Superior Bioavailability of a Novel Lutein and Zeaxanthin Formulation in Healthy Human Subjects

INTRODUCTION: Lutein (L) and zeaxanthin (Z) are carotenoids that are found in the macula of the human eye and are known to improve visual functions. However, poor bioavailability of supplemental L and Z poses a challenge to achieving significant benefits after consumption. We developed a novel patented formulation of L and Z (Ocusorb(®)) and demonstrated the improved bioavailability in a pharmacokinetic clinical study. METHODS: Ninety adult human volunteers were recruited in this randomized, double-blind, parallel, comparative bioavailability study. Volunteers were randomly assigned to receive single dose of 10 mg lutein and 2 mg zeaxanthin from test (LZO) or reference (LZC) formulations after breakfast. Blood samples were collected pre-dose at − 48, − 24, and 0 h and at 2, 4, 6, 8, 10, 12, 16, 20, 24, 48, and 72 h post-dose. Serum concentrations of L and Z were quantified by using a validated HPLC method. The LZO and LZC formulations were compared for L and Z on the basis of C(max), AUC(0–72), and AUC(0–t). RESULTS: All 90 subjects completed the study. The LZO group demonstrated significantly higher levels of L and Z in serum at several time points as compared to LZC group. The LZO group showed significantly higher bioavailability for lutein (2.5 times higher C(max), 2.9 times higher AUC(0–72), and 3.2 times higher AUC(0–t)) and zeaxanthin (1.8 times higher C(max), 2.2 times higher AUC(0–72), and AUC(0–t)) as compared to the LZC group. No safety issues were reported. CONCLUSION: The study results show superior bioavailability of lutein and zeaxanthin from our novel LZO formulation as compared to LZC. The enhanced bioavailability from the LZO formulation can be advantageous for individuals looking to quickly improve their L and Z status and enhance their vision performance. TRIAL REGISTRATION: http://ctri.nic.in/. Identifier: CTRI/2019/11/022082.