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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Connecticut

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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).

Treatment groups

12 Participants
are divided into 2 treatment groups
Group A: Placebo phasePlacebo comparator 1 intervention
Group B: Probiotic phaseExperimental treatment 1 intervention

Trial outcomes

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

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

Secondary outcomes

1

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

Time frame
From baseline to the end of each 6-week intervention phase
2

Body fat composition

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

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

Other outcomes

Sponsors and contacts

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