6-BT), was associated with preserved beta-cell function and diminished&#xD;
        circulating T cell count in (T1D) type 1 diabetes patients. Anti-inflammatory and&#xD;
        insulin-secratogogue effects were established in in vitro- and murine studies in both the&#xD;
        setting of type 1 and type 2 diabetes. Also, 6-BT did not show any toxic effects in cells or&#xD;
        in vivo experiments. In order to obtain safety data before the investigators progress to an&#xD;
        efficacy study in T1D, the investigators aim to perform a phase I/II trial of 6-BT in&#xD;
        metabolic syndrome individuals. If safe, 6-BT may hold a promise as a food supplement in type&#xD;
        1 and 2 diabetes.&#xD;
  &#xD;
        Objective: To assess safety, pharmacokinetics and efficacy of oral dosage of 6-BT in&#xD;
        individuals with metabolic syndrome Study design: A phase I/II, dose finding, placebo&#xD;
        controlled, double blinded trial.&#xD;
  &#xD;
        Study population: Metabolic syndrome individuals or participants with insulin resistance, age&#xD;
        35-70 years, without use of medication.&#xD;
  &#xD;
        Intervention (if applicable): Participants will be given placebo, 2mg, 4mg or 8mg of 6-BT&#xD;
        capsules once daily for 4 weeks (n=9 per arm, total of 36 participants).&#xD;
  &#xD;
        Main study parameters/endpoints:&#xD;
  &#xD;
        The principal outcome will be patient safety and tolerability (biochemical parameters of&#xD;
        kidney and liver function and complete blood count, adverse events) in relation to&#xD;
        improvements in glucose homeostasis (mixed-meal tests and continuous glucose monitoring).&#xD;
        Secondary read-outs will include changes in: immunological profile (ex vivo stimulation of&#xD;
        monocytes, and immunophenotyping of peripheral blood mononuclear cells (PBMC)) and gut&#xD;
        microbiome composition (16s ribosomal ribonucleic acid (rRNA) sequencing). Also, liver fat&#xD;
        content will be determined before and at end of the trial by MRI. As this food derived&#xD;
        metabolite is given to humans for the first time, the investigators will also study its&#xD;
        pharmacokinetics by measuring serum 6-BT concentrations in serum and urine at different&#xD;
        time-points after oral intake.&#xD;
  &#xD;
        Nature and extent of the burden and risks associated with participation, benefit and group&#xD;
        relatedness:&#xD;
  &#xD;
        6-BT is an endogenous (food tryptophan derived) metabolite found in the human circulation.&#xD;
        Our previous trail has shown that fecal microbiota transplantations (FMT) can modulate and&#xD;
        increase plasma 6-BT levels with a positive association with C-peptide (as marker of&#xD;
        pancreatic beta cells function). Additionally, recent investigations have linked higher&#xD;
        plasma 6-BT levels with lower risk of kidney disease progression, supporting the health&#xD;
        benefits of 6-BT beyond T1D. Hence, the investigators do not foresee major adverse reactions.&#xD;
        As there is an urgent need for halting diabetes progression, patients would benefit from the&#xD;
        development of new endogenously occurring therapeutic agents.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 4, 2023</start_date>
    <completion_date type="Anticipated">February 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">February 1, 2025</primary_completion_date>
    <phase>Phase 1/Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>A phase I/II, dose finding, placebo controlled, double blinded trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>To maintain the blinding of the subject and investigators, the identifying labels will be removed from the intervention product at the AMC pharmacy. The study product will be labelled with subject specific information prior to delivery to the study physician, who will hand over the intervention to the participant.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Adverse events</measure>
      <time_frame>4 weeks</time_frame>
      <description>Number of adverse events</description>
    </primary_outcome>
    <primary_outcome>
      <measure>renal function</measure>
      <time_frame>4 weeks</time_frame>
      <description>Number of participants with a decreased kidney function, defined as a rise in serum creatinine of &gt;26,5 micromol/L in 48 h</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Questionnaires</measure>
      <time_frame>4 weeks</time_frame>
      <description>Changes in Gastro-intestinal Quality of Life Index (GIQLI score) (points). The minimum and maximum score are 31 and 155 points respectively, and a higher score reflects a better outcome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Occurence of anemia</measure>
      <time_frame>4 weeks</time_frame>
      <description>Number of patients with Hb &lt; 8,5 mmol/L</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in leucocytes</measure>
      <time_frame>4 weeks</time_frame>
      <description>Number of patients with leucocytes &lt;4,0 or &gt;10,5 x10E9 cells/L</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in trombocytes</measure>
      <time_frame>4 weeks</time_frame>
      <description>Number of patients with trombocytes &lt;150 x 10E9 cells/L</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in aspartate aminotransferase (AST)</measure>
      <time_frame>4 weeks</time_frame>
      <description>Number of patients with AST &gt; 43 IU/L</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in alanine aminotransferas (ALT)</measure>
      <time_frame>4 weeks</time_frame>
      <description>Number of patients with ALT &gt; 45 IU/L</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in alkaline phosphatase (ALP)</measure>
      <time_frame>4 weeks</time_frame>
      <description>Number of patients with ALP &gt; 126 IU/L</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in Gamma-glutamyltransferase (GGT)</measure>
      <time_frame>4 weeks</time_frame>
      <description>Number of patients with GGT &gt; 117 IU/L</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in total bilirubin</measure>
      <time_frame>4 weeks</time_frame>
      <description>Number of patients with total bilirubin &gt; 24 micromol/L</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mixed meal test</measure>
      <time_frame>4 weeks</time_frame>
      <description>Changes in area under the curve (AUC) of glucose after mixed-meal test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mixed meal test</measure>
      <time_frame>4 weeks</time_frame>
      <description>Changes in area under the curve (AUC) of insulin after mixed-meal test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Time-in-range</measure>
      <time_frame>4 weeks</time_frame>
      <description>Increase in Time-in-range (TIR,%), a parameter of continuous glucose monitoring devices, where TIR can be between 0 and 100%. A higher TIR reflects a better outcome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Continuous glucose monitoring</measure>
      <time_frame>4 weeks</time_frame>
      <description>Decrease in glucose variability (GV, %), a parameter of continuous glucose monitoring devices, where GV can be between 0 and 100%. A lower GV reflects a better outcome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Glycemic control</measure>
      <time_frame>4 weeks</time_frame>
      <description>Changes in fasting glucose (mmol/L)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Intestinal microbiota composition</measure>
      <time_frame>4 weeks</time_frame>
      <description>Changes from baseline of relative abundance (%) of bacterial phyla, genera and species between groups and within participants.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Immunologic profile</measure>
      <time_frame>6 weeks</time_frame>
      <description>Absolute counts of different immunologic cell types using Cytometry by time of flight (CyTOF) mass cytometry at baseline, 4 weeks and 6 weeks.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>6-BT pharmacokinetics</measure>
      <time_frame>6-BT pharmacokinetics as described above will be performed at baseline and after 4 weeks.</time_frame>
      <description>Quantitatively measuring plasma concentrations of 6-BT at -15, 30, 60, 90, 120, 240 and 300 minutes following 6-BT capsule ingestion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hepatic stiffness</measure>
      <time_frame>0 and 4 weeks</time_frame>
      <description>Hepatic stiffness will be determined non-invasively by MRI using a special hepatic scanning protocol of 30 minutes</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hepatic fat content</measure>
      <time_frame>0 and 4 weeks</time_frame>
      <description>Hepatic fat content will be determined non-invasively by MRI using a special hepatic scanning protocol of 30 minutes</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dietary intake</measure>
      <time_frame>4 weeks</time_frame>
      <description>Participants are asked to fill out an online dietary questionnaire for the 3 days prior to study visit 2,3,4,5 and 7</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Low-density lipoprotein (LDL)</measure>
      <time_frame>4 weeks</time_frame>
      <description>Changes in LDL (mmol/L)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>High-density lipoprotein (HDL)</measure>
      <time_frame>4 weeks</time_frame>
      <description>Changes in HDL (mmol/L)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Triglycerides</measure>
      <time_frame>4 weeks</time_frame>
      <description>Changes in triglycerides (mmol/L)</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">36</enrollment>
    <condition>Metabolic Syndrome</condition>
    <condition>Diabetes Mellitus</condition>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>An oral placebo capsule once daily for 4 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>2mg 6-BT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>2 mg of 6-BT as an oral capsule once daily for 4 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>4mg 6-BT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>4 mg of 6-BT as an oral capsule once daily for 4 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>8mg 6-BT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>8 mg of 6-BT as an oral capsule once daily for 4 weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>6-BT</intervention_name>
      <description>2,4 or 8mg of 6-BT once daily for 4 weeks</description>
      <arm_group_label>2mg 6-BT</arm_group_label>
      <arm_group_label>4mg 6-BT</arm_group_label>
      <arm_group_label>8mg 6-BT</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>A placebo capsule once daily for 4 weeks</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          • Metabolic syndrome, defined as:&#xD;
  &#xD;
          - ≥3 criteria out of the 5 following criteria:&#xD;
  &#xD;
            -  fasting plasma glucose ≥5.6 mmol/L&#xD;
  &#xD;
            -  triglycerides ≥1.7 mmol/L&#xD;
  &#xD;
            -  waist circumference ≥102 cm&#xD;
  &#xD;
            -  high-density lipoprotein cholesterol ≤1.04 mmol/&#xD;
  &#xD;
            -  blood pressure ≥130/85 mm Hg.&#xD;
  &#xD;
          AND/ OR Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) (&gt;2.5)&#xD;
  &#xD;
            -  Male&#xD;
  &#xD;
            -  Caucasian&#xD;
  &#xD;
            -  35-70 years old&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Use of systemic medication (except for paracetamol), including proton pump inhibitors,&#xD;
               antibiotics and pro-/prebiotics in the past three months or during the study period.&#xD;
  &#xD;
            -  A history of a cardiovascular event&#xD;
  &#xD;
            -  A history of cholecystectomy&#xD;
  &#xD;
            -  Overt untreated gastrointestinal disease or abnormal bowel habits&#xD;
  &#xD;
            -  Liver enzymes&gt;2.5 fold higher than the upper limit of normal range&#xD;
  &#xD;
            -  Smoking&#xD;
  &#xD;
            -  Exclusion criterion for MRI liver (see E4_BROMO_vragenlijst MRI)&#xD;
  &#xD;
            -  Alcohol abuse&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>35 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nordin MJ Hanssen, dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nordin MJ Hanssen, dr.</last_name>
      <phone>020-56691111</phone>
      <email>n.m.j.hanssen@amsterdamumc.nl</email>
    </overall_contact>
    <location>
      <facility>
        <name>Amsterdam UMC</name>
        <address>
          <city>Amsterdam</city>
          <state>Noord-Holland</state>
          <zip>1105AZ</zip>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>N Hanssen, dr</last_name>
        <phone>020-5669111</phone>
        <email>n.m.j.hanssen@amsterdamumc.nl</email>
      </contact>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>April 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)</investigator_affiliation>
      <investigator_full_name>Nordin Hanssen</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Metabolic Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <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/NCT05971524
  org study id: NL83061.018.22
  nct id: NCT05971524
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Safety, pharmacokinetics and efficacy of a novel endogenous plasma metabolite,
        6-bromotryptophan, will be established in metabolic syndrome/ insulin resistant participants.
  Rationale:
  
        A newly identified endogenous plasma microbiome-derived tryptophan metabolite,
        6-bromotryptophan (6-BT), was associated with preserved beta-cell function and diminished
        circulating T cell count in (T1D) type 1 diabetes patients. Anti-inflammatory and
        insulin-secratogogue effects were established in in vitro- and murine studies in both the
        setting of type 1 and type 2 diabetes. Also, 6-BT did not show any toxic effects in cells or
        in vivo experiments. In order to obtain safety data before the investigators progress to an
        efficacy study in T1D, the investigators aim to perform a phase I/II trial of 6-BT in
        metabolic syndrome individuals. If safe, 6-BT may hold a promise as a food supplement in type
        1 and 2 diabetes.
  
        Objective: To assess safety, pharmacokinetics and efficacy of oral dosage of 6-BT in
        individuals with metabolic syndrome Study design: A phase I/II, dose finding, placebo
        controlled, double blinded trial.
  
        Study population: Metabolic syndrome individuals or participants with insulin resistance, age
        35-70 years, without use of medication.
  
        Intervention (if applicable): Participants will be given placebo, 2mg, 4mg or 8mg of 6-BT
        capsules once daily for 4 weeks (n=9 per arm, total of 36 participants).
  
        Main study parameters/endpoints:
  
        The principal outcome will be patient safety and tolerability (biochemical parameters of
        kidney and liver function and complete blood count, adverse events) in relation to
        improvements in glucose homeostasis (mixed-meal tests and continuous glucose monitoring).
        Secondary read-outs will include changes in: immunological profile (ex vivo stimulation of
        monocytes, and immunophenotyping of peripheral blood mononuclear cells (PBMC)) and gut
        microbiome composition (16s ribosomal ribonucleic acid (rRNA) sequencing). Also, liver fat
        content will be determined before and at end of the trial by MRI. As this food derived
        metabolite is given to humans for the first time, the investigators will also study its
        pharmacokinetics by measuring serum 6-BT concentrations in serum and urine at different
        time-points after oral intake.
  
        Nature and extent of the burden and risks associated with participation, benefit and group
        relatedness:
  
        6-BT is an endogenous (food tryptophan derived) metabolite found in the human circulation.
        Our previous trail has shown that fecal microbiota transplantations (FMT) can modulate and
        increase plasma 6-BT levels with a positive association with C-peptide (as marker of
        pancreatic beta cells function). Additionally, recent investigations have linked higher
        plasma 6-BT levels with lower risk of kidney disease progression, supporting the health
        benefits of 6-BT beyond T1D. Hence, the investigators do not foresee major adverse reactions.
        As there is an urgent need for halting diabetes progression, patients would benefit from the
        development of new endogenously occurring therapeutic agents.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: A phase I/II, dose finding, placebo controlled, double blinded trial
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  masking description: To maintain the blinding of the subject and investigators, the identifying labels will be removed from the intervention product at the AMC pharmacy. The study product will be labelled with subject specific information prior to delivery to the study physician, who will hand over the intervention to the participant.
  measure: Adverse events
  time frame: 4 weeks
  description: Number of adverse events
  measure: renal function
  time frame: 4 weeks
  description: Number of participants with a decreased kidney function, defined as a rise in serum creatinine of >26,5 micromol/L in 48 h
  measure: Questionnaires
  time frame: 4 weeks
  description: Changes in Gastro-intestinal Quality of Life Index (GIQLI score) (points). The minimum and maximum score are 31 and 155 points respectively, and a higher score reflects a better outcome.
  measure: Occurence of anemia
  time frame: 4 weeks
  description: Number of patients with Hb < 8,5 mmol/L
  measure: Changes in leucocytes
  time frame: 4 weeks
  description: Number of patients with leucocytes <4,0 or >10,5 x10E9 cells/L
  measure: Changes in trombocytes
  time frame: 4 weeks
  description: Number of patients with trombocytes <150 x 10E9 cells/L
  measure: Changes in aspartate aminotransferase (AST)
  time frame: 4 weeks
  description: Number of patients with AST > 43 IU/L
  measure: Changes in alanine aminotransferas (ALT)
  time frame: 4 weeks
  description: Number of patients with ALT > 45 IU/L
  measure: Changes in alkaline phosphatase (ALP)
  time frame: 4 weeks
  description: Number of patients with ALP > 126 IU/L
  measure: Changes in Gamma-glutamyltransferase (GGT)
  time frame: 4 weeks
  description: Number of patients with GGT > 117 IU/L
  measure: Changes in total bilirubin
  time frame: 4 weeks
  description: Number of patients with total bilirubin > 24 micromol/L
  measure: Mixed meal test
  time frame: 4 weeks
  description: Changes in area under the curve (AUC) of glucose after mixed-meal test
  measure: Mixed meal test
  time frame: 4 weeks
  description: Changes in area under the curve (AUC) of insulin after mixed-meal test
  measure: Time-in-range
  time frame: 4 weeks
  description: Increase in Time-in-range (TIR,%), a parameter of continuous glucose monitoring devices, where TIR can be between 0 and 100%. A higher TIR reflects a better outcome.
  measure: Continuous glucose monitoring
  time frame: 4 weeks
  description: Decrease in glucose variability (GV, %), a parameter of continuous glucose monitoring devices, where GV can be between 0 and 100%. A lower GV reflects a better outcome.
  measure: Glycemic control
  time frame: 4 weeks
  description: Changes in fasting glucose (mmol/L)
  measure: Intestinal microbiota composition
  time frame: 4 weeks
  description: Changes from baseline of relative abundance (%) of bacterial phyla, genera and species between groups and within participants.
  measure: Immunologic profile
  time frame: 6 weeks
  description: Absolute counts of different immunologic cell types using Cytometry by time of flight (CyTOF) mass cytometry at baseline, 4 weeks and 6 weeks.
  measure: 6-BT pharmacokinetics
  time frame: 6-BT pharmacokinetics as described above will be performed at baseline and after 4 weeks.
  description: Quantitatively measuring plasma concentrations of 6-BT at -15, 30, 60, 90, 120, 240 and 300 minutes following 6-BT capsule ingestion
  measure: Hepatic stiffness
  time frame: 0 and 4 weeks
  description: Hepatic stiffness will be determined non-invasively by MRI using a special hepatic scanning protocol of 30 minutes
  measure: Hepatic fat content
  time frame: 0 and 4 weeks
  description: Hepatic fat content will be determined non-invasively by MRI using a special hepatic scanning protocol of 30 minutes
  measure: Dietary intake
  time frame: 4 weeks
  description: Participants are asked to fill out an online dietary questionnaire for the 3 days prior to study visit 2,3,4,5 and 7
  measure: Low-density lipoprotein (LDL)
  time frame: 4 weeks
  description: Changes in LDL (mmol/L)
  measure: High-density lipoprotein (HDL)
  time frame: 4 weeks
  description: Changes in HDL (mmol/L)
  measure: Triglycerides
  time frame: 4 weeks
  description: Changes in triglycerides (mmol/L)
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: An oral placebo capsule once daily for 4 weeks
  arm group label: 2mg 6-BT
  arm group type: Experimental
  description: 2 mg of 6-BT as an oral capsule once daily for 4 weeks
  arm group label: 4mg 6-BT
  arm group type: Experimental
  description: 4 mg of 6-BT as an oral capsule once daily for 4 weeks
  arm group label: 8mg 6-BT
  arm group type: Experimental
  description: 8 mg of 6-BT as an oral capsule once daily for 4 weeks
  intervention type: Dietary Supplement
  intervention name: 6-BT
  description: 2,4 or 8mg of 6-BT once daily for 4 weeks
  arm group label: 2mg 6-BT
  arm group label: 4mg 6-BT
  arm group label: 8mg 6-BT
  intervention type: Dietary Supplement
  intervention name: Placebo
  description: A placebo capsule once daily for 4 weeks
  arm group label: Placebo
  criteria: 
  gender: Male
  minimum age: 35 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Nordin MJ Hanssen, dr.
  role: Principal Investigator
  affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  last name: Nordin MJ Hanssen, dr.
  phone: 020-56691111
  email: n.m.j.hanssen@amsterdamumc.nl
  facility: 
  status: Recruiting
  contact: 
  country: Netherlands
  responsible party type: Sponsor-Investigator
  investigator affiliation: Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
  investigator full name: Nordin Hanssen
  investigator title: Principal Investigator
  mesh term: Metabolic Syndrome
  mesh term: Syndrome
  sharing ipd: No