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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
302
3 capsules per day of GLA for 24 months
3 capsules per day of placebo for 24 months
Virta Health
San Francisco, California, United States
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.
Time frame: 0, 12, 18, and 24 months
Difference in subjective neuropathy symptoms between groups over time
Michigan Neuropathy Screening Instrument (MNSI) administered every 6 months
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 0, 6, 12, 18, and 24 months
Difference in medication prescriptions between groups over time
Prescribed medications obtained from medical record
Time frame: 0, 6, 12, 18, and 24 months
Difference in hemoglobin A1c between groups over time
Time frame: Approximately 0, 6, 12, 18, and 24 months
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Difference in ketones between groups over time
Finger prick ketone values
Time frame: 0, 6, 12, 18, and 24 months
Difference in blood glucose between groups over time
Finger prick glucose values
Time frame: 0, 6, 12, 18, and 24 months