<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/NCT04492930</url>
  </required_header>
  <id_info>
    <org_study_id>RRM-102</org_study_id>
    <nct_id>NCT04492930</nct_id>
  </id_info>
  <brief_title>Effect of 14:10 Time-Restricted Eating on Body Weight and Metabolic Markers</brief_title>
  <official_title>The Effect of 14:10 Hour Time Restricted Eating on Body Weight and Metabolic Markers: An 8-Week Pilot Study in Individuals With Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jenny Craig, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jenny Craig, 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>
      The purpose of this study is to investigate the effect of engaging in time restricted eating&#xD;
      schedule on body weight, blood glucose, and ketones (breath acetone) in individuals with&#xD;
      obesity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are significant metabolic and weight reduction benefits associated with time restricted&#xD;
      feeding/eating. Time restricted eating splits the day into a period of regeneration&#xD;
      (non-eating or natural fasting) and a period of nourishing. Providing the body a period of&#xD;
      regeneration allows the body to go into ketosis, or the elevation in circulating ketone&#xD;
      bodies, a byproduct of fat metabolism. Breath acetone concentration is a good predictor of&#xD;
      ketosis and loss of body fat. In healthy individuals, low concentrations of breath acetone&#xD;
      are 1 to 2 ppm. Engaging in weight loss via nutritional ketosis (engaging in high-fat,&#xD;
      low-carbohydrate diets, caloric restriction diets, or fasting) increases fat utilization,&#xD;
      resulting in increased formation of ketone bodies and breath acetone concentrations ranging&#xD;
      from 4 to 30 ppm. In individuals with obesity, nutritional ketosis facilitates weight loss&#xD;
      and improves insulin sensitivity, lipid profile, and reduces inflammatory markers.&#xD;
&#xD;
      This study will investigate the effect of participating in two different time restricted&#xD;
      eating schedules for 8 weeks on body weight, blood glucose, and ketones.&#xD;
&#xD;
      After being informed about the study and potential risks, all eligible participants giving&#xD;
      written informed consent will be randomized to a different time restricted eating schedule&#xD;
      (ie, one group fasts for a longer period of time). In both of these groups, fasting will&#xD;
      begin each evening and end the following morning.&#xD;
&#xD;
      This is a remote study. All procedures will be conducted at home.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 30, 2020</start_date>
  <completion_date type="Actual">October 31, 2020</completion_date>
  <primary_completion_date type="Actual">October 31, 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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in body weight</measure>
    <time_frame>Week 4</time_frame>
    <description>Change from baseline body weight in the intervention group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in ketone levels (breath acetone)</measure>
    <time_frame>Week 8</time_frame>
    <description>Change from baseline in breath acetone in the intervention group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in blood glucose</measure>
    <time_frame>Week 8</time_frame>
    <description>Change from baseline in blood glucose in the intervention group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in body weight</measure>
    <time_frame>Week 8</time_frame>
    <description>Change from baseline body weight in the intervention group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in weight loss between groups</measure>
    <time_frame>Weeks 4 and 8</time_frame>
    <description>Difference in the change from baseline in body weight between the intervention and control groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first meal</measure>
    <time_frame>Weeks 4 and 8</time_frame>
    <description>Change from baseline in the length of time from consumption of the fasting snack until initiation of the first meal in the intervention group</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Correlation between weight loss and change in ketone levels (breath acetone)</measure>
    <time_frame>Week 8</time_frame>
    <description>Correlation between the change from baseline in breath acetone and the change from baseline in body weight</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">113</enrollment>
  <condition>Time Restricted Feeding</condition>
  <arm_group>
    <arm_group_label>Comparator</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Time restricted eating</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Time restricted eating</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>14:10 Regimen</intervention_name>
    <description>14 hours of fasting, followed by a 10-h diet regimen that includes a fasting snack at 12 hours from the start of the fasting period</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>12:12 Regimen</intervention_name>
    <description>12 hours of fasting, followed by a 12-h diet regimen</description>
    <arm_group_label>Comparator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female individuals between the age of 18 to 65 years (inclusive) at the time&#xD;
             of signing the informed consent&#xD;
&#xD;
          2. Enrollment in the Jenny Craig® Rapid Results™ program&#xD;
&#xD;
          3. Access to a tablet or smartphone with a camera and internet access&#xD;
&#xD;
          4. Body mass index (BMI) at least 30 kg/m2&#xD;
&#xD;
          5. Ability to use a glucometer and Levl device (measures breath acetone)&#xD;
&#xD;
          6. Female participants of childbearing potential will agree to avoid pregnancy during the&#xD;
             study. Medically acceptable methods of contraception include oral contraceptive&#xD;
             medication, an intrauterine device (IUD), an implantable contraceptive (such as&#xD;
             Implanon), an injectable contraceptive (such as Depo-Provera), a barrier method (such&#xD;
             as condom or diaphragm with spermicide), abstinence, or having exclusive sexual&#xD;
             relations with a vasectomized or same sex partner.&#xD;
&#xD;
          7. Capable of giving signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current use of the medications indicated for weight management or treatment of&#xD;
             diabetes or for treatment of psychosis&#xD;
&#xD;
          2. Serious allergy to corn, corn products, or gluten (due to the number of Jenny's&#xD;
             Cuisine® items that contain these food ingredients) that results in throat swelling,&#xD;
             rash, hives, or anaphylactic shock&#xD;
&#xD;
          3. Serious allergy to milk, soy, wheat, peanuts, or tree nuts that results in throat&#xD;
             swelling, rash, hives, or anaphylactic shock&#xD;
&#xD;
          4. Celiac disease&#xD;
&#xD;
          5. Currently being treated with hemodialysis&#xD;
&#xD;
          6. Currently being treated for anorexia/bulimia&#xD;
&#xD;
          7. Require a special diet (vegan, kosher, or halal)&#xD;
&#xD;
          8. Had a baby within the last 6 weeks&#xD;
&#xD;
          9. Are currently breastfeeding&#xD;
&#xD;
         10. Are pregnant&#xD;
&#xD;
         11. Bariatric surgery within the previous 3 years&#xD;
&#xD;
         12. Individuals belonging to the following vulnerable populations (people with&#xD;
             disabilities, people who cannot read, educationally disadvantaged, individuals with a&#xD;
             serious or life threatening illness, prisoners, non-English speakers, economically&#xD;
             disadvantaged individuals, employees of the study sponsor)&#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>Pamela Peeke, MD</last_name>
    <role>Study Director</role>
    <affiliation>Jenny Craig, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jenny Craig</name>
      <address>
        <city>Carlsbad</city>
        <state>California</state>
        <zip>92008</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>November 3, 2020</last_update_submitted>
  <last_update_submitted_qc>November 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>body weight</keyword>
  <keyword>weight loss</keyword>
  <keyword>ketones</keyword>
  <keyword>blood glucose</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Weight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymized dataset of selected variables that underlie results in a publication. Some data may not be amenable to complete anonymization and will not be shared to ensure appropriate confidentiality of participant's data.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>beginning 6 months after publication</ipd_time_frame>
    <ipd_access_criteria>Upon appropriate data request by other scientists</ipd_access_criteria>
  </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/NCT04492930
org study id: RRM-102
nct id: NCT04492930
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate the effect of engaging in time restricted eating
      schedule on body weight, blood glucose, and ketones (breath acetone) in individuals with
      obesity.
There are significant metabolic and weight reduction benefits associated with time restricted
      feeding/eating. Time restricted eating splits the day into a period of regeneration
      (non-eating or natural fasting) and a period of nourishing. Providing the body a period of
      regeneration allows the body to go into ketosis, or the elevation in circulating ketone
      bodies, a byproduct of fat metabolism. Breath acetone concentration is a good predictor of
      ketosis and loss of body fat. In healthy individuals, low concentrations of breath acetone
      are 1 to 2 ppm. Engaging in weight loss via nutritional ketosis (engaging in high-fat,
      low-carbohydrate diets, caloric restriction diets, or fasting) increases fat utilization,
      resulting in increased formation of ketone bodies and breath acetone concentrations ranging
      from 4 to 30 ppm. In individuals with obesity, nutritional ketosis facilitates weight loss
      and improves insulin sensitivity, lipid profile, and reduces inflammatory markers.

      This study will investigate the effect of participating in two different time restricted
      eating schedules for 8 weeks on body weight, blood glucose, and ketones.

      After being informed about the study and potential risks, all eligible participants giving
      written informed consent will be randomized to a different time restricted eating schedule
      (ie, one group fasts for a longer period of time). In both of these groups, fasting will
      begin each evening and end the following morning.

      This is a remote study. All procedures will be conducted at home.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in body weight
time frame: Week 4
description: Change from baseline body weight in the intervention group
measure: Change in ketone levels (breath acetone)
time frame: Week 8
description: Change from baseline in breath acetone in the intervention group
measure: Change in blood glucose
time frame: Week 8
description: Change from baseline in blood glucose in the intervention group
measure: Change in body weight
time frame: Week 8
description: Change from baseline body weight in the intervention group
measure: Difference in weight loss between groups
time frame: Weeks 4 and 8
description: Difference in the change from baseline in body weight between the intervention and control groups
measure: Time to first meal
time frame: Weeks 4 and 8
description: Change from baseline in the length of time from consumption of the fasting snack until initiation of the first meal in the intervention group
measure: Correlation between weight loss and change in ketone levels (breath acetone)
time frame: Week 8
description: Correlation between the change from baseline in breath acetone and the change from baseline in body weight
arm group label: Comparator
arm group type: Active Comparator
description: Time restricted eating
arm group label: Intervention
arm group type: Experimental
description: Time restricted eating
intervention type: Behavioral
intervention name: 14:10 Regimen
description: 14 hours of fasting, followed by a 10-h diet regimen that includes a fasting snack at 12 hours from the start of the fasting period
arm group label: Intervention
intervention type: Behavioral
intervention name: 12:12 Regimen
description: 12 hours of fasting, followed by a 12-h diet regimen
arm group label: Comparator
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pamela Peeke, MD
role: Study Director
affiliation: Jenny Craig, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Body Weight
sharing ipd: Yes
ipd description: Anonymized dataset of selected variables that underlie results in a publication. Some data may not be amenable to complete anonymization and will not be shared to ensure appropriate confidentiality of participant's data.
ipd info type: Study Protocol
ipd time frame: beginning 6 months after publication
ipd access criteria: Upon appropriate data request by other scientists