Diet During PregnancyVEGALIMNCT06155344
Vegetalization of the Maternal Diet During Pregnancy: Association With Pregnancy Outcomes and Newborn Health.
An observational study of Diet During Pregnancy, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Diet During Pregnancy
- What is being tested?
- Food Frequency Questionnaire and Collection of 4 mL maternal blood
- How many people
- 670 participants
- Where
- 1 siteFrance
- Study dates
- 18 Mar 2024to 18 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Pregnant women consulting the CEMAFOER at the Nantes University Hospital for pregnancy monitoring
- Gestational age between 11 and 13 AW +6 days
- Understanding French
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nantes
Nantes, Loire-Atlantique, 44093
Norbert Winer, PU PH, nobert.winer@chu-nantes.fr
Norbert Winer, Dr
About this study
Official title: 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.
- Conditions
- Diet During Pregnancy
- Being tested
- Food Frequency Questionnaire, Collection of 4 mL maternal blood
- Keywords
- Pregnancy, Newborn, Vegetalization, Food
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food Frequency QuestionnaireOther
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 bloodOther
One tube collection of 4 mL maternal blood in the first trimester and at delivery.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Food Frequency Questionnaire; Other: Collection of 4 mL maternal blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 25 minutes
Secondary outcomes (10)
Study the evolution of the vegetation score between the 1st and 3rd trimester of pregnancy
Measured: 6 months
Study changes in diet quality between the 1st and 3rd trimesters of pregnancy
Measured: 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.).
Measured: 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.).
Measured: 6 months
Study the association between the vegetalization of the diet and the lipid profile of women in the 1st trimester and at childbirth.
Measured: 6 months
Study the association between diet quality and lipid profiles of women in the 1st trimester and at childbirth.
Measured: 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.
Measured: 6 months
Study the association between diet quality and total fatty acid status in women at 1st trimester and at childbirth.
Measured: 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.
Measured: 6 months
Study the association between diet quality and the lipid profile of umbilical cord blood at delivery (T3).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start18 Mar 2024
- Primary completion18 Jun 2027 (estimated)
- Study completion18 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet During PregnancyStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 670 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- UMR 1280 PHAN, INRAE - CRESS
- Responsible party
- Sponsor
- Investigators
- Norbert Winer, MD, PHD, Principal investigator, Nantes University HospitalVeronique Ferchaud-Roucher, PhD, Study director, UMR 1280 PHAN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155344
- Sponsor's protocol ID
- RC23_0399
- Other IDs
- 2023-A01997-38
- Acronym
- VEGALIM
- Status last verified
- Feb 2026
- First submitted
- 6 Nov 2023
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VEGALIM : Vegetalization of the Maternal Diet During Pregnancy: Association With Pregnancy Outcomes and Newborn Health.
- ClinicalTrials.gov ID
- NCT06155344
- Acronym / sponsor ID
- VEGALIM / RC23_0399
- Conditions
- Diet During Pregnancy
- Keywords
- Pregnancy, Newborn, Vegetalization, Food
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 670 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- UMR 1280 PHAN, INRAE - CRESS
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 18 Jun 2027 (estimated)
- Study completion
- 18 Dec 2027 (estimated)
- First posted
- 4 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women included in the VEGALIM project | – | Other: Food Frequency Questionnaire, Other: Collection of 4 mL maternal bloodPregnant women consulting CEMAFOER (Center for Maternal and Fetal Pathology Screening and Risk Assessment) of Nantes University Hospital for pregnancy monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Pregnant women consulting the CEMAFOER at the Nantes University Hospital for pregnancy monitoring
- Gestational age between 11 and 13 AW +6 days
- Understanding French
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food Frequency QuestionnaireWe 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 | Pregnant women included in the VEGALIM project |
| Collection of 4 mL maternal bloodOne tube collection of 4 mL maternal blood in the first trimester and at delivery. | Other | Pregnant women included in the VEGALIM project |
Primary outcome
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
10 secondary outcomes
Study the evolution of the vegetation score between the 1st and 3rd trimester of pregnancy
Time frame: 6 months
Study changes in diet quality between the 1st and 3rd trimesters of pregnancy
Time frame: 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
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
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
Study the association between diet quality and lipid profiles of women in the 1st trimester and at childbirth.
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Norbert Winer, MD, PHD principal investigator
Nantes University Hospital
Veronique Ferchaud-Roucher, PhD study director
UMR 1280 PHAN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diet During Pregnancy, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Norbert Winer, MD, PHD (+33 (0)2 40 08 78 00 ext. +33, norbert.winer@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.