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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 diseases, including type 2 diabetes, heart disease, dementias such as Alzheimer's disease and some cancers, continue to represent a major challenge to public health. Many of these diseases are associated with diet and lifestyle factors, and there is an important opportunity for the nutrition sector to provide diet-based support to help consumers proactively reduce risk factors associated with the development of these diseases.

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Metabolic health is a catchall term for a constellation of health indicators and parameters including glucose metabolism, blood pressure, lipid balance and obesity. Collectively, imbalances in these health indicators 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) of 30 or more.1​​ The prevalence of obesity worldwide 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 decades of research linking obesity to cardiovascular outcomes such as coronary disease, stroke, heart failure and premature 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 oesophagus. Obesity is also linked to poor mental health.4​​

Current trends indicate obesity rates will continue to rise around the world, putting an increasing number of people at greater and greater risk for associated chronic diseases. The number of obese children aged five to 19 years old is predicted 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 frequently related to diet and other aspects of their lifestyles, more consumers are feeling 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 that the microbiome is a meaningful target for products that can lead to the 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 potential for favorable weight management properties. The in vivo​ screening process linked Bifidobacterium lactis​​ BPL1 to reductions in total lipids and triglycerides and other parameters related to metabolic health.9,10​​

This early-stage research demonstrated the potential of BPL1 to positively affect parameters associated with weight management. However, with many consumers looking for more scientific proof of efficacy, ADM knew that 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 instil confidence in consumers and show that a product can deliver on its claimed benefits.

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 a 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.

In addition, people in the heat-treated BPL1 group showed improvements in an endpoint that measured visceral fat, (a type of adipose tissue that surrounds organs including the liver and intestines), compared with those in the placebo group. 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 factors associated with a reduction in obesity.

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

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Strains that need to be alive to be effective cannot be formulated into products such as beverages, bakery and confectionery, because conditions during production inactivate the bacteria. Even if a strain can be formulated into a product, the need to keep it activated 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 targeted at weight management, without having to worry about whether the production and storage conditions will render it ineffective.

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 inactivated but are 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 by continuing to expand the frontiers of understanding into the effects of modulating the microbiome. In doing so, ADM stands ready to equip companies to develop exciting new products with real benefits that can empower consumers to maintain their metabolic health.

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1.      Obesity and overweight. WHO​​​​.

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. Circulation​​ 67​​, 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. BMJ​​ 335​​, 1134 (2007).

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5.      Atlas of Childhood Obesity​​.​​.

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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. Foods​​ 38​​, 251–263 (2017).

11.    Carreras N.L., Martorell P., Chenoll E., Genovés S., Ramón D., Aleixandre A. Anti-obesity properties of the strain Bifidobacterium animalis subsp. lactis CECT8145 in Zücker fatty rats. Beneficial Microbes​, 9​: 629-641 (2018).

12.    Gartner Says Only 19% of Marketing Leaders Believe Their Brands’ Values and Actions Are Fully Aligned. Gartner​​

13.    Gut feel: Unlocking the growing potential for digestive health​​.​​.

14.    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. Health​​ 66​​, 87–97 (2018).

15.    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).

16.    Cefalu, W. T. et al.​​ Contribution of visceral fat mass to the insulin resistance of aging. Metabolism​​ 44​​, 954–959 (1995).

17.    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. Metabolism​​ 39​​, 897–901 (1990).

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

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