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

NCT ID: NCT06155344

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 670 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-18
• Study Completion Date: 2026-08-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Food Frequency Questionnaire

Intervention Type: 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.

Collection of 4 mL maternal blood

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Collection of 4 mL maternal blood

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

UMR 1280 PHAN

UNKNOWN

Sponsor Role: collaborator

INRAE - CRESS

UNKNOWN

Sponsor Role: collaborator

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Norbert Winer, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Veronique Ferchaud-Roucher, PhD

Role: STUDY_DIRECTOR

UMR 1280 PHAN

Locations

CHU de Nantes

Nantes, Loire-Atlantique, France

Site Status: RECRUITING

Countries

France

Central Contacts

Norbert Winer, MD, PHD

Role: CONTACT

norbert.winer@chu-nantes.fr

+33 (0)2 40 08 78 00 ext. +33

Facility Contacts

Norbert Winer, PU PH

Role: primary

nobert.winer@chu-nantes.fr

Other Identifiers

2023-A01997-38

Identifier Type: OTHER

Identifier Source: secondary_id

RC23_0399

Identifier Type: -

Identifier Source: org_study_id