Gamma-linolenic Acid Supplementation Study

NCT04481724 | Completed DMC

• 1 other identifier: 2019-6
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Trajectory

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Difference in subjective neuropathy symptoms between groups over time

  0, 6, 12, 18, and 24 months

• Difference in health-related quality of life between groups over time

  0, 6, 12, 18, and 24 months

• Difference in perceived control over eating between groups over time

  0, 6, 12, 18, and 24 months

• Difference in body image and satisfaction between groups over time

  0, 6, 12, 18, and 24 months

• Difference in medication prescriptions between groups over time

  0, 6, 12, 18, and 24 months

Study Arms (2)

gamma-linolenic acid (GLA) supplementation

EXPERIMENTAL

Sonova GLA safflower oil (840 mg GLA per day)

Dietary Supplement: gamma-linolenic acid

placebo control

PLACEBO COMPARATOR

1500 mg 'light' olive oil per day

Dietary Supplement: placebo

Interventions

gamma-linolenic acid DIETARY_SUPPLEMENT

3 capsules per day of GLA for 24 months

gamma-linolenic acid (GLA) supplementation

placebo DIETARY_SUPPLEMENT

3 capsules per day of placebo for 24 months

placebo control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who are pregnant or lactating
• Patients who are taking or are prescribed orlistat

Sponsors & Collaborators

• Virta Health: lead

Study Sites (1)

Virta Health

San Francisco, California, 94105, United States

Location

MeSH Terms

Conditions

Body-Weight Trajectory

Interventions

gamma-Linolenic Acid

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Linolenic Acids; Fatty Acids, Essential; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Fatty Acids, Omega-6

Study Officials

• Shaminie Athinarayanan, PhD

  Virta Health

  PRINCIPAL INVESTIGATOR

• Rebecca Adams, PhD

  Virta Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 19, 2020
• First Posted: July 22, 2020
• Study Start: July 22, 2020
• Primary Completion: February 13, 2023
• Study Completion: September 15, 2023
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)