Superior Bioavailability of a Patented Lutein & Zeaxanthin Macular Carotenoid (MC) Formulation. (7th June 2021)

• Record Type: Journal Article
• Authors: Rai, Deshanie; Morde, Abhijeet; Padigaru, Muralidhara; Srivastava, Vandita; Lal, Mohan; Khatri, Chirag; Rao, Kotagiri
• Is Part Of: Current developments in nutrition. Volume 5(2021)Supplement 2
• Page Start: 78
• Page End: 78
• Publication Date: 2021-06-07
• Subjects: Nutrition -- Periodicals; Nutritional Physiological Phenomena; Nutrition; Periodicals; Periodicals; Fulltext; Internet Resources; Periodicals; 612.3
• DOI: 10.1093/cdn/nzab034_012
• Languages: English
• ISSNs: 2475-2991

Abstract

Abstract: Objectives: Lutein (L) and Zeaxanthin (Z) are the only dietary carotenoids exclusively deposited in the macula and supplementation of these nutrients is associated with visual and cognitive benefits. Ensuring their bioavailability is an important consideration for efficacy. We developed and patented a unique LZ formulation designed for enhanced MC absorption (Test). Our objective was to clinically measure the bioavailability of this Test formulation in comparison to a commercially available formulation (Reference). Methods: This randomized, double-blind, parallel study involved ninety healthy, adult human volunteers. All subjects stayed within the study facility three days before administration of the study products and three days post-dose. Volunteers consumed a single-dose of the Test or Reference product, each comprising of 10 mg L and 2 mg Z immediately after breakfast. Blood samples were collected prior to dosing @ −48, −24 & 0 hrs and subsequently at 2, 4, 6, 8, 10, 12, 16, 20, 24, 48 and 72 hrs post-dose. L and Z levels were measured in serum using the validated HPLC method. The primary outcomes of the study included Cmax, AUC0–72, AUC0-T. Secondary outcomes included AUC0-12, AUC0-24, AUC0-48, AUC0-inf, Tmax and t1/2. Results: All subjects completed the study with 100% compliance and no drop-outs. Serum L and Z levels were significantly higher in the Test group vs. the Reference group with a 2-fold and 1.5-fold greater absorption of L and Z levels, respectively, at all time points. Cmax, AUC0-72 and AUC0-T for serum L levels were 2.5, 2.9 and 3.2-fold greater, respectively, in the group receiving the Test formula. Similarly, the Cmax, AUC0-72 and AUC0-T for serum Z were also significantly greater with the Test formula. Finally, the Cmax and AUC parameters were significantly higher than the 80–125% criteria established by the FDA for bioequivalence confirming the superior bioavailability of Test product compared to Reference product. Conclusions: These clinical findings support the superior bioavailability of this novel and uniquely formulated L Z dietary supplement product. The enhanced bioavailability behavior of this proprietary formulation can be advantageous for individuals looking to quickly improve their L and Z status and enhance their vision protection and performance. Funding Sources: OmniActive Health Technologies.