Gamma-linolenic Acid Supplementation Study

Not Applicable

Completed

• Conditions: Weight Trajectory
• Interventions: Dietary Supplement: gamma-linolenic acid; Dietary Supplement: placebo

• Registration Number: NCT04481724
• Lead Sponsor: Virta Health

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.

Study Timeline

• Study First Submitted: 2020-07-19
• Study First Submitted QC: 2020-07-19
• Study Start: 2020-07-22
• Study First Posted: 2020-07-22
• Primary Completion: 2023-02-13
• Study Completion: 2023-09-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 302

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
gamma-linolenic acid (GLA) supplementation	gamma-linolenic acid	Sonova GLA safflower oil (840 mg GLA per day)
placebo control	placebo	1500 mg 'light' olive oil per day

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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 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 medication prescriptions between groups over time	0, 6, 12, 18, and 24 months	Prescribed medications obtained from medical record
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

Trial Locations

Locations (1)

Virta Health; 🇺🇸 San Francisco, California, United States