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

Part of paid clinical trials in Storrs, Connecticut.

Sponsor
University of Connecticut
Study ID
NCT06912100
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Obese, Otherwise Healthy Volunteers
  • Overweight (BMI > 25)

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Placebo — DIETARY_SUPPLEMENT
    Participants consume capsules containing only an inactive placebo (maltodextrin and magnesium stearate).
  • Probiotic — DIETARY_SUPPLEMENT
    Participants consume capsules containing L. acidophilus (TW01) at 4×10\^10 CFU/capsule (three capsules daily, totaling 1.2×10\^11 CFU/day) plus a commercial fiber source (Fibersol-2).

Study Details

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.

Key Dates

Start date
Jul 1, 2025
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Placebo Comparator: Placebo phase
    Participants consume capsules containing only an inactive placebo (maltodextrin and magnesium stearate).
  • Experimental: Probiotic phase
    Participants consume capsules containing L. acidophilus (TW01) at 4×10\^10 CFU/capsule (three capsules daily, totaling 1.2×10\^11 CFU/day) plus a commercial fiber source (Fibersol-2).

Primary Outcome Measure

Fecal butyrate [ Time Frame: From baseline to the end of each 6-week intervention phase ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Connecticut, Department of Nutritional SciencesStorrsConnecticut06269
Christopher Blesso, Ph.D.
[email protected]
860-486-9049

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By research site
University of Connecticut, Department of Nutritional Sciences· Storrs, CT

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