背景:膳食神经色素叶黄素(L)和玉米黄质(Z)的补充已被证明可以改善成年人视觉和认知功能的许多方面。在这项研究中,我们测试了类似的干预措施是否可以改善青春期前儿童的此类结局.
方法:60名儿童(年龄范围5-12岁)以2:1的比例随机分组,安慰剂对照临床试验。受试者补充含有10mg叶黄素和2mg玉米黄质(LZ)的组合或安慰剂的软糖180天。黄斑色素光密度(MPOD)是主要终点。次要终点包括血清L和Z水平,和脑源性神经营养因子(BDNF),临界闪烁融合(CFF),使用视觉模拟量表(VAS)的眼睛疲劳和疲劳,儿童睡眠习惯问卷-缩写(CSHQ-A),和Creyos健康认知领域,如注意力,专注/集中,情景记忆和学习,视觉空间工作记忆,和视觉空间处理速度。在整个研究过程中,根据体格检查评估安全性。生命体征,临床实验室检查,和监测不良事件。
结果:LZ组在补充后的所有访视中均显示MPOD显著增加,与安慰剂相比,早在第42天显着增加。LZ组血清叶黄素水平显著升高,减少眼睛疲劳和疲劳,和提高认知表现(专注,情景记忆和学习,视觉空间工作记忆)在第90天和第180天与安慰剂相比。Further,LZ组处理速度(CFF)显着增加,注意,视觉空间处理,与安慰剂相比,第180天的血清Z和BDNF水平。没有观察到安全问题。
结论:补充LZ导致MPOD水平升高,随着血清L水平的升高,Z,BDNF。这些变化与接受LZ软糖的儿童的视觉和认知表现的改善以及眼睛疲劳和眼睛疲劳的减少有关。研究产品是安全的,耐受性良好。
背景:http://ctri.nic.在/标识符CTRI/2022/05/042364。
BACKGROUND: Supplementation with dietary neuro-pigments lutein (L) and zeaxanthin (Z) has been shown to improve many aspects of visual and cognitive function in adults. In this
study, we tested whether a similar intervention could improve such outcomes in preadolescent children.
METHODS: Sixty children (age range 5-12 years) were randomized in a 2:1 ratio in this double-blind, placebo-controlled clinical
trial. Subjects were supplemented with gummies containing either a combination of 10 mg lutein and 2 mg zeaxanthin (LZ) or placebo for 180 days. Macular pigment optical density (MPOD) was the primary endpoint. The secondary endpoints included serum levels of L and Z, and brain-derived neurotrophic factor (BDNF), critical flicker fusion (CFF), eye strain and fatigue using visual analogue scales (VAS), Children\'s Sleep Habits Questionnaire-Abbreviated (CSHQ-A), and Creyos Health cognitive domains like attention, focus/concentration, episodic memory and learning, visuospatial working memory, and visuospatial processing speed. Safety was assessed throughout the
study on the basis of physical examination, vital signs, clinical laboratory tests, and monitoring of adverse events.
RESULTS: The LZ group showed significant increases in MPOD at all visits post-supplementation, with significant increases as early as day 42 compared to placebo. The LZ group showed significant increases in serum lutein levels, reduced eye strain and fatigue, and improved cognitive performance (focus, episodic memory and learning, visuospatial working memory) at days 90 and 180 compared to placebo. Further, the LZ group showed significant increases in processing speed (CFF), attention, visuospatial processing, and serum Z and BDNF levels on day 180 compared to placebo. No safety concerns were observed.
CONCLUSIONS: Supplementing LZ resulted in increased MPOD levels, along with increased serum levels of L, Z, and BDNF. These changes were associated with improved visual and cognitive performances and reduction in eye strain and eye fatigue in the children receiving LZ gummies. The investigational product was safe and well tolerated.
BACKGROUND: http://ctri.nic.in/ Identifier CTRI/2022/05/042364.