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

NCT06155344 | Recruiting

• 2 other identifiers: RC23_03992023-A01997-38
• Study Type: observational
• Target: 670
• Locations: 1 country
• Sites: 1

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.

Conditions

Diet During Pregnancy

Keywords

Pregnancy; Newborn; Vegetalization; Food

Outcome Measures

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)

  25 minutes

Secondary Outcomes (10)

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

  6 months

• Study changes in diet quality between the 1st and 3rd trimesters 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 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 Arms (1)

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

Other: Food Frequency Questionnaire; Other: Collection of 4 mL maternal blood

Interventions

Food Frequency Questionnaire OTHER

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.

Pregnant women included in the VEGALIM project

Collection of 4 mL maternal blood OTHER

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

Pregnant women included in the VEGALIM project

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead
• UMR 1280 PHAN: collaborator
• INRAE - CRESS: collaborator

Study Sites (1)

CHU de Nantes

Nantes, Loire-Atlantique, 44093, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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

Study Officials

• Norbert Winer, MD, PHD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

• Veronique Ferchaud-Roucher, PhD

  UMR 1280 PHAN

  STUDY DIRECTOR

Central Study Contacts

Norbert Winer, MD, PHD

CONTACT

+33 (0)2 40 08 78 00; norbert.winer@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: December 4, 2023
• Study Start: March 18, 2024
• Primary Completion (Estimated): June 18, 2027
• Study Completion (Estimated): December 18, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

FR (1)