Amway, 安利

为了解产品功效，在研发阶段，纽崔莱健康研究院与上海交通大学附属新华医院等权威机构合作，开展了一项包含360名受试者的随机双盲临床试验。试验分为安慰剂以及高、中、低3个剂量组，检测内容包括：黄斑色素光密度、视疲劳问卷、干眼测试、明视持久度、食物频率问卷等。

试验结果证明，由叶黄素酯、玉米黄质、黑加仑、菊花、枸杞提取物组成的葆明配方，能够显著改善眼酸痛、视力模糊、干眼症、异物感和流泪等视疲劳问题。

葆明的双盲试验结果被《美国临床营养学杂志》刊登，这也意味着，纽崔莱的功效试验得到了世界最权威营养学机构的认可。

一项由多种植物提取物组成的

全新配方(纽崔莱葆明配方)，改善视

疲劳和干眼症的随机、双盲、

安慰剂对照研究

A novel botanical formula improves eye fatigue and dry eye:

a randomized, double-blind, placebo-controlled study

Juntao Kan,¹ Min Wang,² Ying Liu,³ Hong Zhensheng Gu,⁶ and Jun Du¹

目的: 通过随机、双盲、安慰剂对照的临床试验，评估由叶黄素酯、玉米黄质、黑加仑、菊花、枸杞提取物组成的全新配方，对成人视疲劳的保护作用。

实验：我们将 360 名受试者随机分为四组，每天服用安慰剂或三个剂量的配方（含 6mg、10 mg 或 14mg 叶黄素），持续 90 天。在研究期间，每个受试者在第 1 天、第 45 天和第 90 天有三次访视。

ABSTRACT

Background: With the frequent use of v eye fatigue is becoming more common global nutritional strategy is needed to prevent the aggri symptoms.

Objectives: The objective was to evaluate the protective effect of a novel botanical combination of lutein ester, zeaxanthin, and extracts of blackcurrant, chrysanthemum, and goji berry on adults with eye fatigue in a randomized, double-blind, placebo-controlled clinical trial.

Methods: We randomly allocated 360 participants into 4 groups to receive placebo and 3 doses of our formula (chewable tablets, containing 6 mg, 10 mg, or 14 mg of lutein) once daily for 90 d. Each participant had 3 visits at baseline (V1), 45 d (V2), and 90 d (V3) during the study.

Results: Intervention with the formula improved individual scores of eye fatigue symptoms, including eye soreness, blurred vision, dry eye, foreign body sensation, and tearing. Compared with placebo, the formula at all 3 doses significantly decreased the total score of eye fatigue symptoms and increased the visuognosis persistence time at both V2 and V3. According to the Schirmer test, both 10-mg and 14-mg lutein formula groups had improved tear compared with the placebo. The keratography result first tear break-up time, average tear break-up ti height were significantly increased after form formula at all 3 doses significantly increased optical density at V2 and V3 compared with optical coherence tomography showed no s in retinal thickness and retinal volume across all groups at both visits.

Conclusions: Our botanical formula improves eye fatigue, dry eye, and macular function without changing the retinal structure, and thus it could serve as an effective nutritional strategy in improving eye fatigue without causing serious side effects. Clinical Trial Registry: chiCTR.org.cn (ChiCTR 1800018987). Am J Clin Nutr 2020;00:1–9.

Introduction

Eye fatigue, also defined as asthenopia, is a common condition in both adults and children. A variety of factors can cause eye fatigue, including eye factors (refractive and muscular), psychological factors, and environmental factors (1–4). In particular, the growing use of video display units (VDUs), such as computers, mobile phones, and tablets, has increased the global prevalence of eye fatigue at different stages of life (5, 6). In Chinese college students, the prevalence of eye fatigue is

This study was funded by the National Key R&D Program of China (2018YFC1706800), Nutrition Research Foundation of Chinese Nutrition Society (CNS-DSM2018A35), and Innovation Funding of Amway (China) R&D Center. The study design, implementation, analysis, and interpretation were carried out jointly by the funders and principal investigator. The study

结论：在不改变视网膜结构的情况下，该植物配方改善了视疲劳、干眼症和黄斑功能，同时也没有发现副作用，可以作为一种有效的营养策略。

Address correspondence to Dr. (e-mail: 15901912983@163.com) or Dr. (e-mail: Eric.du@amway.com).

Abbreviations used: AMD, age-related macular degeneration; BUT, tear break-up time; CFDA, China Food and Drug Administration; HFP, heterochromatic flicker photometry; MPOD, macular pigment optical density; OCT, optical coherence tomography; ST, Schirmer test; TCM, traditional Chinese medicine; VDU, video display unit.

Received January 14, 2020. Accepted for publication May 15, 2020. First published online 0, 2020; doi: https://doi.org/10.1093/ajcn/nqaa139.

Am J Clin Nutr 2020;00:1–9. Printed in USA. Copyright © The Author(s) on behalf of the American Society for Nutrition 2020.