TY - JOUR
T1 - Dietary Supplementation with a Combination of Lactoferrin, Fish Oil, and Enterococcus faecium WB2000 for Treating Dry Eye
T2 - A Rat Model and Human Clinical Study
AU - Kawashima, Motoko
AU - Nakamura, Shigeru
AU - Izuta, Yusuke
AU - Inoue, Sachiko
AU - Tsubota, Kazuo
N1 - Funding Information:
This work was supported by Wakamoto Pharmaceutical Co. Ltd. The funding organization had no role in the design or conduct of this research.
Funding Information:
This work was supported by Wakamoto Pharmaceutical Co. Ltd. (funding support, supplement capsules, and placebo capsules). The authors thank Naomi Goto, Masami Sato, and Takashi Kurasawa at the Pharmaceutical Development Division, Wakamoto Pharmaceutical Co. Ltd., for their support and assistance during the study. The funding organization had no role in the design or conduct of this research.
Publisher Copyright:
© 2016 Elsevier Inc. All rights reserved.
Copyright:
Copyright 2018 Elsevier B.V., All rights reserved.
PY - 2016/4/1
Y1 - 2016/4/1
N2 - Purpose To examine the effect of a combined dietary supplement containing fish oil, lactoferrin, zinc, vitamin C, lutein, vitamin E, γ-aminobutanoic acid, and Enterococcus faecium WB2000 on dry eye. Methods A preliminary study in a rat model and a prospective, randomized, double-blind, placebo-controlled study in humans were conducted. Forty Japanese volunteers aged 22 to 59 years were randomized into combined dietary supplement (2 capsules/day; 20 participants) and placebo (vehicle; 19 participants) groups and treated once daily for 8 weeks. Rats received the combined dietary supplement components (10 or 50 mg/kg orally) or vehicle (2% DMSO), and dry eye was mechanically induced for 2 days. Tear production was measured in rats after dry eye was induced. Humans were assessed at baseline and weeks 4 and 8 post-supplementation based on keratoconjunctival epithelial damage; fluorescein tear film breakup time; tear production; biochemical data; information regarding subjective dry eye symptoms by answering a questionnaire; and information regarding adverse events via medical interviews. Results Supplementation dose-dependently mitigated the decrease in tear production in rats. Among subjects with confirmed dry eye, clinical symptoms improved at weeks 4 and 8 more significantly in the supplementation group than in the placebo group (P<.05). The rate of increase in the Schirmer value was greater in the supplementation group. No adverse events occurred. Conclusion Supplementation improved objective and subjective dry eye symptoms.
AB - Purpose To examine the effect of a combined dietary supplement containing fish oil, lactoferrin, zinc, vitamin C, lutein, vitamin E, γ-aminobutanoic acid, and Enterococcus faecium WB2000 on dry eye. Methods A preliminary study in a rat model and a prospective, randomized, double-blind, placebo-controlled study in humans were conducted. Forty Japanese volunteers aged 22 to 59 years were randomized into combined dietary supplement (2 capsules/day; 20 participants) and placebo (vehicle; 19 participants) groups and treated once daily for 8 weeks. Rats received the combined dietary supplement components (10 or 50 mg/kg orally) or vehicle (2% DMSO), and dry eye was mechanically induced for 2 days. Tear production was measured in rats after dry eye was induced. Humans were assessed at baseline and weeks 4 and 8 post-supplementation based on keratoconjunctival epithelial damage; fluorescein tear film breakup time; tear production; biochemical data; information regarding subjective dry eye symptoms by answering a questionnaire; and information regarding adverse events via medical interviews. Results Supplementation dose-dependently mitigated the decrease in tear production in rats. Among subjects with confirmed dry eye, clinical symptoms improved at weeks 4 and 8 more significantly in the supplementation group than in the placebo group (P<.05). The rate of increase in the Schirmer value was greater in the supplementation group. No adverse events occurred. Conclusion Supplementation improved objective and subjective dry eye symptoms.
KW - Schirmer test
KW - dietary supplements
KW - dry eye
KW - tears
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U2 - 10.1016/j.jtos.2015.12.005
DO - 10.1016/j.jtos.2015.12.005
M3 - Article
C2 - 26795265
AN - SCOPUS:84963976424
VL - 14
SP - 255
EP - 263
JO - Ocular Surface
JF - Ocular Surface
SN - 1542-0124
IS - 2
ER -