What is L. acidophilus strain TW01 studying for overweight and obesity?

This study is examining how the probiotic L. acidophilus strain TW01 affects gut bacteria, body fat, and inflammation markers in overweight or obese adults. Researchers want to learn if this probiotic can influence substances in stool and blood that relate to overall health. The trial is led by the University of Connecticut to better understand this probiotic's potential effects.

Who may be eligible for this overweight and obesity clinical trial?

Adults between 18 and 60 years old with a body mass index between 28 and 40 and a waist circumference of at least 35 inches for women or 40 inches for men may be eligible. The study requires participants to consume capsules and meal kits daily and excludes those with certain health conditions or recent antibiotic use. Please review eligibility criteria for more details.

Is there any cost to participate in this overweight and obesity clinical trial?

Study-related care, including the study capsules and all trial visits, is provided at no cost. Personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs outside the study procedures.

Actively Recruiting

Early Phase 1

Age: 18Years - 60Years

All Genders

Healthy Volunteers

ID06912100

A Pilot Study of the Probiotic L. Acidophilus Strain TW01 on Gut Health, Body Composition, and Inflammation

Led by University of Connecticut · Updated on 2025-07-25

Participants Needed

Research Sites

47 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of a probiotic supplement, Lactobacillus acidophilus strain TW01, on gut health, body composition, and inflammation in overweight or obese but otherwise healthy adults aged 18 to 60 years. This early phase pilot study aims to understand how this probiotic, isolated from fermented coffee grounds, influences substances found in stool and blood, gut bacteria composition, and markers of inflammation to explore its impact on overall health. Participants are randomly assigned to one of two groups in a single-blind design. One group consumes capsules containing an inactive placebo, while the other group takes capsules with L. acidophilus TW01 at a dose of 1.2 x 1011 CFU per day plus a commercial fiber source, Fibersol-2. Each intervention phase lasts six weeks. Participants are expected to consume the capsules daily and prepare and eat provided meal kits throughout the study. During the study, researchers collect stool and blood samples to measure fecal butyrate levels, serum inflammation markers, and body fat composition at baseline and after each six-week intervention phase. The study includes safety monitoring and tracks participants adherence to the protocol. The total participation period covers the duration of the intervention phases and assessments, ending by December 2027.

CONDITIONS

Brief Title

L. Acidophilus (Strain TW01) on Gut Health, Body Composition, and Inflammation

Who Can Participate

Age: 18Years - 60Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Age 18 to 60 years
Body mass index (BMI) between 28 kg/m2 and 40 kg/m2
Waist circumference at least 35 inches for women or 40 inches for men
Willing to consume study capsules daily
Willing to prepare and eat provided meal kits
Do not meet any exclusion criteria

You will not qualify if you...

History of immune problems, major digestive surgery, kidney or liver disease, diabetes, heart disease, stroke, peripheral artery or vascular disease, cancer, eating disorders, gut-related diseases, autoimmune diseases, pacemaker use, thyroid disease, gallbladder disease, chronic inflammatory diseases, scleroderma, blood clotting disorders, or intravenous drug use
Weight changes greater than 10% in the past 4 weeks
Use of oral antibiotics or probiotics within one month before or during the study
Current use of GLP-1 analogues, anti-inflammatory drugs like corticosteroids, daily use of NSAIDs (occasional use allowed), blood clotting medications such as warfarin, or immune-suppressing medications
Allergy to dairy products
Currently pregnant or breastfeeding

Research Team

Christopher Blesso, Ph.D.

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