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Completed

NCT Number: NCT04481724

Gamma-linolenic Acid Supplementation Study

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.

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Key information

Conditions

Weight Trajectory Body Weight Body Weight Changes Body-Weight Trajectory Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virta Health

San Francisco, California, 94105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gamma-linolenic acid

Dietary Supplement

3 capsules per day of GLA for 24 months

Placebo

Dietary Supplement

3 capsules per day of placebo for 24 months

Primary outcomes

  1. Difference in change in body weight between groups over time

    Time frame: 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 outcomes

  1. Difference in subjective neuropathy symptoms between groups over time

    Time frame: 0, 6, 12, 18, and 24 months

    Michigan Neuropathy Screening Instrument (MNSI) administered every 6 months

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

    Time frame: 0, 6, 12, 18, and 24 months

    Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) administered every 6 months

  3. Difference in perceived control over eating between groups over time

    Time frame: 0, 6, 12, 18, and 24 months

    Eating Loss of Control Scale (ELOCS) administered every 6 months

  4. Difference in body image and satisfaction between groups over time

    Time frame: 0, 6, 12, 18, and 24 months

    Body Image States Scale (BISS) administered every 6 months

  5. Difference in medication prescriptions between groups over time

    Time frame: 0, 6, 12, 18, and 24 months

    Prescribed medications obtained from medical record

  6. Difference in hemoglobin A1c between groups over time

    Time frame: Approximately 0, 6, 12, 18, and 24 months

  7. Difference in ketones between groups over time

    Time frame: 0, 6, 12, 18, and 24 months

    Finger prick ketone values

  8. Difference in blood glucose between groups over time

    Time frame: 0, 6, 12, 18, and 24 months

    Finger prick glucose values

Sponsors and collaborators

Lead sponsor

Virta Health

Industry

Registry information

Official study title

Effects of Gamma-linolenic Acid Supplementation on Weight Loss Maintenance in the Virta Treatment

Acronym: GLASS

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 22, 2020
Registry last updated
Apr 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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