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Lutein commercial insight Lutein GAYLE DE MARIA PRODUCTS ON THE MARKET Anno 18 - No. 2 ■ March/April 2007 ■ AgroFOOD industry hi-tech 38 Lutein (from Latin lutea meaning "yellow") is one of over 600 known naturally occurring carotenoids. Found in green leafy vegetables such as spinach and kale, lutein is employed by organisms as an antioxidant and for blue light absorption. Lutein was found to be present in a concentrated area of the macula, a small area of the retina responsible for central vision. The hypothesis for the natural concentration is that lutein helps protect from oxidative stress and high-energy light. Various research studies have shown that a direct relationship exists between lutein intake and pigmentation in the eye. Several studies also show that an increase in macula pigmentation decreases the risk for eye diseases such as Age-related Macular Degeneration (AMD). Lutein is naturally present in human diet when fruits and vegetables are consumed. For individuals lacking sufficient lutein intake, lutein-fortified foods are available; since 1996, in fact, lutein has been incorporated into dietary supplements. Its commercial value has recently exploded with an estimated market value of $139 million in 2004 ending up to be one of the fastest growing areas of carotenoid market. Agro Food Industry Hi tech Journal has decided to interview experts from some of the leading companies in this field to find out more about this natural molecule. In the diet, lutein is mostly found in green vegetables, particularly kale and spinach. Lutein and zeaxanthin esters are present in small amounts in fruits. A study by Nebeling et al. (1) showed that 93% of the total amount of lutein and zeaxanthin found in fruit, vegetables and eggs is present either in free or ester form of lutein and zeaxanthin. Tropical fruits like: papaya and oranges are rich in lutein ...lutein helps protect ester. Kemin Health produces from oxidative stress and and commercializes FloraGLO high-energy light... Lutein which is a patented purified free lutein identical to the lutein found in abundance in the human diet and in the body and naturally containing zeaxanthin. "DSM Lutein is free lutein, too", affirms Isabelle Frappa - New Business Development Manager Europe, DSM Nutritional Products. "According to the scientific evidence", states Samanta Maci - Technical Services Manager, Europe, Kemin Health - "only free lutein is found in the human serum regardless of its original dietary source". "Lutein esters must be de-esterified (hydrolyzed) before being absorbed by the body and distributed to the different organs, particularly eyes and skin", adds Maci. The efficacy of this enzymatic process which depends on the activity of the human intestinal enzymes is not clearly established (2, 3). Additionally important factors such as dietary fat and age may affect the kinetics of these compounds. "The body deals with lutein esters in the same way that it deals with many other day to day foods such as dietary fats and vitamins A and E - in a completely natural way. Lutein esters are broken apart as part of the normal process of digestion, releasing lutein for absorption into the Isabelle Frappa bloodstream", stresses Ralf Zink DSM Nutritional Products Global R&D Director, Cognis Nutrition & Health. "The scientific community recognizes lutein esters as a source of lutein because studies consistently show lutein from lutein esters to have excellent bioavailability", he explains, adding: "Lutein from lutein esters and 'free' lutein are both well-absorbed, but lutein from lutein esters may actually be more bioavailable. For example, recent laboratory research predicts that when lutein Samanta Maci is ingested in the free form it is Kemin Health more prone to degradation in the stomach. This is likely to reduce the amount reaching the intestine for absorption into the bloodstream" (Molnar P. et al., Carotenoid Science 2006;10;1). Fit Ingredients e.K., for example, is working on Novopure® Lutein Ester because according to Alexandra Schmid-Riedl - CEO, Fit Ingredients it is of higher bioavailability in comparison to Free-Lutein. "Lutein found in nature for examples in flower petals is chemically bound to various types of fatty acids, known as Lutein Ester", she affirms. Cognis Nutrition & Health also provides a natural lutein ester, named Xangold®, the first patented lutein ester product in the market and a concentrate extracted from marigold flowers grown exclusively for the company. "There is a high demand for both lutein formulations in the dietary supplements market", points out Zohar Nir - V.P. of New Products Development & Scientific Affairs, Lycored Ltd. LycoRed Ltd's patented lutein line, Lyc-O-Lutein, for example includes both free lutein and lutein Di Ester the trans isomer form. Another company that deals with both forms of lutein is OmniActive Health Technologies, the first, and only company in the world with international patents for both Free Lutein (US Patent # 6,743,953, and other patents pending worldwide) and Lutein Esters (US Patent # 6,737,535, and other patents pending worldwide). A vast majority of scientific studies show that high levels of lutein in diet are to be associated with good eye health and low incidence of age related macular ...93% of the total degeneration, and that lutein amount of lutein and deficient diets are associated with zeaxanthin found in fruit, vision problems. The US RDA data vegetables and eggs is present clearly informs the public that either in free or ester form of against the RDA of around 3.7 mg, lutein and zeaxanthin... US diets are at barely at 0.7 mg, Lutein clearly identifying the need to a ...there is a high demand for both lutein formulations in the growing population of baby boomers and the next dietary supplements market... generation of enhancing lutein in diet-through food, or through supplements. A highly respected and authoritative scientific advisory body like the Joint WHO/ FAO Committee JECFA (Joint Expert Committee on Food Additives) assessed all the FloraGLO® Lutein safety data and ruled in September 2004 that lutein (along with its structural isomer zeaxanthin) are safe for human consumption even at maximum daily intake levels of 2 mg/kg body weight (i.e. around 90-150 mg per day for most adults). This clears the way for higher dosages of lutein being incorporated into supplements and nutritional foods over and above current levels. All the information clearly adds up, and appeals the average consumer, to induce the use of lutein as daily supplement. Almost all supplementation studies-whether as lutein esters or free lutein - show a positive correlation with enhanced serum and tissue concentrations of lutein and zeaxathin, and with markers of good eye health. And enough studies keep coming along to show that both forms of lutein in supplement form are relevant. "Hence", states Sanjaya Mariwala - Managing Director, OmniActive Health Technologies, "we strongly believe that both nutritionally relevant forms of lutein-as lutein esters and free lutein- need to be made available to the formulators for appropriate product offerings". FOCUS ON PRODUCTS March/April 2007 ■ Anno 18 - No. 2 Alexandra Schmid-Riedl Fit Ingredients ■ Botanic source and extraction / purification process Cognis: "The carotenoids in our Xangold® lutein ester products are extracted from Marigold flowers (Tagetes erecta), as are all the other commercially available lutein products irrespective of whether they are in the ester or the free form", says Holger Becker - Global Product Line Manager Xangold®, Cognis Nutrition & Health - and he explains to us that the Xangold® concentrate also contains small amounts of naturally-occurring zeaxanthin esters and undergoes the minimum processing necessary to give a top quality, competitively-priced, natural-source product. Xangold natural lutein esters are produced by a patented extraction process. "Together with our patented product concentrate, this serves as a Ralf Zink quality control seal for our Cognis Nutrition & Health customers", he says. The carotenoids (lutein and zeaxanthin esters) are extracted from the marigold flower petals (corollas) solely with the use of an accepted and approved food-grade solvent, which is then evaporated thus achieving a lutein ester concentrate (oleoresin). An alcohol mix then dissolves and separates out any impurities. This extraction and purification method results in a 39 AgroFOOD industry hi-tech We have asked our experts to explain to our readers the process used to achieve their unique product and formulations and to give us details on their properties. To simplify the reading process we have decided to concentrate on one company at a time. Anno 18 - No. 2 ■ March/April 2007 ■ AgroFOOD industry hi-tech Lutein product that contains lutein (and zeaxanthin) in their natural ester form and brings the desired characteristics of enhanced purity. The process and composition is patented in Europe under 1,073,694B1 and in the U.S. under 6,191,293. Cognis' Xangold® was the first patented lutein ester product in the market. DSM: "DSM lutein is originally extracted from tagetes (marigold petals) and formulated into beadlets with Actilease™, a proprietary formulation technology", says Frappa. Fit Ingredients e.K.: Lutein Ester extracted from marigold flowers is rich, safe and natural source of lutein. Naturallyzeaxanthin esters add to the carotenoid profile of natural lutein ester. Lutein ester provides a source of lutein and zeaxanthin preserved in the natural form Lutein-Ester and ZeaxanthinEster from marigold flowers. NovoPure LUTEIN Esters is the only product available in the market produced through Supercritical Fluid Extraction process-(SCF). Using CO2 as media of extraction with the highest concentration of lutein available in the Nutraceutical industry. It contains 40% lutein ester, equivalent to 20% lutein ester , zeaxanthin also in its esterified form. Its solid powder presentation is ideal for application in food supplements, nutraceuticals, functional and baby foods. It is a 100% natural lutein ester concentrate obtained from an extract of marigold flowers (Tagetes erecta) undergone a special patented process without effecting any chemical transformation. "It guarantees that the product is free from pesticides, fungicides and herbicides commonly associated with products of plant origin; thus making it a reliable source of natural lutein and other carotenoids which are easily absorbed by the body", states Schmid-Riedl. "Our principal Novo Agritech Limited utilizes a state of the art Super Critical Fluid Extraction method under a patented process in dissolving Lutein Ester as it exists in marigold flower, utilizing high pressure super critical fluid CO2 at a low temperature", she 40 concludes. Kemin Health: FloraGLO® Lutein is a purified lutein extracted from marigold flower (Tagetes erecta) oleoresin. Marigold oleoresin, which contains lutein esterified with fatty acids, is subjected to a saponification process during which esters are removed. "This saponification process is followed by purification and crystallization steps in order to obtain purified lutein crystals according to the highest standard of quality", says Maci. These steps are based on a unique patented process owned by Kemin: U.S. Patents 5,382,714, 5,648,564, and 6,663,900, Canadian Patent 2,239,971, Japanese Patents 2,790,212 and 3,190,686, European Patent Conventions 0672655 and 0904258, Australian Patent 700,719, Austria Patents 215059 and E191475, Belgium Patents 0904258 and 0672655, Denmark Patent 0672655, France Patents 0904258 and 0672655, Germany Patents 69516031T2 and 69620258, Ireland Patents 0904258 and 0672655, Israeli Patent 124987, Italy Patent 0672655, Korea Patent 214430, Netherlands Patent 0672655, New Zealand Patent 319,825, Mexico Patent 205122, Portugal Patent 0672655, Spain Patent 2147261, Sweden Patent 95300273, Switzerland Patents 0904258 and 0672655, and United Kingdom Patents ...lutein from lutein 0904258 and 0672655. esters and 'free' lutein are both Lycored: Lyc-O-Lutein is extracted from well-absorbed, but lutein from the flower of the marigold (Tagetes lutein esters may actually be erecta). The dried petals of the flower more bioavailable... are rich in lutein and also contain some zeaxanthin in association with the lutein. LycoRed holds a patent on lutein extraction which is adopted from its method for lycopene extraction from tomato solids. Soluble solids are mechanically separated from the insoluble solids, then the patented extraction technology is employed to extract either lutein Di Ester or Free-lutein. "LycoRed's accumulated experience in natural carotenoids has enabled us to produce a product which satisfies the requirements and expectations of our customers", says Nir. OmniActive Health Technologies: "Our complete range of Lutemax® Free Lutein and Lutein Esters products is obtained from marigold (Tagetes erecta) grown on our own contract farms, and marketed under the brand name Lutemax®. We will shortly be initiating our international launch of a Zohar Nir Zeaxanthin product based on such Lycored Ltd natural plant material as well", says Mariwala. "We have consciously developed an entire supply chain for Lutemax® keeping in mind the end-use for human nutrition, completely eliminating the use of shortcuts to stabilize xanthophylls as some manufacturers of feed grade marigold products do, and using better methods of storage, dehydration and extraction using only GRAS solvents", states Abhijit Bhattacharya, Chief Sanjaya Mariwala Operating Officer, OmniActive OmniActive Health Technologies Health Technologies. "Our process ensures that even the GRAS solvents used are within extremely low or non-detectable residual limits. In fact, in order to heighten the need for product safety, we were the first to highlight the need to have ETQ free, GMO-free, BSE-/TSE- free , trans-fat free products", he continues. "Our process ensures high level of stabilization of lutein in terms of the total actives, and the required isomeric form: our products have consistently high levels of the nutritionally desirable trans-isomers of lutein and zeaxanthin. Further, our products are so stabilized that even after subjecting to high impact compression, our vegetarian beadlets continue to show high levels of the trans-lutein isomers, and negligible levels of the less-desirable cis-isomers" he concludes. Formulations Cognis: "The Xangold® range of natural lutein esters is available in multiple concentrations in both oil suspensions and micro-encapsulated, free-flowing tablet-grade powders (beadlets)", says Zink. He adds that in 2001, Cognis was the first company to launch BSE-free and GMO-free lutein ester products especially for the European market. Cognis has a 10% vegetarian beadlet and recently launched a highconcentrate 20% beadlet, which enables formulators to follow the trend and add more potency to the tablet without changing its size. Stability tests on these formulations are conducted by Cognis on both oil suspensions in bulk and soft gelatin capsules, as well as on beadlets in bulk and tablets. "The sophisticated micro-encapsulation technology used provides phenomenal stability of the beadlets and only requires 5% overage in the tabletting process", says Becker. DSM: "DSM Nutritional Products offers excellent, highly stable lutein formulations for a wide range of applications: Lutein 5% CWS/S-TG for direct compression tablets and fortification of foods and beverages and Lutein 20% FS for soft-gelatine capsules", informs us Frappa. ...a vast Lutein 5% CWS/S-TG combines a majority of scientific studies show that high cold water soluble form for the levels of lutein in diet are fortification of effervescent tablets, to be associated with food and beverage products with good eye health and low the tablet grade form suitable for a incidence of age related range of tablet applications. Lutein macular degeneration, 5% CWS/S-TG delivers excellent and that lutein deficient performance in regard of stability diets are associated with vision problems... / multimineral tablets", states Maci. Lycored: The Lyc-O-Lutein line is available in oil suspensions for soft-gel formulations and numerous beadlet formulations for tablets and hard-shell capsules. The centre-piece of the new product line is a highly stable gelatin-free and allergen-free beadlet, containing 20% lutein. Lyc-O-Lutein, is available in vegetarian and gelatin beadlets of various assays for tablets and hard-shell capsules. "The newly launched Lyc-O-Lutein 20%VBAF, allergen-free, vegetarian beadlet", says proudly Nir, "is gaining extra attention from the marketplace due to its high assay which allows manufacturers to save space in the tablet or capsule, leaving room for other combinations of bioactives which enhance the bioactivity of lutein". The formulations have undergone and passed stability testing. The newly developed vegetarian beadlets are very stable even under the conditions of high pressure, present during tableting. OmniActive Health Technologies: Lutemax® Free Lutein and Lutemax® Lutein Esters are offered in a completely range of delivery formulations including Beadlets (for tablets, capsules and dry mixes), Oil Suspensions (for liquid and soft gelatin capsule formulations) and Cold Water Dispersible Powders. "OmniActives has pioneered a new -generation delivery technology", affirms Mariwala, "to offer the world's first complete range vegetarian beadlets of Free Lutein and Lutein Esters under the Lutemax® brand". Lutemax beadlets do not use excipients of animal origin such as gelatin or lactose. They are therefore completely vegetarian, and free from the risk associated with BSE/TSE in ingredient source. OmniActive's proprietary beadlet ingredient system uses a combination of GMO-free, allergen free plant-based excipients which are cellulosic and carbohydrate like in nature. These excipients provide a strong encapsulating matrix and coating for the carotenoid, and protect it from the impact of moisture, oxygen, heat etc. "Our technology enables to make vegetarian beadlets Lutein and handling properties and furthermore contains no ingredient of animal origin. "This formulation answers the market need and consumer requirement for animal- and allergen-free ingredients", affirms Frappa. DSM formulates its carotenoids (and other fat soluble health ingredients) into specially designed beadlets with micro-dispersed carotenoid phase. Lipophilic substances need to be presented in tiny particles in order to be absorbed by the digestive tract and provide their health benefits. "Actilease™ beadlets contain small-sized particles of lipophilic substances in a water soluble shell, combining high bioavailability with excellent stability. The protective matrix prevents tabletting losses and interactions with other compounds and dissolves in the stomach, releasing the micronutrient droplets so that they can be absorbed by the body", adds Frappa. Talking about stability, Frappa says that their formulations have been tested in numerous applications and the stability data are available on request. Fit Ingredients e.K.: Fit Ingredients has two main formulations available: 1) Granular powder 5%,10%, 15%, 2) Extract 10%, 20%, 30%, 40%. "We must remember that Free Lutein is very unstable against heat and light", says Schmid-Riedl. "Lutein Ester, instead, is stable against light and heat. To get exact information about stability, stability studies in the finished product should be carried out because there could be an influence of other ingredients in the finished formulation". Kemin Health: FloraGLO® Lutein is available in dry and liquid forms as follows: FloraGLO® Lutein 5% VG Granules and FloraGLO® Lutein 10%VG tabGrade, FloraGLO® Lutein 20% into Safflower oil. "All FloraGLO® Lutein are preservative and BSE/TSE -free, vegetarian grade and do not require allergen labelling. They are subjected to stability studies performed under ambient (25C, 60% RH) and accelerated (40C, 75% RH) conditions. Additionally Kemin has successfully tested under the same conditions the stability of its dry forms in multivitamins 41 AgroFOOD industry hi-tech ■ March/April 2007 ■ Anno 18 - No. 2 Lutein Anno 18 - No. 2 ■ March/April 2007 ■ AgroFOOD industry hi-tech 42 ...lutein absorption and with lutein concentrations ranging bioavailability is from the standard 5% up to a highaffected by several potency 25% beadlet", adds dietary and non-dietary Mariwala. factors such as the food matrix in which it is Lutein bioavailability consumed, the state of Little information is known about the the food (raw, cooked, pharmacokinetics of lutein and processed), presence of zeaxanthin. A study by DSM fibres and/or other Nutritional Products and Kemin Health carotenoids, tobacco L.C. was conducted with healthy smoke, malabsorption humans to measure the effect of and liver and kidney lutein (originally extracted from diseases... tagetes (marigold petals) and formulated into beadlets by DSM Nutritional Products) and zeaxanthin supplementation on blood plasma (4) The time to reach steady-state plasma concentration, estimation of half-life elimination of all-trans lutein, and other carotenoid profiles were compared in this study. Safety parameters were also assessed. According to the results lutein did not follow dose-linear kinetics, steady state concentration was reached in approximately 5-6 weeks. Half-life calculations for total lutein, all trans lutein, and zeaxanthin ranged from 5-7 days. No toxicity was detected in any of the subjects. Lutein absorption and bioavailability is affected by several dietary and non-dietary factors such as the food matrix in which it is consumed, the state of the food (raw, cooked, processed), presence of fibres and/or other carotenoids, tobacco smoke, malabsorption and liver and kidney diseases. "Several studies", informs us Maci, "have evaluated the bioavailability of supplemental lutein, such as FloraGLO versus dietary lutein such as that of spinach, and other greens and even novel food sources fortified with lutein, such as yellow carrots (57)". The data cited from these papers indicate that FloraGLO Lutein is more bioavailable than lutein from spinach and greenleafy vegetables and lutein-fortified carrots. Another scientific paper (4) completes the series of pharmacokinetic studies of xanthophylls manufactured by DSM Nutritional Products, after publication of the pharmaco-kinetic properties of OPTISHARP™ (Zeaxanthin) early in the year 2004. "In summary", states Frappa, "similar to OPTISHARP™ (Zeaxanthin), DSM Lutein beadlets proved also to be readily bioavailable and did not affect the concentrations of other carotenoids". "Lutein esters, too, including Cognis´ Xangold® natural lutein esters, have been used as the lutein source in many human trials - more than 20 have been published, and there are several trials ongoing", points out Gartner. Also, several studies have been published from research that was part of a project funded by the European Union (AAIR-study), and which used lutein esters as lutein source. This body of research addressed various questions, but all the trials have proven the excellent bioavailability of lutein from lutein esters. The biokinetics of lutein, irrelevant of the source - foods, free lutein supplements or lutein ester supplements - resemble those of carotenoids in general: blood levels start to increase within a few hours of consuming the lutein source and reach a peak after 12 - 24 hours. When consumed for several days in succession, blood levels will reach a plateau after 2-3 weeks and decrease to baseline levels within a few days after consumption is discontinued. Kinetics in tissues may be quite different. For example, lutein levels in the retina of the eye increase much more slowly than in blood - only after some weeks of increased lutein consumption. It is important both for consumers and scientists to understand the implications: it needs to be made clear to consumers that in order to benefit from increased lutein intake - for example for eye health - consumption needs to be sustained (preferably daily) over a long period of time. "Just taking a supplement or eating spinach once in a while won't work!", states Gartner. Scientists need to allow a long enough study period if they want to measure effects in the eye, such as macular pigment density or glare sensitivity: four weeks would be much too short, three to six months is more likely to be adequate. Data sheet Every company declares the values of each carotenoid present into their formulations on a specific data sheet. For example Fit Ingredients' Novopure® lutein content is analysed by U.V. spectrophotometer analysis and zeaxanthin content is reported according to the formulation in %. "We, in OmniActive Health Technologies, have taken the lead in declaring the total xanthophyll values along with levels of the main active ingredient as its trans-isomer and cis-isomers. Further we also declare the total Zeaxanthin content in our products", states Mariwala. "Zeaxanthin is a very important part of the Lyc-O-Lutein", affirms Nir, "and our data sheets reflect its assay accordingly". FloraGLO® Lutein by Kemin Health, instead, is a natural source of both lutein and zeaxanthin. FloraGLO® Lutein provides a lutein: zeaxanthin ratio similar to that found in green vegetables. "Our specification sheet for each product always document the minimum level of lutein as well as of zeaxanthin", explains to us Maci. "Carotenoid values are reported in our data sheets", says Becker, "expressed as typical profiles with a guaranteed minimum, rather than being declared as an exact amount in each batch". "The concentrate contains small amounts of naturallyoccurring zeaxanthin esters in addition to lutein esters and undergoes the minimum processing necessary to deliver a top quality, natural-source product", he concludes. In the Xangold® 15% product, for example, the oil contains not less than 15% lutein esters and related carotenoid esters according to spectrophotometric analysis. OPTISHARP™ 5% CWS/S-TG by DSM Nutritional Products, an animal...it needs to and allergen-free formulation suitable be made clear to for the production of tablets by direct consumers that in order compression and water-soluble for to benefit from fortification of select foods and increased lutein intake beverages, offers pure zeaxanthin. for example for eye "Our zeaxanthin is formulated with the health - consumption Actilease™ beadlet technology and needs to be sustained combines excellent stability with high (preferably daily) over a absorption. Data are available on long period of time... request", states Frappa. Products of all the companies interviewed comply with the European legislation for foods. All certificates and compliance statements (absence of irradiation, GMO, allergen…) are available upon request. REFERENCES 1. 2. 3. 4. 5. 6. 7. Nebeling, L.C., et al., Changes in carotenoid intake in the United States: the 1987 and 1992 National Health Interview Surveys. J Am Diet Assoc, 1997. 97(9): p. 991-6. Breithaupt, D.E., A. Bamedi, and U. Wirt, Carotenol fatty acid esters: easy substrates for digestive enzymes? Comp Biochem Physiol B Biochem Mol Biol, 2002. 132(4): p. 721-8. Granado, F., B. Olmedilla, and I. Blanco, Serum depletion and bioavailability of lutein in type I diabetic patients. Eur J Nutr, 2002. 41(2): p. 47-53. Thurmann, P.A., et al., Plasma kinetics of lutein, zeaxanthin, and 3-dehydro-lutein after multiple oral doses of a lutein supplement. Am J Clin Nutr, 2005. 82(1): p. 88-97. Molldrem, K.L. and S.A. Tanumihardjo, Lutein supplements are not bioavailable in the Mongolian gerbil while consuming a diet with or without cranberries. Int J Vitam Nutr Res, 2004. 74(2): p. 153-60. van het Hof, K.H., et al., Influence of feeding different vegetables on plasma levels of carotenoids, folate and vitamin C. Effect of disruption of the vegetable matrix. Br J Nutr, 1999. 82(3): p. 203-12. Castenmiller, J.J., et al., The food matrix of spinach is a limiting factor in determining the bioavailability of beta-carotene and to a lesser extent of lutein in humans. J Nutr, 1999. 129(2): p. 349-55.