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.

项目总结/摘要 产前补充维生素和微量营养素是全世界孕妇的标准护理; 然而，除了少数成分外，大多数产前补充指南还没有 得到了大量前瞻性临床研究的支持。最近，产前补充剂添加叶黄素和 玉米黄质已经进入美国市场，其目的是增强婴儿的视觉和神经功能。 发展虽然从未进行过临床试验来支持这一论点，但从生理学上讲， 从新生儿的角度来看是合理的，因为这些膳食类胡萝卜素选择性地集中在 在子宫内，特别是在妊娠的第三个三个月期间， 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的黄斑变性， 它们还可以增强对比敏感度、减少眩光残疾、提高视力， 认知贯穿一生。黄斑类胡萝卜素色素在出生时就可以检测到，随着年龄的增长， 在这个时候，他们可以有助于视觉功能和中央凹的发展。从母亲的角度来看， 怀孕的最后三个月是她必须将她的一些类胡萝卜素储存转移到 发育中的婴儿，潜在地使她处于全身性和眼部组织消耗的风险中。 由于对母婴长期健康的重要性， 研究使用国家的最先进的定量评估工具表示;然而，在开始之前， 潜在的非常大的多中心临床试验，进行较小规模的试点研究是合适的，以探索 招聘和保留的可行性，并开发信息，以适当的权力，未来的研究。 目前，关于类胡萝卜素在产前健康中作用的所有可用数据都是横断面或观察性的， 这项拟议中的研究旨在检验以下假设：[a]妊娠晚期确实是一个 母体全身性和眼部类胡萝卜素耗竭期; [B]产前补充市售 可用的产前补充剂含有叶黄素和玉米黄质将抵消这种减少; [c] 与产前类胡萝卜素补充相关的母体类胡萝卜素状态增强将增加 新生儿全身类胡萝卜素水平和黄斑色素。 这项R21研究将为未来更大规模的前瞻性设计和供电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 补充可对母亲视觉功能和婴儿视觉和认知具有有益作用 在正常和高危妊娠中。这些结果也可能为以下方面提供基于证据的支持： 指导产前营养建议的政策决定，以提高母婴类胡萝卜素 特别是在世界上面临营养不良风险的地区。