An interventional study of gamma-linolenic acid and placebo in Weight Trajectory, sponsored by Virta Health. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-24.
Sponsored by Virta Health · Not applicable, Interventional, and Supportive care
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.
19 studies on the registry are indexed under Body-Weight Trajectory; 6 are open to participants now.
This study's enrollment of 302 is above the median of 119 across 15 interventional studies indexed under Body-Weight Trajectory.
Browse Body-Weight Trajectory studies →Virta Health is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sonova GLA safflower oil (840 mg GLA per day)
Dietary Supplement: gamma-linolenic acid
1500 mg 'light' olive oil per day
Dietary Supplement: placebo
3 capsules per day of GLA for 24 months
3 capsules per day of placebo for 24 months
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.
Time frame: 0, 12, 18, and 24 months
Difference in subjective neuropathy symptoms between groups over time
Michigan Neuropathy Screening Instrument (MNSI) administered every 6 months
Time frame: 0, 6, 12, 18, and 24 months
Difference in health-related quality of life between groups over time
Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) administered every 6 months
Time frame: 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
Time frame: 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
Time frame: 0, 6, 12, 18, and 24 months
Difference in medication prescriptions between groups over time
Prescribed medications obtained from medical record
Time frame: 0, 6, 12, 18, and 24 months
Difference in hemoglobin A1c between groups over time
Time frame: Approximately 0, 6, 12, 18, and 24 months
Difference in ketones between groups over time
Finger prick ketone values
Time frame: 0, 6, 12, 18, and 24 months
Difference in blood glucose between groups over time
Finger prick glucose values
Time frame: 0, 6, 12, 18, and 24 months
Plan to share: Yes — 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.
No publications or documents are linked to this record.
Ran from Jul 2020 to primary completion in Feb 2023, 30 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Gamma-Linolenic Acid
Virta Health