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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gamma-linolenic acid (GLA) supplementation | Experimental | Sonova GLA safflower oil (840 mg GLA per day) |
|
| placebo control | Placebo Comparator | 1500 mg 'light' olive oil per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gamma-linolenic acid | Dietary Supplement | 3 capsules per day of GLA for 24 months |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shaminie Athinarayanan, PhD | Virta Health | Principal Investigator |
| Rebecca Adams, PhD | Virta Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virta Health | San Francisco | California | 94105 | United States |
Identifiers will be removed and data could then be used for future research studies or distributed to another investigator for future research studies without additional informed consent.
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| ID | Term |
|---|---|
| D000077962 | Body-Weight Trajectory |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017965 | gamma-Linolenic Acid |
| ID | Term |
|---|---|
| D008042 | Linolenic Acids |
| D005228 | Fatty Acids, Essential |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
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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.
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| placebo | Dietary Supplement | 3 capsules per day of placebo for 24 months |
|
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 |
| D008055 |
| Lipids |
| D043371 | Fatty Acids, Omega-6 |