Probiotics for Obesity

Overseen By Allison Vaughan, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must not be taking: Hunger medications

Disqualifiers: Type 1 diabetes, Vascular disease, Neurological disease, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether probiotics, beneficial bacteria for the gut, can aid in weight loss. The goal is to find a simpler, non-invasive alternative to surgery and medications, which often have side effects. Participants will be divided into two groups: one receiving a probiotic and the other a placebo (inactive substance) to compare results. Suitable candidates for this trial have a BMI between 25 and 40 and have not recently used antibiotics or probiotics. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research that could lead to new, safer weight loss solutions.

Will I have to stop taking my current medications?

You may need to stop taking medications that affect hunger, satiety, or appetite, as well as any on the medication exclusion list. However, if you are on maintenance medications and have been on a stable dose for 6 months, you may not need to stop them.

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

Research has shown that probiotics are generally safe and easy to use. A detailed review found that probiotics can help with various health issues, including obesity, with only a few minor side effects. One study found that taking a specific probiotic for six months led to weight loss and improved cholesterol levels, with very few negative effects reported.

While some studies have found that probiotics do not always lead to significant weight or body mass reduction, they did not report any serious side effects. Probiotics are often considered a safe option for managing weight, making them a promising choice for those who want to avoid the risks of surgery or medications with more side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for obesity?

Researchers are excited about probiotics for obesity because they offer a natural, potentially safer alternative to current treatments, which often include medications and surgery. Unlike standard treatments that may involve chemical interventions or invasive procedures, probiotics work by improving gut health and balancing the microbiome, which can influence weight management. This novel approach could lead to fewer side effects and a more holistic way to tackle obesity, making it a promising area of research.

What evidence suggests that probiotics might be an effective treatment for obesity?

This trial will compare the effects of probiotics and a placebo in addressing obesity. Research has shown that probiotics can aid in weight loss. One study found that a specific daily mix of probiotics led to significant weight loss in overweight adults. Another study discovered that probiotics reduced belly fat, especially in adult women, when combined with dietary changes. A review of multiple studies confirmed that probiotics have a moderate effect on weight loss and improve the body's ability to process sugar and fats. Overall, probiotics are considered a promising and safe option for addressing obesity. ^{1 2 6 7 8}

Who Is on the Research Team?

Arpana Gupta, PhD

Principal Investigator

The Regents of the University of California, Los Angeles

Tien Dong, MD, PhD

Principal Investigator

The Regents of the University of California, Los Angeles

Are You a Good Fit for This Trial?

Adults aged 18-50 with a BMI of 25-40, who are not pregnant or nursing. Excluded if they have Type 1 diabetes, untreated thyroid disease, neurological issues, weigh over 400lbs, had certain abdominal surgeries, major medical conditions as determined by the study doctor, chronic pain or active psychiatric illness including eating disorders in the last two years.

Inclusion Criteria

BMI 25-40

Not Pregnant or Nursing

I am either male or female.

Exclusion Criteria

I am taking medication that affects my hunger or appetite.

I am not using birth control and may plan to get pregnant during the study.

I have not taken any antibiotics in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a combination probiotic or placebo for 12 weeks

12 weeks

3 visits (in-person) at week 0, week 6, and week 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Probiotic

Trial Overview This trial is testing whether probiotics can help people lose weight compared to a placebo. It's for those who find current obesity treatments ineffective and want to avoid bariatric surgery due to its risks and recovery time.

How Is the Trial Designed?

Group I: Probiotic Active Control 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

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]

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]

Probiotic supplementation, particularly with Lactobacillus and Bifidobacterium, has shown promising antiobesity effects in animal models, including reductions in weight gain and fat tissue mass.

Human studies on probiotics for obesity management are limited, and more research is needed to determine their efficacy, as probiotic effects can vary significantly based on strain and individual factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Probiotics on the Microbiota: Effect on Obesity. Nova, E., Pérez de Heredia, F., Gómez-Martínez, S., et al.[2017]

A systematic review of 15 randomized controlled trials involving 957 participants showed that probiotic supplementation led to small but significant reductions in body weight, BMI, and fat percentage in individuals with overweight or obesity.

The reductions in body weight were approximately 0.60 kg, BMI decreased by 0.27 kg/m², and fat percentage decreased by 0.60%, indicating that while probiotics can have a positive effect on weight management, the overall impact is modest.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of probiotics on body weight, body mass index, fat mass and fat percentage in subjects with overweight or obesity: a systematic review and meta-analysis of randomized controlled trials. Borgeraas, H., Johnson, LK., Skattebu, J., et al.[2022]

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 36 male rats, supplementation with Bifidobacterium spp. significantly reduced body and fat weights, as well as harmful blood serum levels related to obesity, after 7 weeks on a high-fat diet.

The probiotics not only lowered levels of triglycerides and glucose but also increased beneficial gut bacteria, indicating their potential as a safe and effective intervention for obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiobesity and lipid-lowering effects of Bifidobacterium spp. in high fat diet-induced obese rats. An, HM., Park, SY., Lee, DK., et al.[2023]

Manipulating gut microbiota through diet, antibiotics, or probiotics can influence the development of obesity, with certain Lactobacillus species linked to weight gain in both animals and humans.

Newborns and infants are especially vulnerable to the effects of antibiotics and probiotics, which may contribute to obesity later in life, highlighting the need for careful consideration in their use during early development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of the manipulation of the gut microbiota in obesity. Million, M., Raoult, D.[2021]

Probiotic supplementation can positively alter the gut microbiota in obese individuals, which may help reduce gut permeability, inflammation, and metabolic disorders associated with obesity.

These changes in gut microbiota diversity and composition create a favorable environment for weight loss, suggesting that probiotics could be a beneficial strategy in managing obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight loss probiotic supplementation effect in overweight and obesity subjects: A review. Guazzelli Marques, C., de Piano Ganen, A., Zaccaro de Barros, A., et al.[2021]

Next-generation probiotics (NGPs) like Akkermansia muciniphila and Hafnia alvei show promise in treating obesity and related disorders, with mechanisms including improving gut health and reducing inflammation.

Initial studies in overweight and obese patients have shown encouraging results, but ongoing safety assessments and more extensive research are needed to fully understand their therapeutic potential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Next-Generation Probiotics in Obesity and Obesity-Associated Disorders: Current Knowledge and Future Perspectives. Vallianou, NG., Kounatidis, D., Tsilingiris, D., et al.[2023]

Citations

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Use of probiotics in preventing and treating excess weight and ... Daily supplementation with the Lab4P probiotic consortium induces significant weight loss in overweight adults. Sci Rep. 2021;11(1):5 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7465252/

Probiotics for the Treatment of Overweight and Obesity in ... The presented research presents the benefits of modifying the composition of the intestinal microbiota as a promising strategy for the treatment of obesity.

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Exploring the relationship between live microbe intake and ... Gomes et al. found that supplementation with a probiotic mixture reduced abdominal obesity in adult females compared to dietary interventions ...

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Impact of probiotics on weight loss, glucose and lipid ... This meta-analysis suggested that probiotic supplementation has a moderate and statistically significant effect on weight loss and glucose and lipid metabolism ...

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The effects of prebiotic, probiotic or synbiotic ... Notably, body weight and BMI showed significant reductions with probiotic treatment for over 15 days at doses ranging from 4.97 × 106 to 7 × 10 ...

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A comprehensive review of probiotics and human health ... Probiotics can be used for the treatment of diabetes, obesity, inflammatory, cardiovascular, respiratory, Central nervous system disease (CNS) and digestive ...

7. ods.od.nih.gov ods.od.nih.gov/factsheets/Probiotics-HealthProfessional/

Probiotics - Health Professional Fact Sheet Probiotics overview for health professionals. Research food and supplement sources, health effects, safety, selection, and use here.

8. nature.com nature.com/articles/s41598-020-60991-7

A randomised controlled study shows supplementation of ... Six months supplementation with Lab4P probiotic resulted in significant weight reduction and improved small dense low-density lipoprotein-cholesterol (sdLDL-C) ...