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SmartGuard™
SmartGuard™
A safe, gentle probiotic developed to help limit daily lead build-up
Lead can negatively impact nearly all the body’s systems and organs3 and can be particularly hazardous to children as it interferes with the rapid and delicate process of brain development.4 SmartGuard™ binds to lead in simulated gastrointestinal in vitro conditions (bile and acidity-resistant) and will be available in a child-friendly powder format that readily dissolves in beverages.
A bright future starts lead free
Lead contamination is a global problem. Lead can be found in soil, dust, and paint, and can contaminate water and food. Once ingested, lead can be stored in the body and can build up over time.
1 in 3
children have high blood lead levels.1, 2 This equates to a staggering 800 million children.
Toxic
Lead is a cumulative toxin that gets trapped in body tissues and builds up over time.
900,000
deaths in 2019 could be attributed to the long-term health impacts of toxic lead in the body3 according to the World Health Organization.
Key benefits of SmartGuard™
SmartGuard™ is a novel ingredient developed to limit daily lead absorption. The SmartGuard™ Lactiplantibacillus plantarum probiotic strain (DSM 33464) was originally isolated from vegetables. The solution is easy to use and has been welcomed by health care practitioners in the United States and parents, alike.6,7
SmartGuard™ aims to limit daily lead build-up by removing ingested lead from the gastrointestinal tract. For children ages 0-7 years in China, estimated daily lead exposure through diet is 12.01-15.56 μg lead/day.8 A daily dose of 1 billion CFU of SmartGuard™ can bind 150 μg of lead in vitro, which corresponds to about 10x the estimated daily lead exposure.
SmartGuard™ is safe for long-term daily use and has been produced and tested to meet EU quality standards. The SmartGuard™ strain and production process are patent protected.
Lead can harm cognitive development
There is no safe level of lead in the body. Lead can negatively impact nearly all the body’s systems and organs.3 Since the 1980s, studies have repeatedly shown that a high blood lead level is associated with a reduction in neurodevelopmental performance.5
Lead poses a higher risk to young, growing children than to adults, as they absorb significantly more of the lead that enters their bodies.3 Additional factors putting children at higher risk are their developing blood-brain barriers1 and behavioral characteristics such as playing outdoors and crawling on the ground.5 If lead enters the bloodstream and crosses the blood-brain barrier, it can disrupt calcium ion signals and ultimately hinder cognitive development. Lead exposure can weaken the immune system, impair growth and appetite, reduce uptake of essential nutrients, and adversely affect behavior and sleep.4,5 Health care professionals advocate for early diagnosis and treatment of elevated blood lead levels due to the irreversible neurological and developmental damages that can occur if untreated.6
Consumers want simple, proven, and safe solutions
We put people at the heart of what we do, which is why consumer insights have been an integral part of developing SmartGuard™. We asked mothers in the US and China about their struggles and hopes for their children. Naturally, mothers were concerned about health risks, including the possibility of lead exposure leading to intellectual impairment and impacts on overall development.7 They were also concerned about the lack of a simple, clear solution.7 Collectively, they sought safe solutions with proven efficacy and quality ingredients to manage lead exposure.7
How SmartGuard™ should work in the body
SmartGuard™ binds to lead in simulated gastrointestinal conditions in vitro. The SmartGuard™ Lactiplantibacillus plantarum strain (DSM 33464) binds to lead on the cell surface and sequesters lead particles inside the cell, which can be readily seen by microscopy.
Let’s take a look under the microscope!
This is an in vitro microscopic image showing the SmartGuard™ strain binding lead (10,000X magnification). The lead binding on the cell surface and the sequestration of lead inside the cell are both clearly visible. The lead binding in simulated gastrointestinal in vitro conditions indicates that this mode of action should take place in the human gut.
Mode of action*
- Lead ingested through contaminated food and water enters the gut.
- SmartGuard™ specifically binds lead in the gut to prevent lead release into the bloodstream and absorption into the body.
- Lead in the gut remains bound by SmartGuard™ until it can be gently excreted from the body.
*MoA as suggested by in vitro and in vivo trials, currently being evaluated within human clinical trials.9,10
Clinical trials are underway
Clinical trials investigating the benefits of SmartGuard™ in children9 and young women of childbearing age10 are already underway. At Novozymes OneHealth, we’re conducting the first parallel, randomized, double-blind, placebo controlled clinical trial to evaluate the effect of Lactiplantibacillus plantarum (DSM 33464) on blood lead levels and general well-being of children.9 We’re also performing a second parallel, randomized, double-blind, placebo controlled clinical trial in young women of childbearing age.10 These studies will assess the strain’s ability to decrease lead absorption into the bloodstream by gently excreting the heavy metal from the body.
Let’s create something extraordinary together
If you’re ready to take your products the next level. We are here to help. From cutting edge biotechnology to specialist formulation and marketing. Whatever your dreams are for your brand. Together we can make it happen, let's talk.
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Sources
High blood lead levels” ≥ 5 µg/dL, according to the WHO Guideline for Clinical Management of Exposure to Lead. World Health Organization. 27 October 2021. “WHO guidance to reduce illness due to lead exposure”. WHO guidance to reduce illness due to lead exposure
Rees, N. and Fuller, R. “The toxic truth: children’s exposure to lead pollution undermines a generation of future potential.” (UNICEF and PureEarth, 2020).
World Health Organization. 11 October 2021. “Lead poisoning fact sheet”.
Centers for Disease Control and Prevention. 9 August 2022. Childhood lead poisoning prevention program, “Health effects of lead exposure”. Health Effects of Lead Exposure | Lead | CDC
World Health Organization. 2010. Childhood lead poisoning. Childhood lead poisoning (who.int)
Novozymes OneHealth proprietary explorative study with healthcare practitioners in the United States, (moderated sessions, 2020)
Novozymes OneHealth proprietary consumer insights studies of mothers of children diagnosed with elevated blood lead levels, China, 2018 (focus group), 2019 (moderated sessions), United States (2020 (moderated sessions).
Buqing, Zhong, et al. (2017). Probabilistic modeling of aggregate lead exposure in children aged 0-7 years of urban China using an adapted IEUBK model. Science of the Total Environment. Vol 584-585: pages 259-267.
NIH U.S. National Library of Medicine, Clinicaltrials.gov. A trial to evaluate the efficacy and safety of lactobacillus plantarum DSM 33464 on blood lead levels in children. https://clinicaltrials.gov/ct2/show/NCT04891666
NIH U.S. National Library of Medicine, Clinicaltrials.gov Effect of lactobacillus plantarum DSM 33464 on blood lead levels in young women of child-bearing age. https://clinicaltrials.gov/ct2/show/NCT05507021