Trial reportAdvances in therapy2026
Enhanced Bioavailability of a Novel Oil-Based Lutein Formulation: A Randomized, Double-Blind, Single-Dose, Comparative Oral Bioavailability Study in Healthy Adults.
Trial report in Advances in therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Authors and funding
3 authors.
Funding
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Abstract
introductionLutein is a dietary xanthophyll carotenoid with established roles in ocular health, yet its systemic bioavailability is highly variable and dependent on the nature of the formulation. This study was designed to compare the bioavailability and pharmacokinetic profile of a newly formulated oil suspension of lutein (LUT) with a commercially available reference lutein formulation (REF), following a single oral dose under fed conditions in healthy adults.
methodsThis was a randomized, double-blind, single-dose, parallel-group comparative bioavailability study conducted in healthy adult male subjects (n = 80). Subjects received a single oral dose of 25 mg lutein as either LUT or REF under standardized high-fat fed conditions. Serial blood samples were collected - 2.00 and 0.00 h (pre-dose) and 2.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00, 48.00 and 72.00 h (post-dose). Serum lutein concentrations were quantified using a validated HPLC method. Pharmacokinetic parameters, including Cmax, Tmax, AUC
resultsPeak serum lutein concentrations were observed between 12 and 24 h post-dose for both formulations. LUT demonstrated significantly higher baseline-corrected serum lutein concentrations than REF from 8 h through 72 h (p < 0.05). Maximum serum concentration (C
conclusionThe LUT formulation provides significantly greater systemic lutein bioavailability than the reference formulation following single-dose administration under fed conditions, highlighting the critical influence of formulation design on lutein bioavailability. Future clinical efficacy studies are warranted to evaluate the impact of this enhanced bioavailability.
trial registrationClinical Trials Registry of India: CTRI/2018/01/011167.
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