<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/NCT04481724</url>
  </required_header>
  <id_info>
    <org_study_id>2019-6</org_study_id>
    <nct_id>NCT04481724</nct_id>
  </id_info>
  <brief_title>Gamma-linolenic Acid Supplementation Study</brief_title>
  <acronym>GLASS</acronym>
  <official_title>Effects of Gamma-linolenic Acid Supplementation on Weight Loss Maintenance in the Virta Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Virta Health</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Virta Health</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>
      Weight regain following weight loss is common. In rodent models of obesity and pilot studies&#xD;
      in humans, increasing membrane arachidonic acid content improves fuel partitioning and&#xD;
      prevents weight regain. This study aims to understand the effect of gamma-linolenic acid&#xD;
      (GLA) supplementation on weight loss maintenance in Virta Health patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary purpose of this research is to determine if GLA supplementation reduces weight&#xD;
      regain over 24 months in Virta Health patients.&#xD;
&#xD;
      The secondary purpose is to determine the effect of GLA supplementation on diabetes-related&#xD;
      outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 22, 2020</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</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>
    <intervention_model_description>Participants will be randomized 3:1, GLA:placebo. Interim analyses of the primary outcome will be performed at 12 and 18 months; if greater weight loss is maintained in the GLA compared to placebo group, the study will be unblinded and placebo group participants will cross over to the GLA group for the remainder of the trial.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in change in body weight between groups over time</measure>
    <time_frame>0, 12, 18, and 24 months</time_frame>
    <description>Body weight measured on a calibrated scale. Interim analyses at 12 and 18 months; if greater weight loss is maintained in the GLA compared to placebo group, the study will be unblinded and placebo group participants will cross over to GLA for the remainder of the trial.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in subjective neuropathy symptoms between groups over time</measure>
    <time_frame>0, 6, 12, 18, and 24 months</time_frame>
    <description>Michigan Neuropathy Screening Instrument (MNSI) administered every 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in health-related quality of life between groups over time</measure>
    <time_frame>0, 6, 12, 18, and 24 months</time_frame>
    <description>Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) administered every 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in perceived control over eating between groups over time</measure>
    <time_frame>0, 6, 12, 18, and 24 months</time_frame>
    <description>Eating Loss of Control Scale (ELOCS) administered every 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in body image and satisfaction between groups over time</measure>
    <time_frame>0, 6, 12, 18, and 24 months</time_frame>
    <description>Body Image States Scale (BISS) administered every 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in medication prescriptions between groups over time</measure>
    <time_frame>0, 6, 12, 18, and 24 months</time_frame>
    <description>Prescribed medications obtained from medical record</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in hemoglobin A1c between groups over time</measure>
    <time_frame>Approximately 0, 6, 12, 18, and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in ketones between groups over time</measure>
    <time_frame>0, 6, 12, 18, and 24 months</time_frame>
    <description>Finger prick ketone values</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in blood glucose between groups over time</measure>
    <time_frame>0, 6, 12, 18, and 24 months</time_frame>
    <description>Finger prick glucose values</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">302</enrollment>
  <condition>Weight Trajectory</condition>
  <arm_group>
    <arm_group_label>gamma-linolenic acid (GLA) supplementation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sonova GLA safflower oil (840 mg GLA per day)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>1500 mg 'light' olive oil per day</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>gamma-linolenic acid</intervention_name>
    <description>3 capsules per day of GLA for 24 months</description>
    <arm_group_label>gamma-linolenic acid (GLA) supplementation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>3 capsules per day of placebo for 24 months</description>
    <arm_group_label>placebo control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age greater than or equal to 18 yrs&#xD;
&#xD;
          -  Patients referred to Virta Health by employers or insurers&#xD;
&#xD;
          -  Weight loss greater than or equal to 7% of initial weight and current BMI &gt; 25 kg/m2&#xD;
&#xD;
          -  Willing to take 3 supplement capsules daily&#xD;
&#xD;
          -  Able to understand study procedures and willing to provide informed consent&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are pregnant or lactating&#xD;
&#xD;
          -  Patients who are taking or are prescribed orlistat&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shaminie Athinarayanan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Virta Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rebecca Adams, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Virta Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Virta Health</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>October 11, 2022</last_update_submitted>
  <last_update_submitted_qc>October 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body-Weight Trajectory</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Evening primrose oil</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Identifiers will be removed and data could then be used for future research studies or distributed to another investigator for future research studies without additional informed consent.</ipd_description>
  </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/NCT04481724
org study id: 2019-6
nct id: NCT04481724
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Weight regain following weight loss is common. In rodent models of obesity and pilot studies
      in humans, increasing membrane arachidonic acid content improves fuel partitioning and
      prevents weight regain. This study aims to understand the effect of gamma-linolenic acid
      (GLA) supplementation on weight loss maintenance in Virta Health patients.
The primary purpose of this research is to determine if GLA supplementation reduces weight
      regain over 24 months in Virta Health patients.

      The secondary purpose is to determine the effect of GLA supplementation on diabetes-related
      outcomes.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomized 3:1, GLA:placebo. Interim analyses of the primary outcome will be performed at 12 and 18 months; if greater weight loss is maintained in the GLA compared to placebo group, the study will be unblinded and placebo group participants will cross over to the GLA group for the remainder of the trial.
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Investigator)
measure: Difference in change in body weight between groups over time
time frame: 0, 12, 18, and 24 months
description: Body weight measured on a calibrated scale. Interim analyses at 12 and 18 months; if greater weight loss is maintained in the GLA compared to placebo group, the study will be unblinded and placebo group participants will cross over to GLA for the remainder of the trial.
measure: Difference in subjective neuropathy symptoms between groups over time
time frame: 0, 6, 12, 18, and 24 months
description: Michigan Neuropathy Screening Instrument (MNSI) administered every 6 months
measure: Difference in health-related quality of life between groups over time
time frame: 0, 6, 12, 18, and 24 months
description: Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) administered every 6 months
measure: Difference in perceived control over eating between groups over time
time frame: 0, 6, 12, 18, and 24 months
description: Eating Loss of Control Scale (ELOCS) administered every 6 months
measure: Difference in body image and satisfaction between groups over time
time frame: 0, 6, 12, 18, and 24 months
description: Body Image States Scale (BISS) administered every 6 months
measure: Difference in medication prescriptions between groups over time
time frame: 0, 6, 12, 18, and 24 months
description: Prescribed medications obtained from medical record
measure: Difference in hemoglobin A1c between groups over time
time frame: Approximately 0, 6, 12, 18, and 24 months
measure: Difference in ketones between groups over time
time frame: 0, 6, 12, 18, and 24 months
description: Finger prick ketone values
measure: Difference in blood glucose between groups over time
time frame: 0, 6, 12, 18, and 24 months
description: Finger prick glucose values
arm group label: gamma-linolenic acid (GLA) supplementation
arm group type: Experimental
description: Sonova GLA safflower oil (840 mg GLA per day)
arm group label: placebo control
arm group type: Placebo Comparator
description: 1500 mg 'light' olive oil per day
intervention type: Dietary Supplement
intervention name: gamma-linolenic acid
description: 3 capsules per day of GLA for 24 months
arm group label: gamma-linolenic acid (GLA) supplementation
intervention type: Dietary Supplement
intervention name: placebo
description: 3 capsules per day of placebo for 24 months
arm group label: placebo control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shaminie Athinarayanan, PhD
role: Principal Investigator
affiliation: Virta Health
last name: Rebecca Adams, PhD
role: Study Director
affiliation: Virta Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Body-Weight Trajectory
mesh term: Evening primrose oil
sharing ipd: Yes
ipd description: Identifiers will be removed and data could then be used for future research studies or distributed to another investigator for future research studies without additional informed consent.