Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
302 participants
INTERVENTIONAL
2020-07-22
2023-09-15
Brief Summary
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Detailed Description
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The secondary purpose is to determine the effect of GLA supplementation on diabetes-related outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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gamma-linolenic acid (GLA) supplementation
Sonova GLA safflower oil (840 mg GLA per day)
gamma-linolenic acid
3 capsules per day of GLA for 24 months
placebo control
1500 mg 'light' olive oil per day
placebo
3 capsules per day of placebo for 24 months
Interventions
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gamma-linolenic acid
3 capsules per day of GLA for 24 months
placebo
3 capsules per day of placebo for 24 months
Eligibility Criteria
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Inclusion Criteria
* 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 taking or are prescribed orlistat
18 Years
ALL
No
Sponsors
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Virta Health
INDUSTRY
Responsible Party
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Principal Investigators
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Shaminie Athinarayanan, PhD
Role: PRINCIPAL_INVESTIGATOR
Virta Health
Rebecca Adams, PhD
Role: STUDY_DIRECTOR
Virta Health
Locations
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Virta Health
San Francisco, California, United States
Countries
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Other Identifiers
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2019-6
Identifier Type: -
Identifier Source: org_study_id
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