Obese, Otherwise Healthy Volunteers, Overweight (BMI > 25)
Conditions
Keywords
obesity, probiotics, gut health
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.
Interventions
DIETARY_SUPPLEMENTPlacebo
Participants consume capsules containing only an inactive placebo (maltodextrin and magnesium stearate).
DIETARY_SUPPLEMENTProbiotic
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).
Sponsors
University of Connecticut
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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 6. Do not fit any
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fecal butyrate | 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
| Measure | Time frame | Description |
|---|---|---|
| Serum inflammation marker | 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 |
| Body fat composition | 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). |
Countries
United States
Outcome results
None listed