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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorNantes University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pregnant women consulting the CEMAFOER at the Nantes University Hospital for pregnancy monitoring

Gestational age between 11 and 13 AW +6 days

Understanding French

Disqualifiers

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

Trial population

Patients will be included during the 1st trimester follow-up visit (at 11-13 amenorrhea weeks (AW) + 6 days), organized by the maternal and fetal pathology screening and risk assessment center (CEMAFOER) at the Nantes University Hospital. Patients will then be informed of the research project, and their written consent to participate in the study will be obtained.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Food Frequency Questionnaire

    Other intervention

    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.

  • Collection of 4 mL maternal blood

    Other intervention

    One tube collection of 4 mL maternal blood in the first trimester and at delivery.

Treatment groups

670 Participants
are divided into 1 treatment group
Group A: Pregnant women included in the VEGALIM project2 interventions

Trial outcomes

Primary outcomes

1

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 outcomes

1

Study the evolution of the vegetation score between the 1st and 3rd trimester of pregnancy

Time frame
6 months
2

Study changes in diet quality between the 1st and 3rd trimesters of pregnancy

Time frame
6 months
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nantes University Hospital

Lead sponsor

UMR 1280 PHAN

Collaborator

INRAE - CRESS

Collaborator