A Study to Evaluate the Effect of SlimBiotics L. Fermentum K8 Postbiotic on Weight Management and Metabolic Health Outcomes

Overseen By Patrick Renner, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SlimBiotics Inc.

Must not be taking: Sulfonylureas, Probiotics, Laxatives, others

Disqualifiers: Pregnancy, Oncological, Psychiatric, Allergies, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a plant-based supplement called SlimBiotics to help people manage their weight and improve their metabolic health. It uses a special type of bacteria from fermented millet to achieve these benefits.

Will I have to stop taking my current medications?

The trial requires that you stop taking any regular medications, including over-the-counter ones, that might affect the study's goals, such as probiotics, laxatives, and steroids.

Is the treatment generally safe for humans?

The treatment, including its variations like SlimBiotics L. Fermentum K8 Postbiotic, has been studied in different forms and conditions, showing no serious safety concerns in humans. Studies on similar probiotic treatments have not shown harmful effects, suggesting they are generally safe for human use. ^{1 2 3 4 5}

How does SlimBiotics L. Fermentum K8 Postbiotic treatment differ from other treatments?

SlimBiotics L. Fermentum K8 Postbiotic is unique because it involves the use of postbiotics, which are non-viable bacterial products or metabolic byproducts from probiotic bacteria, to potentially modulate gut health. Unlike traditional probiotics that rely on live bacteria, postbiotics can offer similar benefits without the need for live organisms, making them potentially more stable and easier to incorporate into various forms of treatment. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment SlimBiotics L. Fermentum K8 Postbiotic?

Research shows that synbiotic treatments, which combine probiotics and prebiotics, can increase beneficial bacteria like Bifidobacterium in the gut. This suggests that similar treatments, like SlimBiotics L. Fermentum K8 Postbiotic, might also support gut health by enhancing the presence of good bacteria. ^{1 11 12 13 14}

Are You a Good Fit for This Trial?

Inclusion Criteria

Women & Men

18+

BMI between 25-32 (average BMI of subjects shall not exceed 30)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the SlimBiotics postbiotic or placebo for weight management and metabolic health

12 weeks

Hybrid trial with in-person and virtual assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• SlimBiotics L. Fermentum K8 Postbiotic

How Is the Trial Designed?

Group I: Intervention Group (SlimBiotic Postbiotic) Experimental Treatment 1 Intervention

Participants will take 1 serving (1 capsule) per day.

Group II: Placebo Group Placebo Group 1 Intervention

Participants will take 1 serving (1 capsule) per day.

Who Is Running the Clinical Trial?

SlimBiotics Inc.

Lead Sponsor

Trials

4

Recruited

480+

Slimbiotics

Lead Sponsor

Trials

2

Recruited

180+

Slimbiotics

Lead Sponsor

Trials

4

Recruited

480+

Citruslabs

Industry Sponsor

Trials

94

Recruited

5,100+

Published Research Related to This Trial

In a trial with 15 healthy volunteers, a 4-week synbiotic intervention combining specific probiotics and chicory-derived inulin showed no adverse effects, indicating its safety for consumption.

The intervention led to an increase in the abundance of beneficial gut bacteria, particularly Bifidobacteriaceae, while the overall diversity of the gut microbiome remained unchanged, suggesting targeted effects of the synbiotics on gut health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synbiotic Intervention with Lactobacilli, Bifidobacteria, and Inulin in Healthy Volunteers Increases the Abundance of Bifidobacteria but Does Not Alter Microbial Diversity. Rubin, IMC., Mollerup, S., Broholm, C., et al.[2023]

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]

Citations

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

Synbiotic Intervention with Lactobacilli, Bifidobacteria, and Inulin in Healthy Volunteers Increases the Abundance of Bifidobacteria but Does Not Alter Microbial Diversity. [2023]

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

Prebiotics enhance persistence of fermented-food associated bacteria in in vitro cultivated fecal microbial communities. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Impact of a fermented soy beverage supplemented with acerola by-product on the gut microbiota from lean and obese subjects using an in vitro model of the human colon. [2021]

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

Matrix Effects on the Delivery Efficacy of Bifidobacterium animalis subsp. lactis BB-12 on Fecal Microbiota, Gut Transit Time, and Short-Chain Fatty Acids in Healthy Young Adults. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

A synbiotic concept containing spore-forming Bacillus strains and a prebiotic fiber blend consistently enhanced metabolic activity by modulation of the gut microbiome in vitro. [2020]

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

Genotoxicity assessment of multispecies probiotics using reverse mutation, mammalian chromosomal aberration, and rodent micronucleus tests. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Safety of Novel Microbes for Human Consumption: Practical Examples of Assessment in the European Union. [2020]

8. 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]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Safety Assessment of Bacteroides Uniformis CECT 7771, a Symbiont of the Gut Microbiota in Infants. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Understanding the prebiotic potential of different dietary fibers using an in vitro continuous adult fermentation model (PolyFermS). [2019]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Identification of Lactobacillus Strains Capable of Fermenting Fructo-Oligosaccharides and Inulin. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Dietary modulation of the human gut microflora using prebiotics. [2017]

13. England pubmed.ncbi.nlm.nih.gov

The synthesis of n-caproate from lactate: a new efficient process for medium-chain carboxylates production. [2022]

14. India pubmed.ncbi.nlm.nih.gov

Malt sprout, an underused beer by-product with promising potential for the growth and dehydration of lactobacilli strains. [2020]