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Recruiting NCT06155344

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

— Observational Diet During Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Food Frequency Questionnaire, Collection of 4 mL maternal blood.
Who it may be relevant to
Registry conditions: Diet During Pregnancy. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other Food Frequency Questionnaire
    We will obtain a global index of vegetalization of the diet (the Plant based Diet Index: PDI) from data obtained using semi-quantitative questionnaires on food frequency (Food Frequency Questionnaire (FFQ)) validated on the national ELFE cohort (French Longitudinal Study from Childhood (https://www.elfe-france.fr)) and completed by women in the 1st trimester of pregnancy (T1) and at delivery.
  • Other Collection of 4 mL maternal blood
    One tube collection of 4 mL maternal blood in the first trimester and at delivery.

Primary outcome measures

  • 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) [Time frame: 25 minutes]
Secondary outcome measures (10)
  • Study the evolution of the vegetation score between the 1st and 3rd trimester of pregnancy [Time frame: 6 months]
  • Study changes in diet quality between the 1st and 3rd trimesters of pregnancy [Time frame: 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.). [Time frame: 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.). [Time frame: 6 months]
  • Study the association between the vegetalization of the diet and the lipid profile of women in the 1st trimester and at childbirth. [Time frame: 6 months]
  • Study the association between diet quality and lipid profiles of women in the 1st trimester and at childbirth. [Time frame: 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. [Time frame: 6 months]
  • Study the association between diet quality and total fatty acid status in women at 1st trimester and at childbirth. [Time frame: 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. [Time frame: 6 months]
  • Study the association between diet quality and the lipid profile of umbilical cord blood at delivery (T3). [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • CHU de Nantes — Nantes

Identifiers

NCT: NCT06155344 · RC23_0399 · 2023-A01997-38

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗