<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/NCT04499599</url>
  </required_header>
  <id_info>
    <org_study_id>20201920</org_study_id>
    <nct_id>NCT04499599</nct_id>
  </id_info>
  <brief_title>Effects of Fast Bar on Physiological Fasting</brief_title>
  <acronym>FastBar</acronym>
  <official_title>Randomized, Single-blinded, Controlled, Parallel-arm Study to Evaluate the Effect of Fast Bar(TM) on Physiological Fasting Condition</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>L-Nutra Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>L-Nutra Inc</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>
      This study evaluates how Fast Bar(TM), a specially formulated energy bar, affects the&#xD;
      physiological condition in participants after an overnight fasting. Participants will fast&#xD;
      for 19 hours (Fast Group), consume a breakfast Bar (Breakfast Group) or a Fast Bar(TM) (Fast&#xD;
      Bar Group) after an approximately 15-hour overnight fasting. Participants will be assessed&#xD;
      for physiological parameters associated with fasting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Interest in fasting-based programs (i.e. intermittent fasting) for improvement of health and&#xD;
      longevity continues to grow. While benefits of intermittent fasting have been convincingly&#xD;
      demonstrated in rodent models, the more limited data in humans is less clear.&#xD;
&#xD;
      The short-term fasting (e.g. 12 to 48 hours in duration) utilized in many intermittent&#xD;
      fasting programs are considered safe, but some individuals may find them subjectively&#xD;
      difficult. As such, the question of whether the benefits of fasting can be obtained while&#xD;
      small amounts of food are consumed is of substantial interest.&#xD;
&#xD;
      One commercially available product that is designed to be consumed during periods of&#xD;
      intermittent fasting is the Fast Bar™,which stems out of the well-researched&#xD;
      fasting-mimicking diet to assist prolonged fasting. The unique formulation of the Fast Bar™&#xD;
      is hypothesized to minimize deviations in metabolic biomarkers associated with a fasting&#xD;
      state. This may allow for extension of a fasting period through reduced subjective difficulty&#xD;
      of fasting.The objective of this study is to evaluate the metabolic and subjective effects of&#xD;
      consuming a novel food product (Fast Bar™) after a short period of fasting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Actual">September 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 28, 2020</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>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>For comparison between the placebo breakfast bar and the Fast Bar groups, the participants are masked.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Ketone Area Under the Curve</measure>
    <time_frame>BHB Area Under the Curve between 0 to 4 hours after consuming the study foods</time_frame>
    <description>Blood ketone (ß-hydroxybutyrate, BHB) area under the curve (AUC) will be measured with a Abbott Precision Xtra Blood Glucose and Ketone Monitoring Meter Kit on 0, 1, 2, 3, and 4 hours after consuming the study foods.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glucose Area Under the Curve</measure>
    <time_frame>Glucose Area Under the Curve between 0 to 4 hours after consuming the study foods</time_frame>
    <description>Blood glucose area under the curve (AUC) will be measured with a Abbott Precision Xtra Blood Glucose and Ketone Monitoring Meter Kit on 0, 1, 2, 3, and 4 hours after consuming the study foods.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Fasting</condition>
  <arm_group>
    <arm_group_label>Fast Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 19 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Breakfast Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 15 hours and then consume a breakfast bar on day 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fast Bar Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 15 hours and then consume a Fast Bar on day 2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dinner</intervention_name>
    <description>Study subjects will consume a standardized ready-to-eat meal as dinner.</description>
    <arm_group_label>Breakfast Group</arm_group_label>
    <arm_group_label>Fast Bar Group</arm_group_label>
    <arm_group_label>Fast Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fasting</intervention_name>
    <description>Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours.</description>
    <arm_group_label>Breakfast Group</arm_group_label>
    <arm_group_label>Fast Bar Group</arm_group_label>
    <arm_group_label>Fast Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Study food</intervention_name>
    <description>Study subjects will either continue to fast for 6 hours (Fast Group), consume either a breakfast (Breakfast Group) or a Fast Bar (Fast Bar Group).</description>
    <arm_group_label>Breakfast Group</arm_group_label>
    <arm_group_label>Fast Bar Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability and willingness to provide written informed consent;&#xD;
&#xD;
          -  Ability and willingness to use Zoom teleconference;&#xD;
&#xD;
          -  Ability and willingness to perform the study tests and adhere to study protocol (to&#xD;
             the best of the participant's knowledge);&#xD;
&#xD;
          -  BMI 20-35 kg/m2 (inclusive) at screening;&#xD;
&#xD;
          -  In good health (as determined by medical history to evaluate acute or ongoing chronic&#xD;
             medical diagnoses/conditions that have been present for at least 90 days).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has any medical disease or condition that, in the opinion of the principal&#xD;
             investigator (PI) or appropriate study personnel, precludes study participation*&#xD;
             (*Including acute, subacute, intermittent or chronic medical disease or condition that&#xD;
             would place the subject at an unacceptable risk of injury, render the subject unable&#xD;
             to meet the requirements of the protocol, or may interfere with the evaluation of&#xD;
             responses or the subject's successful completion of this trial);&#xD;
&#xD;
          -  History of gastric bypass (based on medical history provided at screening);&#xD;
&#xD;
          -  Under medications aimed at keeping blood glucose under control (based on medical&#xD;
             history provided at screening);&#xD;
&#xD;
          -  Type 1 diabetes (based on medical history provided at screening);&#xD;
&#xD;
          -  Taking insulin, insulin analogs, or octreotide (based on medical history provided at&#xD;
             screening);&#xD;
&#xD;
          -  Food allergies which would make the subject unable to consume the food provided (based&#xD;
             on medical history and information provided at screening) (participants will be asked&#xD;
             to review the ingredient lists for the dinner meal, the breakfast and the Fast Bar,&#xD;
             and to state that they are not allergic to the ingredients to the best of their&#xD;
             knowledge);&#xD;
&#xD;
          -  Women who are pregnant;&#xD;
&#xD;
          -  Alcohol dependency (alcohol intake greater than two drinks per day for women and three&#xD;
             drinks per day for men) (based on medical history and information provided at&#xD;
             screening).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William C Hsu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>L-Nutra Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>L-Nutra Inc.</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <results_first_submitted>September 4, 2021</results_first_submitted>
  <results_first_submitted_qc>September 4, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 4, 2021</results_first_posted>
  <last_update_submitted>September 4, 2021</last_update_submitted>
  <last_update_submitted_qc>September 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fast Bar</keyword>
  <keyword>Fasting</keyword>
  <keyword>Intermittent fasting</keyword>
  <keyword>Ketone bodies</keyword>
  <keyword>ß-hydroxybutyrate</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 19, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT04499599/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 13, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT04499599/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Fast Group</title>
          <description>Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 19 hours.&#xD;
Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner.&#xD;
Fasting: Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours.</description>
        </group>
        <group group_id="P2">
          <title>Breakfast Group</title>
          <description>Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 15 hours and then consume a breakfast bar on day 2.&#xD;
Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner.&#xD;
Fasting: Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours.&#xD;
Study food: Study subjects will either continue to fast for 6 hours (Fast Group), consume either a breakfast (Breakfast Group) or a Fast Bar (Fast Bar Group).</description>
        </group>
        <group group_id="P3">
          <title>Fast Bar Group</title>
          <description>Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 15 hours and then consume a Fast Bar on day 2.&#xD;
Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner.&#xD;
Fasting: Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours.&#xD;
Study food: Study subjects will either continue to fast for 6 hours (Fast Group), consume either a breakfast (Breakfast Group) or a Fast Bar (Fast Bar Group).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="35"/>
                <participants group_id="P3" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="35"/>
                <participants group_id="P3" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Fast Group</title>
          <description>Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 19 hours.&#xD;
Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner.&#xD;
Fasting: Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours.</description>
        </group>
        <group group_id="B2">
          <title>Breakfast Group</title>
          <description>Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 15 hours and then consume a breakfast bar on day 2.&#xD;
Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner.&#xD;
Fasting: Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours.&#xD;
Study food: Study subjects will either continue to fast for 6 hours (Fast Group), consume either a breakfast (Breakfast Group) or a Fast Bar (Fast Bar Group).</description>
        </group>
        <group group_id="B3">
          <title>Fast Bar Group</title>
          <description>Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 15 hours and then consume a Fast Bar on day 2.&#xD;
Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner.&#xD;
Fasting: Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours.&#xD;
Study food: Study subjects will either continue to fast for 6 hours (Fast Group), consume either a breakfast (Breakfast Group) or a Fast Bar (Fast Bar Group).</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="35"/>
            <count group_id="B2" value="35"/>
            <count group_id="B3" value="35"/>
            <count group_id="B4" value="105"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46" spread="11.5"/>
                    <measurement group_id="B2" value="45.9" spread="12.5"/>
                    <measurement group_id="B3" value="46.4" spread="10.9"/>
                    <measurement group_id="B4" value="46.1" spread="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="72"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Ketone Area Under the Curve</title>
        <description>Blood ketone (ß-hydroxybutyrate, BHB) area under the curve (AUC) will be measured with a Abbott Precision Xtra Blood Glucose and Ketone Monitoring Meter Kit on 0, 1, 2, 3, and 4 hours after consuming the study foods.</description>
        <time_frame>BHB Area Under the Curve between 0 to 4 hours after consuming the study foods</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fast Group</title>
            <description>Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 19 hours.&#xD;
Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner.&#xD;
Fasting: Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours.</description>
          </group>
          <group group_id="O2">
            <title>Breakfast Group</title>
            <description>Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 15 hours and then consume a breakfast bar on day 2.&#xD;
Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner.&#xD;
Fasting: Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours.&#xD;
Study food: Study subjects will either continue to fast for 6 hours (Fast Group), consume either a breakfast (Breakfast Group) or a Fast Bar (Fast Bar Group).</description>
          </group>
          <group group_id="O3">
            <title>Fast Bar Group</title>
            <description>Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 15 hours and then consume a Fast Bar on day 2.&#xD;
Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner.&#xD;
Fasting: Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours.&#xD;
Study food: Study subjects will either continue to fast for 6 hours (Fast Group), consume either a breakfast (Breakfast Group) or a Fast Bar (Fast Bar Group).</description>
          </group>
        </group_list>
        <measure>
          <title>Ketone Area Under the Curve</title>
          <description>Blood ketone (ß-hydroxybutyrate, BHB) area under the curve (AUC) will be measured with a Abbott Precision Xtra Blood Glucose and Ketone Monitoring Meter Kit on 0, 1, 2, 3, and 4 hours after consuming the study foods.</description>
          <units>mg/dL*h</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="35"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.27" spread=".53"/>
                    <measurement group_id="O2" value="0.62" spread="0.18"/>
                    <measurement group_id="O3" value="1.17" spread="0.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Glucose Area Under the Curve</title>
        <description>Blood glucose area under the curve (AUC) will be measured with a Abbott Precision Xtra Blood Glucose and Ketone Monitoring Meter Kit on 0, 1, 2, 3, and 4 hours after consuming the study foods.</description>
        <time_frame>Glucose Area Under the Curve between 0 to 4 hours after consuming the study foods</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fast Group</title>
            <description>Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 19 hours.&#xD;
Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner.&#xD;
Fasting: Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours.</description>
          </group>
          <group group_id="O2">
            <title>Breakfast Group</title>
            <description>Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 15 hours and then consume a breakfast bar on day 2.&#xD;
Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner.&#xD;
Fasting: Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours.&#xD;
Study food: Study subjects will either continue to fast for 6 hours (Fast Group), consume either a breakfast (Breakfast Group) or a Fast Bar (Fast Bar Group).</description>
          </group>
          <group group_id="O3">
            <title>Fast Bar Group</title>
            <description>Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 15 hours and then consume a Fast Bar on day 2.&#xD;
Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner.&#xD;
Fasting: Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours.&#xD;
Study food: Study subjects will either continue to fast for 6 hours (Fast Group), consume either a breakfast (Breakfast Group) or a Fast Bar (Fast Bar Group).</description>
          </group>
        </group_list>
        <measure>
          <title>Glucose Area Under the Curve</title>
          <description>Blood glucose area under the curve (AUC) will be measured with a Abbott Precision Xtra Blood Glucose and Ketone Monitoring Meter Kit on 0, 1, 2, 3, and 4 hours after consuming the study foods.</description>
          <units>mg/dL*h</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="35"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="365" spread="50"/>
                    <measurement group_id="O2" value="401.4" spread="42.3"/>
                    <measurement group_id="O3" value="363.5" spread="37.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 days.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Fast Group</title>
          <description>Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 19 hours.&#xD;
Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner.&#xD;
Fasting: Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours.</description>
        </group>
        <group group_id="E2">
          <title>Breakfast Group</title>
          <description>Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 15 hours and then consume a breakfast bar on day 2.&#xD;
Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner.&#xD;
Fasting: Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours.&#xD;
Study food: Study subjects will either continue to fast for 6 hours (Fast Group), consume either a breakfast (Breakfast Group) or a Fast Bar (Fast Bar Group).</description>
        </group>
        <group group_id="E3">
          <title>Fast Bar Group</title>
          <description>Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 15 hours and then consume a Fast Bar on day 2.&#xD;
Dinner: Study subjects will consume a standardized ready-to-eat meal as dinner.&#xD;
Fasting: Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours.&#xD;
Study food: Study subjects will either continue to fast for 6 hours (Fast Group), consume either a breakfast (Breakfast Group) or a Fast Bar (Fast Bar Group).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Min Wei</name_or_title>
      <organization>L-Nutra, Inc.</organization>
      <phone>323.791.2426</phone>
      <email>mwei@l-nutra.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04499599
org study id: 20201920
nct id: NCT04499599
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates how Fast Bar(TM), a specially formulated energy bar, affects the
      physiological condition in participants after an overnight fasting. Participants will fast
      for 19 hours (Fast Group), consume a breakfast Bar (Breakfast Group) or a Fast Bar(TM) (Fast
      Bar Group) after an approximately 15-hour overnight fasting. Participants will be assessed
      for physiological parameters associated with fasting.
Interest in fasting-based programs (i.e. intermittent fasting) for improvement of health and
      longevity continues to grow. While benefits of intermittent fasting have been convincingly
      demonstrated in rodent models, the more limited data in humans is less clear.

      The short-term fasting (e.g. 12 to 48 hours in duration) utilized in many intermittent
      fasting programs are considered safe, but some individuals may find them subjectively
      difficult. As such, the question of whether the benefits of fasting can be obtained while
      small amounts of food are consumed is of substantial interest.

      One commercially available product that is designed to be consumed during periods of
      intermittent fasting is the Fast Bar™,which stems out of the well-researched
      fasting-mimicking diet to assist prolonged fasting. The unique formulation of the Fast Bar™
      is hypothesized to minimize deviations in metabolic biomarkers associated with a fasting
      state. This may allow for extension of a fasting period through reduced subjective difficulty
      of fasting.The objective of this study is to evaluate the metabolic and subjective effects of
      consuming a novel food product (Fast Bar™) after a short period of fasting.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Outcomes Assessor)
masking description: For comparison between the placebo breakfast bar and the Fast Bar groups, the participants are masked.
measure: Ketone Area Under the Curve
time frame: BHB Area Under the Curve between 0 to 4 hours after consuming the study foods
description: Blood ketone (ß-hydroxybutyrate, BHB) area under the curve (AUC) will be measured with a Abbott Precision Xtra Blood Glucose and Ketone Monitoring Meter Kit on 0, 1, 2, 3, and 4 hours after consuming the study foods.
measure: Glucose Area Under the Curve
time frame: Glucose Area Under the Curve between 0 to 4 hours after consuming the study foods
description: Blood glucose area under the curve (AUC) will be measured with a Abbott Precision Xtra Blood Glucose and Ketone Monitoring Meter Kit on 0, 1, 2, 3, and 4 hours after consuming the study foods.
arm group label: Fast Group
arm group type: Active Comparator
description: Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 19 hours.
arm group label: Breakfast Group
arm group type: Placebo Comparator
description: Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 15 hours and then consume a breakfast bar on day 2.
arm group label: Fast Bar Group
arm group type: Experimental
description: Subjects will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1. Subjects will fast overnight for approximately 15 hours and then consume a Fast Bar on day 2.
intervention type: Other
intervention name: Dinner
description: Study subjects will consume a standardized ready-to-eat meal as dinner.
arm group label: Breakfast Group
arm group label: Fast Bar Group
arm group label: Fast Group
intervention type: Other
intervention name: Fasting
description: Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours.
arm group label: Breakfast Group
arm group label: Fast Bar Group
arm group label: Fast Group
intervention type: Other
intervention name: Study food
description: Study subjects will either continue to fast for 6 hours (Fast Group), consume either a breakfast (Breakfast Group) or a Fast Bar (Fast Bar Group).
arm group label: Breakfast Group
arm group label: Fast Bar Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: William C Hsu, MD
role: Principal Investigator
affiliation: L-Nutra Inc
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 