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ADM: Clinically validating probiotics and postbiotics to meet growing demand for metabolic health products

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The prevalence of chronic diseases is increasing among populations around the world, posing a tremendous burden on healthcare systems. Despite advances in medical therapeutics and technologies, these noncommunicable diseases, including type 2 diabetes, heart disease, Alzheimer's disease and some cancers, continue to represent a major challenge to public health. Many of these are substantively modulated by diet and lifestyle, and there is an important opportunity for the nutrition sector to provide diet-based solutions to help consumers proactively reduce their risk of developing these diseases.

Metabolic health is a catchall term for a constellation of symptoms and parameters including glucose metabolism, blood pressure, lipid balance and obesity. Collectively, those symptoms and parameters are implicated in many of the biggest health problems facing advanced and emerging economies.

Obesity alone is a major driver of poor health outcomes. In 2016, more than 650 million adults were categorized as obese globally, as defined by a body mass index (BMI) or 30 or more.1​ The prevalence of obesity has nearly tripled since 1975. Almost 2 billion adults — two out of every five people aged 18 years old and over — are overweight.

There are now decades of research linking obesity to cardiovascular outcomes such as coronary disease, stroke, heart failure and death.2​ Obesity is also associated with increased risk of developing a range of cancers, including those of the breast and the bowel.3​ In postmenopausal women, BMI is implicated in around 50% of cases of endometrial cancer and adenocarcinoma of the esophagus. Obesity is also linked to poor mental health.4

Current trends indicate obesity rates will continue to rise, putting people around the world at greater and greater risk for associated chronic diseases. The number of obese children aged five to 19 years old is expected to increase by 61% this decade.5​ Unchecked, rising rates of obesity could overburden healthcare systems and create a public health crisis.

Modulating the microbiome to aid weight management

Because development of obesity and its associated chronic diseases are related to diet and other aspects of their lifestyles, consumers feel empowered to improve their health through modifications to these factors. The trend is creating a growing opportunity for food, beverage and nutrition companies to formulate new products that meet the expanding and diverse needs of consumers.

Companies can seize that opportunity by building on the fast-growing body of research linking the bacteria found in the gut to health outcomes. The research suggests the microbiome is a meaningful target for products that can lead to improvements in health parameters that consumers are trying to achieve, including outcomes related to obesity.

The microbiome is implicated in the storage of fats and other mechanisms that potentially affect an individual’s weight.6–8​ In light of those links, ADM used its proprietary in vivo ​fat reduction model to screen for a bacterial strain with favorable weight management properties. The screening process linked Bifidobacterium lactis​ BPL1 to reductions in total lipids and triglycerides and other parameters related to metabolic health.9,10

The early-stage research demonstrated the potential of BPL1 to positively affect weight management. However, with many consumers skeptical of marketing claims, ADM knew it needed to generate additional data to gain the trust that supports initial and ongoing purchases.11–13

That thinking led ADM to run a randomized, double-blind, placebo-controlled human clinical trial, a type of study that is considered the gold standard to achieve high quality data from human intervention studies, and is perhaps the most effective way to instill confidence in consumers and show a product can deliver on its claimed benefits.

Woman with smoothie Kamil Macniak - shutterstock _600x300

Examining BPL1 in a pilot clinical trial

Investigators enrolled 135 abdominally obese people in the clinical trial and randomized them to take either live BPL1, heat-treated BPL1 or placebo once a day for three months.14​ The study linked both forms of BPL1 to reductions in endpoints such as BMI and waist circumference.

Similarly, heat-treated BPL1 outperformed placebo against an endpoint that measured visceral fat, a type of adipose tissue that surrounds organs including the liver and intestines. Visceral fat levels are correlated to poor metabolic health and have been identified as a predictor of mortality in men.15–17​ In linking heat-treated BPL1 to reductions in visceral fat, ADM therefore pointed to the potential for the strain to play a role in positively affecting health functions impacted by the obesity crisis.

The fact that the trial linked both forms of BPL1 to reductions in visceral fat and other endpoints, and, if anything, found the heat-treated form is more effective, creates the opportunity to provide benefits to food and beverage products where processing otherwise precludes the inclusion of live microorganisms, better known as probiotics.

Strains that need to be alive to be effective cannot be formulated into many products, such as those in the beverage, bakery and confectionery categories, because conditions during production kill the bacteria. Even if a strain can be formulated into a product, the need to keep it alive impacts the shelf life and storage conditions.

Heat-treated BPL1 (HT-BPL1) is free from those constraints. Manufacturers can use heat-treated BPL1 to develop products with weight management benefits, without having to worry about whether the production and storage conditions will render it ineffective.

Woman Eating Bar Rido - stock.adobe.com_600x300

Developing science-backed postbiotic products

The clinical data positions HT-BPL1 as part of the emerging class of postbiotics, a term for bacterial strains that are no longer living but still effective. Recognizing the potential for postbiotics to bring demonstrated effectiveness to new product categories, ADM is applying its scientific capabilities to the field, for example by looking for the specific component that drives the effects seen with heat-treated BPL1. 

Through innovative research, ADM is expanding the opportunities in this exciting market category by building on its long legacy of scientific exploration and continuing to expand the frontiers of understanding of the effects of modulating the microbiome. In doing so, ADM stands to equip brands to develop exciting new products with real benefits and thereby empower consumers to maintain their metabolic health.

References

1.      Obesity and overweight. WHOhttps://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight​.

2.      Hubert, H. B., Feinleib, M., McNamara, P. M. & Castelli, W. P. Obesity as an independent risk factor for cardiovascular disease: a 26-year follow-up of participants in the Framingham Heart Study. Circulation67​, 968–977 (1983).

3.      Reeves, G. K. et al.​ Cancer incidence and mortality in relation to body mass index in the Million Women Study: cohort study. BMJ335​, 1134 (2007).

4.      Rajan, T. M. & Menon, V. Psychiatric disorders and obesity: A review of association studies. J. Postgrad. Med.63​, 182–190 (2017).

5.      Atlas of Childhood Obesity​. http://s3-eu-west-1.amazonaws.com/wof-files/11996_Childhood_Obesity_Atlas_Report_ART_V2.pdf​.

6.      Bäckhed, F. et al.​ The gut microbiota as an environmental factor that regulates fat storage. Proc. Natl. Acad. Sci. U. S. A.101​, 15718–15723 (2004).

7.      Turnbaugh, P. J. et al.​ An obesity-associated gut microbiome with increased capacity for energy harvest. Nature444​, 1027–1031 (2006).

8.      Boroni Moreira, A. P., Fiche Salles Teixeira, T., do C Gouveia Peluzio, M. & de Cássia Gonçalves Alfenas, R. Gut microbiota and the development of obesity. Nutr. Hosp.27​, 1408–1414 (2012).

9.      Martorell, P. et al.​ Probiotic Strain Bifidobacterium animalis subsp. lactis CECT 8145 Reduces Fat Content and Modulates Lipid Metabolism and Antioxidant Response in Caenorhabditis elegans. J. Agric. Food Chem.64​, 3462–3472 (2016).

10.    Caimari, A. et al.​ Heat-killed Bifidobacterium animalis subsp. Lactis CECT 8145 increases lean mass and ameliorates metabolic syndrome in cafeteria-fed obese rats. J. Funct. Foods38​, 251–263 (2017).

11.    Gartner Says Only 19% of Marketing Leaders Believe Their Brands’ Values and Actions Are Fully Aligned. Gartnerhttps://www.gartner.com/en/newsroom/press-releases/2019-10-21-gartner-says-only-19--of-marketing-leaders-believe-th​.

12.    Gut feel: Unlocking the growing potential for digestive health​. https://www.vitafoodsinsights.com/sites/vitafoodsinsights.com/files/VFI-DM-DigestiveHealth-0619.pdf​.

13.    Valentine, A. A., Schumacher, J. R., Murphy, J. & Ma, Y. J. Dietary supplement use, perceptions, and associated lifestyle behaviors in undergraduate college students, student-athletes, and ROTC cadets. J Am. Coll. Health66​, 87–97 (2018).

14.    Pedret, A. et al.​ Effects of daily consumption of the probiotic Bifidobacterium animalis subsp. lactis CECT 8145 on anthropometric adiposity biomarkers in abdominally obese subjects: a randomized controlled trial. Int. J. Obes. ​ 43​, 1863–1868 (2019).

15.    Cefalu, W. T. et al.​ Contribution of visceral fat mass to the insulin resistance of aging. Metabolism44​, 954–959 (1995).

16.    Seidell, J. C., Björntorp, P., Sjöström, L., Kvist, H. & Sannerstedt, R. Visceral fat accumulation in men is positively associated with insulin, glucose, and C-peptide levels, but negatively with testosterone levels. Metabolism39​, 897–901 (1990).

17.    Kuk, J. L. et al.​ Visceral Fat Is an Independent Predictor of All-cause Mortality in Men*. Obesity ​ 14​, 336–341 (2006).