Not Yet RecruitingNot Applicable

Diet Quality of Pregnant Women With a Strict Plant-based Diet Versus an Omnivorous Diet

256 participantsStarted 2025-01-01

Plain-language summary

The goal of this observational study is to compare the nutritional intake among pregnant women with a strict plant-based diet versus an omnivorous diet. The main aim is to compare vitamin B12 intake. Participants will be asked to: * fill out a health questionnaire * fill out a three-day food diary * undergo blood sampling Researchers will compare pregnant women with a strict plant-based diet and pregnant women with an omnivorous diet to see if their nutritional intake is comparable.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Before 27 weeks of pregnancy * Age \>18 years * Strict plant-based diet (vegan diet), defined as a diet without ingestion of animal products (i.e., intake less than once a month during) the entire pregnancy or omnivorous diet, defined as a diet that includes meat * Willing and able to give written informed consent and to understand, participate and comply with the research project requirements Exclusion Criteria: * Food allergy that influences the nutritional intake, e.g., milk allergy, celiac disease, and lactose intolerance * Medical history of gastrointestinal diseases such as Crohn's disease and other diseases associated with vitamin B12 deficiencies such as (pre-existing) diabetes. * Medical history of abdominal surgery interfering with nutrient uptake, such as gastric bypass and intestinal resections * Pre-existing cardio-vascular diseases or auto-immune diseases * Insufficient understanding of the Dutch language

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Vitamin B12 intake in mcg/day

Timeframe: Participants will fill out the food diary between 27 and 30 weeks of pregnancy

Trial details

NCT IDNCT06046703

SponsorMaastricht University Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12-31

Contact for this trial

Deidre Meulenbroeks, Dr.

0031433874768 voedingzwangerschap@mumc.nl

View on ClinicalTrials.gov More Vitamin B 12 Deficiency trials