Clinical trial NCT04481724: Gamma-linolenic Acid Supplementation Study
Official title: Effects of Gamma-linolenic Acid Supplementation on Weight Loss Maintenance in the Virta Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Trajectory
Lead sponsor: Virta Health
Sponsor class: INDUSTRY
First posted: 2020-07-22
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Difference in change in body weight between groups over time
timeFrame: 0, 12, 18, and 24 months
Secondary outcomes:
measure: Difference in subjective neuropathy symptoms between groups over time
timeFrame: 0, 6, 12, 18, and 24 months
measure: Difference in health-related quality of life between groups over time
timeFrame: 0, 6, 12, 18, and 24 months
measure: Difference in perceived control over eating between groups over time
timeFrame: 0, 6, 12, 18, and 24 months
measure: Difference in body image and satisfaction between groups over time
timeFrame: 0, 6, 12, 18, and 24 months
measure: Difference in medication prescriptions between groups over time
timeFrame: 0, 6, 12, 18, and 24 months
measure: Difference in hemoglobin A1c between groups over time
timeFrame: Approximately 0, 6, 12, 18, and 24 months
measure: Difference in ketones between groups over time
timeFrame: 0, 6, 12, 18, and 24 months
measure: Difference in blood glucose between groups over time
timeFrame: 0, 6, 12, 18, and 24 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Virta Health
state: California
Study officials:
affiliation: Virta Health
name: Shaminie Athinarayanan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virta Health
name: Rebecca Adams, PhD
role: STUDY_DIRECTOR
References: