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

February 5, 2026 updated by: Nantes University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

670

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44093
        • Recruiting
        • CHU de Nantes
        • Principal Investigator:
          • Norbert Winer, Dr
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time 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)
Time Frame: 25 minutes
25 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Study changes in diet quality between the 1st and 3rd trimesters of pregnancy
Time Frame: 6 months
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
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
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
6 months
Study the association between diet quality and lipid profiles of women in the 1st trimester and at childbirth.
Time Frame: 6 months
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
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
6 months
Study the evolution of the vegetation score between the 1st and 3rd trimester of pregnancy
Time Frame: 6 months
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
6 months
Study the association between diet quality and the lipid profile of umbilical cord blood at delivery (T3).
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Collaborators

UMR 1280 PHAN
INRAE - CRESS

Investigators

  • Principal Investigator: Norbert Winer, MD, PHD, Nantes University Hospital
  • Study Director: Veronique Ferchaud-Roucher, PhD, UMR 1280 PHAN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2024

Primary Completion (Estimated)

June 18, 2027

Study Completion (Estimated)

December 18, 2027

Study Registration Dates

First Submitted

November 6, 2023

First Submitted That Met QC Criteria

November 24, 2023

First Posted (Actual)

December 4, 2023

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RC23_0399
  • 2023-A01997-38 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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