Depression - Major Depressive DisorderPhase 1ACV-MTPIES-002NCT07899424
Microbiota Modulation for Psychiatry Patients
A Phase 1 study testing Dietary Supplement: Acetate (Apple Cider Vinegar) in people with Depression - Major Depressive Disorder and Generalized Anxiety Disorder (GAD), run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial summary
The investigators aim to confirm pilot study findings (REB 119638) on the effects of delayed release apple cider vinegar (drACV). The investigators aimed to determine the feasibility that the acetate in ACV would counteract the problematic weight gain and metabolic side effects associated with the most common… Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- Depression - Major Depressive Disorder, Generalized Anxiety Disorder (GAD), Anxiety
- What is being tested?
- Dietary Supplement: Acetate (Apple Cider Vinegar)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Nov 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 16 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ability to read, understand, and communicate in English.
- Signed informed consent obtained prior to any study-related activities
- Between the ages of 16 and 45
- Currently on a stable dose (> 8 weeks) of an antidepressant, mood stabilizer, and/or antipsychotic drug
- Evidence of medication-associated metabolic disturbance (approximately greater than 5% of initial body weight and current BMI >21.7kg/m2) by self-report.
- Relative psychiatric stability by self report (no medication changes or acute suicidality in previous 8 weeks)).
- A patient of the General Adult Ambulatory Mental Health Services (GAAMHS), Child and Adolescent Mental Health Services, or First Episode Mood and Anxiety Program (FEMAP) at London Health Sciences Centre (LHSC)
Who cannot join
- Participants who are unable to read, understand, and communicate in English.
- Participants who are unable to follow multi-step instructions independently, as determined by the treating psychiatrist.
- Participants who are pregnant, planning to get pregnant, or breastfeeding.
- Patients on medications that have weight loss as a potential side effect i.e. topiramate, metformin, psychostimulants.
- Current active eating disorder i.e. bulimia nervosa, binge eating disorder, anorexia nervosa
- Currently on a weight-loss diet plan i.e. ketogenic diet, detox diet
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- Currently using a medication for weight loss i.e. Contrave (bupropion / naltrexone), Saxenda (liraglutide)
- Current use of dietary supplements for weight loss i.e. garcinia cambogia; or use within 4 weeks prior to study initiation
- Bowel surgery
- Crohn's disease or other bowel conditions
- Allergy to any IP ingredients
- Blood/bleeding/liver/kidney disorders
- Currently enrolled in other clinical trial which may affect their study outcome
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluating Change in Metabolic Biomarkers of Psychiatric Patients Through Modulation of the Gut Microbiota With Apple Cider Vinegar Powder in Delayed Release Capsules.
The investigators aim to confirm pilot study findings (REB 119638) on the effects of delayed release apple cider vinegar (drACV). The investigators aimed to determine the feasibility that the acetate in ACV would counteract the problematic weight gain and metabolic side effects associated with the most common psychiatric medications. Our pilot study recruited 11 participants from the First Episode Mood and Anxiety Program (FEMAP) who had experienced (by self-report) weight gain concurrent with medication use. The investigators found that drACV was well tolerated with adherence above 90% and resulted in reduced LDL cholesterol, improved lipids in 7 participants, altered microbiota composition in the direction associated with improved metabolic and mental health outcomes, and the emergence of a potential "responder phenotype". The investigators did not, however, find significant effects on weight.
The investigators aim to expand that study by 1) including a larger sample; 2) Conducting a detailed analysis of the microbiome and identifying immune and genomic factors associated with response, thereby further defining responder and non-responder phenotypes that emerged in the initial analysis, 3) collecting additional biological, psychological, and social data to permit complex multivariate modelling on gene-environment interactions for mechanistic research.
The investigators will seek to recruit sixty-two participants from FEMAP, the General Adult Ambulatory Mental Health Services (GAAMHS) and Child and Adolescent Mental Health Services at LHSC. Participants need to have experienced weight gain by self-report and clinician estimation, be psychiatrically stable on steady doses of medication, and be between the ages of 16-45.
- Being tested
- Dietary Supplement: Acetate (Apple Cider Vinegar)
- Keywords
- Probiotics, Psychiatry, Weight, Microbiome
- Medical subject headings
- Generalized Anxiety Disorder, Anxiety Disorders, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Supplement: Acetate (Apple Cider Vinegar)Other
Consumer-grade apple cider vinegar (ACV) capsules will have extra enteric coating applied for delivery further into the GI tract.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 16-45 year old patients on stable dose of psychiatric medication for treatment of mental health conditions. Receives: Other: Dietary Supplement: Acetate (Apple Cider Vinegar) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cholesterol
Change in LDL cholesterol corresponding to 15% or greater reduction for responders, and less than 5% reduction for non-responders
Measured: From enrollment to 12-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899424
- Sponsor's protocol ID
- 127774
- Acronym
- ACV-MTPIES-002
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Change in Metabolic Biomarkers of Psychiatric Patients Through Modulation of the Gut Microbiota With Apple Cider Vinegar Powder in Delayed Release Capsules.
- ClinicalTrials.gov ID
- NCT07899424
- Acronym / sponsor ID
- ACV-MTPIES-002 / 127774
- Keywords
- Probiotics, Psychiatry, Weight, Microbiome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 27 Oct 2026 (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.
The investigators aim to confirm pilot study findings (REB 119638) on the effects of delayed release apple cider vinegar (drACV). The investigators aimed to determine the feasibility that the acetate in ACV would counteract the problematic weight gain and metabolic side effects associated with the most common psychiatric medications. Our pilot study recruited 11 participants from the First Episode Mood and Anxiety Program (FEMAP) who had experienced (by self-report) weight gain concurrent with medication use. The investigators found that drACV was well tolerated with adherence above 90% and resulted in reduced LDL cholesterol, improved lipids in 7 participants, altered microbiota composition in the direction associated with improved metabolic and mental health outcomes, and the emergence of a potential "responder phenotype". The investigators did not, however, find significant effects on weight.
The investigators aim to expand that study by 1) including a larger sample; 2) Conducting a detailed analysis of the microbiome and identifying immune and genomic factors associated with response, thereby further defining responder and non-responder phenotypes that emerged in the initial analysis, 3) collecting additional biological, psychological, and social data to permit complex multivariate modelling on gene-environment interactions for mechanistic research.
The investigators will seek to recruit sixty-two participants from FEMAP, the General Adult Ambulatory Mental Health Services (GAAMHS) and Child and Adolescent Mental Health Services at LHSC. Participants need to have experienced weight gain by self-report and clinician estimation, be psychiatrically stable on steady doses of medication, and be between the ages of 16-45.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Dietary Supplement: Acetate (Apple Cider Vinegar)16-45 year old patients on stable dose of psychiatric medication for treatment of mental health conditions. |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Ability to read, understand, and communicate in English.
- Signed informed consent obtained prior to any study-related activities
- Between the ages of 16 and 45
- Currently on a stable dose (> 8 weeks) of an antidepressant, mood stabilizer, and/or antipsychotic drug
- Evidence of medication-associated metabolic disturbance (approximately greater than 5% of initial body weight and current BMI >21.7kg/m2) by self-report.
Key exclusion criteria (13 listed)
- Participants who are unable to read, understand, and communicate in English.
- Participants who are unable to follow multi-step instructions independently, as determined by the treating psychiatrist.
- Participants who are pregnant, planning to get pregnant, or breastfeeding.
- Patients on medications that have weight loss as a potential side effect i.e. topiramate, metformin, psychostimulants.
- Current active eating disorder i.e. bulimia nervosa, binge eating disorder, anorexia nervosa
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 |
|---|---|---|
| Dietary Supplement: Acetate (Apple Cider Vinegar)Consumer-grade apple cider vinegar (ACV) capsules will have extra enteric coating applied for delivery further into the GI tract. | Other | Intervention |
Primary outcome
Cholesterol
Time frame: From enrollment to 12-week follow-up
Change in LDL cholesterol corresponding to 15% or greater reduction for responders, and less than 5% reduction for non-responders
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dietary Supplement: Acetate (Apple Cider Vinegar) in people with Depression - Major Depressive Disorder and Generalized Anxiety Disorder (GAD), run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
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 7 inclusion and 13 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: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth A Osuch (519-646-6000 ext. 65188, elizabeth.osuch@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cholesterol (time frame: From enrollment to 12-week follow-up). 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 27 Oct 2026.