Weight Trajectory
Conditions
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.
Interventions
DIETARY_SUPPLEMENTgamma-linolenic acid
3 capsules per day of GLA for 24 months
DIETARY_SUPPLEMENTplacebo
3 capsules per day of placebo for 24 months
Sponsors
Virta Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in change in body weight between groups over time | 0, 12, 18, and 24 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in health-related quality of life between groups over time | 0, 6, 12, 18, and 24 months | Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) administered every 6 months |
| Difference in perceived control over eating between groups over time | 0, 6, 12, 18, and 24 months | Eating Loss of Control Scale (ELOCS) administered every 6 months |
| Difference in body image and satisfaction between groups over time | 0, 6, 12, 18, and 24 months | Body Image States Scale (BISS) administered every 6 months |
| Difference in subjective neuropathy symptoms between groups over time | 0, 6, 12, 18, and 24 months | Michigan Neuropathy Screening Instrument (MNSI) administered every 6 months |
| Difference in hemoglobin A1c between groups over time | Approximately 0, 6, 12, 18, and 24 months | — |
| Difference in ketones between groups over time | 0, 6, 12, 18, and 24 months | Finger prick ketone values |
| Difference in blood glucose between groups over time | 0, 6, 12, 18, and 24 months | Finger prick glucose values |
| Difference in medication prescriptions between groups over time | 0, 6, 12, 18, and 24 months | Prescribed medications obtained from medical record |
Countries
United States
Outcome results
None listed