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NCT Number: NCT06912100

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.

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Key information

Conditions

Overweight (BMI > 25) Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obese, Otherwise Healthy Volunteers Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Connecticut, Department of Nutritional Sciences

Storrs, Connecticut, 06269, United States

Location status: Recruiting

Location contact

Christopher Blesso, Ph.D.

CONTACT

[email protected]

860-486-9049

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Do not fit any exclusion criteria

Exclusion criteria

  • 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

Treatment and study plan

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).

Primary outcomes

  1. Fecal butyrate

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

    Determine the effects of the probiotic on the short-chain fatty acid, butyrate (mmol/L), a marker of gut health in stool

Secondary outcomes

  1. Serum inflammation marker

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

    Determine the effects of the probiotic on a marker of inflammation, high-sensitivity C-reactive protein (hsCRP) (mg/L), in the bloodstream

  2. Body fat composition

    Time frame: From baseline to end of each 6-week intervention phase

    Determine the effects of the probiotic on body fat composition by bioelectric impedance analysis (% of body weight).

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Blesso, Ph.D.

CONTACT

[email protected]

860-486-9049

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 4, 2025
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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