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/NCT05986500</url>
    </required_header>
    <id_info>
      <org_study_id>1-10-72-49-23</org_study_id>
      <nct_id>NCT05986500</nct_id>
    </id_info>
    <brief_title>The GALAXY-1 Project</brief_title>
    <official_title>The GALAXY-1 Project: Galactose - the Ideal Carbohydrate Supplement for Exercise</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Aarhus</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Aarhus</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>
        &quot;The understanding of the two sugars, glucose and fructose, has been thoroughly investigated&#xD;
        regarding their impact on human metabolism during exercise. The consumption of the sugar&#xD;
        galactose is an intriguing alternative and can be beneficial, especially for individuals with&#xD;
        type 1 Diabetes, as it reduces the need for insulin to maintain normal blood sugar levels.&#xD;
        Additionally, galactose oxidation rates during exercise are only 50-60% compared to glucose,&#xD;
        primarily due to liver storage and/or the requirement for conversion to glucose in the liver&#xD;
        before oxidation. This delay in metabolism can prevent hyperglycemia before exercise and&#xD;
        provide extended protection against episodes of hypoglycemia during and after exercise&#xD;
        through a moderate and prolonged glycemic response.&#xD;
  &#xD;
        The purpose of this experiment is to investigate whether galactose is taken up by skeletal&#xD;
        muscles and the heart in response to exercise or hyperinsulinemia. Using non-invasive&#xD;
        18F-FDGal PET, the investigators will examine this in a randomized controlled study design.&#xD;
        The results could contribute to updating dietary recommendations, particularly for&#xD;
        individuals with type 1 diabetes who struggle to maintain normal blood sugar levels during&#xD;
        and after exercise.&quot;&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        It is generally accepted that saccharides have to be converted into glucose before they can&#xD;
        be oxidized and used to produce energy. As a result, non-glucose saccharides affect blood&#xD;
        glucose levels differently than glucose. For example, the saccharide fructose requires&#xD;
        hepatic conversion to glucose, causing more constant blood sugar levels and less risk of both&#xD;
        glucose excursions and hypoglycemia during exercise. However, metabolization of fructose&#xD;
        increases the risk of developing nonalcoholic fatty liver disease due to the stimulation of&#xD;
        de novo lipogenesis and blocking of β-fatty acid oxidation. Consequently, a different&#xD;
        carbohydrate source with the same glycemic profile as fructose but without the undesirable&#xD;
        hepatic effects would be preferable. Galactose is the third of the three quantitively&#xD;
        important dietary monosaccharides in a regular Western diet. Lactose (disaccharide of&#xD;
        galactose and glucose) from dairy products is the primary source of dietary galactose, but&#xD;
        galactose is also found in other food sources such as fruits and vegetables. While the impact&#xD;
        of glucose and fructose on human metabolism has been extensively studied, there is limited&#xD;
        knowledge of the effects of galactose as a nutritional supplement during or before exercise,&#xD;
        and it is also unknown whether it can have clinical applications.&#xD;
  &#xD;
        Intake of galactose or lactose instead of glucose prior to exercise may be advantageous,&#xD;
        particularly for individuals with diabetes, since it lowers the insulin requirement to&#xD;
        maintain euglycemia. Furthermore, galactose oxidation rates during exercise are only 50-60%&#xD;
        compared to glucose, presumably due to hepatic storage and/or a requirement for conversion to&#xD;
        glucose in the liver before oxidation. This delay in end-point metabolism could prevent&#xD;
        hyperglycemia prior to exercise and at the same time provide prolonged protection from&#xD;
        hypoglycemia during and after exercise via the prolonged and moderated glycemic response. In&#xD;
        line with this, a recent study from the investigators' collaborator Gareth Wallis's group&#xD;
        showed that lactose ingestion in relation to exercise increased fat oxidation and lowered&#xD;
        carbohydrate oxidation compared to sucrose ingestion. Accordingly, ingestion of the lactose&#xD;
        component - galactose - instead of regular glucose-containing carbohydrates is an intriguing&#xD;
        option if blood glucose excursions are to be avoided. However, it is still unclear whether&#xD;
        the beneficial metabolic effects of galactose are all caused by the hepatic delay in&#xD;
        conversion to glucose or if galactose is also used directly by skeletal muscle as a source of&#xD;
        energy. To address this, the investigators recently performed positron emission tomography&#xD;
        (PET) pilot studies in two pigs using the galactose analogue 18F-FDGal to measure&#xD;
        insulin-stimulated skeletal and cardiac muscle galactose uptake. Although muscle galactose&#xD;
        uptake was clearly less than for glucose, it was evident that some uptake can be stimulated&#xD;
        by insulin, particularly in the heart. These preliminary data question the current perception&#xD;
        that galactose requires conversion to glucose in the liver before it can be utilized as a&#xD;
        source of energy. However, studies in anesthetized pigs obviously cannot determine whether a&#xD;
        similar direct muscle uptake of galactose can be stimulated by exercise per se, as is the&#xD;
        case for glucose.&#xD;
  &#xD;
        Purpose:&#xD;
  &#xD;
        The purpose of this experiment is to investigate whether galactose is: 1) taken up by&#xD;
        skeletal muscle and extra-hepatic organs, 2) if galactose uptake is affected by prior aerobic&#xD;
        exercise, and 3) if and to what extent insulin stimulates galactose uptake.&#xD;
  &#xD;
        Methods:&#xD;
  &#xD;
        Eight healthy participants will be studied twice in randomized order with 18F-FDGal PET scans&#xD;
        during saline infusion (study day 1), and during a hyperinsulinemic-euglycemic clamp (study&#xD;
        day 2). To stimulate galactose uptake in the femoral skeletal muscles, each participant will&#xD;
        perform a 60-minute one-legged exercise prior to the PET scan. The non-exercised leg will&#xD;
        serve as a control to quantify exercise-stimulated galactose uptake (Figure 2). During each&#xD;
        study day, participants will receive a galactose infusion (bolus: 6 mmol, infusion rate: 1&#xD;
        mmol/min) to mimic concentrations of galactose similar to what can be achieved after&#xD;
        galactose ingestion (1-2 mmol/L) (10). This design allows the investigators to quantify both&#xD;
        the independent and combined effects of insulin and exercise on galactose uptake in skeletal&#xD;
        muscle.&#xD;
  &#xD;
        Volunteers:&#xD;
  &#xD;
        Inclusion criteria:&#xD;
  &#xD;
          1. Age 50-75 years&#xD;
  &#xD;
          2. Males or post-menopausal females&#xD;
  &#xD;
          3. BMI 18.5-30 kg/m2&#xD;
  &#xD;
        Exclusion criteria:&#xD;
  &#xD;
          1. Clinically significant heart, lung, kidney, liver, endocrine, or malignant disease based&#xD;
             on information obtained during an initial screening visit as well as blood samples&#xD;
  &#xD;
          2. Blood donation within the last 3 months&#xD;
  &#xD;
          3. Smoking&#xD;
  &#xD;
          4. Alcohol- or substance abuse&#xD;
  &#xD;
          5. Participation in other clinical trials involving ionizing radiation within the last 6&#xD;
             months&#xD;
  &#xD;
          6. Claustrophobia&#xD;
  &#xD;
          7. Not being physically able to exercise one leg for one hour&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">May 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2024</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>Crossover Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Galactose uptake in skeletal muscle</measure>
      <time_frame>Measurements will be made on each of the two study days</time_frame>
      <description>Skeletal muscle galactose uptake rate (μmol/min/g) measured by 2-(18)F-fluoro-2-deoxy-d-galactose (18F-FDGal)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cardiac galactose uptake</measure>
      <time_frame>Measurements will be made on each of the two study days</time_frame>
      <description>Cardiac galactose uptake rate (μmol/min/g) measured by 2-(18)F-fluoro-2-deoxy-d-galactose (18F-FDGal)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hepatic galactose uptake</measure>
      <time_frame>Measurements will be made on each of the two study days</time_frame>
      <description>Hepatic galactose uptake rate (μmol/min/g) measured by 2-(18)F-fluoro-2-deoxy-d-galactose (18F-FDGal)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma glucose levels</measure>
      <time_frame>Measurements will be made on a screening day and during each of the two study days</time_frame>
      <description>Measured in blood samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Skeletal muscle arterio-venous galactose balance</measure>
      <time_frame>Measurements will be mader during each of the two study days</time_frame>
      <description>Differences in arterio-venous galactose concentrations taken through catheters in both vv. famoralis and a. radialis</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">8</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Galactose</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The participants will receive a galactose infusion</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Saline</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The participants will receive a saline infusion</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Galactose</intervention_name>
      <description>The participants will receive a galactose infusion (bolus: 6 mmol, infusion rate: 1 mmol/min)</description>
      <arm_group_label>Galactose</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>No intervention</intervention_name>
      <description>The participants will receive a saline infusion</description>
      <arm_group_label>Saline</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 50-75 years&#xD;
  &#xD;
            2. Male or post-menopausal female&#xD;
  &#xD;
            3. BMI 18.5-30 kg/m2&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Clinically significant heart, lung, kidney, kidney, liver, endocrine or malignant&#xD;
               disease based on information obtained during an initial screening visit as well as&#xD;
               blood samples&#xD;
  &#xD;
            2. Blood donation within the last 3 months&#xD;
  &#xD;
            3. Smoking&#xD;
  &#xD;
            4. Alcohol- or substance abuse&#xD;
  &#xD;
            5. Participation in other clinical trials involving ionizing radiation within the last 6&#xD;
               months&#xD;
  &#xD;
            6. Claustrophobia&#xD;
  &#xD;
            7. Not being physically able to exercise one leg for one hour&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Thien V Luong, MD</last_name>
      <phone>+4531513750</phone>
      <email>thiluo@clin.au.dk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Esben Søndergaard, MD, PhD</last_name>
      <email>esben.sondergaard@clin.au.dk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Aarhus University Hospital</name>
        <address>
          <city>Aarhus N</city>
          <state>Jutland</state>
          <zip>8200</zip>
          <country>Denmark</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Galactose</keyword>
    <keyword>Exercise</keyword>
    <keyword>PET</keyword>
    <keyword>Insulin</keyword>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05986500
  org study id: 1-10-72-49-23
  nct id: NCT05986500
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  "The understanding of the two sugars, glucose and fructose, has been thoroughly investigated
        regarding their impact on human metabolism during exercise. The consumption of the sugar
        galactose is an intriguing alternative and can be beneficial, especially for individuals with
        type 1 Diabetes, as it reduces the need for insulin to maintain normal blood sugar levels.
        Additionally, galactose oxidation rates during exercise are only 50-60% compared to glucose,
        primarily due to liver storage and/or the requirement for conversion to glucose in the liver
        before oxidation. This delay in metabolism can prevent hyperglycemia before exercise and
        provide extended protection against episodes of hypoglycemia during and after exercise
        through a moderate and prolonged glycemic response.
  
        The purpose of this experiment is to investigate whether galactose is taken up by skeletal
        muscles and the heart in response to exercise or hyperinsulinemia. Using non-invasive
        18F-FDGal PET, the investigators will examine this in a randomized controlled study design.
        The results could contribute to updating dietary recommendations, particularly for
        individuals with type 1 diabetes who struggle to maintain normal blood sugar levels during
        and after exercise."
  It is generally accepted that saccharides have to be converted into glucose before they can
        be oxidized and used to produce energy. As a result, non-glucose saccharides affect blood
        glucose levels differently than glucose. For example, the saccharide fructose requires
        hepatic conversion to glucose, causing more constant blood sugar levels and less risk of both
        glucose excursions and hypoglycemia during exercise. However, metabolization of fructose
        increases the risk of developing nonalcoholic fatty liver disease due to the stimulation of
        de novo lipogenesis and blocking of β-fatty acid oxidation. Consequently, a different
        carbohydrate source with the same glycemic profile as fructose but without the undesirable
        hepatic effects would be preferable. Galactose is the third of the three quantitively
        important dietary monosaccharides in a regular Western diet. Lactose (disaccharide of
        galactose and glucose) from dairy products is the primary source of dietary galactose, but
        galactose is also found in other food sources such as fruits and vegetables. While the impact
        of glucose and fructose on human metabolism has been extensively studied, there is limited
        knowledge of the effects of galactose as a nutritional supplement during or before exercise,
        and it is also unknown whether it can have clinical applications.
  
        Intake of galactose or lactose instead of glucose prior to exercise may be advantageous,
        particularly for individuals with diabetes, since it lowers the insulin requirement to
        maintain euglycemia. Furthermore, galactose oxidation rates during exercise are only 50-60%
        compared to glucose, presumably due to hepatic storage and/or a requirement for conversion to
        glucose in the liver before oxidation. This delay in end-point metabolism could prevent
        hyperglycemia prior to exercise and at the same time provide prolonged protection from
        hypoglycemia during and after exercise via the prolonged and moderated glycemic response. In
        line with this, a recent study from the investigators' collaborator Gareth Wallis's group
        showed that lactose ingestion in relation to exercise increased fat oxidation and lowered
        carbohydrate oxidation compared to sucrose ingestion. Accordingly, ingestion of the lactose
        component - galactose - instead of regular glucose-containing carbohydrates is an intriguing
        option if blood glucose excursions are to be avoided. However, it is still unclear whether
        the beneficial metabolic effects of galactose are all caused by the hepatic delay in
        conversion to glucose or if galactose is also used directly by skeletal muscle as a source of
        energy. To address this, the investigators recently performed positron emission tomography
        (PET) pilot studies in two pigs using the galactose analogue 18F-FDGal to measure
        insulin-stimulated skeletal and cardiac muscle galactose uptake. Although muscle galactose
        uptake was clearly less than for glucose, it was evident that some uptake can be stimulated
        by insulin, particularly in the heart. These preliminary data question the current perception
        that galactose requires conversion to glucose in the liver before it can be utilized as a
        source of energy. However, studies in anesthetized pigs obviously cannot determine whether a
        similar direct muscle uptake of galactose can be stimulated by exercise per se, as is the
        case for glucose.
  
        Purpose:
  
        The purpose of this experiment is to investigate whether galactose is: 1) taken up by
        skeletal muscle and extra-hepatic organs, 2) if galactose uptake is affected by prior aerobic
        exercise, and 3) if and to what extent insulin stimulates galactose uptake.
  
        Methods:
  
        Eight healthy participants will be studied twice in randomized order with 18F-FDGal PET scans
        during saline infusion (study day 1), and during a hyperinsulinemic-euglycemic clamp (study
        day 2). To stimulate galactose uptake in the femoral skeletal muscles, each participant will
        perform a 60-minute one-legged exercise prior to the PET scan. The non-exercised leg will
        serve as a control to quantify exercise-stimulated galactose uptake (Figure 2). During each
        study day, participants will receive a galactose infusion (bolus: 6 mmol, infusion rate: 1
        mmol/min) to mimic concentrations of galactose similar to what can be achieved after
        galactose ingestion (1-2 mmol/L) (10). This design allows the investigators to quantify both
        the independent and combined effects of insulin and exercise on galactose uptake in skeletal
        muscle.
  
        Volunteers:
  
        Inclusion criteria:
  
          1. Age 50-75 years
  
          2. Males or post-menopausal females
  
          3. BMI 18.5-30 kg/m2
  
        Exclusion criteria:
  
          1. Clinically significant heart, lung, kidney, liver, endocrine, or malignant disease based
             on information obtained during an initial screening visit as well as blood samples
  
          2. Blood donation within the last 3 months
  
          3. Smoking
  
          4. Alcohol- or substance abuse
  
          5. Participation in other clinical trials involving ionizing radiation within the last 6
             months
  
          6. Claustrophobia
  
          7. Not being physically able to exercise one leg for one hour
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Galactose uptake in skeletal muscle
  time frame: Measurements will be made on each of the two study days
  description: Skeletal muscle galactose uptake rate (μmol/min/g) measured by 2-(18)F-fluoro-2-deoxy-d-galactose (18F-FDGal)
  measure: Cardiac galactose uptake
  time frame: Measurements will be made on each of the two study days
  description: Cardiac galactose uptake rate (μmol/min/g) measured by 2-(18)F-fluoro-2-deoxy-d-galactose (18F-FDGal)
  measure: Hepatic galactose uptake
  time frame: Measurements will be made on each of the two study days
  description: Hepatic galactose uptake rate (μmol/min/g) measured by 2-(18)F-fluoro-2-deoxy-d-galactose (18F-FDGal)
  measure: Plasma glucose levels
  time frame: Measurements will be made on a screening day and during each of the two study days
  description: Measured in blood samples
  measure: Skeletal muscle arterio-venous galactose balance
  time frame: Measurements will be mader during each of the two study days
  description: Differences in arterio-venous galactose concentrations taken through catheters in both vv. famoralis and a. radialis
  arm group label: Galactose
  arm group type: Experimental
  description: The participants will receive a galactose infusion
  arm group label: Saline
  arm group type: Experimental
  description: The participants will receive a saline infusion
  intervention type: Other
  intervention name: Galactose
  description: The participants will receive a galactose infusion (bolus: 6 mmol, infusion rate: 1 mmol/min)
  arm group label: Galactose
  intervention type: Other
  intervention name: No intervention
  description: The participants will receive a saline infusion
  arm group label: Saline
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Thien V Luong, MD
  phone: +4531513750
  email: thiluo@clin.au.dk
  last name: Esben Søndergaard, MD, PhD
  email: esben.sondergaard@clin.au.dk
  facility: 
  country: Denmark
  responsible party type: Sponsor
  sharing ipd: Undecided