Gamma-linolenic Acid Supplementation Study

NCT ID: NCT04481724

Last Updated: 2024-04-24

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-22

Study Completion Date

2023-09-15

Brief Summary

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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

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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.

Conditions

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Weight Trajectory

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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gamma-linolenic acid (GLA) supplementation

Sonova GLA safflower oil (840 mg GLA per day)

Group Type EXPERIMENTAL

gamma-linolenic acid

Intervention Type DIETARY_SUPPLEMENT

3 capsules per day of GLA for 24 months

placebo control

1500 mg 'light' olive oil per day

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

placebo

3 capsules per day of placebo for 24 months

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Virta Health

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Other Identifiers

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2019-6

Identifier Type: -

Identifier Source: org_study_id

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