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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Weight Trajectory Dietary Supplement: gamma-linolenic acid Dietary Supplement: placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 302 participants
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
Official Title: Effects of Gamma-linolenic Acid Supplementation on Weight Loss Maintenance in the Virta Treatment
Actual Study Start Date : July 22, 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: gamma-linolenic acid (GLA) supplementation
Sonova GLA safflower oil (840 mg GLA per day)
 Dietary Supplement: gamma-linolenic acid
3 capsules per day of GLA for 24 months
Placebo Comparator: placebo control
1500 mg 'light' olive oil per day
 Dietary Supplement: placebo
3 capsules per day of placebo for 24 months


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. Difference in medication prescriptions between groups over time [ Time Frame: 0, 6, 12, 18, and 24 months ]
    Prescribed medications obtained from medical record

  6. Difference in hemoglobin A1c between groups over time [ Time Frame: Approximately 0, 6, 12, 18, and 24 months ]
  7. Difference in ketones between groups over time [ Time Frame: 0, 6, 12, 18, and 24 months ]
    Finger prick ketone values

  8. Difference in blood glucose between groups over time [ Time Frame: 0, 6, 12, 18, and 24 months ]
    Finger prick glucose values


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04481724


Locations
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United States, California
Virta Health
San Francisco, California, United States, 94105
Sponsors and Collaborators
Virta Health
Investigators
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Principal Investigator: Shaminie Athinarayanan, PhD Virta Health
Study Director: Rebecca Adams, PhD Virta Health
More Information
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Responsible Party: Virta Health
ClinicalTrials.gov Identifier: NCT04481724    
Other Study ID Numbers: 2019-6
First Posted: July 22, 2020    Key Record Dates
Last Update Posted: October 13, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Body-Weight Trajectory
Body Weight Changes
Body Weight
Evening primrose oil
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Dermatologic Agents