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临床试验/NCT06155344
NCT06155344招募中不适用

VEGALIM : Vegetalization of the Maternal Diet During Pregnancy: Association With Pregnancy Outcomes and Newborn Health.

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 670 人开始时间: 2024年3月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
670
试验地点
1
主要终点
Characterizing the levels of plant-based food consumption at the beginning of pregnancy (at the end of the first trimester of pregnancy) based on the completion of the Food Frequency Questionnaire (FFQ, scale from 0 to 6 ; 0 being the worst outcome)

研究概览

简要总结

Reducing consumption of foods of animal origin in favor of more plant-based diets is a major environmental, public health and economic challenge. Data on the health effects of highly vegetalized diets are available only in adults. Few studies report the effect of the level of vegetalization of the maternal diet during pregnancy on the mother's health, and the development and health of the child. The VEGALIM project aims to describe the level of vegetalization of pregnant women's diets and the nutritional quality of their diets early in pregnancy (first trimester) and late pregnancy, and to explore the potential effects on their plasma lipid profile that may impact on their health during pregnancy and the health of the newborn.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women consulting the CEMAFOER at the Nantes University Hospital for pregnancy monitoring
  • Gestational age between 11 and 13 AW +6 days
  • Understanding French

排除标准

  • Patients under 18 years of age
  • Patient who objected to being included in the study
  • Patient with cognitive problems that prevent her from answering questionnaires

研究组 & 干预措施

Pregnant women included in the VEGALIM project

Pregnant women consulting CEMAFOER (Center for Maternal and Fetal Pathology Screening and Risk Assessment) of Nantes University Hospital for pregnancy monitoring

干预措施: Food Frequency Questionnaire (Other)

Pregnant women included in the VEGALIM project

Pregnant women consulting CEMAFOER (Center for Maternal and Fetal Pathology Screening and Risk Assessment) of Nantes University Hospital for pregnancy monitoring

干预措施: Collection of 4 mL maternal blood (Other)

结局指标

主要结局

Characterizing the levels of plant-based food consumption at the beginning of pregnancy (at the end of the first trimester of pregnancy) based on the completion of the Food Frequency Questionnaire (FFQ, scale from 0 to 6 ; 0 being the worst outcome)

时间窗: 25 minutes

次要结局

  • Study the association between diet quality and lipid profiles of women in the 1st trimester and at childbirth.(6 months)
  • Study the association between diet quality in the first trimester of pregnancy and pregnancy outcomes (such as prematurity, birth weight, maternal pathologies not present at the time of inclusion (gestational diabetes, pre-eclampsia, etc.).(6 months)
  • Study changes in diet quality between the 1st and 3rd trimesters of pregnancy(6 months)
  • Study the association between the vegetalization of the diet and the total fatty acid status of women in the 1st trimester and at childbirth.(6 months)
  • Study the evolution of the vegetation score between the 1st and 3rd trimester of pregnancy(6 months)
  • Studying the association between vegetarian diets in the first trimester of pregnancy and pregnancy outcomes (such as prematurity, birth weight, maternal pathologies not present at the time of inclusion (gestational diabetes, pre-eclampsia, etc.).(6 months)
  • Study the association between the vegetalization of the diet and the lipid profile of women in the 1st trimester and at childbirth.(6 months)
  • Study the association between diet quality and total fatty acid status in women at 1st trimester and at childbirth.(6 months)
  • Identify other biological markers, such as vitamins, that may be impacted by a change in diet, and study the influence of diet quality on these potential plasma markers of patient and of Umbilical cord blood plasma.(6 months)
  • Study the association between diet quality and the lipid profile of umbilical cord blood at delivery (T3).(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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