A new human clinical research study from Ennature Biopharma, India, unveils the outcome that lutein esters can improve overall eye health significantly, in as little as four weeks.
The randomized, placebo-controlled trial included 128 healthy volunteers aged between 18-50. It evaluated primarily for the improvement in Macular Pigment Optical Density (MPOD) and other secondary parameters of eye health such as eye contrast sensitivity, dry eyes, visual processing speed, intra ocular pressure. It was conducted over a period of 12-week supplementation, with assessments during weeks two, four, eight and 12 respectively.
The study involved three different active groups containing different lutein ester variants – namely Xanthogreen, Xanthogreen TOS and Xanthogreen ULTRA – at different doses, along with the placebo. All of the Xanthogreen® variants in the study were super critically extracted (SCFE) from marigold flowers (tagetes erecta) through a single stage patented process.
The participants receiving daily supplementation of all the three active groups demonstrated a statistically significant improvement of MPOD at all measured eccentric angles (0.25, 0.5 and 1.0) by flicker photometry, against the placebo, in as little as four weeks onwards.
Among the active groups, Xanthogreen TOS showed a superior efficacy profile, with improvement of MPOD by 20% in the fourth week and 43% in week 12 from the baseline. Whereas the other active groups, namely Xanthogreen and Xanthogreen Ultra, showed 32% and 30% improvement of MPOD in week 12 from the baseline, respectively.
In addition, all three active groups showed a significant improvement in eye contrast sensitivity, by more than 50% improvement from the baseline at week 12, an important aspect of the visual acuity. For the same parameter, Xanthogreen TOS and Xanthogreen Ultra showed statistically significant results than the placebo from week four until week 12. Xanthogreen showed statistically significant results from week eight onwards.
Commenting on the product launch, Arumugam Raghavan, Head, Sales & Marketing at Nutraceuticals states: “We are excited to launch our range of Xanthogreen ingredients. We have never seen any ingredient with such superior efficacy profile in this space, from any published studies for more than two decades.
“It addresses various challenges the industry faces in the eye health space, such as long-term supplementation, global product compliances, limited application formats, and formulating shelf stable products with no overages.
“Having three active groups in the study provides multiple options for formulators to incorporate these ingredients, regarding applications and dose levels, and that too with natural and clean label options.”
Eye health insights
A review published in January 2024 highlights that 196 million people globally are affected by age-related macular degeneration (AMD), and this number is projected to rise to 288 million by 2040. It is also observed by researchers, specifically post-COVID, that eye fatigue and macular degeneration is progressing at a faster pace due to increased screen time.
If left unmanaged, digital eye strain (DES) can decrease work productivity, impair sleep and hinder overall quality of life. The American Optometric Association (AOA)-Deloitte researchers estimate that in 2023 alone, unaddressed DES symptoms cost the US healthcare system an estimated $151B due to lost worker productivity and worker wellbeing.
In FMCG Gurus' survey, 52% of North American consumers said they want to improve their eye care, so that eyesight remain healthy and active later in life. The recommended dietary intake of lutein is 6-8 mg per day for eye health but attaining those levels in the diet can be a challenge with everchanging lifestyle habits.
As per the 2019 study, the average consumption of lutein is 1-3 mg per day in North America, and the same was 1.5-4 mg per day in Europe, through their daily diet.
Visionary eye support
Lutein esters are naturally occurring compounds in the marigold flowers which are thermodynamically more stable at ambient conditions with better bioavailability. It is a precursor to the free lutein in the commercial extraction process. Harsh chemicals like potassium hydroxide, methanol and hexane are often needed to convert lutein ester into free lutein.
Xanthogreen is a clean and natural alternative as it is processed without any chemicals or solvents through SCFE using CO2. Formulated with a proprietary technology platform, SCEMOD™ (Super Critically Enabled Molecular Optimal Dispersion), it enhances the solubility of the ingredient significantly to an extent of 20% against the poor solubility of conventional free lutein (0.02%) which is widely available in the market.
The superior efficacy of the ingredient is contributed to the above technological benefits, as it helps in the better absorption of the nutrients and also facilitates the formulators to create shelf-stable finished products in different delivery formats like gummies, ready to mix (RTM), shots, and soft gels at low doses. With complete control on the supply chain with full traceability and global product compliance, it makes it easy for the finished product brands to launch one formula globally.
Ennature Biopharma is a natural ingredients division of India Glycols Ltd that has strong manufacturing expertise of various carotenoids like lutein, zeaxanthin and astaxanthin. It has a state-of-the-art supercritical SCFE facility in India, with global accreditations since 2009.
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