Status:
RECRUITING
L. Acidophilus (Strain TW01) on Gut Health, Body Composition, and Inflammation
Lead Sponsor:
University of Connecticut
Conditions:
Overweight (BMI > 25)
Obese, Otherwise Healthy Volunteers
Eligibility:
All Genders
18-60 years
Phase:
EARLY_PHASE1
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 compo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06912100
Start Date
July 1 2025
End Date
December 1 2027
Last Update
July 25 2025
Active Locations (1)
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1
University of Connecticut, Department of Nutritional Sciences
Storrs, Connecticut, United States, 06269