CHU de Nantes
Nantes, Loire-Atlantique, 44093, France
Location status: Recruiting
Recruiting
NCT Number: NCT06155344
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Food Frequency Questionnaire
OtherWe 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
OtherOne tube collection of 4 mL maternal blood in the first trimester and at delivery.
Primary outcomes
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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
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Study the evolution of the vegetation score between the 1st and 3rd trimester of pregnancy
Time frame: 6 months
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Study changes in diet quality between the 1st and 3rd trimesters of pregnancy
Time frame: 6 months
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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
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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
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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
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Study the association between diet quality and lipid profiles of women in the 1st trimester and at childbirth.
Time frame: 6 months
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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
-
Study the association between diet quality and total fatty acid status in women at 1st trimester and at childbirth.
Time frame: 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
-
Study the association between diet quality and the lipid profile of umbilical cord blood at delivery (T3).
Time frame: 6 months
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Nantes University Hospital
Other
Collaborators
- INRAE - CRESS
- UMR 1280 PHAN
Registry information
Official study title
VEGALIM : Vegetalization of the Maternal Diet During Pregnancy: Association With Pregnancy Outcomes and Newborn Health.
Acronym: VEGALIM
Important dates
- Study start
- 2024
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Dec 4, 2023
- Registry last updated
- Feb 9, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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