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新生儿生长和肥胖研究(GAINS):产前 DHA 补充方案的影响。

Growth and adiposity in newborns study (GAINS): The influence of prenatal DHA supplementation protocol.

机构信息

Department of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, KS, United States of America.

Department of Biostatistics, University of Kansas Medical Center, Kansas City, KS, United States of America.

出版信息

Contemp Clin Trials. 2023 Sep;132:107279. doi: 10.1016/j.cct.2023.107279. Epub 2023 Jul 3.

DOI:10.1016/j.cct.2023.107279
PMID:37406769
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10852997/
Abstract

BACKGROUND

Obesity and central fat mass (FM) accrual drive disease development and are related to greater morbidity and mortality. Excessive gestational weight gain (GWG) increases fetal fat accretion resulting in greater offspring FM across the lifespan. Studies associate greater maternal docosahexaenoic acid (DHA) levels with lower offspring FM and lower visceral adipose tissue during childhood, however, most U.S. pregnant women do not consume an adequate amount of DHA. We will determine if prenatal DHA supplementation is protective for body composition changes during infancy and toddlerhood in offspring exposed to excessive GWG.

METHODS AND DESIGN

Infants born to women who participated in the Assessment of DHA on Reducing Early Preterm Birth randomized controlled trial (ADORE; NCT02626299) will be invited to participate. Women were randomized to either a high 1000 mg or low 200 mg daily prenatal DHA supplement starting in the first trimester of pregnancy. Offspring body composition and adipose tissue distribution will be measured at 2 weeks, 6 months, 12 months, and 24 months using dual energy x-ray absorptiometry. Maternal GWG will be categorized as excessive or not excessive based on clinical guidelines.

DISCUSSION

Effective strategies to prevent obesity development are lacking. Exposures during the prenatal period are important in the establishment of the offspring phenotype. However, it is largely unknown which exposures can be successfully targeted to have a meaningful impact. This study will determine if prenatal DHA supplementation modifies the relationship between maternal weight gain and offspring FM and FM distribution at 24 months of age.

ETHICS AND DISSEMINATION

The University of Kansas Medical Center Institutional Review Board (IRB) approved the study protocol (STUDY00140895). The results of the trial will be disseminated at conferences and in peer reviewed publications.

TRIAL REGISTRATION

ClinicalTrials.gov ID: NCT03310983.

摘要

背景

肥胖和中心脂肪量(FM)的增加会导致疾病的发生,并与更高的发病率和死亡率相关。过多的妊娠期体重增加(GWG)会增加胎儿脂肪的积累,从而导致整个生命周期内后代的 FM 增加。研究表明,母体二十二碳六烯酸(DHA)水平较高与儿童时期后代 FM 较低和内脏脂肪组织较少有关,但大多数美国孕妇没有摄入足够的 DHA。我们将确定在暴露于过多 GWG 的后代中,产前 DHA 补充是否对婴儿期和幼儿期的身体成分变化具有保护作用。

方法和设计

将邀请参加评估 DHA 减少早期早产随机对照试验(ADORE;NCT02626299)的女性所生的婴儿参加。女性在妊娠早期随机分配接受每日 1000 毫克或 200 毫克的高剂量或低剂量产前 DHA 补充剂。使用双能 X 射线吸收法在 2 周、6 个月、12 个月和 24 个月时测量后代的身体成分和脂肪组织分布。根据临床指南,将产妇 GWG 分为过多或不过多。

讨论

缺乏有效的肥胖预防策略。在后代表型的建立中,产前暴露是很重要的。然而,很大程度上还不知道哪些暴露可以被成功地靶向以产生有意义的影响。这项研究将确定产前 DHA 补充是否会改变母体体重增加与后代 FM 和 24 个月时 FM 分布之间的关系。

伦理和传播

堪萨斯大学医学中心机构审查委员会(IRB)批准了研究方案(STUDY00140895)。试验结果将在会议和同行评议出版物中公布。

试验注册

ClinicalTrials.gov ID:NCT03310983。

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The Kansas University DHA Outcomes Study (KUDOS) clinical trial: long-term behavioral follow-up of the effects of prenatal DHA supplementation.堪萨斯大学二十二碳六烯酸结局研究(KUDOS)临床试验:产前二十二碳六烯酸补充对行为影响的长期随访
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