Dietary Salicylates and Preeclampsia

Официальное название

Nutritional Sources of Salicylates and Disorders of Placental Angiogenesis in Preeclampsia

Обзор

Preeclampsia (PE) is an important pregnancy complication and cause of maternal and perinatal mortality and morbidity. The underlying etiology and pathophysiology of preeclampsia is incompletely understood but it involves dysfunctional cytotrophoblastic invasion, placental ischemia, and release of inflammatory and endothelial mediators. Placenta dysfunction in PE is related to angiogenic balance. Currently, therapeutic options for the prevention and treatment of PE are limited. It is known that the risk of PE is reduced by low-dose aspirin. Therefore, the influence of salicylates on the development of PE seems to need to be investigated. This project plans to examine the preventive effects of food sources of salicylic acid and compare their effects with aspirin. Therefore, the aim of the present study is thus answer the following questions. whether the maternal dietary intake of salicylates is related to placental angiogenesis; 2. whether naturally occurring salicylates have the same effects on preeclampsia development and placental angiogenesis as aspirin. To answer these questions we plan to carry out a human study with pregnant women. Due to the above the planned research aims to determine the association between maternal dietary intake of salicylates and placental angiogenesis and the risk of preeclampsia development. Although PE remains an incurable disease, the results of this project will enable the development of dietary recommendations for the prevention and treatment of preeclampsia. Moreover, the results of this study may be useful in lowering the cost of maternal and fetal complications from preeclampsia and the cost of their hospitalization.

Подробное описание

Preeclampsia (PE) is one of the most important complications in pregnancy worldwide and is responsible for over 70,000 maternal deaths each year around the world. Babies born to women with PE often suffer from intrauterine growth restriction and preterm birth along with increased fetal pro-inflammatory profiles which require a long and costly hospitalization. PE results in placental dysfunction and it is now accepted that PE is a placental disease. Placenta dysfunction in PE is related to impaired angiogenic balance. Currently, therapeutic options for the prevention and treatment of PE are limited. It is known that the risk of PE is reduced by low-dose aspirin.

Therefore, the influence of salicylates on the development of PE seems to need to be investigated.

This project plans to examine the preventive effect of natural salicylates and compare their effects with aspirin. Therefore, the aim of the present study thus answer the following questions. whether the maternal dietary intake of natural salicylates is related to placental angiogenesis; 2. whether naturally occurring salicylates have the same effects on preeclampsia development and placental angiogenesis as aspirin.

The study will aim to determine the association between maternal dietary intake of salicylates and placental angiogenesis and the risk of preeclampsia development.

The study will be carried out in around 500 pregnant women (healthy and with PE) aged 18-45 years.

Daily food intake will be determined based on the FFQ questionnaire and dietary intake interviews. The amount of salicylic acid and total salicylates in the daily diet will be processed and evaluated.

Blood samples were collected from a maternal vein at the time of delivery. In plasma, it will be assayed salicylates, salicylic acid, TNFα, and hsCRP concentrations. Biomarkers of angiogenesis will be assayed in plasma: concentration of VEGF, PLGF, and sFLT1.

The placentas will be collected after delivery. Biomarkers of angiogenesis will be assayed in the placenta: concentration of VEGF, PLGF, and sFLT1. In the placenta, it will be measured mRNA and proteins of STOX 1. The vascularization process will be evaluated in the placenta.

Women will collect 24-hour urine. Salicylates and salicylic acid will be assayed in urine.

Первичные конечные точки

• daily intake using 24-hour Dietary Recall [Срок оценки: 3 years]
• salicylates [Срок оценки: 3 years]
• angiogenesis biomarker: sFLT1 [Срок оценки: 3 years]
• angiogenesis biomarker: VEGF [Срок оценки: 3 years]
• angiogenesis biomarker: PLGF [Срок оценки: 3 years]
• STOX-1 protein [Срок оценки: 3 years]
• inflammatory biomarker: TNFα [Срок оценки: 3 years]
• inflammatory biomarker: hsCRP [Срок оценки: 3 years]

Критерии участия

Критерии включения

• age 18-45 years
• healthy women with no previous adverse medical history and women with diagnosed preeclampsia
• singleton pregnancy
• people who have the full ability to give informed consent.

Критерии исключения

• pregnancies with detectable fetal defects, chromosomal abnormalities, genetic syndromes
• infections
• history of chronic hypertension, metabolic disorder before or during pregnancy, or the presence of high-risk factors such as heart diseases, diabetes, and renal diseases.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Польша · 1 центр

• Poznan University of Life Sciences — Poznan

Идентификаторы

NCT: NCT06239363 · 34/2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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