Probiotic for Obesity

Overseen By Christopher Blesso, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Connecticut

Must not be taking: GLP-1 analogues, Anti-inflammatories, NSAIDs, others

Disqualifiers: Immunodeficiency, Diabetes, Heart disease, others

Compensation: Varies

Number of Visits: Unknown

12 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications. The trial excludes participants who are currently taking GLP-1 analogues, anti-inflammatory medications, daily NSAIDs, medications affecting blood clotting, or those that suppress the immune system.

What data supports the effectiveness of the treatment L. Acidophilus (Strain TW01) for obesity?

Research shows that L. Acidophilus can help reduce body weight, fat mass, and inflammation in mice on a high-fat diet by improving gut health and metabolism. This suggests it might be a promising treatment for obesity. ^{1 2 3 4 5}

Is L. Acidophilus (Strain TW01) safe for human use?

Probiotics, including Lactobacillus strains, are generally considered safe and well-tolerated in humans, as they have been used in various studies without significant safety concerns. ^{1 2 3 6 7}

How does the treatment L. Acidophilus (Strain TW01) for obesity differ from other treatments?

L. Acidophilus (Strain TW01) is unique because it targets obesity by improving gut health, reducing inflammation, and enhancing metabolism, which are not typical focuses of standard obesity treatments. This probiotic works by restoring balance in gut bacteria and strengthening the intestinal barrier, which can help reduce body weight and fat mass. ^{1 3 8 9 10}

What is the purpose of 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 is for individuals with pneumonia or who are overweight, aiming to explore the effects of L. acidophilus (strain TW01) on gut health and body composition. Participants should be interested in how probiotics might influence their stool substances, blood markers, gut bacteria, and inflammation levels.

Inclusion Criteria

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

Exclusion Criteria

I have not taken antibiotics or probiotics within the last month.

Weight changes > 10% over the last 4 weeks

Dairy allergy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Placebo Phase

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

6 weeks

Probiotic Phase

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)

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• L. Acidophilus (Strain TW01)

Trial Overview The study tests a probiotic supplement (L. acidophilus strain TW01) against a placebo to see if it improves gut health and reduces inflammation. It's a pilot study examining changes in stool and blood substances, gut bacteria diversity, body composition, and inflammatory markers.

Participant Groups

Group I: Probiotic phase Experimental Treatment 1 Intervention

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).

Group II: Placebo phase Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of Connecticut

Lead Sponsor

Trials

194

Recruited

162,000+

Findings from Research

In a 12-week clinical trial involving 81 adults with obesity, the probiotic Lactobacillus plantarum K50 (LPK) significantly reduced total cholesterol and triglyceride levels compared to a placebo, indicating potential benefits for blood lipid profiles.

While LPK did not lead to significant changes in body weight or fat mass, it positively altered gut microbiota composition, which correlated with changes in visceral fat, suggesting a mechanism for its effects on lipid metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Lactobacillus plantarum K50 on Lipids in Koreans With Obesity: A Randomized, Double-Blind Controlled Clinical Trial. Sohn, M., Na, GY., Chu, J., et al.[2022]

In a study involving 87 adults with obesity tendencies, the probiotic Lactobacillus gasseri SBT2055 (LG2055) significantly reduced abdominal visceral fat by an average of 4.6% and subcutaneous fat by 3.3% over 12 weeks, indicating its potential effectiveness in combating obesity.

Participants consuming LG2055 also experienced significant reductions in body weight (1.4%), BMI (1.5%), and waist circumference (1.8%), while the control group showed no significant changes, highlighting the probiotic's role in improving metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulation of abdominal adiposity by probiotics (Lactobacillus gasseri SBT2055) in adults with obese tendencies in a randomized controlled trial. Kadooka, Y., Sato, M., Imaizumi, K., et al.[2022]

In a study involving 100 overweight and obese participants, the probiotic supplement MED-02 significantly reduced body fat mass by 1166.82 g and body weight by 2.06 kg over 12 weeks compared to a placebo.

The safety profile of MED-02 was confirmed as no serious adverse effects were reported, indicating it is a safe option for weight management in overweight and obese individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of MED-02 Containing Two Probiotic Strains, Limosilactobacillus fermentum MG4231 and MG4244, on Body Fat Reduction in Overweight or Obese Subjects: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Study. Cho, YG., Yang, YJ., Yoon, YS., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Lactobacillus acidophilus ameliorates obesity in mice through modulation of gut microbiota dysbiosis and intestinal permeability. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Probiotic Strains and Intervention Total Doses for Modulating Obesity-Related Microbiota Dysbiosis: A Systematic Review and Meta-analysis. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Lactobacillus plantarum K50 on Lipids in Koreans With Obesity: A Randomized, Double-Blind Controlled Clinical Trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Regulation of abdominal adiposity by probiotics (Lactobacillus gasseri SBT2055) in adults with obese tendencies in a randomized controlled trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Probiotics L. plantarum and L. curvatus in combination alter hepatic lipid metabolism and suppress diet-induced obesity. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Lactic Acid Bacteria Strains Differently Modulate Gut Microbiota and Metabolic and Immunological Parameters in High-Fat Diet-Fed Mice. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Lactobacillus fermentum CECT5716 ameliorates high fat diet-induced obesity in mice through modulation of gut microbiota dysbiosis. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Anti-obese effects of two Lactobacilli and two Bifidobacteria on ICR mice fed on a high fat diet. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Lactobacillus acidophilus LA5 improves saturated fat-induced obesity mouse model through the enhanced intestinal Akkermansia muciniphila. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of MED-02 Containing Two Probiotic Strains, Limosilactobacillus fermentum MG4231 and MG4244, on Body Fat Reduction in Overweight or Obese Subjects: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Study. [2022]