SlimBiotics Postbiotic for Weight Loss

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new plant-based postbiotic supplement, SlimBiotics L. Fermentum K8 Postbiotic, to determine its effectiveness in weight management and metabolic health improvement. Participants will be divided into two groups: one will receive the SlimBiotics supplement, and the other will take a placebo. The goal is to assess whether this supplement effectively supports weight loss and metabolic health improvements compared to no active treatment. Individuals with a BMI between 25 and 32, who are generally healthy and own a sleep-tracking device, might be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to innovative research in weight management and metabolic health.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the SlimBiotics L. Fermentum K8 Postbiotic has undergone various tests, and these studies found no serious safety issues in people. Participants did not experience major health problems due to the postbiotic. Treatments tested extensively on humans are usually considered safe, meaning most people did not have adverse reactions. For those considering joining a trial with this postbiotic, previous research suggests it is likely safe for people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard weight management treatments that often rely on dietary changes, exercise, or medications, SlimBiotics L. Fermentum K8 Postbiotic offers a unique approach by utilizing a specific postbiotic. This postbiotic is derived from L. Fermentum K8, a type of beneficial bacteria known to support gut health, which is increasingly recognized for its role in weight and metabolic health. Researchers are excited about this treatment because it targets gut microbiota, potentially offering a natural and less invasive alternative to traditional methods. This innovative mechanism of action could provide a new avenue for managing weight and improving metabolic outcomes, making it a promising option for those seeking alternatives to current therapies.

What evidence suggests that this trial's treatments could be effective for weight management and metabolic health?

Research has shown that L. fermentum strains, such as the K8 in SlimBiotics, might aid in weight management and improve metabolism. In this trial, participants in the intervention group will receive SlimBiotics L. Fermentum K8 Postbiotic. Studies suggest these strains can reduce certain immune responses and increase the release of defensins, proteins that protect the gut. This may enhance digestion and metabolism. Although detailed information on SlimBiotics itself is still being gathered, the positive effects of similar strains offer a hopeful outlook for its role in weight management. ^{1 2 3 4 6}

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. clinicaltrials.gov clinicaltrials.gov/study/NCT05912699?term=postbiotic&viewType=Table&rank=5

A Study to Evaluate the Effect of SlimBiotics L. Fermentum ... This study is to evaluate the efficacy of a postbiotic supplement on weight management and metabolic health. This study will be conducted as a hybrid trial ...

2. withpower.com withpower.com/trial/phase-body-weight-6-2023-4af27

A Study to Evaluate the Effect of SlimBiotics L. Fermentum ... This trial is testing a plant-based supplement called SlimBiotics to help people manage their weight and improve their metabolic health.

3. ctv.veeva.com ctv.veeva.com/study/a-study-to-evaluate-the-effect-of-slimbiotics-l-fermentum-k8-postbiotic-on-weight-management-and-me

A Study to Evaluate the Effect of SlimBiotics L. Fermentum K8 ... This study is to evaluate the efficacy of a postbiotic supplement on weight management and metabolic health.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10346309/

Effect of a Probiotic and a Synbiotic on Body Fat Mass, Body ... L. fermentum strains K7-Lb1, K8-Lb1 and K11-Lb3 were found to suppress Th1 and Th2 response and to enhance defensin release by enterocytes, ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05917314

A Study to Evaluate the Effect of SlimBiotics Probiotic ... This study is to evaluate the efficacy of a probiotic supplement on weight management and metabolic health. This study will be conducted as a hybrid trial ...

6. trial.medpath.com trial.medpath.com/clinical-trial/4f5cca0e4d3bc2ff/effect-synbiotic-body-fat-mass-weight-management

Effect of Synbiotic L. Fermentum Strains on Body Fat Mass A Study to Evaluate the Effect of SlimBiotics L. Fermentum K8 Postbiotic on Weight Management and Metabolic Health Outcomes. Not Yet RecruitingNot Applicable.