Nutrileads’ Novel Immune Ingredient, BeniCaros® Receives No Questions from FDA on GRAS Declaration

April 21, 2022 – Nutrileads has received a letter with no questions from the United States Food and Drug Administration (FDA) regarding their Generally Recognized As Safe (GRAS) application for their revolutionary immune health ingredient, BeniCaros®. The FDA letter states that the agency has no questions to Nutrileads’ application for GRAS status for BeniCaros® for inclusion in Dietary Supplements, Beverages and Functional Foods. 

GRAS is a designation created by the FDA under the Federal Food, Drug and Cosmetic Act. It determines that a new food ingredient or additive has adequate evidence of safety to be consumed under the conditions and dosage of intended use.

Launched in the US in October 2021, BeniCaros® is an award-winning, natural, clinically proven immune health ingredient that trains your immune system to be fit.  BeniCaros® is the commercial name for the unique polysaccharide (fiber), also known as cRG-I (rhamnogalacturonan-I  derived from carrot pomace). A recently published breakthrough clinical trial demonstrated that BeniCaros® improved immune response and resilience in a validated Rhinovirus respiratory infection model. 

Established in 2012, Nutrileads is an innovative health ingredients company that develops and commercializes crop-derived food ingredients with clinically proven health benefits.  NutriLeads’ proprietary ingredients undergo clinical trials to demonstrate their efficacy in improving human health and are taken through regulatory approval for market access before being licensed out to partner companies, that will incorporate the ingredients in their finished products to bring the benefits to consumers. 

What sets Nutrileads apart is their dedication to the scientific discovery of innovative techniques that unlock the health potential of natural foods, meaning that all ingredients developed by the company bring benefits that are science-based.  Living up to this standard means that Nutrileads submitted its GRAS self-affirmed dossier to the FDA for evaluation.  Opening their submission to FDA review and receiving a letter of no questions highlights the confidence that Nutrileads has in the quality of the ingredient and the scientific substantiation behind BeniCaros®.

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Stem and Root and Nutrileads Announce Launch of Daily Immunity for Optimized Immune Function Powered by BeniCaros for Ground Breaking Immunity Support

March 15, 2022 – Stem & Root, a product line developed by Bayer, and NutriLeads, a natural health ingredients company announced today the launch of a new and innovative immune product called Daily Immunity featuring the award-winning ingredient, BeniCarosTM. Stem & Root Daily Immunity is substantiated by breakthrough clinical trials, tying BeniCarosTM, and zinc – a unique natural blend to support a healthy immune function.

“Everything we do is to create products that fill a consumer need. Consumers are being more proactive with their health especially when it comes to immunity, said Kyle Garner, General Manager of Stem & Root. Our product line of all natural products, Stem & Root, delivers the power of nature that is backed by science. Daily Immunity rounds out our lineup of products, supported by over 100 clinical trials that provide daily support for your immune system,” Garner added.

BeniCaros™ is an award-winning, natural, plant-based, clean-label immune ingredient with clinically proven health benefits. It is a carrot-derived rhamnogalacturonan-I (cRG-I), a soluble polysaccharide, unlocked from the carrot cell wall through Nutrileads’ proprietary extraction process. BeniCaros™ supports your immune system to be at its best when needed the most.

“We are proud to collaborate with Stem & Root, a natural product line of Bayer. Bayer is a company that sets the bar in terms of the supplement industry’s highest standards with products that contain scientifically substantiated ingredients” said Erik Dam, CEO of NutriLeads. “We are thrilled that our BeniCaros™ will now be available to consumers in Stem & Root Daily Immunity to train their immune system to be fit all year round.” Dam said.

Stem & Root Daily Immunity is now available on Amazon in the US along with other best sellers from the brand.

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NutriLeads’ clinical trial demonstrates that daily intake of BeniCaros helps support protective innate immune responses

Pivotal study published in Nutrients showing that Nutrileads’ proprietary carrot-derived rhamnogalacturonan-I (cRG-I) (commercially known as BeniCaros) fiber, accelerates protective anti-viral immune responses and reduces symptoms after an experimental infection with common cold virus in humans.

20 January 2022, Wageningen, the Netherlands. Dutch health ingredients company, NutriLeads, announced the publication of the positive results of a pivotal clinical trial demonstrating that its award-winning ingredient cRG-I, commercially known as Benicaros, helps support protective immune responses to a common respiratory infection.      

The Dietary Intake of Carrot-Derived Rhamnogalacturonan-I Accelerates and Augments the Innate Immune and Anti-Viral Interferon Response to Rhinovirus Infection and Reduces Duration and Severity of Symptoms in Humans in a Randomized Trial” has been published in the open access journal Nutrients1.

Conducted in collaboration with the Amsterdam University Medical Centre (UMC; location AMC), NIZO Food Research, and StatistiCal B.V. in the Netherlands, the BeniCaros clinical trial assessed how the food ingredient carrot-derived rhamnogalacturonan-I (cRG-I) impacted peoples’ responses to an experimentally induced mild rhinovirus infection. Rhinoviruses are responsible for common colds and impose an enormous economic burden on society. In the randomized, double-blind, placebo-controlled trial, 146 healthy adults were given either cRG-I or the placebo for eight weeks, after which they were exposed to a standardized dose of an attenuated rhinovirus via the nose. In the clinical study, daily consumption of BeniCaros prior to the rhinovirus infection significantly accelerated protective innate immune and antiviral responses, resulting in a 20% reduction in severity of symptoms, and a 25% reduction in symptom duration. 

René Lutter, PhD, Principal Investigator at the Amsterdam UMC, who runs the rhinovirus challenge model in collaboration with NIZO, commented: “The impact of cRG-I on the immune response observed in this nutritional intervention study is the biggest that I have ever seen with this model. It is clinically relevant and especially exciting because fast innate antiviral and immune responses are important for limiting infections with respiratory viruses.” 

The ingredient cRG-I is a unique polysaccharide upcycled from carrot pomace, a by-product of carrot juice production. It has been developed as a natural food ingredient to promote healthy immune function as previously shown2. BeniCaros was launched for formulation in dietary supplements and functional food and beverages in the US in October 2021. 

Commenting on the publication and impact of the findings, Ruud Albers, PhD, CSO of NutriLeads, said: “This publication is the culmination of extensive work by numerous people over ten years, and I am grateful to all involved for their dedication. The unique design of this trial was essential to demonstrate that consumption of cRG-I as a dietary supplement accelerated protective anti-viral immune responses, reducing the symptoms triggered by a standardized infection with a common cold virus. With increasing awareness of immune health over the past years, the discovery that cRG-I trains the immune system to respond faster when needed, is timely and particularly relevant.  

These exciting results fully support our earlier findings with cRG-I2 and play an important role in supporting the launch of BeniCaros (cRG-I) our immune health ingredient. This publication is a significant milestone for the company as we progress in our mission to unlock the potential of clinically proven food ingredients”. 

References
1. https://www.mdpi.com/2072-6643/13/12/4395

2. https://www.mdpi.com/2072-6643/13/3/963

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NutriLeads wins the Fi Europe Innovation Award in the Health Innovation Category for BeniCaros

November 30, 2021

NutriLeads team won the Health Innovation Award for BeniCaros, a proprietary ingredient for immune health clinically proven to support and optimize immune function and response. The Fi Innovation Awards not only recognise outstanding ingredients and concepts in the fields of health, sustainability, sensory and technology innovation, but they also validate the value and impact of these innovations on the industry as well as recognising the intensive development efforts.

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Staying immune fit: how to train the body’s defence system

The immune system is the body’s surveillance system that responds to infections. It’s our defence against the various challenges that we encounter every day, most of which are fought off without notice, reports Ruud Albers, CSO, NutriLeads

Optimal functioning of the immune system is crucial to remain fit and enjoy life to its fullest. To respond to infections, the immune system deploys two interconnected defence methods: the innate and the adaptive immune system. The innate immune system is the body’s first line of defence; it can quickly respond to infections without needing to first learn how to recognise an invading pathogen.

It also triggers the adaptive immune system, which takes time to identify a particular infection and generate immunological memory. Effective innate immune responses limit the extent of an infection early on and ensure that many infections are curbed before their presence can even be realised.

Just like other parts of the body, the immune system needs to be nourished and trained to effectively respond to challenges. A fit immune system ensures the best outcomes: quick, appropriate and effective responses against infections. Immune fitness provides the resilience required for the body to remain in a healthy balanced state — or quickly bounce back to it — in the face of daily infectious challenges from potentially harmful agents.

The majority (70–80%) of immune cells within the human body are found in the stomach where they work together with the gut microbiota to regulate immune balance. The immune system co-evolves with the gut microbiota and both work together to defend against pathogens and to develop tolerance for beneficial microbes.

The immune system senses what passes through the gut and its responsiveness is tuned by the signals it detects from food, especially from specific fibres and the gut microbiota.

Cells from the immune system circulate from the gut to other parts of the body to relay the messages they picked up in the gut. A healthy diet comprising sufficient fibres that contain appropriate signals, combined with the crosstalk between the gut microbiota and the immune system, supports protective responses against pathogens, promotes tolerance to harmless microbes and avoids harmful chronic inflammatory responses.

The maintenance of this delicate balance between consumed food, the gut microbiota that grows on it and the immune system is crucial to human health, especially when faced with harmful agents that threaten to adversely affect our well-being.

The immune system requires energy and micronutrients to perform its basic functions. However, to be at its best, it also needs to be trained through exposure to specific patterns (signals) from the diet and the gut microbiota. Fibres are particularly important when it comes to training the immune system and reinforcing a healthy level of crosstalk between the gut microbiota and the immune system.

However, similar to the fact that not all vitamins are the same, not all fibres have the same characteristics … and some are more effective than others. A fit immune system requires that nutritional deficiencies (vitamin B6, C, D and zinc, for example) are adequately supplemented and that it receives appropriate “training” stimuli in the gut from the diet and the microbiota.

Recently, it was discovered that a specific fibre derived from carrot pomace (rhamnogalacturonan-I or cRG-I) has unique properties when it comes to supporting immune fitness. When unlocked from the plant cell wall, complex chemical patterns in cRG-I are recognised by the innate immune system in the gut, contributing to its training.

cRG-I is not digested, but preferentially fermented by beneficial micro-organisms that produce metabolites — such as short chain fatty acids — which also affect the immune system.1 With this dual mode of action, cRG-I contributes to immune fitness by training immune cells in the gut, which, after migration through the body, improves immune system responsiveness.

NutriLeads’ clinical studies have shown that cRG-I produced by upcycling carrot pomace, a side stream of carrot juice production, is safe for human consumption, signals to the innate immune system and stimulates beneficial micro-organisms and their production of immune supportive metabolites.2–5

In a unique clinical trial, it was subsequently shown that the daily intake of 0.3 g of cRG-I accelerates protective immune responses against a common pathogen, significantly reducing its impact.6

Immune fitness requires more than the right micronutrients; the immune system needs training. Carrot RG-I has been clinically demonstrated to prepare the immune system to be fit all year round and is now commercially available for the first time. It offers the opportunity to develop new dietary supplements, functional foods and beverages with a differentiating immune health claim and communication versus micronutrient supplementation alone.

References

  1. D. Wu, et al., “Rethinking the Impact of RG-I Mainly from Fruits and Vegetables on Dietary Health,” Critical Reviews in Food Science and Nutrition 60(17), 2938–2960 (2020).
  2. D. Jonker,et al., “Safety Assessment of Rhamnogalacturonan-Enriched Carrot Pectin Fraction: 90-Day Oral Toxicity Study in Rats and In Vitro Genotoxicity Studies,” Food and Chemical Toxicology 139, 111243 (2020).
  3. S. McKay, et al., “Development of an Affordable, Sustainable and Efficacious Plant-Based Immunomodulatory Food Ingredient Based on Bell Pepper or Carrot RG-I Pectic Polysaccharides,” Nutrients 13(3), 963 (2021).
  4. P. Van den Abbeele, et al., “A Novel Non-Digestible, Carrot-Derived Polysaccharide (cRG-I) Selectively Modulates the Human Gut Microbiota While Promoting Gut Barrier Integrity: An Integrated In Vitro Approach,” Nutrients 12(7), 1917 (2020).
  5. P. Van den Abbeele, et al., “Consistent Prebiotic Effects of Carrot RG-I on the Gut Microbiota of Four Human Adult Donors in the SHIME® Model Despite Baseline Individual Variability,” Microorganisms 9(10), 2142 (2021).
  6. R. Lutter, et al., “Dietary Intake of Carrot-Derived Rhamnogalacturonan-I Accelerates and Augments the Innate Immune and Anti-Viral Interferon Response to Rhinovirus Infection and Reduces Duration and Severity of Symptoms in Humans,” submitted for publication.

Article in Nutraceutical Business Review, date: 4 November 2021.

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NutriLeads launches clinically backed BeniCaros™ for sustainable, year-round immune support

October 1, 2021, Wageningen, The Netherlands – Dutch health ingredients company, NutriLeads, announced the launch of its proprietary immune health ingredient, BeniCaros™. Upcycled from carrot pomace, BeniCaros is developed for supplements and functional food & beverages, and it is clinically supported to help to prepare your immune system to be fit all year round.

NutriLead’s proprietary extraction process unlocks rhamnogalacturonan-I (RG-I), the polysaccharide that gives BeniCaros its potential to deliver a dual mechanism of immune support. BeniCaros and its benefits are based on many years of robust pre-clinical and clinical research providing evidence that daily consumption of BeniCaros prepares the healthy immune system to function at its best when it matters most. As little as 0.3 grams per day was shown to be effective in a pivotal clinical trial. BeniCaros works by supporting the immune system to become more responsive to potential threats and challenges while also stimulating beneficial gut microorganisms and their metabolites, which in turn support immune responses.

“I have been active in this field for more than 25-years and have never seen another ingredient with such distinctive data supporting its effectiveness. Our main clinical trial demonstrates unique and very consistent effects of BeniCaros,” said Dr. Ruud Albers, CSO of Nutrileads. “There are many immune health ingredient options out there, but very few that work like BeniCaros and even fewer that work with the same efficacy to support immune function. At a time when demand has surged for immune health solutions, we see BeniCaros as a clear and unique way to improve health and wellness.”

BeniCaros is a soluble fiber made using a proprietary process by upcycling carrot pomace, a side stream of carrot juice production. It is a sustainably produced, tasteless and odorless powder that does not use artificial additives, making it a very label friendly ingredient. BeniCaros can be formulated into most functional food, beverage and supplement formats and meets consumer demands for a sustainable, clean ingredient that makes a difference.

“Having worked with the NutriLeads team on the development of BeniCaros since 2015, I am thrilled that we can now launch BeniCaros and make its benefits available to consumers together with our partners, the food & beverage and supplement companies,” said Erik Dam, CEO of NutriLeads. “There is no better way to get these benefits. While you can eat carrots, and RG-I is a natural component of carrots, it requires our proprietary technology to fully unlock RG-I from the carrot and make it available in the gut where it can do its work. BeniCaros delivers superior benefits for optimal health outcomes at a time when consumers want and need it most.”

NutriLeads has signed its first agreements and is currently in further discussions with other food companies and supplement manufacturers to incorporate BeniCaros into dietary supplements and functional food and beverage products.

Learn more about NutriLeads and BeniCaros by meeting Erik Dam, Ruud Albers and the NutriLeads team at stand #H70E at VitaFoods Europe, booth #5531 at SupplySide West, stand #30L81 at FI Food Ingredients in Germany.

About NutriLeads

Established in 2012, NutriLeads is a Health Ingredients company advancing nutrition to strengthen human health. Based on our proprietary RG-I platform, we are developing a portfolio of natural, plant-based ingredients that are clinically proven to support human physiology and modulate the gut microbiome. The Company’s first commercially available RG-I-based ingredient, BeniCaros, supports immune function. The ingredient, which is extracted from carrots, is developed for the formulation of dietary supplements and functional foods. The Company is headquartered in Wageningen, the Netherlands, a world-renowned center for nutrition and health research and development, also known as the ‘Food valley’.

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Nutrileads appoints Erik Dam as CEO to propel the company towards successful commercialization of its lead ingredient BeniCaros

3 June, 2021

Dutch health ingredients innovator, NutriLeads, announces the appointment of Erik Dam as CEO to lead the company’s transition from a health ingredients innovator to a commercial health ingredients company based on a strong science foundation.
Erik Dam has been appointed as CEO as of June 1st, 2021. The leadership team will further consist of Ruud Albers (CSO), Annick Mercenier (CIO) and Jan Jongsma (COO).

To put this change in context of Nutrileads’ successful development, Ruud Albers explains: “Since founding Nutrileads with Erik and Annick, I combined the roles of CEO and CSO. I am delighted that we have now reached the time for Erik, who has been the CBO and CFO since 2014, to take over as CEO. With his background in marketing and general management, I am convinced that Erik will catalyze the further evolution of Nutrileads from a R&D-driven organization to a company that develops, produces and sells clinically proven health ingredients. Together with Annick and the rest of the R&D team, I will continue to follow my passion and focus on the exciting science behind our unique ingredients, supporting production and sales to bring substantiated health benefits to consumers.”

Prior to joining Nutrileads as co-founder in 2014, Erik started his career at Andersen Consulting before entering the life sciences industry in 1993 at Baxter where he held international marketing and general management roles. In 2005 Erik joined the Medical Nutrition division of Numico/Danone where he held global VP roles in strategy and general management. He started his own consultancy company in 2013 with a focus on commercialising Nutrition & Life Sciences innovations.

”The last 7 years at NutriLeads have been an exciting journey and we have accomplished a lot with the team under the leadership of Ruud. I’m thrilled to lead the next phase during which we will establish NutriLeads as a commercial health ingredient company with leading ingredient brands starting with BeniCaros for immune health,” Erik adds.

Sanne Melles, chairman of the supervisory board of NutriLeads comments: “The board is thankful for Ruud Albers’ leadership of NutriLeads since its establishment and wishes Erik Dam all the best in his new role aimed at transforming NutriLeads into a health ingredient company and driving the business forward.

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NUTRIGUT consortium, coordinated by NutriLeads, wins Eurostars grant to develop next generation gut health ingredient

13 April, 2021 – A consortium comprising Nutrileads (NL, coordinator), Ambiotis (FR), ProDigest (B) and Örebro University (SE) won a 3 years Eurostars grant for their innovative NUTRIGUT project.

NUTRIGUT will deliver a new RG-I based food ingredient with protective effects on gut health, one of the top properties sought by consumers. The ingredient is derived from common crops or a side stream of crop processing, will be 100% natural and will display technological properties that make it easy to incorporate in food and beverage matrixes. By project end, the consortium will have performed in vitro and in vivo characterization of the new ingredient and established the capacity of the ingredient to protect the gut barrier. During the project, novel assays will be developed and optimized to study the effect of functional ingredients on the host.

The project has been kicked off on April 1st, 2021 as an online event, with 15 participants and 2 National project coordinators.

Annick Mercenier (Nutrileads` PI):

“Winning this grant is further validation of the relevance of the RG-I platform. I am looking forward to working with this consortium of partners that bring together complementary expertise with the aim of developing novel assays and a new ingredient in order to establish its beneficial effect on different components of the gut ecosystem”.

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Scientific paper by NutriLeads shows that its plant-based RG-I food ingredients support immune function and modulate the microbiota

25 March 2021

  • First scientific data showing immune supportive properties of plant-based RG-I derived from bell pepper and carrot
  • Study published in the “Nutrition, Immunity and Viral infection” special issue of the peer-reviewed journal, Nutrients
  • Immune health is a top priority for today’s consumers with six in ten people looking for functional foods and beverages to support their immunity [1]

Dutch health ingredients innovator, NutriLeads, announces the first peer-reviewed publication of data proving the immune modulating properties of its proprietary pectin-derived rhamnogalacturonan-I (RG-I) polysaccharides in the journal Nutrients.[2]

RG-I are natural, plant-derived compounds (polysaccharides), that interact with the gut bacteria (microbiota) and the host innate immune system. In selected traditional plant extracts, such pectic polysaccharides have previously been shown to have immunostimulatory effects. However, these traditional remedies are often expensive, derived from non-renewable sources, and could face regulatory challenges.

In this recent publication, NutriLeads shows that RG-I can be extracted from affordable and renewable crops, namely carrots and bell peppers, and even obtained from side streams of crop processing, allowing for sustainable and scalable production. RG-I from both carrot and bell pepper showed immune stimulating and microbiota modulating activity in vitro. Furthermore, bell pepper RG-I was shown to enhance innate immune responsiveness in a proof-of-concept trial in humans.

Commenting on the publication and the expected impact of the findings, Ruud Albers, PhD, CEO of NutriLeads, said: “We are delighted to share these new data, demonstrating the immunomodulatory effects of plant-based RG-I, which have the potential to bring health benefits to us all. We are particularly pleased that we can successfully derive RG-I from sustainable and widely available sources.

Due to the pandemic, immune health is even higher on the agenda than ever before, and we believe that this research shows that dietary supplementation with RG-I from specific food crops is ideally suited to support immune function and modulate the microbiota. We are well advanced with generating additional evidence showing the immune benefits of carrot-derived RG-I and are working together with Food and Food Supplement companies to deliver these benefits to consumers in the second half of 2021.”

Demand for food supplements and food and beverage products with immune health properties has been growing sharply in recent years. The global immune health supplements market alone was estimated to be worth USD 16.32 billion in 2019 and is expected to reach USD 29.40 billion by 2027.[3] In addition, recent research shows that 64% of respondents will aim to improve their immunity in the next 12 months.[4]

NutriLeads’ lead ingredient, BeniCaros, extracted from carrot pomace (a side stream from carrot juice production), has been developed to support immune function. This ingredient is expected to be available in the US for the formulation of dietary supplements and functional foods in the second half of 2021.

References
1. Innova Consumer Survey 2020 – https://www.prnewswire.com/il/news-releases/innova-identifies-top-10-food-and-beverage-trends-to-accelerate-innovation-in-2021-301155638.html

2. Early access article available at: https://www.mdpi.com/2072-6643/13/3/963

3. https://www.globenewswire.com/news-release/2020/10/27/2115103/0/en/Immune-Health-Supplements-Market-Worth-USD-29-40-Billion-at-7-4-CAGR-Rapid-Changes-in-Lifestyles-to-Bolster-Growth-says-Fortune-Business-Insights.html

4.  FMCG Gurus, Top Ten Trends for 2021, Dec 2020. https://fmcggurus.com/webinar-top-ten-trends-2021/

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