NCT07899424Toborzás még nem indult1. fázis
Microbiota Modulation for Psychiatry Patients
Evaluating Change in Metabolic Biomarkers of Psychiatric Patients Through Modulation of the Gut Microbiota With Apple Cider Vinegar Powder in Delayed Release Capsules.
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 27.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 1. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 62 (tervezett)
- Első benyújtás
- 2026. okt. 8.
- Kezdés
- 2026. nov.
- Elsődleges befejezés
- 2029. nov.
- Fő szponzor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Betegségek
- Depresszió
- NCT-szám
- NCT07899424
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1. fázis
- Tervezett résztvevők: 62
- 2026. nov. és az elsődleges befejezés (2029. nov.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Patients on medications that have weight loss as a potential side effect i.e. topiramate, metformin, psychostimulants.
- Currently on a weight-loss diet plan i.e. ketogenic diet, detox diet
- 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
Más betegség
- Current active eating disorder i.e. bulimia nervosa, binge eating disorder, anorexia nervosa
- Crohn's disease or other bowel conditions
- Allergy to any IP ingredients
- Blood/bleeding/liver/kidney disorders
Egyéb
- 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.
- Currently enrolled in other clinical trial which may affect their study outcome
Kiket keres a vizsgálat
- 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)
Életkor a regiszterben: 16 év – 45 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.