Gamma-linolenic Acid Supplementation Study

Study Overview
=================
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.

Official Title
-----------------
Effects of Gamma-linolenic Acid Supplementation on Weight Loss Maintenance in the Virta Treatment

Conditions
-----------------
Weight Trajectory

Intervention / Treatment
-----------------
* Dietary Supplement: gamma-linolenic acid
* Dietary Supplement: placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gamma-linolenic acid (GLA) supplementation<br>Sonova GLA safflower oil (840 mg GLA per day) | Dietary Supplement: gamma-linolenic acid<br>* 3 capsules per day of GLA for 24 months<br>|
| Placebo Comparator: placebo control<br>1500 mg 'light' olive oil per day | Dietary Supplement: placebo<br>* 3 capsules per day of placebo for 24 months<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0, 12, 18, and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in subjective neuropathy symptoms between groups over time | Michigan Neuropathy Screening Instrument (MNSI) administered every 6 months | 0, 6, 12, 18, and 24 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 | 0, 6, 12, 18, and 24 months | 
| Difference in perceived control over eating between groups over time | Eating Loss of Control Scale (ELOCS) administered every 6 months | 0, 6, 12, 18, and 24 months | 
| Difference in body image and satisfaction between groups over time | Body Image States Scale (BISS) administered every 6 months | 0, 6, 12, 18, and 24 months | 
| Difference in medication prescriptions between groups over time | Prescribed medications obtained from medical record | 0, 6, 12, 18, and 24 months | 
| Difference in hemoglobin A1c between groups over time |  | Approximately 0, 6, 12, 18, and 24 months | 
| Difference in ketones between groups over time | Finger prick ketone values | 0, 6, 12, 18, and 24 months | 
| Difference in blood glucose between groups over time | Finger prick glucose values | 0, 6, 12, 18, and 24 months |