Weight TrajectoryGLASSNCT04481724
Gamma-linolenic Acid Supplementation Study
A study testing gamma-linolenic acid in people with Weight Trajectory, run by Virta Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight Trajectory
- What is being tested?
- gamma-linolenic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 302 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2020to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who are pregnant or lactating
- Patients who are taking or are prescribed orlistat
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Gamma-linolenic Acid Supplementation on Weight Loss Maintenance in the Virta Treatment
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.
Read the 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.
- Conditions
- Weight Trajectory
- Being tested
- gamma-linolenic acid, placebo
- Medical subject headings
- Body-Weight Trajectory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gamma-linolenic acidDietary supplement
3 capsules per day of GLA for 24 months
placeboDietary supplement
3 capsules per day of placebo for 24 months
| Study group | Role | What they receive |
|---|---|---|
| gamma-linolenic acid (GLA) supplementation | Experimental | Sonova GLA safflower oil (840 mg GLA per day) Receives: Dietary Supplement: gamma-linolenic acid |
| placebo control | Placebo comparator | 1500 mg 'light' olive oil per day Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 12, 18, and 24 months
Secondary outcomes (8)
Difference in subjective neuropathy symptoms between groups over time
Michigan Neuropathy Screening Instrument (MNSI) administered every 6 months
Measured: 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
Measured: 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
Measured: 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
Measured: 0, 6, 12, 18, and 24 months
Difference in medication prescriptions between groups over time
Prescribed medications obtained from medical record
Measured: 0, 6, 12, 18, and 24 months
Difference in hemoglobin A1c between groups over time
Measured: Approximately 0, 6, 12, 18, and 24 months
Difference in ketones between groups over time
Finger prick ketone values
Measured: 0, 6, 12, 18, and 24 months
Difference in blood glucose between groups over time
Finger prick glucose values
Measured: 0, 6, 12, 18, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start22 Jul 2020
- Primary completion13 Feb 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight TrajectoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virta Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shaminie Athinarayanan, PhD, Principal investigator, Virta HealthRebecca Adams, PhD, Study director, Virta Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481724
- Sponsor's protocol ID
- 2019-6
- Acronym
- GLASS
- Status last verified
- Apr 2024
- First submitted
- 19 Jul 2020
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Gamma-linolenic Acid Supplementation on Weight Loss Maintenance in the Virta Treatment
- ClinicalTrials.gov ID
- NCT04481724
- Acronym / sponsor ID
- GLASS / 2019-6
- Conditions
- Weight Trajectory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Virta HealthIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2020 (actual)
- Primary completion
- 13 Feb 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 22 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| gamma-linolenic acid (GLA) supplementation | Experimental | Dietary Supplement: gamma-linolenic acidSonova GLA safflower oil (840 mg GLA per day) |
| placebo control | Placebo comparator | Dietary Supplement: placebo1500 mg 'light' olive oil per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who are pregnant or lactating
- Patients who are taking or are prescribed orlistat
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gamma-linolenic acid3 capsules per day of GLA for 24 months | Dietary supplement | gamma-linolenic acid (GLA) supplementation |
| placebo3 capsules per day of placebo for 24 months | Dietary supplement | placebo control |
Primary outcome
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.
8 secondary outcomes
Difference in subjective neuropathy symptoms between groups over time
Time frame: 0, 6, 12, 18, and 24 months
Difference in health-related quality of life between groups over time
Time frame: 0, 6, 12, 18, and 24 months
Difference in perceived control over eating between groups over time
Time frame: 0, 6, 12, 18, and 24 months
Difference in body image and satisfaction between groups over time
Time frame: 0, 6, 12, 18, and 24 months
Difference in medication prescriptions between groups over time
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
Time frame: 0, 6, 12, 18, and 24 months
Difference in blood glucose between groups over time
Time frame: 0, 6, 12, 18, and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaminie Athinarayanan, PhD principal investigator
Virta Health
Rebecca Adams, PhD study director
Virta Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gamma-linolenic acid in people with Weight Trajectory, run by Virta Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in change in body weight between groups over time (time frame: 0, 12, 18, and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.