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Gamma-linolenic Acid Supplementation Study (GLASS)

Primary Purpose

Weight Trajectory

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
gamma-linolenic acid
placebo
Sponsored by
Virta Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Weight Trajectory

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Virta Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

gamma-linolenic acid (GLA) supplementation

placebo control

Arm Description

Sonova GLA safflower oil (840 mg GLA per day)

1500 mg 'light' olive oil per day

Outcomes

Primary Outcome Measures

Difference in change in body weight between groups over time
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

Difference in subjective neuropathy symptoms between groups over time
Michigan Neuropathy Screening Instrument (MNSI) administered every 6 months
Difference in health-related quality of life between groups over time
Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) administered every 6 months
Difference in perceived control over eating between groups over time
Eating Loss of Control Scale (ELOCS) administered every 6 months
Difference in body image and satisfaction between groups over time
Body Image States Scale (BISS) administered every 6 months
Difference in medication prescriptions between groups over time
Prescribed medications obtained from medical record
Difference in hemoglobin A1c between groups over time
Difference in ketones between groups over time
Finger prick ketone values
Difference in blood glucose between groups over time
Finger prick glucose values

Full Information

First Posted
July 19, 2020
Last Updated
October 11, 2022
Sponsor
Virta Health
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1. Study Identification

Unique Protocol Identification Number
NCT04481724
Brief Title
Gamma-linolenic Acid Supplementation Study
Acronym
GLASS
Official Title
Effects of Gamma-linolenic Acid Supplementation on Weight Loss Maintenance in the Virta Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 22, 2020 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virta Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Trajectory

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
302 (Actual)

8. Arms, Groups, and Interventions

Arm Title
gamma-linolenic acid (GLA) supplementation
Arm Type
Experimental
Arm Description
Sonova GLA safflower oil (840 mg GLA per day)
Arm Title
placebo control
Arm Type
Placebo Comparator
Arm Description
1500 mg 'light' olive oil per day
Intervention Type
Dietary Supplement
Intervention Name(s)
gamma-linolenic acid
Intervention Description
3 capsules per day of GLA for 24 months
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
3 capsules per day of placebo for 24 months
Primary Outcome Measure Information:
Title
Difference in change in body weight between groups over time
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.
Time Frame
0, 12, 18, and 24 months
Secondary Outcome Measure Information:
Title
Difference in subjective neuropathy symptoms between groups over time
Description
Michigan Neuropathy Screening Instrument (MNSI) administered every 6 months
Time Frame
0, 6, 12, 18, and 24 months
Title
Difference in health-related quality of life between groups over time
Description
Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) administered every 6 months
Time Frame
0, 6, 12, 18, and 24 months
Title
Difference in perceived control over eating between groups over time
Description
Eating Loss of Control Scale (ELOCS) administered every 6 months
Time Frame
0, 6, 12, 18, and 24 months
Title
Difference in body image and satisfaction between groups over time
Description
Body Image States Scale (BISS) administered every 6 months
Time Frame
0, 6, 12, 18, and 24 months
Title
Difference in medication prescriptions between groups over time
Description
Prescribed medications obtained from medical record
Time Frame
0, 6, 12, 18, and 24 months
Title
Difference in hemoglobin A1c between groups over time
Time Frame
Approximately 0, 6, 12, 18, and 24 months
Title
Difference in ketones between groups over time
Description
Finger prick ketone values
Time Frame
0, 6, 12, 18, and 24 months
Title
Difference in blood glucose between groups over time
Description
Finger prick glucose values
Time Frame
0, 6, 12, 18, and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaminie Athinarayanan, PhD
Organizational Affiliation
Virta Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rebecca Adams, PhD
Organizational Affiliation
Virta Health
Official's Role
Study Director
Facility Information:
Facility Name
Virta Health
City
San Francisco
State/Province
California
ZIP/Postal Code
94105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Gamma-linolenic Acid Supplementation Study

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