The world has a serious obesity problem. From the Americas to Zimbabwe, a fast-rising proportion of people are classed as obese or overweight. People initially sought out diets to bring their waistlines under control but increasingly are shunning these methods in favor of healthy lifestyles that prioritize real, wholesome food. Probiotics can play an important role in these lifestyles but will only gain traction if, like UAS Labs’ Lactobacillus gasseri BNR17, they are backed by high-quality clinical data.
The need for effective approaches to weight management is more pressing than ever. Obesity, as defined by a body mass index (BMI) of 30 or more, has nearly tripled globally since 1975.1 That rapid rise means more than 650 million adults were obese as of 2016. Almost 2 billion adults were overweight. Data on children suggest the obesity figures will continue to rise. In 2016, 340 million children and adolescents aged five to 19 were overweight or obese. More than 40 million children under the age of five were obese.
The data show obesity is a global problem but it is a particularly-acute challenge in the US, where 40% of adults and 19% of children and adolescents are obese.2 As the obesity epidemic hit the US earlier and harder than other countries, the responses of Americans to the crisis can show what may happen in the rest of the world in the years to come.
Many Americans responded to the obesity crisis by dieting. A poll run in the US from 2013 to 2016 found almost half of people had tried to lose weight within the past 12 months.3 Among women aged 20 to 59, the figure increases to around 60%. However, none of the multitude of diet plans tried by these people have brought the crisis under control.
Having grown dissatisfied with the results achieved by diets, people are focusing more on wellness than weight loss. Evidence for the trend includes a CBD Marketing analysis of 8.6 million online posts, which found 18 to 35 year olds have little interest in dieting or fat-free foods.4 Instead of bouncing from fad diet to fad diet, these consumers are making healthy, natural meals at home and realigning their lifestyles to promote wellbeing.
The role of probiotics in healthy lifestyles
Probiotics fit into this holistic approach to health. Yet, relatively few people incorporate supplements into weight management regimes. Of the 9,117 people polled by the US National Center for Health Statistics, 122 took dietary supplements for weight loss.5 That suggests that while 50% of Americans are trying to lose weight, just 1% of people use supplements to help them achieve this goal.
Doubt about the efficacy of supplements is one reason for low uptake. A survey of undergraduate students at a midwestern university found people were more skeptical about the efficacy of weight loss products than any other type of dietary supplement.6 The students were right to be skeptical. A study of people who lost 5% or more of their body weight found no link between nonprescription products and successful dieting.7
The data paints the picture of a supplement market with huge potential — both from commercial and health perspectives — that is being held back by a historic lack of scientifically-validated products.
Clinically-validated probiotics are starting to fill this gap in the market. Having gained familiarity with probiotics in the context of digestive health, consumers are seeking out products that address other specific health needs or wants. The emergence of heart healthy probiotics is one sign of this trend. Another sign is the rise of weight management products, which accounted for 6% of new probiotic supplement launches in 2015.8
The growth of the category gives consumers a way to adopt personalized and semi-personalized regimes that support weight management through the use of probiotic supplements. This approach to weight management is in keeping with the broader move away from fad diets and toward ongoing healthy living.
To maintain momentum, manufacturers need to win over consumers with high-quality clinical data that dispels doubts about efficacy.
The evidence to support BNR17
UAS Labs responded to the need for clinically-validated probiotics that fit into consumers’ healthy, weight-conscious lifestyles by licensing Lactobacillus gasseri BNR17 from AceBiome. The strain has been through extensive preclinical analysis and three clinical trials, and is approved in South Korea as a functional ingredient for helping reduce body fat.
The scientific validation of Lactobacillus gasseri BNR17 began after the strain was isolated from human breast milk. In preclinical tests, animals that received the strain gained weight more slowly. The studies also linked Lactobacillus gasseri BNR17 to significant reductions in white adipose tissue.
That led to research into the strain’s weight management mechanism of action. The data are from animals, so caveats apply, but they link the strain to the upregulation of genes related to the use of fats and changes in the levels of hormones involved in the control of appetite and metabolism.
These preclinical tests of BNR17’s efficacy and mechanism generated data to support the advance of the strain into clinical trials in humans. The first of three placebo-controlled clinical trials of the strain enrolled around 60 overweight adults. After 12 weeks, the BMI and waist and hip circumferences of subjects who took two capsules of Lactobacillus gasseri BNR17 before meals had decreased significantly.
The second clinical trial repeated the findings in obese and overweight adults. Subjects in the BNR17 arm experienced reductions in BMI and waist and hip circumferences. The trial also linked the strain to declines in body weight and visceral adipose tissue, the fat that surrounds organs and is associated with health issues.
With the first two trials generating data on the weight management applications of BNR17, the researchers then ran a third clinical study to assess its effect on digestive wellness. The third study linked BNR17 to the normalization of bowel habits in people with irritable bowel syndrome.
UAS Labs licensed BNR17 on the strength of the preclinical and clinical data package detailed above. The package paints BNR17 as a probiotic of particular promise, a point that was reinforced when 15 experts judged Lactobacillus gasseri BNR17 to be the weight management ingredient of the year in the 2018 NutraIngredients-USA Awards. The award reflects the quality of the clinical documentation built up around BNR17 to date.
Yet, UAS Labs has no plans to rest on its laurels. Instead, the company's researchers are preparing a well-powered protocol for a clinical trial that will target relevant weight management biomarkers. The trial, which is due to get underway early in 2019, is designed to provide further high-quality evidence of the role BNR17 can play in healthy, weight-aware lifestyles.
Producing high-quality probiotics
The clinical trial is one of several ways in which UAS Labs plans to further burnish the status of the strain through the deployment of its expertise and capabilities. UAS Labs’ other efforts leverage the strain-to-solution capabilities it has built up to give it total control over its ingredients and finished products.
Following a $60 million investment, UAS Labs can perform fermentation, concentration and freeze drying in a closed loop production system that monitors temperature, pH and other vital parameters around the clock. The system is designed to ensure each step in the process takes place under the optimal conditions for probiotic viability. When combined with rigorous testing, the system ensures all of the freeze-dried probiotic concentrate that leaves UAS Labs’ facility has the right identity and purity.
Probiotic brand owners can source supplies of freeze-dried BNR17 produced in this highly-controlled system from UAS Labs. Some of the concentrate goes to UAS Labs’ own finished goods manufacturing facility located in Wausau, WI, US for standardizing and blending into capsules, tablets and other consumer-ready formulations.
Regardless of whether companies buy the freeze-dried concentrate or finished products, they will get a product with a rare pedigree. In licensing BNR17, UAS Labs has combined a clinically-validated probiotic with one of the few end-to-end production processes in the world. To reinforce this strong proposition, UAS Labs is investing in further development of the strain.
The result is a probiotic that is poised to address a major need created by a confluence of trends. With obesity rising around the world and consumer attitudes to weight management changing, there is a need for personalized and semi-personalized supplement regimes that support healthy lifestyles. The data suggest BNR17 can meet this need and help people achieve their health goals.
4. New Research Proves Millennials Are Upsetting the Grocery Cart with Their Focus on Fresh, Fitness and Flavor. Available at: https://www.prnewswire.comnew-research-proves-millennials-are-upsetting-the-grocery-cart-with-their-focus-on-fresh-fitness-and-flavor-300526046. (Accessed: 21st August 2018)
5. NHANES 2013-2014: Dietary Supplement Use 30-Day - Individual Dietary Supplements Data Documentation, Codebook, and Frequencies. Available at: https://wwwn.cdc.gov/Nchs/Nhanes/2013-2014/DSQIDS_H.htm#DSQ128N. (Accessed: 20th August 2018)
6. 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).
8. What Will It Take to Expand Probiotics’ Customer Base? Available at: http://www.nutritionaloutlook.com/digestive-health/what-will-it-take-expand-probiotics-customer-base. (Accessed: 20th August 2018)