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Not yet recruitingNCT07899424ACV-MTPIES-002Updated Oct 27, 2026

Microbiota Modulation for Psychiatry Patients

A Phase 1 interventional study of Dietary Supplement: Acetate (Apple Cider Vinegar) in Depression - Major Depressive Disorder, Generalized Anxiety Disorder (GAD) and Anxiety, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Not yet recruiting. Open to participants aged 16 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Phase 1, Interventional, and Treatment

Updated Oct 27, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
62
Allocation
Not applicable
Ages
16 Years to 45 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Depression - Major Depressive Disorder
  • Generalized Anxiety Disorder (GAD)
  • Anxiety

Keywords

  • Probiotics
  • Psychiatry
  • Weight
  • Microbiome
03

In context

Generalized Anxiety Disorder

147 studies on the registry are indexed under Generalized Anxiety Disorder; 86 are open to participants now.

This study's planned enrollment of 62 is below the median of 100 across 120 interventional studies indexed under Generalized Anxiety Disorder.

Browse Generalized Anxiety Disorder studies →

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the lead sponsor of 329 studies on the registry; 134 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  1. Ability to read, understand, and communicate in English.
  2. Signed informed consent obtained prior to any study-related activities
  3. Between the ages of 16 and 45
  4. Currently on a stable dose (> 8 weeks) of an antidepressant, mood stabilizer, and/or antipsychotic drug
  5. Evidence of medication-associated metabolic disturbance (approximately greater than 5% of initial body weight and current BMI >21.7kg/m2) by self-report.
  6. Relative psychiatric stability by self report (no medication changes or acute suicidality in previous 8 weeks)).
  7. 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)

Exclusion criteria

Exclusion Criteria:

  1. Participants who are unable to read, understand, and communicate in English.
  2. Participants who are unable to follow multi-step instructions independently, as determined by the treating psychiatrist.
  3. Participants who are pregnant, planning to get pregnant, or breastfeeding.
  4. Patients on medications that have weight loss as a potential side effect i.e. topiramate, metformin, psychostimulants.
  5. Current active eating disorder i.e. bulimia nervosa, binge eating disorder, anorexia nervosa
  6. Currently on a weight-loss diet plan i.e. ketogenic diet, detox diet
  7. Currently using a medication for weight loss i.e. Contrave (bupropion / naltrexone), Saxenda (liraglutide)
  8. Current use of dietary supplements for weight loss i.e. garcinia cambogia; or use within 4 weeks prior to study initiation
  9. Bowel surgery
  10. Crohn's disease or other bowel conditions
  11. Allergy to any IP ingredients
  12. Blood/bleeding/liver/kidney disorders
  13. Currently enrolled in other clinical trial which may affect their study outcome
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
62 participants (estimated)

Study arms

  • Experimental
    Intervention

    16-45 year old patients on stable dose of psychiatric medication for treatment of mental health conditions.

    Other: Dietary Supplement: Acetate (Apple Cider Vinegar)

Interventions

  • OtherDietary 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.

06

What researchers measure

Primary outcomes

  1. Cholesterol

    Change in LDL cholesterol corresponding to 15% or greater reduction for responders, and less than 5% reduction for non-responders

    Time frame: From enrollment to 12-week follow-up

07

Study locations

No study locations are listed for this record.

08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07899424
Responsible party
Sponsor
First posted
Oct 27, 2026
Start date
Nov 2026 (estimated)
Primary completion
Nov 2029 (estimated)
Completion
Nov 2029 (estimated)
Last update
Oct 27, 2026

Study contacts

Elizabeth A Osuch
Contact
elizabeth.osuch@lhsc.on.ca
519-646-6000 ext. 65188

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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