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To determine the feasibility of whether the addition of key prebiotics administered orally can mitigate some of the most problematic side-effects of the most common psychiatric medications - weight gain and metabolic abnormalities caused by some antidepressants, mood stabilizers and antipsychotics. In the initial part of the study, we aim to determine feasibility of the study and evaluate participant compliance.
Our clinical trial will encourage the growth of Akkermansia muciniphila (AM) through enteric-coated orally-administered acetate (apple cider vinegar powder in capsules) in 16-to-28 year-old patients who have already experienced weight gain while on stable doses of psychiatric medication, with the hypothesis that the addition of this prebiotic will result in alterations in gut microbiota and measurable weight loss, as well as improvement in metabolic measurements.
Primary Objective:
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transition-Age Adults | Experimental | 16-25 year old patients on stable dose of antipsychotic medication for treatment of depression or anxiety. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetate (Apple Cider Vinegar) | Dietary Supplement | Consumer-grade apple cider vinegar (ACV) capsules will have extra enteric coating applied for delivery further into the GI tract. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Recruitment success | Number of potential participants approached to number expressing interest, and number invited to number recruited (recruitment success) | 5 months |
| Feasibility: Retention | Number recruited to number retained (attrition) | 5 months |
| Feasibility: Adherence | Number adhering to intervention protocol quantified through number of capsules returned at end of trial | 5 months |
| Feasibility: Adverse Events | A study-specific data form for collecting adverse events | 5 months |
| Akkermansia Muciniphila abundance | Relative abundance (proportion) of AM in stool at inception compared to all other species identified, and change in relative abundance from pre- to post-intervention | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | Standard Medical-grade floor scale | 5 months, recorded monthly |
| Metabolic Indicator: Blood pressure | Blood pressure using medical-grade arm cuff (mm/Hg, Systolic and Diastolic) |
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Inclusion Criteria:
For an eligible patient, all inclusion criteria must be answered "yes"
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Osuch, MD | Contact | 519-646-6000 | 65188 | elizabeth.osuch@lhsc.on.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Episode Mood and Anxiety Disorders Program (FEMAP) | Recruiting | London | Ontario | N6A 3H8 | Canada |
We do not plan to share IPD with other researchers
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N-of-1 type prospective study
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| 5 months |
| Metabolic Indicator: High-Density Lipoproteins | HDL cholesterol assayed from antecubital blood draw, expressed in mg/dL | 5 months |
| Mood: Depression | Quick Inventory of Depressive Symptomatology (QIDS-SR, Rush et al. 2003) - baseline scores to describe the sample, change from pre-post intervention to explore potential treatment effect | 5 months, captured monthly |
| Mood: Anxiety | Overall Anxiety Severity and Impairment Scale (OASIS, Barlow et al. 2010) - baseline scores to describe the sample, change from pre-post intervention to explore potential treatment effect | 5 months, captured monthly |
| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000085 | Acetates |
| ID | Term |
|---|---|
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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