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

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

Nutrients

10.3390/nu15102325

http://dx.doi.org/10.3390/nu15102325

Karen M. L. Tan, Jolene Chee, Kezlyn L. M. Lim, Maisie Ng, Min Gong, Jia Xu, Felicia Tin, Padmapriya Natarajan, Bee Lan Lee, Choon Nam Ong, Mya Thway Tint, Michelle Z. L. Kee, Falk Müller-Riemenschneider, Peter D. Gluckman, Michael J. Meaney, Mukkesh Kumar, Neerja Karnani, Johan G. Eriksson, Bindu Nandanan, Adrian Wyss, David Cameron-Smith

16 May 2023

Tan, K. M. L., Chee, J., Lim, K. L. M., Ng, M., Gong, M., Xu, J., Tin, F., Natarajan, P., Lee, B. L., Ong, C. N., Tint, M. T., Kee, M. Z. L., Müller-Riemenschneider, F., Gluckman, P. D., Meaney, M. J., Kumar, M., Karnani, N., Eriksson, J. G., Nandanan, B., … Cameron-Smith, D. (2023). Safety, Tolerability, and Pharmacokinetics of β-Cryptoxanthin Supplementation in Healthy Women: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial. Nutrients, 15(10), 2325. https://doi.org/10.3390/nu15102325

Background: β-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 β-cryptoxanthin, and placebo. At 2, 4, and 8 weeks of supplementation, plasma carotenoid levels were measured. The effects of β-cryptoxanthin on blood retinoid-dependent gene expression, mood, physical activity and sleep, metabolic parameters, and fecal microbial composition were investigated. Results: β-cryptoxanthin supplementation for 8 weeks (3 and 6 mg/day) was found to be safe and well tolerated. Plasma β-cryptoxanthin concentration was significantly higher in the 6 mg/day group (9.0 ± 4.1 µmol/L) compared to 3 mg/day group (6.0 ± 2.6 µmol/L) (p < 0.03), and placebo (0.4 ± 0.1 µmol/L) (p < 0.001) after 8 weeks. Plasma all-trans retinol, α-cryptoxanthin, α-carotene, β-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 β-cryptoxanthin supplementation over 8 weeks lead to high plasma concentrations of β-cryptoxanthin, with no impact on other carotenoids, and was well tolerated in healthy women.

Attribution 4.0 International (CC BY 4.0)

Funding for this work was provided by DSM Nutritional Products Ltd.

https://oar.a-star.edu.sg/communities-collections/articles/20675

2072-6643

Bioinformatics Institute