RecruitingNot ApplicableNCT06030362

Probiotic Intervention Study

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


Sponsor

University of California, Los Angeles

Enrollment

100 participants

Start Date

Jul 18, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether taking a probiotic supplement can improve gut health, metabolism, and appetite in adults who are overweight or obese. **You may be eligible if...** - You are between 18 and 50 years old - Your BMI is between 25 and 40 - You are not currently pregnant or breastfeeding - You are male or female **You may NOT be eligible if...** - You have type 1 (insulin-dependent) diabetes - You have had stomach or bowel surgery, including weight loss surgery - You have untreated thyroid disease or a major neurological condition - You are currently taking medications that affect appetite or hunger - You have used probiotics or antibiotics in the last 3 months - You have a psychiatric illness (including active eating disorders) that has occurred in the last 2 years - You are pregnant, recently gave birth (less than 6 months), or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTProbiotic

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

DIETARY_SUPPLEMENTPlacebo

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


Locations(1)

University of California

Los Angeles, California, United States

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NCT06030362


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