An interventional study of Probiotic and Placebo in Obesity and Food Addiction, sponsored by University of California, Los Angeles. Recruiting at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Treatment
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 programs. However, lifestyle, diet, and behavioral interventions may provide between 7-10% reduction in initial weight and even fewer with long-term weight loss. In severely obese patients (BMI>40 or BMI>35 with comorbidities), bariatric surgery is also a potential treatment, but there is a high barrier for patients to undergo surgery for weight loss. These barriers include an aversion to major abdominal surgery, long recovery time, potential risk of vitamin deficiency, and risk for abdominal pain. For these reasons, there is a paramount need for other treatments for obesity and for food addiction.
The current standard of care for obesity and food addiction is difficult to implement and lacks sustained efficacy. Most struggle to complete treatment, lose minimal weight, lack sustained weight loss, and engage in the well-known "YoYo" diet phenomenon. While bariatric surgery is currently the only effective treatment for obesity, there are several barriers associated with it such as eligibility requirements, invasiveness, difficult recovery, and cost making it not readily available for everyone. Some approved medications that help with obesity, such as orlistat, lorcaserin, or naltrexone-bupropion, have not been widely adopted by providers or patients due to their limited responses and adverse side effects. Probiotic cocktails have shown to be safe with little to no side effects. Preclinical models of probiotics demonstrate the ability to curb obesity in animal models. Therefore, a probiotic that is able to show significant weight loss along with lifestyle modifications would be highly adopted and desirable.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 100 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dietary Supplement: Probiotic
Dietary Supplement: Placebo
Dietary Supplement taken once daily for 3 months (90 days).
Dietary Supplement taken once daily for 3 months (90days).
Differences in metabolite concentrations pre & post intervention - Stool
Measurement of metabolomics via stool specimen.
Time frame: Collected three times by the participant at home, once at baseline (week 0), once at mid-study (week 6), and once at the final 3month appointment (week 12).
Differences in metabolite concentrations pre & post intervention - Blood
Measurement of metabolomics via blood specimen.
Time frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (week 6), and once at the final 3month appointment (week 12).
Differences in microbiome levels pre & post intervention - Stool
16S RNA sequencing to measure microbiome levels via stool specimen.
Time frame: Collected three times by the participant at home, once at baseline (week 0), once at mid-study (week 6), and once at the final 3month appointment (week 12).
Differences in microbiome levels pre & post intervention - Blood
16S RNA sequencing to measure microbiome levels via blood specimen.
Time frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (week 6), and once at the final 3month appointment (week 12).
Differences in microbiome levels pre & post intervention - Stool
Shotgun metagenomics, sequencing to measure microbiome levels via stool specimen.
Time frame: Collected three times by the participant at home, once at baseline (week 0), once at mid-study (week 6), and once at the final 3month appointment (week 12).
Differences in microbiome levels pre & post intervention - Blood
Shotgun metagenomics, sequencing to measure microbiome levels via blood specimen.
Time frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (week 6), and once at the final 3month appointment (week 12).
Differences in Subjective Stress Response - PANAS
Between and within group differences on the negative affect subscale from the Brief Positive Affect and Negative Affect Scale (PANAS) before and after the laboratory stress tasks. PANAS scores can range from 10-50 for both the positive and negative affect, with the lower scores representing lower levels of positive/negative affect, and higher scores representing higher levels of positive/negative affect.
Time frame: Lasting approximately 10 minutes, measured pre & post the laboratory stress tasks, at baseline (week 0) and end of study (week 12).
Changes in Autonomic Measures - Heart Rate Variability
Between and within group differences in overall average change in heart rate variability pre and post each laboratory stress task.
Time frame: Measured throughout each laboratory stress task during the baseline (week 0) and end of study (week 12) visits, lasting approximately 1 hour.
Changes in Autonomic Measures - Skin Conductance
Between and within group differences in overall average change in skin conductance response (SCR) pre and post each laboratory stress task measured using BIOPAC GSR (galvanized skin response) 100C system. Measured in Hz.
Time frame: Measured throughout each laboratory stress task during the baseline (week 0) and end of study (week 12) visit. Lasting approximately 1 hour.
Changes in Autonomic Measures - Diastolic & Systolic blood pressure
Between and within group differences in overall average change in both diastolic and systolic blood pressure pre and post each laboratory stress task.
Time frame: Measured throughout each laboratory stress task during the baseline (week 0) and end of study (week 12) visit. Lasting approximately 1 hour.
Differences in Attention/Executive Function - Color Stroop
Between and within group differences on the time it takes to complete the Color Stroop attention/executive function lab stress task.
Time frame: Lasting approximately 10minutes, measured at baseline (week 0) and end of study (week 12).
Differences in Attention/Executive Function - Trails A & B
Between and within group differences on the time it takes to complete the Trails A \& B attention/executive function lab stress task.
Time frame: Lasting approximately 10minutes, measured at baseline (week 0) and end of study (week 12).
Differences in Emotional Arousal System - IAPS task
Between and within group differences in valence and emotional arousal ratings during the International Affective Picture System (IAPS) task.
Time frame: Lasting approximately 15minutes, measured at baseline (week 0) and end of study (week 12).
Systolic and Diastolic Blood Pressure
Measurement of the pressure of circulating blood at rest
Time frame: Measured three times, once at each in-clinic appointment (week 0, week 6, week 12).
Anthropometrics - BMI
Measurement of height(in) \& weight(lbs), used to calculate body mass index (BMI).
Time frame: Measured three times, once at each in-clinic appointment (week 0, week 6, & week 12)
Questionnaire Data - Diet
Use of validated surveys including the Food Frequency questionnaire, Food Choice Questionnaire.
Time frame: Self-Reported by the participant at home, collected 3 times (1) before beginning the dietary supplement, (2) at least 1 week before the mid-study appointment, and (3) within 1 week of finishing the 90-day dietary supplement.
Questionnaire Data
Use of validated surveys to assess ingestive behaviors, stress, health, physical activity, etc.
Time frame: Self-Reported by the participant at home, collected 3 times (1) before beginning the dietary supplement, (2) at least 1 week before the mid-study appointment, and (3) within 1 week of finishing the 90-day dietary supplement.
Anthropometrics - waist and hip circumference
Measurement of waist and hip circumference (cm).
Time frame: Measured three times, once at each in-clinic appointment (week 0, week 6, & week 12)
Differences in Multimodal Brain Signatures
Neuroimaging of a subset of participants brain via magnetic resonance imaging (MRI) procedure.
Time frame: Optional - Measured twice, once at baseline (week 0) and once at end of study (week 12) visit. Lasting approximately 1.5hours.
Plan to share: No — At this time there is no plan to make the de-identified data available for sharing with other researchers.
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University of California, Los Angeles