Actively Recruiting

Early Phase 1
Age: 18Years - 60Years
All Genders
Healthy Volunteers
NCT06912100

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

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

12

Participants Needed

1

Research Sites

126 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a pilot research study to investigate the effects of a probiotic supplement (L. acidophilus, strain TW01) on substances found in the stool and bloodstream, gut bacteria composition, body composition, as well as any relationship of these substances with markers of inflammation. Lactobacillus acidophilus is commonly found in a variety of fermented foods, including yogurt, cheese, and kefir, due to its ability to produce lactic acid and other substances. This bacterium is generally well-tolerated in healthy individuals and has a longstanding history of safe use. The investigators are doing this pilot study to see if a particular probiotic, called L. acidophilus (strain TW01) and isolated from fermented coffee grounds, can make a positive difference in human gut and overall health. Specifically, the investigators want to look at how this probiotic affects certain substances in human stool and blood, the makeup of the bacteria in the gut, and aspects of body composition. The investigators are also interested in whether these changes relate to markers of inflammation, which can tell us more about their impact on overall health. This probiotic strain has been shown in other studies to be safe and well tolerated, and the investigators hope our research will help us better understand how it works and whether it might support health in humans.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 60 years
  • Body mass index (BMI) between 28 and 40 kg/m2
  • Waist circumference 2 88 cm (35 inches) for women, 2 102 cm (40 inches) for men
  • Willing to consume study capsules daily
  • Willing to prepare and eat provided meal kits
  • Must not meet any exclusion criteria
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Connecticut, Department of Nutritional Sciences

Storrs, Connecticut, United States, 06269

Actively Recruiting

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Research Team

C

Christopher Blesso, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

PREVENTION

Number of Arms

2

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