<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/NCT03830268</url>
  </required_header>
  <id_info>
    <org_study_id>2017-714</org_study_id>
    <nct_id>NCT03830268</nct_id>
  </id_info>
  <brief_title>Acute Medium Chain Triglycerides (MCT) Intake in Young and Older Participants</brief_title>
  <acronym>Opti-MCT</acronym>
  <official_title>Optimisation of Acute Medium Chain Triglycerides Intake Characteristics on Different Plasma Metabolites in Young and Older Participants</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>Yes</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>
      Compare plasma metabolites following different conditions paired with a dietary MCT beverage&#xD;
      over an 8-hour metabolic day protocol in young and older participants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2, 2017</start_date>
  <completion_date type="Actual">June 25, 2019</completion_date>
  <primary_completion_date type="Actual">June 25, 2019</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>Parallel Assignment</intervention_model>
    <intervention_model_description>10 young and 10 older participants undergoing six separate but identical metabolic visits (interventions)</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Concentration of plasma ketones (acetoacetate and B-hydroxybutyrate)</measure>
    <time_frame>8 hours</time_frame>
    <description>To compare acute ketonemia following different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Concentration of plasma glucose</measure>
    <time_frame>8 hours</time_frame>
    <description>To compare acute glucose following different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of plasma insulin</measure>
    <time_frame>8 hours</time_frame>
    <description>To compare acute insulin following different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of plasma free fatty acids</measure>
    <time_frame>8 hours</time_frame>
    <description>To compare acute free fatty acids following different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Ketonemia</condition>
  <arm_group>
    <arm_group_label>MCT intake in young participants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol in young participants.&#xD;
Interventions:&#xD;
No MCT intake with breakfast, no lunch (i.e. CTL)&#xD;
No MCT intake with lunch, no breakfast (i.e CTL inverted)&#xD;
10g of Betaquik with breakfast, no lunch (i.e BQ10)&#xD;
20g of Betaquik with breakfast, no lunch (i.e BQ20)&#xD;
10g of Betaquik with low-carbs breakfast, no lunch (i.e BQ10LC)&#xD;
10g of Betaquik with lunch, no breakfast (i.e BQ10 inverted)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MCT intake in older participants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol in older participants.&#xD;
Interventions:&#xD;
No MCT intake with breakfast, no lunch (i.e. CTL)&#xD;
No MCT intake with lunch, no breakfast (i.e CTL inverted)&#xD;
10g of Betaquik with breakfast, no lunch (i.e BQ10)&#xD;
20g of Betaquik with breakfast, no lunch (i.e BQ20)&#xD;
10g of Betaquik with low-carbs breakfast, no lunch (i.e BQ10LC)&#xD;
10g of Betaquik with lunch, no breakfast (i.e BQ10 inverted)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>No MCT intake with breakfast, no lunch</intervention_name>
    <description>Water given with a regular standardize breakfast and water given at noon without lunch.</description>
    <arm_group_label>MCT intake in young participants</arm_group_label>
    <other_name>CTL</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>No MCT intake with lunch, no breakfast</intervention_name>
    <description>Water given in the beginning of the metabolic study day without breakfast and water given at noon with a regular standardize lunch.</description>
    <arm_group_label>MCT intake in young participants</arm_group_label>
    <other_name>CTL inverted</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>10g of Betaquik</intervention_name>
    <description>BQ10 given with a regular standardize breakfast and BQ10 given at noon without lunch.</description>
    <arm_group_label>MCT intake in older participants</arm_group_label>
    <arm_group_label>MCT intake in young participants</arm_group_label>
    <other_name>BQ10</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>10g of Betaquik with low-carbs breakfast</intervention_name>
    <description>BQ10 given with a low-carbs standardize breakfast and BQ10 given at noon without lunch.</description>
    <arm_group_label>MCT intake in young participants</arm_group_label>
    <other_name>BQ10LC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>20g of Betaquik</intervention_name>
    <description>BQ20 given with a regular standardize breakfast and BQ20 given at noon without lunch.</description>
    <arm_group_label>MCT intake in young participants</arm_group_label>
    <other_name>BQ20</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>10g of Betaquik with lunch, no breakfast</intervention_name>
    <description>BQ10 given in the beginning of the metabolic study day without breakfast and BQ10 given at noon with a regular standardize lunch.</description>
    <arm_group_label>MCT intake in young participants</arm_group_label>
    <other_name>BQ10 inverted</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  10 health young (20-40 y old) and 10 health older (&gt; 60 y old) participants&#xD;
&#xD;
          -  Men and women&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  smoking&#xD;
&#xD;
          -  diabetes (fasting glucose &gt;7.0 mmol/l and glycated hemoglobin &gt;6.9%)&#xD;
&#xD;
          -  strenuous aerobic exercise more than three times a week&#xD;
&#xD;
          -  untreated hypertension, dyslipidemia, and abnormal renal, liver, heart or thyroid&#xD;
             function&#xD;
&#xD;
          -  under medication known to affect triglycerides and carbohydrates metabolism (i.e.&#xD;
             diuretics, beta-blockers, steroids, insulin sensitizing)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Rearsh Centre on Aging</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H4C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Cunnane SC, Courchesne-Loyer A, St-Pierre V, Vandenberghe C, Pierotti T, Fortier M, Croteau E, Castellano CA. Can ketones compensate for deteriorating brain glucose uptake during aging? Implications for the risk and treatment of Alzheimer's disease. Ann N Y Acad Sci. 2016 Mar;1367(1):12-20. doi: 10.1111/nyas.12999. Epub 2016 Jan 14.</citation>
    <PMID>26766547</PMID>
  </reference>
  <reference>
    <citation>Croteau E, Castellano CA, Fortier M, Bocti C, Fulop T, Paquet N, Cunnane SC. A cross-sectional comparison of brain glucose and ketone metabolism in cognitively healthy older adults, mild cognitive impairment and early Alzheimer's disease. Exp Gerontol. 2018 Jul 1;107:18-26. doi: 10.1016/j.exger.2017.07.004. Epub 2017 Jul 12.</citation>
    <PMID>28709938</PMID>
  </reference>
  <reference>
    <citation>Courchesne-Loyer A, Croteau E, Castellano CA, St-Pierre V, Hennebelle M, Cunnane SC. Inverse relationship between brain glucose and ketone metabolism in adults during short-term moderate dietary ketosis: A dual tracer quantitative positron emission tomography study. J Cereb Blood Flow Metab. 2017 Jul;37(7):2485-2493. doi: 10.1177/0271678X16669366. Epub 2016 Jan 1.</citation>
    <PMID>27629100</PMID>
  </reference>
  <reference>
    <citation>Courchesne-Loyer A, Fortier M, Tremblay-Mercier J, Chouinard-Watkins R, Roy M, Nugent S, Castellano CA, Cunnane SC. Stimulation of mild, sustained ketonemia by medium-chain triacylglycerols in healthy humans: estimated potential contribution to brain energy metabolism. Nutrition. 2013 Apr;29(4):635-40. doi: 10.1016/j.nut.2012.09.009. Epub 2012 Dec 28.</citation>
    <PMID>23274095</PMID>
  </reference>
  <reference>
    <citation>Castellano CA, Nugent S, Paquet N, Tremblay S, Bocti C, Lacombe G, Imbeault H, Turcotte E, Fulop T, Cunnane SC. Lower brain 18F-fluorodeoxyglucose uptake but normal 11C-acetoacetate metabolism in mild Alzheimer's disease dementia. J Alzheimers Dis. 2015;43(4):1343-53. doi: 10.3233/JAD-141074.</citation>
    <PMID>25147107</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>March 24, 2020</last_update_submitted>
  <last_update_submitted_qc>March 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ketones</keyword>
  <keyword>Medium Chain Triglycerides</keyword>
  <keyword>Glucose</keyword>
  <keyword>Insulin</keyword>
  <keyword>Free fatty acids</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03830268
org study id: 2017-714
nct id: NCT03830268
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Compare plasma metabolites following different conditions paired with a dietary MCT beverage
      over an 8-hour metabolic day protocol in young and older participants.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: 10 young and 10 older participants undergoing six separate but identical metabolic visits (interventions)
primary purpose: Basic Science
masking: None (Open Label)
measure: Concentration of plasma ketones (acetoacetate and B-hydroxybutyrate)
time frame: 8 hours
description: To compare acute ketonemia following different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol.
measure: Concentration of plasma glucose
time frame: 8 hours
description: To compare acute glucose following different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol.
measure: Concentration of plasma insulin
time frame: 8 hours
description: To compare acute insulin following different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol.
measure: Concentration of plasma free fatty acids
time frame: 8 hours
description: To compare acute free fatty acids following different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol.
arm group label: MCT intake in young participants
arm group type: Experimental
description: Different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol in young participants.
Interventions:
No MCT intake with breakfast, no lunch (i.e. CTL)
No MCT intake with lunch, no breakfast (i.e CTL inverted)
10g of Betaquik with breakfast, no lunch (i.e BQ10)
20g of Betaquik with breakfast, no lunch (i.e BQ20)
10g of Betaquik with low-carbs breakfast, no lunch (i.e BQ10LC)
10g of Betaquik with lunch, no breakfast (i.e BQ10 inverted)
arm group label: MCT intake in older participants
arm group type: Experimental
description: Different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol in older participants.
Interventions:
No MCT intake with breakfast, no lunch (i.e. CTL)
No MCT intake with lunch, no breakfast (i.e CTL inverted)
10g of Betaquik with breakfast, no lunch (i.e BQ10)
20g of Betaquik with breakfast, no lunch (i.e BQ20)
10g of Betaquik with low-carbs breakfast, no lunch (i.e BQ10LC)
10g of Betaquik with lunch, no breakfast (i.e BQ10 inverted)
intervention type: Dietary Supplement
intervention name: No MCT intake with breakfast, no lunch
description: Water given with a regular standardize breakfast and water given at noon without lunch.
arm group label: MCT intake in young participants
other name: CTL
intervention type: Dietary Supplement
intervention name: No MCT intake with lunch, no breakfast
description: Water given in the beginning of the metabolic study day without breakfast and water given at noon with a regular standardize lunch.
arm group label: MCT intake in young participants
other name: CTL inverted
intervention type: Dietary Supplement
intervention name: 10g of Betaquik
description: BQ10 given with a regular standardize breakfast and BQ10 given at noon without lunch.
arm group label: MCT intake in older participants
arm group label: MCT intake in young participants
other name: BQ10
intervention type: Dietary Supplement
intervention name: 10g of Betaquik with low-carbs breakfast
description: BQ10 given with a low-carbs standardize breakfast and BQ10 given at noon without lunch.
arm group label: MCT intake in young participants
other name: BQ10LC
intervention type: Dietary Supplement
intervention name: 20g of Betaquik
description: BQ20 given with a regular standardize breakfast and BQ20 given at noon without lunch.
arm group label: MCT intake in young participants
other name: BQ20
intervention type: Dietary Supplement
intervention name: 10g of Betaquik with lunch, no breakfast
description: BQ10 given in the beginning of the metabolic study day without breakfast and BQ10 given at noon with a regular standardize lunch.
arm group label: MCT intake in young participants
other name: BQ10 inverted
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
citation: Cunnane SC, Courchesne-Loyer A, St-Pierre V, Vandenberghe C, Pierotti T, Fortier M, Croteau E, Castellano CA. Can ketones compensate for deteriorating brain glucose uptake during aging? Implications for the risk and treatment of Alzheimer's disease. Ann N Y Acad Sci. 2016 Mar;1367(1):12-20. doi: 10.1111/nyas.12999. Epub 2016 Jan 14.
PMID: 26766547
citation: Croteau E, Castellano CA, Fortier M, Bocti C, Fulop T, Paquet N, Cunnane SC. A cross-sectional comparison of brain glucose and ketone metabolism in cognitively healthy older adults, mild cognitive impairment and early Alzheimer's disease. Exp Gerontol. 2018 Jul 1;107:18-26. doi: 10.1016/j.exger.2017.07.004. Epub 2017 Jul 12.
PMID: 28709938
citation: Courchesne-Loyer A, Croteau E, Castellano CA, St-Pierre V, Hennebelle M, Cunnane SC. Inverse relationship between brain glucose and ketone metabolism in adults during short-term moderate dietary ketosis: A dual tracer quantitative positron emission tomography study. J Cereb Blood Flow Metab. 2017 Jul;37(7):2485-2493. doi: 10.1177/0271678X16669366. Epub 2016 Jan 1.
PMID: 27629100
citation: Courchesne-Loyer A, Fortier M, Tremblay-Mercier J, Chouinard-Watkins R, Roy M, Nugent S, Castellano CA, Cunnane SC. Stimulation of mild, sustained ketonemia by medium-chain triacylglycerols in healthy humans: estimated potential contribution to brain energy metabolism. Nutrition. 2013 Apr;29(4):635-40. doi: 10.1016/j.nut.2012.09.009. Epub 2012 Dec 28.
PMID: 23274095
citation: Castellano CA, Nugent S, Paquet N, Tremblay S, Bocti C, Lacombe G, Imbeault H, Turcotte E, Fulop T, Cunnane SC. Lower brain 18F-fluorodeoxyglucose uptake but normal 11C-acetoacetate metabolism in mild Alzheimer's disease dementia. J Alzheimers Dis. 2015;43(4):1343-53. doi: 10.3233/JAD-141074.
PMID: 25147107
responsible party type: Sponsor
mesh term: Ketosis
sharing ipd: No