Decoding Evidence-Based Nutraceuticals : Perform to convince

Decoding Evidence-Based Nutraceuticals : Perform to convince

In the burgeoning field of nutraceuticals, the intersection of scientific substantiation and regulatory compliance is where effective supplements come to life. This article delves into the various types of efficacy studies and innovative ingredients that will be able to boost the legitimacy and potency of your future development!

The selection of active ingredients depends on the desired market position, budget and long-term vision of the product. For a cost-sensitive approach, a combination of actives based on literature and limited in vitro evidence may be enough. For companies targeting high-end segments or seeking to establish a solid foothold in a scientifically demanding market, investment in more evidence-based ingredients could be a decisive driver of success.

In-Vitro Studies : The Foundation

In-vitro studies serve as the foundational layer of scientific evidence. These tests are performed in controlled environments outside a living organism, typically using isolated cells, tissues, or biochemical assays. For example, in-vitro assays might explore how a new plant sterol impacts cholesterol synthesis in hepatic cells, offering initial insights into its cholesterol-lowering potential. While in-vitro results can be promising, they don't always replicate in more complex biological systems, and thus cannot be used alone to substantiate health claims for nutraceuticals.

In-Vivo Studies : Bridging the Gap

In-vivo studies take the research a step further, involving whole living organisms, usually animal models, to observe the biological effects of a nutraceutical ingredient under more complex physiological conditions. These studies can shed light on the bioavailability and metabolism of a substance. In-vivo studies provide a more relevant perspective on an ingredient's efficacy, yet they are not without ethical considerations and cannot always be directly extrapolated to human health outcomes.

Clinical Studies : The Pinnacle of Proof

Clinical studies are the gold standard and the most compelling form of evidence when it comes to substantiating health claims for nutraceuticals. These trials involve human participants and are designed to test the safety and efficacy of an ingredient or supplement under specific conditions. A randomized controlled trial (RCT), for example, might evaluate the effects of a fish oil supplement on triglyceride levels in individuals with hyperlipidemia. The outcomes of such studies carry significant weight in the eyes of both consumers and regulatory bodies.

The ever-evolving regulatory landscape of the nutraceutical industry demands that health claims are supported by a hierarchy of evidence. In-vitro findings must be complemented by in-vivo and clinical data to meet the stringent requirements set forth by authorities like the FDA and EFSA. Legislation is in constant flux, and claims must be carefully crafted to reflect the latest guidelines and research developments.

Navigating this complex regulatory environment requires a thorough understanding of the different tiers of scientific investigation and how they translate into compliant and compelling health claims. It also brings exciting opportunities, such as the opening of probiotics claims in France in 2023.

Co-Branding : Leveraging Partnerships for Enhanced Credibility

In the world of nutraceuticals, co-branding with reputable suppliers can significantly amplify the credibility and appeal of a product. Co-branding goes beyond just sharing a name; it's about aligning with partners who are committed to the same standards of scientific rigor and regulatory compliance. This strategic alliance can lead to joint marketing efforts, shared expertise, and a stronger presence in the market.


Recognizing the importance of strategic collaborations, we are excited to bring you insights from Dr. Bodo Speckmann, Health Science & Technology Lead at Evonik’s business incubator Creavis to discover how teaming up with industry leaders like Evonik can help you achieve your goal of taking your products to the next level.

                                                            Bodo Speckmann


Can you provide insights into Evonik's key strategies for innovating in the nutraceutical industry, including the use of data and research to differentiate your products ?

The nutraceuticals market continues to shift towards dietary supplements and functional foods that have proven health benefits, and are safe, convenient and comfortable for consumers to take during their normal daily routines. Evonik specializes in a range of health areas where demand for science-based nutraceuticals is growing strongly. These areas include cardiovascular health, cognitive health and gut health. Our latest new product innovation, a new category of nutraceuticals called IN VIVO BIOTICS” has been developed and launched by our incubation center Creavis along our RD&I activities within Evonik’s one of six innovation growth fields. These next-generation synbiotics combine probiotics with health ingredients that can specifically convert ingredients in the human intestine into bioactive substances. Evonik’s human probiotic business is committed to developing evidence-based nutrition and healthcare products to promote health and wellbeing. By leveraging the power of probiotics and other bioactive ingredients, we focus on prevention and adjuvant nutritional therapies. We aim to improve the lives of people globally which is aligned with the groups’ sustainability handprint targets of our products, especially people at risk for chronic diseases and women in all life stages.

Could you share a specific example of a nutraceutical ingredient developed by Evonik where innovation and data played a pivotal role, leading to a distinctive offering in the market ?

I am happy to share insights into a very recent example: the development of our product IN VIVO BIOTICS™ gluten tolerance. To date, there is no satisfying and convenient nutritional therapy for people with gluten-related disorders. Existing solutions beyond the gluten-free diet are lacking efficacy and are also difficult to implement. We approached this need by utilizing the role of the human gut microbiome in the body’s response towards gluten. Gluten proteins are difficult to digest, and fragments released upon incomplete digestion can be problematic. Microbes can support here by various modes of action. One being the fast and complete degradation of gluten. 

We therefore searched our huge biobank of microbial strains using bioinformatic and microbiological analyses to identify a unique combination of natural probiotic strains (B4U™) with complementary enzyme production for gluten degradation. Our synbiotic formulation comprises the strains in the form of viable cells as well as lysates thereof, the latter, to allow for an immediate start of action. By this, an acute as well as persistent efficacy is enabled, as the strains can engraft in the gastrointestinal tract and provide a continuous supply of proteases. This provides efficacy but also convenience to consumers. Besides its suitability for gluten sensitive people, we are now testing the efficacy of IN VIVO BIOTICS™ gluten tolerance as an adjuvant nutritional intervention for celiac disease patients in a randomized, controlled, double-blinded clinical trial.


In what ways does Evonik actively support customers in their product development ?

Evonik actively supports customers in their product development by providing expertise in product formulation, regulatory support in the field of dietary supplements, and legal compliance in communicating health benefits and functional features of the products. We have a deep understanding of the science behind probiotics, nutrition & health, as well as the consumer market and relevant trends, which we apply in our product development and with which we support our customers. This ensures that our customers receive high-quality products that meet regulatory requirements and are tailored to meet the needs of their target market.

We encourage you to delve deeper into our portfolio to discover how these principles can be applied to your product development strategies. Our team is eager to collaborate with you, providing regulatory guidance and technical support.

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