Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects

怀孕期间补充类胡萝卜素：对眼部和全身的影响

• 批准号: 9920147
• 负责人: PAUL STEVEN BERNSTEIN
• 金额: $ 19.06万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-05-01 至 2022-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9920147
• 关键词: Adult; Age; American; Assessment tool; Birth; Blood; Carotenoids; Clinic; Clinical; Clinical Research; Clinical Trials; Conflict (Psychology); Contrast Sensitivity; Data; Development; Dietary Carotenoid; Elderly; Eye; Formulation; Foundations; Future; Glare; Guidelines; Health; High Pressure Liquid Chromatography; High-Risk Pregnancy; Human; Image; Infant; Intervention; Intervention Studies; Life; Literature; Lutein; Macular degeneration; Malnutrition; Maternal Health; Measures; Micronutrients; Mothers; Multi-Institutional Clinical Trial; Newborn Infant; Nutritional; Outcome Measure; Phase; Physiological; Pigments; Pilot Projects; Placenta; Policies; Pregnancy; Pregnancy Trimesters; Pregnant Women; Prenatal care; Publishing; Raman Spectrum Analysis; Randomized; Recommendation; Reporting; Risk; Role; Serum; Skin; Structure; Study Subject; Supplementation; Techniques; Testing; Third Pregnancy Trimester; Time; Tissues; Vision; Visual; Visual Acuity; Vitamins; Xanthophylls; clinical practice; cognitive development; contrast enhanced; design; disability; evidence base; in utero; macula; minimal risk; neonate; neurodevelopment; postnatal; prenatal; prenatal health; prospective; randomized controlled study; recruit; relating to nervous system; standard of care; vision development; visual cognition; zeaxanthin

Project Summary/Abstract Prenatal vitamin and micronutrient supplementation is standard-of-care for pregnant women worldwide; however, with the exception of a few ingredients, most prenatal supplementation guidelines are not yet supported by substantial prospective clinical research. Recently, prenatal supplements with added lutein and zeaxanthin have entered the American market with the stated intentions of enhancing infant visual and neural development. Although clinical trials were never performed to support this contention, it is physiologically plausible from the neonate's perspective because these dietary carotenoids are selectively concentrated in human ocular and neural tissue in utero, especially during the third trimester of pregnancy, and there is increasing evidence that lutein and zeaxanthin not only protect against macular degeneration in the elderly, but they may also function to enhance contrast sensitivity, decrease glare disability, and increase visual acuity and cognition throughout life. The macular carotenoid pigment is detectable at birth, and levels increase with age at a time when they can contribute to visual function and foveal development. From the mother's perspective, the last trimester of pregnancy is a time when she must transfer some of her carotenoid stores to the developing infant, potentially putting her at risk for depletion systemically and in her ocular tissues. Because of the importance to the long-term health of both mothers and their infants, a randomized, controlled study using state-of-the-art quantitative assessment tools is indicated; however, before embarking on a potentially very large multi-center clinical trial, it is appropriate to conduct a smaller-scale pilot study to explore the feasibility of recruitment and retention and to develop the information to properly power future studies. Currently, all available data on the role of carotenoids in prenatal health are cross-sectional or observational, The proposed study is designed to test the hypotheses that: [a] the third trimester of pregnancy is indeed a period of maternal systemic and ocular carotenoid depletion; [b] prenatal supplementation with commercially available prenatal supplements containing lutein and zeaxanthin will counteract this reduction; [c] the enhanced maternal carotenoid status associated with prenatal carotenoid supplementation will increase systemic carotenoid levels and macular pigment in their newborn infants. This R21 study will provide necessary preliminary data to design and power future, larger-scale prospective clinical trials with further optimized formulations to determine whether prenatal and postnatal carotenoid supplementation can have beneficial effects on maternal visual function and on infant visual and cognitive development in normal and high-risk pregnancies. The results may also provide evidence-based support to guide policy decisions about prenatal nutritional recommendations to enhance maternal and infant carotenoid status, especially in regions of the world at risk for malnutrition.

项目概要/摘要 产前补充维生素和微量营养素是全世界孕妇的护理标准； 然而，除了少数成分外，大多数产前补充指南尚未制定 得到大量前瞻性临床研究的支持。最近，添加了叶黄素和 玉米黄质已进入美国市场，其目的是增强婴儿的视觉和神经功能 发展。尽管从未进行过临床试验来支持这一论点，但它在生理学上是正确的 从新生儿的角度来看，这是合理的，因为这些膳食类胡萝卜素选择性地集中在 子宫内的人类眼部和神经组织，尤其是在妊娠晚期， 越来越多的证据表明，叶黄素和玉米黄质不仅可以预防老年人黄斑变性，而且 它们还可以起到增强对比敏感度、减少眩光残疾、提高视力和 认知贯穿一生。黄斑类胡萝卜素色素在出生时即可检测到，并且水平随着年龄的增长而增加 此时它们可以促进视觉功能和中央凹发育。从母亲的角度来看， 怀孕的最后三个月是她必须将一些类胡萝卜素储备转移到子宫的时期。 正在发育的婴儿，可能使她面临全身和眼组织衰竭的风险。 由于对母亲及其婴儿的长期健康很重要，因此需要进行随机、对照的研究 表明使用最先进的定量评估工具进行研究；然而，在开始之前 可能是非常大的多中心临床试验，适合进行较小规模的试点研究来探索 招募和保留的可行性，并开发信息以适当推动未来的研究。 目前，所有关于类胡萝卜素在产前健​​康中的作用的可用数据都是横截面或观察性的， 拟议的研究旨在检验以下假设：[a]妊娠晚期确实是一个 母体全身和眼部类胡萝卜素消耗期； [b] 商业产前补充 含有叶黄素和玉米黄质的产前补充剂将抵消这种减少； [c] 的 与产前类胡萝卜素补充相关的母体类胡萝卜素状态的增强将增加 新生儿的全身类胡萝卜素水平和黄斑色素。 这项 R21 研究将为设计和支持未来更大规模的前瞻性研究提供必要的初步数据 进一步优化配方的临床试验，以确定产前和产后类胡萝卜素是否 补充剂可以对母亲的视觉功能以及婴儿的视觉和认知产生有益的影响 正常和高风险妊娠的发育。结果还可能为以下方面提供基于证据的支持： 指导有关产前营养建议的政策决策，以增强孕产妇和婴儿的类胡萝卜素水平 状况，特别是在世界上面临营养不良风险的地区。