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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06155344
Acronym
VEGALIM
Enrollment
670
Registered
2023-12-04
Start date
2024-03-18
Completion date
2027-12-18
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diet During Pregnancy

Keywords

Pregnancy, Newborn, Vegetalization, Food

Brief summary

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

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.

OTHERCollection of 4 mL maternal blood

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

Sponsors

Nantes University Hospital
Lead SponsorOTHER
UMR 1280 PHAN
CollaboratorUNKNOWN
INRAE - CRESS
CollaboratorUNKNOWN

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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)25 minutes

Secondary

MeasureTime frame
Study the evolution of the vegetation score between the 1st and 3rd trimester of pregnancy6 months
Study changes in diet quality between the 1st and 3rd trimesters of pregnancy6 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 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 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 lipid profiles of women in the 1st trimester and at childbirth.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 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

Countries

France

Contacts

CONTACTNorbert Winer, MD, PHD
norbert.winer@chu-nantes.fr+33 (0)2 40 08 78 00
PRINCIPAL_INVESTIGATORNorbert Winer, MD, PHD

Nantes University Hospital

STUDY_DIRECTORVeronique Ferchaud-Roucher, PhD

UMR 1280 PHAN

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026