Sero-Probiotic LEAN DF

Clinical Applications

Supports Healthy Weight Management*
Promotes Gut Barrier Function*
Promotes Intake of Less Calories*
Supports Reduction of Body Fat Mass*

Sero-Probiotic LEAN DF features vegetarian, gluten- and dairy-free, patented HOWARU® Shape Bifidobacterium animalis subsp lactis B420. This probiotic strain has been proven safe, effective, and well-tolerated. It has been shown to assist with healthy body composition by improving gut barrier function, supporting the reduction of body fat mass, and promoting less calorie consumption.*

All Serotonin Nutraceuticals LLC. Formulas Meet or Exceed cGMP Quality Standards

Discussion

At the turn of the 20th century, Nobel Prize laureate Ilya Metchnikov introduced the concept that bacteria in yogurt can support the neutralization of gut pathogens, which may, in turn, support human longevity. Since then, the role of beneficial bacteria in human health has become well established in the literature and continues to evolve. In 2002, the FAO (Food and Agriculture Organization of the United Nations) and WHO (World Health Organization) working group experts established a definition of probiotics as “live strains of strictly selected microorganisms, which, when administered in adequate amounts, confer a health benefit on the host.” Results of clinical studies have suggested a positive effect of supplemental probiotics on a wide range of health concerns, including gastrointestinal issues, allergies, immune support, and weight management.*

Epithelial integrity is key to the function of the gastrointestinal tract, and according to in vitro and animal research, disturbance of this integrity appears to be linked to metabolic disorders. To address the potential effects of consuming specific probiotic bacteria to protect epithelial cells from the effects of pathogenic bacteria, Caco-2 cells were treated with cell-free supernatants (CFSs) of four probiotics—Bifidobacterium lactis 420 (B420), Bifidobacterium lactis HN019, Lactobacillus acidophilus NCFM, and Lactobacillus salivarius Ls-33—and by a cell-free supernatant of a pathogenic bacteria Escherichia coli (EHEC) O157.

Tight junction integrity as well as expression of cyclooxygenases were measured with results suggesting that the B420 CFS counteracted damage done by the EHEC CFS. One cannot be certain that B420 CFS would prevent junction damage by live bacteria EHEC, but the results suggest that probiotic bacteria produce soluble metabolites that appear to protect epithelial cells and positively influence cytokine balance. Awareness of the existence and activity of soluble bacterial metabolites in vitro leads to speculation whether the same metabolites are also formed in the intestine with similar effects in vivo. However, the evidence presented does seem to suggest that oral consumption of B420 probiotic may benefit epithelial integrity.*

In animal research, the potential benefit of B420 in reducing high-fat, diet-induced body weight gain and diabetes was studied with results indicating a reduction of fat mass and glucose intolerance in both obese and diabetic mice. Reduced intestinal mucosal adherence and decreased levels of plasma lipopolysaccharide suggested a mechanism related to reduced translocation of gut microbes.*

HOWARU® Shape B420 (Bifidobacterium animalis subsp lactis B420)

The in vitro and experimental animal studies discussed above utilized B420 with positive results in improving epithelial integrity and potential for role in weight management. These results led to the need for a human trial to validate these effects. In a double-blind, placebo-controlled study in overweight volunteers (N = 225) aged 18-65, the effects of B420 and the combination of B420 with a prebiotic fiber on body-fat mass and other weight-related parameters were assessed. The authors speculated that the underlying mechanism for reduction of body fat mass could have been related to circulating zonulin (a potential marker of gut barrier function) and C-reactive protein (CRP), a speculation that had been supported by previous findings with similar results. Subjects were not required to make changes to their dietary or exercise habits. Body composition was monitored with dual-energy X-ray absorptiometry, and the primary outcome was a relative change in body fat mass between treatment groups were compared to placebo. Secondary endpoints included anthropometric measurements, food intake, and blood and fecal biomarkers. Although results showed that B420 in combination with the prebiotic offered the most significant benefits when compared to placebo (6.4% reduction in body fat mass), B420 alone (10^10 CFU/day) resulted in reduced body fat mass by 4.0% with changes in fat mass being most pronounced in the abdominal region and in waist circumference. Significant reduced caloric intake was also shown in both groups compared to placebo, and there were no differences between groups in the incidence of adverse events.*

Building on the data reported for B420 thus far, investigators looked into whether changes in the gut microbiota were associated with the clinical benefits and obesity-related issues. Fecal and plasma samples from a subset (n = 134) of the participants in the above-mentioned clinical trial were assessed at baseline, two months, and six months as well as one month post-intervention. Consumption of B420 resulted in alterations of the specific gut microbiota populations, Lactobacillus and Akkermansia muciniphila. Akkermansia muciniphila, often in lower amounts in obese individuals with metabolic disorders, is associated with improved metabolic health. This strain supports gut barrier function and has been proposed to be one of the mediators for the probiotic benefits of B420. More clinical trials are warranted to confirm these effects in larger participant populations and to further elucidate the underlying mechanisms.*

Serotonin Nutraceuticals LLC. packages the Sero-Probiotic LEAN DF capsules in sealed, nitrogen-purged blister packs to serve as protection from factors known to compromise the stability of probiotics, such as heat, moisture, and oxygen. To further support resistance to low pH and the delivery of microorganisms to the small intestines, Serotonin Nutraceuticals LLC. utilizes DRcaps™ gastro-resistant capsules. These specially designed, innovative capsules help slow exposure of actives to stomach acid to promote a more targeted release.*

*Also referred to in more recent literature as Bifidobacterium animalis subsp lactis.

Directions

Take one capsule with water daily, or as directed by your healthcare practitioner. Consult your healthcare practitioner prior to use. Individuals taking medication should discuss potential interactions with their healthcare practitioner.

Does Not Contain

Wheat, gluten, soy, animal or dairy products, fish, shellfish, peanuts, tree nuts, egg, ingredients derived from genetically modified organisms (GMOs), artificial colors, artificial sweeteners, or artificial preservatives.

References

Singh VP, Sharma J, Babu S, et al. Role of probiotics in health and disease: a review. J Pak Med Assoc. 2013 Feb;63(2):253-7. [PMID: 23894906]
Report of a joint FAO/WHO Working Group on Drafting Guidelines for the Evaluation of Probiotics in Food. FAO; London, ON, Canada. 30 April–1 May 2002. https://www.who.int/foodsafety/fs_management/en/probiotic_guidelines.pdf. Accessed December 11, 2018.
Wilkins T, Sequoia J. Probiotics for gastrointestinal conditions: a summary of the evidence. Am Fam Physician. 2017 Aug 1;96(3):170-178. [PMID: 28762696]
Markowiak P, Śliżewska K. Effects of probiotics, prebiotics, and synbiotics on human health. Nutrients. 2017 Sep 15;9(9). pii: E1021. [PMID: 28914794]
Sanders M, Merenstein C, Merrifield C, et al. Probiotics for human use. Nutrition Bulletin. 2018 Sept;43(3):212–225. doi: 10.1111/nbu.12334. https://onlinelibrary.wiley.com/doi/epdf/10.1111/nbu.12334. Accessed December 11, 2018.
Kadooka Y, Sato M, Imaizumi K, et al. Regulation of abdominal adiposity by probiotics (Lactobacillus gasseri SBT2055) in adults with obese tendencies in a randomized controlled trial. Eur J Clin Nutr. 2010 Jun;64(6):636-43. [PMID: 20216555]
Stenman LK, Lehtinen MJ, Meland N, et al. Probiotic with or without fiber controls body fat mass, associated with serum zonulin, in overweight and obese adults-randomized controlled trial. EBioMedicine. 2016 Nov;13:190-200. [PMID: 27810310]
Putalaah S, Salusjärvi T, Nordström M, et al. Effect of four probiotic strains and Escherichia coli O157 on tight junction integrity and cyclo-oxygenase expression. Res Microbiol. 2008 Nov-Dec;159(9-10):692-8. [PMID: 18787373]
Stenman LK, Waget A, Garret C, et al. Potential probiotic Bifidobacterium animalis ssp. lactis 420 prevents weight gain and glucose intolerance in diet-induced obese mice. Benef Microbes. 2014 Dec;5(4):437-45. [PMID: 25062610]
Hibberd AA, Yde CC, Ziegler ML, et al. Probiotic or synbiotic alters the gut microbiota and metabolism in a randomised controlled trial of weight management in overweight adults. Benef Microbes. 2018 Dec 1;9(6):857-868. [PMID: 30525950]

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

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