Probiotic Intervention Study

Double Blinded Placebo Controlled Feasibility Study to Evaluate a Combination Probiotic in Adults With Obesity

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Food Addiction
• Intervention / Treatment: Dietary supplement: Probiotic; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Allison Vaughan, MPH; Phone Number: 3108257206; Email: GuptaLab@mednet.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • University of California
      • Contact: Allison Vaughan, MPH; Phone Number: 3108257206; Email: GuptaLab@mednet.ucla.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Dietary Supplement taken once daily for 3 months (90days).
Active Comparator: Probiotic	Dietary supplement: Probiotic; Dietary Supplement taken once daily for 3 months (90 days).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in metabolite concentrations pre & post intervention - Stool	Measurement of metabolomics via stool specimen.	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.	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.	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.	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.	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.	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).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	Lasting approximately 10minutes, 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	Measured three times, once at each in-clinic appointment (week 0, week 6, week 12).
Questionnaire Data	Use of validated surveys to assess ingestive behaviors, stress, health, physical activity, etc.	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).	Measured three times, once at each in-clinic appointment (week 0, week 6, & 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.	Lasting approximately 15minutes, measured at baseline (week 0) and end of study (week 12).
Anthropometrics - BMI	Measurement of height(in) & weight(lbs), used to calculate body mass index (BMI).	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.	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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in Multimodal Brain Signatures	Neuroimaging of a subset of participants brain via magnetic resonance imaging (MRI) procedure.	Optional - Measured twice, once at baseline (week 0) and once at end of study (week 12) visit. Lasting approximately 1.5hours.

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: Arpana Gupta, PhD, The Regents of the University of California, Los Angeles; Principal Investigator: Tien Dong, MD, PhD, The Regents of the University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: August 4, 2023
• First Submitted That Met QC Criteria: September 6, 2023
• First Posted (Actual): September 11, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Probiotic; Dietary Supplement
• Additional Relevant MeSH Terms: Mental Disorders; Nutrition Disorders; Overnutrition; Body Weight; Overweight; Behavior, Addictive; Compulsive Behavior; Impulsive Behavior; Feeding and Eating Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Food Addiction; Obesity; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Probiotics
• Other Study ID Numbers: IRB 22-000796

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: At this time there is no plan to make the de-identified data available for sharing with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No