Probiotic intervention for obesity and food addiction
Double Blinded Placebo Controlled Feasibility Study to Evaluate a Combination Probiotic in Adults With Obesity
This study is testing whether a probiotic can help adults with obesity and food addiction lose weight and feel better about their eating habits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06030362 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a probiotic intervention on individuals struggling with obesity and food addiction. It aims to provide an alternative treatment option for patients who face barriers to traditional weight loss methods, such as bariatric surgery. Participants will be randomly assigned to receive either the probiotic or a placebo, and their weight loss and food addiction symptoms will be monitored over the course of the intervention. The study targets adults aged 18-50 with a BMI between 25 and 40, focusing on those who do not have significant comorbidities that could interfere with the results.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-50 with a BMI between 25 and 40 who do not have significant comorbidities.
Not a fit: Patients with severe comorbidities, recent drastic weight loss, or active psychiatric illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could offer a non-invasive treatment option for obesity and food addiction, potentially leading to improved weight management and overall health.
How similar studies have performed: While the use of probiotics for weight management is an emerging area of interest, this specific approach has not been extensively tested in clinical settings, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ages 18-50 * BMI 25-40 * Male and Female * Not Pregnant or Nursing Exclusion Criteria: * Co-morbidities including but not limited to: * Type 1 (insulin dependent) diabetes * vascular disease * drastic weight loss (more than 10lbs over the preceding 2months) * frequent strenuous exercise (i.e. marathon runners/heavy weight lifting) * abdominal surgeries including weight loss surgery or partial/complete resection of stomach or bowel * untreated thyroid disease * neurological disease * Major medical condition the PI/MD feels would put the subject at risk or interfere with data collection. * Chronic pain * Diagnosed DSM IV active psychiatric illness including eating disorders. Must not be active or present for at least 2 years. Participants with a positive endorsement on the MINI+ will be excluded. * Using medications known to affect hunger/satiety/appetite * Pregnant, lactating, postpartum less than 6months. * Women of childbearing potential who are not practicing birth control or are planning to get pregnant during the study. * Use of oral/IV antibiotics within the last 3 months * Use of probiotics in the last 3 months. * Heavy use of alcohol and drugs will be determined by a positive endorsement on the MINI+. If the MINI+ is positive for alcohol or drug dependence or abuse, the participant will be excluded. In regards to tobacco use, participants will be excluded if they smoke more than 1/2 pack per day. * Cannabis use will not be exclusionary. If the MINI+ is positive for drug dependence or abuse, the participant will be excluded. * Significant change in usual diet and/or weight loss of more than 10lbs in the last 2 months. * Anyone taking medicines on the medication exclusion list. * Non-English Speakers (due to the use of validated questionnaires and limited availability of translated copies, participants must be fluent in English so that they will be able to read and follow directions easily. * Maintenance pharmacotherapies will not be exclusionary so long as they have been on a stable dose for 6months. * Body weight at enrollment greater than 400lbs. * Exclude from Optional MRI if: participant is unable to safely participate in the MRI (claustrophobia, presence of devices affected by MRI such as pacemakers, neurostimulators, metallic foreign bodies, etc.).
Where this trial is running
Los Angeles, California
- University of California — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Arpana Gupta, PhD — The Regents of the University of California, Los Angeles
- Study coordinator: Allison Vaughan, MPH
- Email: GuptaLab@mednet.ucla.edu
- Phone: 3108257206
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.