<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/NCT04490226</url>
  </required_header>
  <id_info>
    <org_study_id>ABW-2020-VK</org_study_id>
    <nct_id>NCT04490226</nct_id>
  </id_info>
  <brief_title>Endogenous vs. Exogenous Ketone Bodies</brief_title>
  <official_title>Impact of Endogenous vs. Exogenous Ketone Bodies on Appetite Control and Macronutrient Oxidation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Kiel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kiel</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>
      Aim of the study is to compare the origin of ketone bodies: endogenous ketone bodies due to&#xD;
      36 hours fasting or 24 hours of ketogenic diet vs. exogenous ketone bodies as supplements&#xD;
      additional to normal diet.&#xD;
&#xD;
      Secondary aim of the study is to validate the new metabolic chambers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each study week starts with a 3-day run-in period with controlled diet at home and ends with&#xD;
      a test-meal (breakfast) in the lab and following food record over the rest of the day at&#xD;
      home.&#xD;
&#xD;
        1. week: physical activity level (PAL) 1.3, 3 intervention days in the metabolic chamber:&#xD;
           ad libitum energy intake, washout day, isocaloric diet, 36 hours fasting&#xD;
&#xD;
        2. week: physical activity level (PAL) 1.3, 2 intervention days in the metabolic chamber:&#xD;
           isocaloric diet, 36 hours fasting&#xD;
&#xD;
        3. week: physical activity level (PAL) 1.6, 2 intervention days in the metabolic chamber:&#xD;
           ad libitum energy intake, 36 hours fasting&#xD;
&#xD;
        4. week: physical activity level (PAL) 1.6, 2 intervention days in the metabolic chamber:&#xD;
           isocaloric diet, ketogenic diet (isocaloric)&#xD;
&#xD;
        5. week: physical activity level (PAL) 1.6, 2 intervention days in the metabolic chamber:&#xD;
           isocaloric diet, isocaloric diet + ketone body supplements (isocaloric)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 21, 2020</start_date>
  <completion_date type="Actual">July 23, 2021</completion_date>
  <primary_completion_date type="Actual">July 23, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>all subjects are undergoing each intervention</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>appetite control - ghrelin</measure>
    <time_frame>24 hours</time_frame>
    <description>ghrelin concentration in plasma (24 hour AUC)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>appetite control - GLP-1 concentration in plasma</measure>
    <time_frame>24 hours</time_frame>
    <description>Glucose Like Peptide-1 concentration in plasma (24 hour AUC)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>appetite control - PYY concentration in plasma</measure>
    <time_frame>24 hours</time_frame>
    <description>Peptide YY concentration in plasma (24 hour AUC)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>appetite control - subjective feelings of hunger</measure>
    <time_frame>24 hours</time_frame>
    <description>measured with visual analogue scales (24 hour AUC). The scale consists of a 10 cm vertical line anchored with &quot;not hungry at all&quot; at the left side and with &quot;extremely hungry&quot; at the right side.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>appetite control - satiety quotient</measure>
    <time_frame>30 min</time_frame>
    <description>satiety quotient of standard test-breakfast after 24 hours of intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>macronutrient oxidation</measure>
    <time_frame>24 hours</time_frame>
    <description>measured with indirect calorimetry in a metabolic chamber</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>energy expenditure</measure>
    <time_frame>24 hours</time_frame>
    <description>measured with indirect calorimetry in a metabolic chamber</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>glycemia - glucose AUC</measure>
    <time_frame>24 hours</time_frame>
    <description>glucose AUC from continuous glucose monitoring data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>repeatability of energy expenditure measurements</measure>
    <time_frame>24 hours</time_frame>
    <description>repeated measurement of 24h-energy expenditure in a metabolic chamber on inactive isocaloric and fasting days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ß-Hydroxybutyrate concentration in serum</measure>
    <time_frame>24 hours</time_frame>
    <description>24 hour ß-Hydroxybutyrate concentration in serum (AUC)</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>fasting, active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>36 hours fasting, PAL 1.6</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ketogenic diet, active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>24 hours of ketogenic diet (liquid meals), PAL 1.6</description>
  </arm_group>
  <arm_group>
    <arm_group_label>exogeneous ketone bodies, active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>24 hours of ketone body supplements (Beta-Hydroxybutyrate as Ca-Mg-salt) additional to a normal diet (liquid meals), PAL 1.6</description>
  </arm_group>
  <arm_group>
    <arm_group_label>fasting, inactive</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>36 hours fasting, PAL 1.3</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Beta-Hydroxybutyrate as Ca-Mg-salt, active</intervention_name>
    <description>24 hour intervention with ketone body supplements additional to a normal diet (isocaloric diet in total) to induce ketosis (exogenous ketone bodies), in a metabolic chamber at physical activity level of 1.6, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.6.</description>
    <arm_group_label>exogeneous ketone bodies, active</arm_group_label>
    <arm_group_label>fasting, active</arm_group_label>
    <arm_group_label>fasting, inactive</arm_group_label>
    <arm_group_label>ketogenic diet, active</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>ketogenic diet (KetoCal® 4:1 Neutral, Nutricia GmbH, Erlangen, Germany), active</intervention_name>
    <description>24 hour interventions with ketogenic isocaloric diet to induce ketosis (endogenous ketone bodies), in a metabolic chamber at physical activity level of 1.6, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.6.</description>
    <arm_group_label>exogeneous ketone bodies, active</arm_group_label>
    <arm_group_label>fasting, active</arm_group_label>
    <arm_group_label>fasting, inactive</arm_group_label>
    <arm_group_label>ketogenic diet, active</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>fasting, active</intervention_name>
    <description>36 hours of fasting, in a metabolic chamber at physical activity level of 1.6, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.6.</description>
    <arm_group_label>exogeneous ketone bodies, active</arm_group_label>
    <arm_group_label>fasting, active</arm_group_label>
    <arm_group_label>fasting, inactive</arm_group_label>
    <arm_group_label>ketogenic diet, active</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>fasting, inactive</intervention_name>
    <description>36 hours of fasting, in a metabolic chamber at physical activity level of 1.3, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.3.&#xD;
The same intervention is reproduced one week later.</description>
    <arm_group_label>exogeneous ketone bodies, active</arm_group_label>
    <arm_group_label>fasting, active</arm_group_label>
    <arm_group_label>fasting, inactive</arm_group_label>
    <arm_group_label>ketogenic diet, active</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy&#xD;
&#xD;
          -  BMI 19-29 kg/m2&#xD;
&#xD;
          -  low-medium habitual physical activity&#xD;
&#xD;
          -  women using hormonal contraceptive&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  smoking&#xD;
&#xD;
          -  chronic illnesses&#xD;
&#xD;
          -  food allergies / intolerances&#xD;
&#xD;
          -  vegans and vegetarians&#xD;
&#xD;
          -  regular high physical activity (exercise &gt;1 hour/d)&#xD;
&#xD;
          -  current weight loss diet / weight loss of &gt;5 kg in the last 3 months&#xD;
&#xD;
          -  pregnant / lactating women&#xD;
&#xD;
          -  persons incapable of giving informed legal consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anja Bosy-Westphal, PhD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Human Nutrition, Kiel University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Human Nutrition</name>
      <address>
        <city>Kiel</city>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>September 30, 2021</last_update_submitted>
  <last_update_submitted_qc>September 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Kiel</investigator_affiliation>
    <investigator_full_name>Prof. Dr. Dr. Anja Bosy-Westphal</investigator_full_name>
    <investigator_title>Prof. Anja Bosy-Westphal, PhD, MD</investigator_title>
  </responsible_party>
  <keyword>ketone bodies</keyword>
  <keyword>appetite control</keyword>
  <keyword>macronutrient oxidation</keyword>
  <keyword>metabolic chamber</keyword>
  <keyword>exogenous ketones</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04490226
org study id: ABW-2020-VK
nct id: NCT04490226
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aim of the study is to compare the origin of ketone bodies: endogenous ketone bodies due to
      36 hours fasting or 24 hours of ketogenic diet vs. exogenous ketone bodies as supplements
      additional to normal diet.

      Secondary aim of the study is to validate the new metabolic chambers.
Each study week starts with a 3-day run-in period with controlled diet at home and ends with
      a test-meal (breakfast) in the lab and following food record over the rest of the day at
      home.

        1. week: physical activity level (PAL) 1.3, 3 intervention days in the metabolic chamber:
           ad libitum energy intake, washout day, isocaloric diet, 36 hours fasting

        2. week: physical activity level (PAL) 1.3, 2 intervention days in the metabolic chamber:
           isocaloric diet, 36 hours fasting

        3. week: physical activity level (PAL) 1.6, 2 intervention days in the metabolic chamber:
           ad libitum energy intake, 36 hours fasting

        4. week: physical activity level (PAL) 1.6, 2 intervention days in the metabolic chamber:
           isocaloric diet, ketogenic diet (isocaloric)

        5. week: physical activity level (PAL) 1.6, 2 intervention days in the metabolic chamber:
           isocaloric diet, isocaloric diet + ketone body supplements (isocaloric)
allocation: Non-Randomized
intervention model: Crossover Assignment
intervention model description: all subjects are undergoing each intervention
primary purpose: Basic Science
masking: None (Open Label)
measure: appetite control - ghrelin
time frame: 24 hours
description: ghrelin concentration in plasma (24 hour AUC)
measure: appetite control - GLP-1 concentration in plasma
time frame: 24 hours
description: Glucose Like Peptide-1 concentration in plasma (24 hour AUC)
measure: appetite control - PYY concentration in plasma
time frame: 24 hours
description: Peptide YY concentration in plasma (24 hour AUC)
measure: appetite control - subjective feelings of hunger
time frame: 24 hours
description: measured with visual analogue scales (24 hour AUC). The scale consists of a 10 cm vertical line anchored with "not hungry at all" at the left side and with "extremely hungry" at the right side.
measure: appetite control - satiety quotient
time frame: 30 min
description: satiety quotient of standard test-breakfast after 24 hours of intervention
measure: macronutrient oxidation
time frame: 24 hours
description: measured with indirect calorimetry in a metabolic chamber
measure: energy expenditure
time frame: 24 hours
description: measured with indirect calorimetry in a metabolic chamber
measure: glycemia - glucose AUC
time frame: 24 hours
description: glucose AUC from continuous glucose monitoring data
measure: repeatability of energy expenditure measurements
time frame: 24 hours
description: repeated measurement of 24h-energy expenditure in a metabolic chamber on inactive isocaloric and fasting days
measure: ß-Hydroxybutyrate concentration in serum
time frame: 24 hours
description: 24 hour ß-Hydroxybutyrate concentration in serum (AUC)
arm group label: fasting, active
arm group type: Experimental
description: 36 hours fasting, PAL 1.6
arm group label: ketogenic diet, active
arm group type: Experimental
description: 24 hours of ketogenic diet (liquid meals), PAL 1.6
arm group label: exogeneous ketone bodies, active
arm group type: Experimental
description: 24 hours of ketone body supplements (Beta-Hydroxybutyrate as Ca-Mg-salt) additional to a normal diet (liquid meals), PAL 1.6
arm group label: fasting, inactive
arm group type: Experimental
description: 36 hours fasting, PAL 1.3
intervention type: Dietary Supplement
intervention name: Beta-Hydroxybutyrate as Ca-Mg-salt, active
description: 24 hour intervention with ketone body supplements additional to a normal diet (isocaloric diet in total) to induce ketosis (exogenous ketone bodies), in a metabolic chamber at physical activity level of 1.6, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.6.
arm group label: exogeneous ketone bodies, active
arm group label: fasting, active
arm group label: fasting, inactive
arm group label: ketogenic diet, active
intervention type: Dietary Supplement
intervention name: ketogenic diet (KetoCal® 4:1 Neutral, Nutricia GmbH, Erlangen, Germany), active
description: 24 hour interventions with ketogenic isocaloric diet to induce ketosis (endogenous ketone bodies), in a metabolic chamber at physical activity level of 1.6, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.6.
arm group label: exogeneous ketone bodies, active
arm group label: fasting, active
arm group label: fasting, inactive
arm group label: ketogenic diet, active
intervention type: Dietary Supplement
intervention name: fasting, active
description: 36 hours of fasting, in a metabolic chamber at physical activity level of 1.6, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.6.
arm group label: exogeneous ketone bodies, active
arm group label: fasting, active
arm group label: fasting, inactive
arm group label: ketogenic diet, active
intervention type: Dietary Supplement
intervention name: fasting, inactive
description: 36 hours of fasting, in a metabolic chamber at physical activity level of 1.3, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.3.
The same intervention is reproduced one week later.
arm group label: exogeneous ketone bodies, active
arm group label: fasting, active
arm group label: fasting, inactive
arm group label: ketogenic diet, active
criteria: 
gender: All
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anja Bosy-Westphal, PhD, MD
role: Principal Investigator
affiliation: Institute of Human Nutrition, Kiel University
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University of Kiel
investigator full name: Prof. Dr. Dr. Anja Bosy-Westphal
investigator title: Prof. Anja Bosy-Westphal, PhD, MD