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

NCT06912100 | Recruiting Early Phase 1

• 1 other identifier: B2025-0034
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

obesity; probiotics; gut health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Serum inflammation marker

  From baseline to the end of each 6-week intervention phase

• Body fat composition

  From baseline to end of each 6-week intervention phase

Study Arms (2)

Placebo phase

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Probiotic phase

EXPERIMENTAL

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

Interventions

Placebo DIETARY_SUPPLEMENT

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

Placebo phase

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).

Probiotic phase

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60 years
• Body mass index (BMI) between 28 kg/m2 and 40 kg/m2
• Waist circumference ≥ 88 cm or 35 inches for women, ≥ 102 cm or 40 inches for men
• Willing to consume experimental capsules daily
• Willing to prepare and consume the delivered meal kits

You may not qualify if:

• 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
• Weight changes \> 10% over the last 4 weeks
• Oral antibiotics and/or probiotics use up to 1 month prior to study and during study
• 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.
• Dairy allergy
• Currently pregnant or breast-feeding

Sponsors & Collaborators

• University of Connecticut: lead

Study Sites (1)

University of Connecticut, Department of Nutritional Sciences

Storrs, Connecticut, 06269, United States

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Christopher Blesso, Ph.D.

CONTACT

860-486-9049; christopher.blesso@uconn.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 4, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)