Probiotic Intervention Study

NCT06030362 | Recruiting

• 1 other identifier: IRB 22-000796
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Obesity; Food Addiction

Keywords

Probiotic; Dietary Supplement

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (12)

• Differences in Subjective Stress Response - PANAS

  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

  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

  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

  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

  Lasting approximately 10minutes, measured at baseline (week 0) and end of study (week 12).

Other Outcomes (1)

• Differences in Multimodal Brain Signatures

  Optional - Measured twice, once at baseline (week 0) and once at end of study (week 12) visit. Lasting approximately 1.5hours.

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Dietary Supplement taken once daily for 3 months (90 days).

Probiotic

Placebo DIETARY_SUPPLEMENT

Dietary Supplement taken once daily for 3 months (90days).

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ages 18-50
• BMI 25-40
• Male and Female
• Not Pregnant or Nursing

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Food Addiction

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Addictive; Compulsive Behavior; Impulsive Behavior; Behavior; Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allison Vaughan, MPH

CONTACT

3108257206; GuptaLab@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: September 11, 2023
• Study Start: July 18, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)