Panel discussion on...
from plants to clinically proven standardized extracts
The high quality of standardized extracts reflects the quality and richness of active compounds in the plants.
The parameters to be considered to select the best raw material are related to chemical and microbiological contamination, quantity, richness and variability of active compounds to maintain the naturalness of the extract in the final standardization. A large body of scientific evidence suggests that the phytocomplex (pool of active molecules of a specific plant) has greater activity than individual substances: with a selective extraction it is possible to obtain standardized extracts containing a pool of active compounds that acts synergically each other excluding from the extract inactive and uninteresting compounds. By doing so, it is possible to produce branded ingredients based on a few specific active compounds specific to the raw material with demonstrated activity and safety in human clinical studies. Globalization and the expansion of the nutraceuticals market increased the request for raw materials. This has led unfortunately to the commercialization of adulterated extracts (1,2).
With the latest advances in analytical techniques, it is possible to investigate the raw material and the finished extract to control and identify adulteration: for example, DNA barcoding is fast and quite cheap to ensure the right species used in the extract (2); however the adulteration can be related not only to the botanical species, but also to the addition of natural or synthetic actives within the extract, therefore, the DNA analysis must be complemented by High Performance Liquid Chromatography (HPLC) analysis to identify the active plant compounds in the extract and verify the match between the metabolic profile of the extract and the plants from which it comes, but this alone may not be sufficient to certify non-adulteration(3). In quality control, the use of High-Performance Thin Layer Chromatography (HPTLC) is very frequent; although it is a rapid technique suitable for whole plant extract of common plants, the lack of validated standards of several plant species puts it on the back burner for this purpose. Besides this risk, the rapid climatic change can threaten the reproducibility of the plants and then of the extracts. As known, plants interact with the environment and active compounds are an expression of this. Unfortunately, we cannot prevent and control some events such as climate change or pests, which could be dangerous. However, by controlling cultivation and processing it is possible to produce standardized extracts. We work together with the farmers paying great attention to the short supply chain, ethical cultivation of plants, and knowledge of the balsamic period of plants in different climatic conditions and times of the year thinking that it is the only strategy to counteract this chemical profile change.
The market of nutraceuticals is full of a wide range of active compounds and extracts in several products in which the slogan is “more is better”, but this is not always true. This challenge is due to the few plants and active compounds admitted compared to the huge number of different extracts and products with the same application, and often the only strategy of the industries is to increase the concentration of the allowed active compounds in order to overtake the competitor. This has led to highly concentrated extracts with high dosages without taking care of any study of safety or efficacy. For these reasons, to protect and keep the quality of our ingredients, we have been working since the beginning to produce standardized extracts clinically proven in terms of safety and activity in order to find the right, and not the higher, dosage.
To do this, the approach must be systematic, scientific and starts from a deep knowledge of the extract in terms of metabolic profile, variability and standardization. Supporting the activity and safety of an extract with clinical trials is a plus for the consumers, for the company which produces the extract and for the company which commercialized the finished product. Despite this approach is becoming common in the market of botanicals, the literature is full of trials missing any statistical power analyses or placebo. Methods, even for botanicals, must include fair randomization, blinding, and placebo-controlled treatment. For nutraceuticals, inclusion and exclusion criteria are key points to have strong and clear evidence from the clinical trial. According to regulations, enrolled subjects must be "healthy," but it is very difficult to define this condition by evaluating the right parameters. It would be appropriate to include not only parameters to demonstrate the efficacy of the extract for the application studied, but also to evaluate a safety panel. It is common practice to evaluate biomarker cut-off values to assess the extract's contribution to maintaining or reducing these values, but often the differences are not statistically significant because the starting point is not above normal values. Because nutraceuticals should be used by healthy people to maintain their health status, the duration of treatment should be long and should depend on the application tested; however, the market needs quick results to ensure activity in a few days/weeks. Since botanicals are rich in polyphenols with high antioxidant activity, they should be used in chronic treatments to combat, day after day, the real-life imbalances that lead to aging by increasing the risk of degenerative and metabolic syndromes.
More than purely physical health
When we look at the science of sports and active nutrition, it has shifted fro m a purely physical health focus to overall health, highlighting mental well-being. As emphasized by Nutrition insight referring to the Olympics, “mental health is a topic that is now being more and more communicated by athletes and is no longer hidden as it was before.” The key success factors to win any competition are not only the strength, but also a clear-mind with sharp focus, and less anxiety. For companies working on the active lifestyle space, key elements for new product launch are a holistic approach focusing on prevention as well as recovery and strong and scientific claims according to individual market regulations. Brands have the opportunity to accompany consumers in a long-term process of forming healthier habits. They can do that by offering products that are not only functional but also tasty and affordable and thus help people adopt a proactive approach and avoid ephemeral diets and nutrition traps.
Latest ingredient innovation for active nutrition
Before deciding which trend and which innovation to apply to your brand, there is a simple checklist one can follow:
- For each of the trends and ingredients or new science, what is the awareness in your market? It can vary from high, something everyone knows, to something very niche that only people with specific lifestyles/ specific concerns know and would be interested in.
- Do you know what type of consumer you want to address? You can target the mass market consumer or the early adopter consumer, but you need to be conscious about it and select the right innovation and the right message that will be attractive to each target group. Many of the trends and innovations still have low awareness in the mass market and are more relevant for the early adopter consumer. This is something to be aware of when building your strategy and choosing a trend and therefore make a conscious choice.
- Choose the right consumer narrative and connect it to your brand. Think about the story you want to tell and choose the right consumer narrative. For example, do you want to appeal to a consumer’s emotions? Or connect them with their roots and traditions? Or maybe sell a ritual and an experience and not just a product? All valid options but you need to be clear about it to choose the one that best resonates in your market.
R&D Manager - Bionap
Scientific and Marketing Director - EPO
Head of Scientific Communications & Marketing - Euromed
CEO - Fermedix
R&D Coordinator - FLANAT Research Italia
Data Analyst - FMCG Gurus
CSO - Flytexia
Scientific Manager - Flytexia
Product Innovation and Development Manager - INDENA
Senior Research Manager - INDENA
Junior Product Scientist - INDENA
Medicine Hunter - KSM-66 Ashwagandha
Alessandro Giuseppe Tricomi
Food Supplement Manufacturing - Natural Ingredients Solution
Quality Control - Natural Ingredients Solution
Market Manager, Nutraceutical – ROELMI HPC
General Secretary – S.I.Fit. (Italian Society of Phytotherapy)
Associate Professor in Organic Chemistry - University of Milano-Bicocca
Associate Professor in Organic Chemistry - University of Milano-Bicocca
References and notes
- Ariffin SH, A Wahab I, Hassan Y, Abd Wahab MS. Adulterated Traditional-Herbal Medicinal Products and Its Safety Signals in Malaysia. Drug Healthc Patient Saf. 2021 Jun 8;13:133-140. doi: 10.2147/DHPS.S305953. PMID: 34135639; PMCID: PMC8197568
- Parveen I, Gafner S, Techen N, Murch SJ, Khan IA. DNA Barcoding for the Identification of Botanicals in Herbal Medicine and Dietary Supplements: Strengths and Limitations. Planta Med. 2016 Sep;82(14):1225-35. doi: 10.1055/s-0042-111208. Epub 2016 Jul 8. PMID: 27392246.
- Mohammed Abubakar B, Mohd Salleh F, Shamsir Omar MS, Wagiran A. Review: DNA Barcoding and Chromatography Fingerprints for the Authentication of Botanicals in Herbal Medicinal Products. Evid Based Complement Alternat Med. 2017;2017:1352948. doi: 10.1155/2017/1352948. Epub 2017 Apr 27. PMID: 28536641; PMCID: PMC5425840.