<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/NCT03826472</url>
  </required_header>
  <id_info>
    <org_study_id>PKE AlmondButter</org_study_id>
    <nct_id>NCT03826472</nct_id>
  </id_info>
  <brief_title>Almond Butter and Fasting Glucose</brief_title>
  <official_title>Almond Butter and Fasting Glucose in Adults With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Penn State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Penn State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A two-period randomized crossover study will be conducted to determine the effect of almond&#xD;
      butter as an evening snack on fasting blood glucose in adults with type 2 diabetes, not&#xD;
      taking insulin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Control of fasting blood glucose is a challenge for many individuals with diabetes.&#xD;
      Researchers want to better understand how a nighttime snack can affect morning fasting blood&#xD;
      glucose. A two-period randomized crossover trial will be conducted. Participants will be&#xD;
      randomized to receive each treatment for 1 week. During the almond butter treatment,&#xD;
      participants will consume 2 tbsp of almond butter per day as an evening snack. The control&#xD;
      treatments will be a no-snack control. Fasting blood glucose, as well as glucose trends, will&#xD;
      be measured using Continuous Glucose Monitor (CGM). Participants will also be asked to take&#xD;
      simple cognitive tests on a study-provided smartphone each day of the study and report their&#xD;
      daily food intake and physical activity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 8, 2019</start_date>
  <completion_date type="Actual">March 1, 2020</completion_date>
  <primary_completion_date type="Actual">March 1, 2020</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>CGM devices will be blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Fasting glucose</measure>
    <time_frame>2 weeks</time_frame>
    <description>Measured by continuous glucose monitoring (interstitial glucose)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glucose trends</measure>
    <time_frame>2 weeks</time_frame>
    <description>Measured by continuous glucose monitoring (interstitial glucose)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inhibitory control</measure>
    <time_frame>2 weeks</time_frame>
    <description>Measured by smartphone-based cognitive task</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Type2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Almond Butter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will consume one ounce per day (~32 g) of almond butter as an evening snack (i.e., after dinner and before sleep).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No-snack Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will consume nothing besides water after dinner/bed sleep.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Almond Butter</intervention_name>
    <description>Natural almond butter</description>
    <arm_group_label>Almond Butter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals with diagnosed type 2 diabetes&#xD;
&#xD;
          -  Not on insulin therapy&#xD;
&#xD;
          -  On stable does of oral antihyperglycemic agent (no dose change for 6 months)&#xD;
&#xD;
          -  Currently monitoring blood glucose at home via glucometer&#xD;
&#xD;
          -  Willing and able to adhere to study protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals with type 1 diabetes, cardiovascular disease, kidney disease, liver&#xD;
             disease, cancer or inflammatory conditions (e.g. GI disorders, rheumatoid arthritis)&#xD;
&#xD;
          -  Women who are pregnant, breastfeeding, or have been pregnant within the last 6 months&#xD;
             or breastfeeding within the last 6 weeks&#xD;
&#xD;
          -  Individuals who smoke or use tobacco products&#xD;
&#xD;
          -  Use of insulin therapy or sulfonylurea medications&#xD;
&#xD;
          -  Allergy to any tree nut&#xD;
&#xD;
          -  Liver or kidney disease&#xD;
&#xD;
          -  Allergy to Dexcom CGM adhesive&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Penny M Kris-Etherton, PhD, RDN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Penn State</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Penn State</name>
      <address>
        <city>University Park</city>
        <state>Pennsylvania</state>
        <zip>16802</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>March 26, 2020</last_update_submitted>
  <last_update_submitted_qc>March 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Penn State University</investigator_affiliation>
    <investigator_full_name>Penny</investigator_full_name>
    <investigator_title>Distinguished Professor of Nutrition</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>October 4, 2021</submitted>
    <returned>October 26, 2021</returned>
    <submitted>August 4, 2022</submitted>
    <returned>August 25, 2022</returned>
    <submitted>September 15, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03826472
org study id: PKE AlmondButter
nct id: NCT03826472
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
A two-period randomized crossover study will be conducted to determine the effect of almond
      butter as an evening snack on fasting blood glucose in adults with type 2 diabetes, not
      taking insulin.
Control of fasting blood glucose is a challenge for many individuals with diabetes.
      Researchers want to better understand how a nighttime snack can affect morning fasting blood
      glucose. A two-period randomized crossover trial will be conducted. Participants will be
      randomized to receive each treatment for 1 week. During the almond butter treatment,
      participants will consume 2 tbsp of almond butter per day as an evening snack. The control
      treatments will be a no-snack control. Fasting blood glucose, as well as glucose trends, will
      be measured using Continuous Glucose Monitor (CGM). Participants will also be asked to take
      simple cognitive tests on a study-provided smartphone each day of the study and report their
      daily food intake and physical activity.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: CGM devices will be blinded.
measure: Fasting glucose
time frame: 2 weeks
description: Measured by continuous glucose monitoring (interstitial glucose)
measure: Glucose trends
time frame: 2 weeks
description: Measured by continuous glucose monitoring (interstitial glucose)
measure: Inhibitory control
time frame: 2 weeks
description: Measured by smartphone-based cognitive task
arm group label: Almond Butter
arm group type: Experimental
description: Participants will consume one ounce per day (~32 g) of almond butter as an evening snack (i.e., after dinner and before sleep).
arm group label: No-snack Control
arm group type: No Intervention
description: Participants will consume nothing besides water after dinner/bed sleep.
intervention type: Other
intervention name: Almond Butter
description: Natural almond butter
arm group label: Almond Butter
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Penny M Kris-Etherton, PhD, RDN
role: Principal Investigator
affiliation: Penn State
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Penn State University
investigator full name: Penny
investigator title: Distinguished Professor of Nutrition
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No
submitted: October 4, 2021
returned: October 26, 2021
submitted: August 4, 2022
returned: August 25, 2022
submitted: September 15, 2023