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/NCT05983562</url>
    </required_header>
    <id_info>
      <org_study_id>RKT2D_concentrate</org_study_id>
      <nct_id>NCT05983562</nct_id>
    </id_info>
    <brief_title>Examining the Feasibility of Prolonged Ketone Concentrate Supplement Drink Consumption in Adults With Type 2 Diabetes</brief_title>
    <official_title>Examining the Feasibility of Prolonged Ketone Concentrate Supplement Drink Consumption in Adults With Type 2 Diabetes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of British Columbia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of British Columbia</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>
        Brief Summary:&#xD;
  &#xD;
        Ketones are a source of energy and signaling molecule that are produced by the body when not&#xD;
        consuming any food or consistently eating a low-carbohydrate &quot;keto&quot; diet. Blood ketones can&#xD;
        be used as a source of energy by the body, but they may also act as signals that impact how&#xD;
        different cells in the body function.&#xD;
  &#xD;
        Recently, ketone supplements have been developed that can be consumed as a drink. These&#xD;
        supplements can raise blood ketones without having to fast or eat a &quot;keto&quot; diet. Previous&#xD;
        studies have shown that these supplement drinks can lower blood sugar without having to make&#xD;
        any other dietary changes. Drinking these ketone supplements may therefore be an effective&#xD;
        strategy to improve blood sugar control and influence how cells function.&#xD;
  &#xD;
        To find out if it is feasible for people with type 2 diabetes to drink these ketones&#xD;
        supplements regularly over 90 days, we will compare between two groups in this study: one&#xD;
        group that will be asked to drink ketone supplements, and one group that will be asked to&#xD;
        drink a placebo supplement.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 26, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2023</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>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>To determine the feasibility of conducting a randomized controlled trial (RCT) on the effects of consumption of a ketone supplement in adults with type 2 diabetes in free-living environment for 90 days: Recruitment rate of participants into the trial</measure>
      <time_frame>Start of enrolment to completion of enrolment</time_frame>
      <description>A recruitment rate of at least 4 participants per month (which will ensure the study is fully enrolled within a 1-year timeline) will be acceptable.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To determine the feasibility of conducting such an RCT: Compliance as measured by the self-reported volume of ketone supplement drink consumed</measure>
      <time_frame>Across the 90-day intervention period (days 0 through 90)</time_frame>
      <description>≥ 67% of the drinks provided being consumed by participants as determined via self-report (i.e., an average of two out of three drinks per day being consumed) will be acceptable.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To determine the feasibility of conducting such an RCT: Retention as measured by the number of participants that complete the study</measure>
      <time_frame>Across the 90-day intervention period (days 0 through 90)</time_frame>
      <description>≤ 30% of recruited participants dropping out of the study will be acceptable</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Measures of glycemic control (HbA1c)</measure>
      <time_frame>Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)</time_frame>
      <description>Glycemic control will be measured by assessing HbA1c in a clinical laboratory.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measures of glycemic control (postprandial glucose area under the curve)</measure>
      <time_frame>Days -5 through 9 (5 days of baseline and first 9 days of intervention period) and days 77 through 90 (last 2 weeks)</time_frame>
      <description>Glycemic control will be measured by continuous glucose monitoring using the FreeStyle Libre 2 (Abbott) and quantified by assessing 2-hour postprandial hyperglycemia.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measures of glycemic control (average daily glucose)</measure>
      <time_frame>Days -5 through 9 (5 days of baseline and first 9 days of intervention period) and days 77 through 90 (last 2 weeks)</time_frame>
      <description>Glycemic control will be measured by continuous glucose monitoring using the FreeStyle Libre 2 (Abbott) and quantified by assessing the average daily glucose.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measures of glycemic control (glucose variability)</measure>
      <time_frame>Days -5 through 9 (5 days of baseline and first 9 days of intervention period) and days 77 through 90 (last 2 weeks)</time_frame>
      <description>Glycemic control will be measured by continuous glucose monitoring using the FreeStyle Libre 2 (Abbott) and quantified by assessing glucose variability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Supplement acceptability</measure>
      <time_frame>Days 1, 45, and 90</time_frame>
      <description>Supplement acceptability will be assessed via questionnaire.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gastrointestinal distress</measure>
      <time_frame>Days 1, 45, and 90</time_frame>
      <description>Gastrointestinal distress will be assessed via questionnaire.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-reported body weight</measure>
      <time_frame>Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)</time_frame>
      <description>Self-reported body weight will be assessed by questionnaire.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-reported waist circumference</measure>
      <time_frame>ay 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)</time_frame>
      <description>Self-reported waist circumference will be assessed by questionnaire (using study-provided measurement tape).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-reported energy consumption</measure>
      <time_frame>Days 0 (pre-intervention/baseline), 45, and 90</time_frame>
      <description>Self-reported energy consumption will be assessed via 24-hour dietary recalls.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Levels of perceived hunger</measure>
      <time_frame>Days 0 (pre-intervention/baseline), 45, and 90</time_frame>
      <description>Levels of perceived hunger will be assessed via questionnaire.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>High-sensitivity c-reactive protein</measure>
      <time_frame>Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)</time_frame>
      <description>High-sensitivity c-reactive protein will be measured in a clinical laboratory.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hematology panel</measure>
      <time_frame>Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)</time_frame>
      <description>Hematology panel will be measured in a clinical laboratory.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Liver enzymes (ALT, AST)</measure>
      <time_frame>Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)</time_frame>
      <description>Liver enzymes (ALT, AST) will be measured in a clinical laboratory.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lipid panel (triglycerides, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, non-high density lipoprotein cholesterol, cholesterol/high-density lipoprotein cholesterol ratio)</measure>
      <time_frame>Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)</time_frame>
      <description>Lipid panel will be measured in a clinical laboratory.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Levels of physical activity</measure>
      <time_frame>Days 0 (pre-intervention/baseline) and 45</time_frame>
      <description>Theory of planned behaviour will be assessed via questionnaire.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep quality</measure>
      <time_frame>Days 0 (pre-intervention/baseline), 45, and 90</time_frame>
      <description>Sleep quality will be assessed via questionnaire.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cravings</measure>
      <time_frame>Days 0 (pre-intervention/baseline), 45, and 90</time_frame>
      <description>Cravings will be assessed via questionnaire.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-rated health</measure>
      <time_frame>Days 0 (pre-intervention/baseline), 45, and 90</time_frame>
      <description>Self-rated health and its impacts on daily life will be assessed via questionnaire.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-reported blood pressure (systolic and diastolic)</measure>
      <time_frame>Days 0 (pre-intervention/baseline), 45, and 90</time_frame>
      <description>Self-reported blood pressure (systolic and diastolic) will be assessed via questionnaire (via study-provided blood pressure monitors).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Theory of planned behaviour</measure>
      <time_frame>Days 0 (pre-intervention/baseline) and 45</time_frame>
      <description>Theory of planned behaviour will be assessed via questionnaire.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall acceptability</measure>
      <time_frame>Day 90 or in case of withdrawal</time_frame>
      <description>Will be assessed via an open ended questionnaire either at completion time or in case of withdrawal</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Diabetes Mellitus, Type 2</condition>
    <condition>Hyperglycemia</condition>
    <condition>Ketosis</condition>
    <arm_group>
      <arm_group_label>Experimental: Exogenous Ketone Supplement</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be instructed to consume a total of 177 mL of the exogenous ketone supplement drink (for a total of 30 g of beta-hydroxybutyrate) per day (3 doses at 59 mL containing 10 g of beta-hydroxybutyrate each) for a period of 90 days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo Comparator: Inert placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Participants will be instructed to consume an equivalent volume (177 mL) of taste- and volume-matched placebo per day (3 doses at 59 mL) for 90 days.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Dietary Supplement: D-β-hydroxybutyric acid with R-1,3-butanediol</intervention_name>
      <description>Pre-intervention (baseline) and post-intervention measurements will be obtained before and after the 90-day period respectively.</description>
      <arm_group_label>Experimental: Exogenous Ketone Supplement</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Inert placebo</intervention_name>
      <description>Pre-intervention (baseline) and post-intervention measurements will be obtained before and after the 90-day period respectively</description>
      <arm_group_label>Placebo Comparator: Inert placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  diagnosed with type 2 diabetes by a physician at least 1 year prior&#xD;
  &#xD;
            -  stable use of glucose-lowering medications for at least three months&#xD;
  &#xD;
            -  must be able to read and understand English in order to complete the study&#xD;
               questionnaires&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  competitively trained endurance athlete&#xD;
  &#xD;
            -  actively attempting to gain or lose weight&#xD;
  &#xD;
            -  having a history of mental illness or existing neurological disease&#xD;
  &#xD;
            -  having a history of cardiovascular events in the last two years, hypoglycemia,&#xD;
               irritable bowel syndrome, or inflammatory bowel disease&#xD;
  &#xD;
            -  are currently taking SGLT2 inhibitors or insulin&#xD;
  &#xD;
            -  are using more than 2 classes of glucose-lowering medication&#xD;
  &#xD;
            -  currently following a ketogenic diet or regularly taking ketone supplements&#xD;
  &#xD;
            -  unable to commit to a 90-day trial&#xD;
  &#xD;
            -  being unable to follow remote guidance by internet or smartphone&#xD;
  &#xD;
            -  currently taking natural or over-the-counter supplements specifically designed to&#xD;
               lower blood glucose (e.g., berberine, bitter melon)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>69 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jonathan Little, PhD</last_name>
      <phone>250-807-9876</phone>
      <email>jonathan.little@ubc.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Juan Pablo Tortoriello, MD</last_name>
      <phone>250-864-2003</phone>
      <email>jptorto@mail.ubc.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of British Columbia Okanagan</name>
        <address>
          <city>Kelowna</city>
          <state>British Columbia</state>
          <zip>V1V 1V7</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jonathan P Little</last_name>
        <phone>2508079876</phone>
        <email>jonathan.little@ubc.ca</email>
      </contact>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of British Columbia</investigator_affiliation>
      <investigator_full_name>Jonathan Little</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetes Mellitus</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
      <mesh_term>Hyperglycemia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The investigators will share individual patient data (de-identified) with researchers upon reasonable request.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>The de-identified data and associated documents will be made available to researchers upon reasonable request for the duration that is required by the researchers.</ipd_time_frame>
      <ipd_access_criteria>Researchers from accredited institutions will be granted access to the de-identified data and associated documents provided they can show that it will be used for a research-related purpose (e.g., meta-analysis).</ipd_access_criteria>
    </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/NCT05983562
  org study id: RKT2D_concentrate
  nct id: NCT05983562
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Brief Summary:
  
        Ketones are a source of energy and signaling molecule that are produced by the body when not
        consuming any food or consistently eating a low-carbohydrate "keto" diet. Blood ketones can
        be used as a source of energy by the body, but they may also act as signals that impact how
        different cells in the body function.
  
        Recently, ketone supplements have been developed that can be consumed as a drink. These
        supplements can raise blood ketones without having to fast or eat a "keto" diet. Previous
        studies have shown that these supplement drinks can lower blood sugar without having to make
        any other dietary changes. Drinking these ketone supplements may therefore be an effective
        strategy to improve blood sugar control and influence how cells function.
  
        To find out if it is feasible for people with type 2 diabetes to drink these ketones
        supplements regularly over 90 days, we will compare between two groups in this study: one
        group that will be asked to drink ketone supplements, and one group that will be asked to
        drink a placebo supplement.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: To determine the feasibility of conducting a randomized controlled trial (RCT) on the effects of consumption of a ketone supplement in adults with type 2 diabetes in free-living environment for 90 days: Recruitment rate of participants into the trial
  time frame: Start of enrolment to completion of enrolment
  description: A recruitment rate of at least 4 participants per month (which will ensure the study is fully enrolled within a 1-year timeline) will be acceptable.
  measure: To determine the feasibility of conducting such an RCT: Compliance as measured by the self-reported volume of ketone supplement drink consumed
  time frame: Across the 90-day intervention period (days 0 through 90)
  description: ≥ 67% of the drinks provided being consumed by participants as determined via self-report (i.e., an average of two out of three drinks per day being consumed) will be acceptable.
  measure: To determine the feasibility of conducting such an RCT: Retention as measured by the number of participants that complete the study
  time frame: Across the 90-day intervention period (days 0 through 90)
  description: ≤ 30% of recruited participants dropping out of the study will be acceptable
  measure: Measures of glycemic control (HbA1c)
  time frame: Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
  description: Glycemic control will be measured by assessing HbA1c in a clinical laboratory.
  measure: Measures of glycemic control (postprandial glucose area under the curve)
  time frame: Days -5 through 9 (5 days of baseline and first 9 days of intervention period) and days 77 through 90 (last 2 weeks)
  description: Glycemic control will be measured by continuous glucose monitoring using the FreeStyle Libre 2 (Abbott) and quantified by assessing 2-hour postprandial hyperglycemia.
  measure: Measures of glycemic control (average daily glucose)
  time frame: Days -5 through 9 (5 days of baseline and first 9 days of intervention period) and days 77 through 90 (last 2 weeks)
  description: Glycemic control will be measured by continuous glucose monitoring using the FreeStyle Libre 2 (Abbott) and quantified by assessing the average daily glucose.
  measure: Measures of glycemic control (glucose variability)
  time frame: Days -5 through 9 (5 days of baseline and first 9 days of intervention period) and days 77 through 90 (last 2 weeks)
  description: Glycemic control will be measured by continuous glucose monitoring using the FreeStyle Libre 2 (Abbott) and quantified by assessing glucose variability.
  measure: Supplement acceptability
  time frame: Days 1, 45, and 90
  description: Supplement acceptability will be assessed via questionnaire.
  measure: Gastrointestinal distress
  time frame: Days 1, 45, and 90
  description: Gastrointestinal distress will be assessed via questionnaire.
  measure: Self-reported body weight
  time frame: Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
  description: Self-reported body weight will be assessed by questionnaire.
  measure: Self-reported waist circumference
  time frame: ay 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
  description: Self-reported waist circumference will be assessed by questionnaire (using study-provided measurement tape).
  measure: Self-reported energy consumption
  time frame: Days 0 (pre-intervention/baseline), 45, and 90
  description: Self-reported energy consumption will be assessed via 24-hour dietary recalls.
  measure: Levels of perceived hunger
  time frame: Days 0 (pre-intervention/baseline), 45, and 90
  description: Levels of perceived hunger will be assessed via questionnaire.
  measure: High-sensitivity c-reactive protein
  time frame: Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
  description: High-sensitivity c-reactive protein will be measured in a clinical laboratory.
  measure: Hematology panel
  time frame: Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
  description: Hematology panel will be measured in a clinical laboratory.
  measure: Liver enzymes (ALT, AST)
  time frame: Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
  description: Liver enzymes (ALT, AST) will be measured in a clinical laboratory.
  measure: Lipid panel (triglycerides, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, non-high density lipoprotein cholesterol, cholesterol/high-density lipoprotein cholesterol ratio)
  time frame: Day 0 (pre-intervention/baseline) and day 90 (post-intervention/follow-up)
  description: Lipid panel will be measured in a clinical laboratory.
  measure: Levels of physical activity
  time frame: Days 0 (pre-intervention/baseline) and 45
  description: Theory of planned behaviour will be assessed via questionnaire.
  measure: Sleep quality
  time frame: Days 0 (pre-intervention/baseline), 45, and 90
  description: Sleep quality will be assessed via questionnaire.
  measure: Cravings
  time frame: Days 0 (pre-intervention/baseline), 45, and 90
  description: Cravings will be assessed via questionnaire.
  measure: Self-rated health
  time frame: Days 0 (pre-intervention/baseline), 45, and 90
  description: Self-rated health and its impacts on daily life will be assessed via questionnaire.
  measure: Self-reported blood pressure (systolic and diastolic)
  time frame: Days 0 (pre-intervention/baseline), 45, and 90
  description: Self-reported blood pressure (systolic and diastolic) will be assessed via questionnaire (via study-provided blood pressure monitors).
  measure: Theory of planned behaviour
  time frame: Days 0 (pre-intervention/baseline) and 45
  description: Theory of planned behaviour will be assessed via questionnaire.
  measure: Overall acceptability
  time frame: Day 90 or in case of withdrawal
  description: Will be assessed via an open ended questionnaire either at completion time or in case of withdrawal
  arm group label: Experimental: Exogenous Ketone Supplement
  arm group type: Experimental
  description: Participants will be instructed to consume a total of 177 mL of the exogenous ketone supplement drink (for a total of 30 g of beta-hydroxybutyrate) per day (3 doses at 59 mL containing 10 g of beta-hydroxybutyrate each) for a period of 90 days.
  arm group label: Placebo Comparator: Inert placebo
  arm group type: Placebo Comparator
  description: Participants will be instructed to consume an equivalent volume (177 mL) of taste- and volume-matched placebo per day (3 doses at 59 mL) for 90 days.
  intervention type: Dietary Supplement
  intervention name: Dietary Supplement: D-β-hydroxybutyric acid with R-1,3-butanediol
  description: Pre-intervention (baseline) and post-intervention measurements will be obtained before and after the 90-day period respectively.
  arm group label: Experimental: Exogenous Ketone Supplement
  intervention type: Other
  intervention name: Inert placebo
  description: Pre-intervention (baseline) and post-intervention measurements will be obtained before and after the 90-day period respectively
  arm group label: Placebo Comparator: Inert placebo
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: 69 Years
  healthy volunteers: No
  last name: Jonathan Little, PhD
  phone: 250-807-9876
  email: jonathan.little@ubc.ca
  last name: Juan Pablo Tortoriello, MD
  phone: 250-864-2003
  email: jptorto@mail.ubc.ca
  facility: 
  status: Recruiting
  contact: 
  country: Canada
  responsible party type: Principal Investigator
  investigator affiliation: University of British Columbia
  investigator full name: Jonathan Little
  investigator title: Professor
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2
  mesh term: Hyperglycemia
  sharing ipd: Yes
  ipd description: The investigators will share individual patient data (de-identified) with researchers upon reasonable request.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: The de-identified data and associated documents will be made available to researchers upon reasonable request for the duration that is required by the researchers.
  ipd access criteria: Researchers from accredited institutions will be granted access to the de-identified data and associated documents provided they can show that it will be used for a research-related purpose (e.g., meta-analysis).