Safety, Tolerability, and Pharmacokinetics of beta-Cryptoxanthin Supplementation in Healthy Women: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial

Background: beta-cryptoxanthin is a dietary carotenoid for which there have been few studies on the safety and pharmacokinetics following daily oral supplementation. Methods: 90 healthy Asian women between 21 and 35 years were randomized into three groups: 3 and 6 mg/day oral beta-cryptoxanthin, and placebo. At 2, 4, and 8 weeks of supplementation, plasma carotenoid levels were measured. The effects of beta-cryptoxanthin on blood retinoid-dependent gene expression, mood, physical activity and sleep, metabolic parameters, and fecal microbial composition were investigated. Results: beta-cryptoxanthin supplementation for 8 weeks (3 and 6 mg/day) was found to be safe and well tolerated. Plasma beta-cryptoxanthin concentration was significantly higher in the 6 mg/day group (9.0 +/- 4.1 mu mol/L) compared to 3mg/day group (6.0 +/- 2.6 mu mol/L) (p < 0.03), and placebo (0.4 +/- 0.1 mu mol/L) (p < 0.001) after 8 weeks. Plasma all-trans retinol, alpha-cryptoxanthin, alpha-carotene, beta-carotene, lycopene, lutein, and zeaxanthin levels were not significantly changed. No effects were found on blood retinol-dependent gene expression, mood, physical activity and sleep, metabolic parameters, and fecal microbial composition. Conclusions: Oral beta-cryptoxanthin supplementation over 8 weeks lead to high plasma concentrations of beta-cryptoxanthin, with no impact on other carotenoids, and was well tolerated in healthy women.