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/NCT06022094</url>
    </required_header>
    <id_info>
      <org_study_id>2024-5195</org_study_id>
      <nct_id>NCT06022094</nct_id>
    </id_info>
    <brief_title>Effect of a Two-month Carbohydrate-restricted Diet on Energy Metabolism in a Seniors' Residence</brief_title>
    <acronym>SAGE</acronym>
    <official_title>Effect of a Two-month Carbohydrate-restricted Diet on Energy Metabolism in a Seniors' Residence: The SAGE Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Université de Sherbrooke</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Université de Sherbrooke</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The present study will assess the effects on glucose, ketones and other blood biomarkers&#xD;
        fuels, cognition, quality of life, physical activity and well-being of a reduced carbohydrate&#xD;
        menu (R-CHO) for 2 months in a population living in a residence for the elderly. This&#xD;
        intervention study, identified as the SAGE project (phase 2), follows on from the Ketohome&#xD;
        project (phase 1) assessing the feasibility of such a project.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Finding an effective therapeutic strategy for Alzheimer's disease (AD) is a societal&#xD;
        priority, but it also remains a major challenge. With one exception in 2021, no new&#xD;
        pharmaceutical treatment for AD has been approved for over 20 years. However, several&#xD;
        clinical trials demonstrate the potential of ketogenic interventions to restore brain energy&#xD;
        and improve cognition in people with mild cognitive impairment and AD. Recently, the largest&#xD;
        and longest clinical trial of its kind shows that compensating for energy deficit in the&#xD;
        brain during aging improves brain metabolic and cognitive functioning in people with early AD&#xD;
        and could potentially delay AD.&#xD;
  &#xD;
        One of the main types of ketogenic intervention is the highly reduced carbohydrate (5-10% of&#xD;
        daily energy value compared to a normal value of 50-65%) and very high fat ketogenic diet.&#xD;
        Despite the now well-established safety of the ketogenic diet and its therapeutic value in&#xD;
        the treatment of epilepsy and type 2 diabetes, the latter remains difficult to implement in&#xD;
        because of the compliance challenge. A reduced glycemic load diet where intake of refined&#xD;
        carbohydrates and added sugar is restricted is found to be much less restrictive than a&#xD;
        ketogenic diet. Phase 1 of this project showed that decreased carbohydrate (sugar) intake may&#xD;
        improve long-term glycemic control and compliance compared to more severe carbohydrate&#xD;
        restriction. Having better blood glucose control may also be important in decreasing the risk&#xD;
        of AD possibly by improving the metabolic profile and/or by promoting the production and use&#xD;
        of ketones. However, its effectiveness in helping cognition in the elderly is still unknown&#xD;
        and any changes in dietary habits can be addressed with some resistance.&#xD;
  &#xD;
        The objective of this project is therefore to answer the following question: does a reduction&#xD;
        in carbohydrates of 30 to 50% for 2 months reduce the risk of AD by improving the metabolic&#xD;
        profile in people living in a senior residence?&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 10, 2023</start_date>
    <completion_date type="Anticipated">July 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 15, 2023</primary_completion_date>
    <phase>N/A</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>
      <intervention_model_description>All participants will eat a reduced carb menu for 2 months</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in blood glucose levels</measure>
      <time_frame>2 months</time_frame>
      <description>Blood glucose will be monitored continuously with a real-time continuous glucose monitor (CGM) for two 10-days periods; before/after intervention in people in a senior residence.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in blood ketones levels</measure>
      <time_frame>2 months</time_frame>
      <description>Blood ketones will be measured before/after the intervention in people in a senior residence via blood sampling.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in blood insulin levels</measure>
      <time_frame>2 months</time_frame>
      <description>Blood insulin will be measured before/after the intervention in people in a senior residence via blood sampling.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in blood triglycerides levels,</measure>
      <time_frame>2 months</time_frame>
      <description>Blood triglycerides levels will be measured before/after the intervention in people in a senior residence via blood sampling.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in blood cholesterol levels</measure>
      <time_frame>2 months</time_frame>
      <description>Blood cholesterol levels will be measured before/after the intervention in people in a senior residence via blood sampling.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in blood glycated hemoglobin levels</measure>
      <time_frame>2 months</time_frame>
      <description>Blood glycated hemoglobin levels will be measured before/after the intervention in people in a senior residence via blood sampling.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Healthy Aging</condition>
    <arm_group>
      <arm_group_label>Delta of before/after the intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Data will be collected before and after the reduced carb intervention</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>2 months of reduced carb menus</intervention_name>
      <description>Participants will eat a reduced carb menu for 2 months</description>
      <arm_group_label>Delta of before/after the intervention</arm_group_label>
      <other_name>R-CHO</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Senior men or women residing in VÜ resident home;&#xD;
  &#xD;
            -  Understand, read and write French;&#xD;
  &#xD;
            -  Possess sufficient visual and auditory acuity to pass the cognitive tests;&#xD;
  &#xD;
            -  Available during the intervention period&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Body mass index &lt; 20;&#xD;
  &#xD;
            -  T1 diabetic;&#xD;
  &#xD;
            -  Insulin-dependent T2 diabetic;&#xD;
  &#xD;
            -  Mini Mental State Exam (MMSE) &lt; 20;&#xD;
  &#xD;
            -  Weight loss &gt;10% in the last 6 months, involuntary or voluntary;&#xD;
  &#xD;
            -  Known and uncontrolled hypoglycaemia;&#xD;
  &#xD;
            -  Moderate to severe digestive illnesses that may be aggravated by dietary changes;&#xD;
  &#xD;
            -  Severe dysphagia;&#xD;
  &#xD;
            -  Supplementation with medium chain triglycerides oil, ketone salts, ketone ester,&#xD;
               adherence to the ketogenic diet, reduced carbohydrate diet, intermittent fasting, or&#xD;
               other diet or supplements that may significantly increase ketones in the past month;&#xD;
  &#xD;
            -  Participation in other intervention research projects on nutrition or aimed at&#xD;
               metabolic change simultaneously.&#xD;
  &#xD;
            -  Medical condition that could prevent the participant from completing the study&#xD;
               according to the doctor's opinion&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Camille Vandenberghe, MSc</last_name>
      <phone>819-780-2220</phone>
      <phone_ext>45235</phone_ext>
      <email>camille.vandenberghe@usherbrooke.ca</email>
    </overall_contact>
    <location>
      <facility>
        <name>Research Center on Aging</name>
        <address>
          <city>Sherbrooke</city>
          <state>Quebec</state>
          <zip>J1H 4C4</zip>
          <country>Canada</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Nutritional intervention</keyword>
    <keyword>Glucose monitoring</keyword>
    <keyword>Reduced carb diet</keyword>
    <keyword>Energy metabolism</keyword>
    <keyword>Ketones</keyword>
    <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/NCT06022094
  org study id: 2024-5195
  nct id: NCT06022094
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The present study will assess the effects on glucose, ketones and other blood biomarkers
        fuels, cognition, quality of life, physical activity and well-being of a reduced carbohydrate
        menu (R-CHO) for 2 months in a population living in a residence for the elderly. This
        intervention study, identified as the SAGE project (phase 2), follows on from the Ketohome
        project (phase 1) assessing the feasibility of such a project.
  Finding an effective therapeutic strategy for Alzheimer's disease (AD) is a societal
        priority, but it also remains a major challenge. With one exception in 2021, no new
        pharmaceutical treatment for AD has been approved for over 20 years. However, several
        clinical trials demonstrate the potential of ketogenic interventions to restore brain energy
        and improve cognition in people with mild cognitive impairment and AD. Recently, the largest
        and longest clinical trial of its kind shows that compensating for energy deficit in the
        brain during aging improves brain metabolic and cognitive functioning in people with early AD
        and could potentially delay AD.
  
        One of the main types of ketogenic intervention is the highly reduced carbohydrate (5-10% of
        daily energy value compared to a normal value of 50-65%) and very high fat ketogenic diet.
        Despite the now well-established safety of the ketogenic diet and its therapeutic value in
        the treatment of epilepsy and type 2 diabetes, the latter remains difficult to implement in
        because of the compliance challenge. A reduced glycemic load diet where intake of refined
        carbohydrates and added sugar is restricted is found to be much less restrictive than a
        ketogenic diet. Phase 1 of this project showed that decreased carbohydrate (sugar) intake may
        improve long-term glycemic control and compliance compared to more severe carbohydrate
        restriction. Having better blood glucose control may also be important in decreasing the risk
        of AD possibly by improving the metabolic profile and/or by promoting the production and use
        of ketones. However, its effectiveness in helping cognition in the elderly is still unknown
        and any changes in dietary habits can be addressed with some resistance.
  
        The objective of this project is therefore to answer the following question: does a reduction
        in carbohydrates of 30 to 50% for 2 months reduce the risk of AD by improving the metabolic
        profile in people living in a senior residence?
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: All participants will eat a reduced carb menu for 2 months
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Change in blood glucose levels
  time frame: 2 months
  description: Blood glucose will be monitored continuously with a real-time continuous glucose monitor (CGM) for two 10-days periods; before/after intervention in people in a senior residence.
  measure: Change in blood ketones levels
  time frame: 2 months
  description: Blood ketones will be measured before/after the intervention in people in a senior residence via blood sampling.
  measure: Change in blood insulin levels
  time frame: 2 months
  description: Blood insulin will be measured before/after the intervention in people in a senior residence via blood sampling.
  measure: Change in blood triglycerides levels,
  time frame: 2 months
  description: Blood triglycerides levels will be measured before/after the intervention in people in a senior residence via blood sampling.
  measure: Change in blood cholesterol levels
  time frame: 2 months
  description: Blood cholesterol levels will be measured before/after the intervention in people in a senior residence via blood sampling.
  measure: Change in blood glycated hemoglobin levels
  time frame: 2 months
  description: Blood glycated hemoglobin levels will be measured before/after the intervention in people in a senior residence via blood sampling.
  arm group label: Delta of before/after the intervention
  arm group type: Experimental
  description: Data will be collected before and after the reduced carb intervention
  intervention type: Other
  intervention name: 2 months of reduced carb menus
  description: Participants will eat a reduced carb menu for 2 months
  arm group label: Delta of before/after the intervention
  other name: R-CHO
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Camille Vandenberghe, MSc
  phone: 819-780-2220
  phone ext: 45235
  email: camille.vandenberghe@usherbrooke.ca
  facility: 
  country: Canada
  responsible party type: Sponsor
  sharing ipd: No