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

[{"label":"BACKGROUND","text":"\u03b2-cryptoxanthin is a dietary carotenoid for which there have been few studies on the safety and pharmacokinetics following daily oral supplementation."},{"label":"METHODS","text":"90 healthy Asian women between 21 and 35 years were randomized into three groups: 3 and 6 mg\/day oral \u03b2-cryptoxanthin, and placebo. At 2, 4, and 8 weeks of supplementation, plasma carotenoid levels were measured. The effects of \u03b2-cryptoxanthin on blood retinoid-dependent gene expression, mood, physical activity and sleep, metabolic parameters, and fecal microbial composition were investigated."},{"label":"RESULTS","text":"\u03b2-cryptoxanthin supplementation for 8 weeks (3 and 6 mg\/day) was found to be safe and well tolerated. Plasma \u03b2-cryptoxanthin concentration was significantly higher in the 6 mg\/day group (9.0 \u00b1 4.1 \u00b5mol\/L) compared to 3 mg\/day group (6.0 \u00b1 2.6 \u00b5mol\/L) ( < 0.03), and placebo (0.4 \u00b1 0.1 \u00b5mol\/L) ( < 0.001) after 8 weeks. Plasma all-trans retinol, \u03b1-cryptoxanthin, \u03b1-carotene, \u03b2-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."},{"label":"CONCLUSIONS","text":"Oral \u03b2-cryptoxanthin supplementation over 8 weeks lead to high plasma concentrations of \u03b2-cryptoxanthin, with no impact on other carotenoids, and was well tolerated in healthy women."}]