Status:
RECRUITING
Probiotic Intervention Study
Lead Sponsor:
University of California, Los Angeles
Conditions:
Obesity
Food Addiction
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
The current standard of care for obesity is the optimal management of comorbid conditions such as diabetes and hyperlipidemia, and counseling on diet, weight loss, or increased physical activity progr...
Eligibility Criteria
Inclusion
- Ages 18-50
- BMI 25-40
- Male and Female
- Not Pregnant or Nursing
Exclusion
- 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.).
Key Trial Info
Start Date :
July 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06030362
Start Date
July 18 2023
End Date
July 31 2026
Last Update
July 29 2025
Active Locations (1)
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1
University of California
Los Angeles, California, United States, 90095