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Gamma-linolenic Acid Supplementation Study (GLASS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04481724
Recruitment Status : Active, not recruiting
First Posted : July 22, 2020
Last Update Posted : October 13, 2022
Sponsor:
Information provided by (Responsible Party):
Virta Health

Tracking Information
First Submitted Date  ICMJE July 19, 2020
First Posted Date  ICMJE July 22, 2020
Last Update Posted Date October 13, 2022
Actual Study Start Date  ICMJE July 22, 2020
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2020)
Difference in change in body weight between groups over time [ Time Frame: 0, 12, 18, and 24 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2020)
  • Difference in subjective neuropathy symptoms between groups over time [ Time Frame: 0, 6, 12, 18, and 24 months ]
    Michigan Neuropathy Screening Instrument (MNSI) administered every 6 months
  • Difference in health-related quality of life between groups over time [ Time Frame: 0, 6, 12, 18, and 24 months ]
    Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) administered every 6 months
  • Difference in perceived control over eating between groups over time [ Time Frame: 0, 6, 12, 18, and 24 months ]
    Eating Loss of Control Scale (ELOCS) administered every 6 months
  • Difference in body image and satisfaction between groups over time [ Time Frame: 0, 6, 12, 18, and 24 months ]
    Body Image States Scale (BISS) administered every 6 months
  • Difference in medication prescriptions between groups over time [ Time Frame: 0, 6, 12, 18, and 24 months ]
    Prescribed medications obtained from medical record
  • Difference in hemoglobin A1c between groups over time [ Time Frame: Approximately 0, 6, 12, 18, and 24 months ]
  • Difference in ketones between groups over time [ Time Frame: 0, 6, 12, 18, and 24 months ]
    Finger prick ketone values
  • Difference in blood glucose between groups over time [ Time Frame: 0, 6, 12, 18, and 24 months ]
    Finger prick glucose values
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gamma-linolenic Acid Supplementation Study
Official Title  ICMJE Effects of Gamma-linolenic Acid Supplementation on Weight Loss Maintenance in the Virta Treatment
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Weight Trajectory
Intervention  ICMJE
  • Dietary Supplement: gamma-linolenic acid
    3 capsules per day of GLA for 24 months
  • Dietary Supplement: placebo
    3 capsules per day of placebo for 24 months
Study Arms  ICMJE
  • Experimental: gamma-linolenic acid (GLA) supplementation
    Sonova GLA safflower oil (840 mg GLA per day)
    Intervention: Dietary Supplement: gamma-linolenic acid
  • Placebo Comparator: placebo control
    1500 mg 'light' olive oil per day
    Intervention: Dietary Supplement: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 29, 2021)
302
Original Estimated Enrollment  ICMJE
 (submitted: July 19, 2020)
296
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age greater than or equal to 18 yrs
  • Patients referred to Virta Health by employers or insurers
  • Weight loss greater than or equal to 7% of initial weight and current BMI > 25 kg/m2
  • Willing to take 3 supplement capsules daily
  • Able to understand study procedures and willing to provide informed consent
  • English-speaking

Exclusion Criteria:

  • Patients who are pregnant or lactating
  • Patients who are taking or are prescribed orlistat
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04481724
Other Study ID Numbers  ICMJE 2019-6
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan 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.
Current Responsible Party Virta Health
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Virta Health
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shaminie Athinarayanan, PhD Virta Health
Study Director: Rebecca Adams, PhD Virta Health
PRS Account Virta Health
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP