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

NCT ID: NCT06912100

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2027-12-31

Brief Summary

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Placebo phase

Participants consume capsules containing only an inactive placebo (maltodextrin and magnesium stearate).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Participants consume capsules containing only an inactive placebo (maltodextrin and magnesium stearate).

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).

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: 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).

Interventions

Placebo

Participants consume capsules containing only an inactive placebo (maltodextrin and magnesium stearate).

Intervention Type: 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).

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Connecticut

OTHER

Sponsor Role: lead

Responsible Party

Christopher Blesso

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Connecticut, Department of Nutritional Sciences

Storrs, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Christopher Blesso, Ph.D.

Role: CONTACT

christopher.blesso@uconn.edu

860-486-9049

Facility Contacts

Christopher Blesso, Ph.D.

Role: primary

christopher.blesso@uconn.edu

860-486-9049

Other Identifiers

B2025-0034

Identifier Type: -

Identifier Source: org_study_id