This double-blind, randomized clinical trial aimed to assess the effectiveness and safeness of Bifidobacterium breve B-3 (BB-3) for reducing body fat.

According to the “carbohydrate-insulin model” (CIM), obesity arises from hormonal responses to highly processed carbohydrates rather than through the “energy balance model” (EBM), which states that obesity occurs due to a lack of energy intake.

Obesity prevalence has doubled in more than 70 countries since 1980 and has continuously increased in most others. In 2015, 107.7 million kids and 603.7 million adults were obese.

Between 1990 and 2017, the number of deaths and disability-adjusted life years (DALYs) associated with high body mass index (BMI) doubled for both men and women.

In 2017, high BMI was associated with ischemic heart disease, diabetes mellitus, chronic kidney disease, hypertension, and low back pain, as found in the Global Burden of Disease Study level 3.

It has also been declared that obesity is responsible for 80% of diabetes cases and 20% of heart disease cases worldwide. Obesity is associated with inherent complications and many chronic illnesses, such as type 2 diabetes, hypertension, arteriosclerosis, stroke, osteoarthritis, & obstructive sleep apnea.

In recent studies, it has been proposed that gut microbiota may affect obesity. Furthermore, altering the composition of the gut microbial ecosystem has been proposed as a novel way of treating obesity. This is because it supports energy balance, fat storage, neurohormonal function, and immune system function.

Several previous studies show that bifidobacteria can improve weight or body fat-related indicators. For example, Bifidobacterium breve B-3 (BB-3) has a patent for reducing body fat. In addition, Bifidobacterium demonstrated its efficacy against obesity in a non-clinical study conducted on mice.

In this randomized, double-blind, placebo-controlled clinical trial, experts recruited healthy individuals via a written notice posted on Semyung University Korean Medicine Hospital’s website and bulletin board until the scientists reached the target sample size.

In April 2021, the first participant was enrolled. It took 14 weeks to complete the study, including a maximum 2-week wash-out period and a safety assessment two weeks after the last visit. A full 21-day wash-out period was required for participants with a drug history or concurrent use of prohibited medications or foods.

The researchers performed a baseline assessment and provided the participants with 33-day supplies of the investigational product or placebo.

Participants in the study were randomly categorized into treatment and placebo groups on the second visit (within three weeks of the first visit), which served as the baseline time point. The researchers performed a baseline assessment, and the experts provided 33-day supplies of the investigational product or placebo to the participants.

BB-3 was the main ingredient in the investigational product, and the daily intake of BB-3 was five billion CFUs per capsule in the BB-3 group. The test and placebo capsules were manufactured similarly in shape, size, and color. The test capsules disintegrated in the stomach.

For 12 weeks, The participants took test or placebo drugs orally once daily. During visits 2, 3, and 4, participants were prescribed one month’s dose, then encouraged to continue taking it.

Compared to the placebo group, the BB-3 group had significantly lower body weight and body mass index at 12 weeks. In addition, at 12 weeks, the waist and hip circumferences of the BB-3 group were lower than those of the placebo group.

As a result of these findings, not only BB-3 can reduce body fat and weight, waist circumference, and hip circumferences safely and effectively. Scientists should conduct more research on the outcomes of BB-3 on intestinal conditions, its mechanisms, and the effects of hormone changes on human metabolism in the future.

Written by