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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Overweight (BMI > 25); Obese, Otherwise Healthy Volunteers
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Probiotic

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Christopher Blesso, Ph.D.; Phone Number: 860-486-9049; Email: christopher.blesso@uconn.edu

Study Locations

• United States
  • Connecticut
    • Storrs, Connecticut, United States, 06269
      • Recruiting
      • University of Connecticut, Department of Nutritional Sciences
      • Contact: Christopher Blesso, Ph.D.; Phone Number: 860-486-9049; Email: christopher.blesso@uconn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age 18-60 years
2. Body mass index (BMI) between 28 kg/m2 and 40 kg/m2
3. Waist circumference ≥ 88 cm or 35 inches for women, ≥ 102 cm or 40 inches for men
4. Willing to consume experimental capsules daily
5. Willing to prepare and consume the delivered meal kits
6. Do not fit any exclusion criteria

Exclusion Criteria:

1. Self-reported history of immunodeficiency, major gastrointestinal surgery, renal or liver disease, diabetes, heart disease, stroke, peripheral artery/vascular disease, cancer, eating disorders, gut-associated pathologies, autoimmune diseases, pacemaker, thyroid disease, gallbladder disease, chronic inflammatory diseases, scleroderma, blood clotting disorders, intravenous drug use
2. Weight changes > 10% over the last 4 weeks
3. Oral antibiotics and/or probiotics use up to 1 month prior to study and during study
4. Currently taking GLP-1 analogues (e.g., Ozempic), anti-inflammatory medications (e.g., corticosteroids), daily use of nonsteroidal anti-inflammatory drugs (NSAIDs) (occasional use is permitted), medications which primarily affect blood clotting (e.g., warfarin), or any medications that suppress the immune system.
5. Dairy allergy
6. Currently pregnant or breast-feeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo phase; Participants consume capsules containing only an inactive placebo (maltodextrin and magnesium stearate).	Dietary supplement: Placebo; 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).	Dietary supplement: Probiotic; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fecal butyrate	Determine the effects of the probiotic on the short-chain fatty acid, butyrate (mmol/L), a marker of gut health in stool	From baseline to the end of each 6-week intervention phase

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum inflammation marker	Determine the effects of the probiotic on a marker of inflammation, high-sensitivity C-reactive protein (hsCRP) (mg/L), in the bloodstream	From baseline to the end of each 6-week intervention phase
Body fat composition	Determine the effects of the probiotic on body fat composition by bioelectric impedance analysis (% of body weight).	From baseline to end of each 6-week intervention phase

Collaborators and Investigators

• Sponsor: University of Connecticut

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: March 28, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Actual): July 25, 2025
• Last Update Submitted That Met QC Criteria: July 22, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: obesity; probiotics; gut health
• Additional Relevant MeSH Terms: Pathologic Processes; Nutrition Disorders; Overnutrition; Body Weight; Overweight; Inflammation
• Other Study ID Numbers: B2025-0034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Only IPD used in the results publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No