Status:
NOT_YET_RECRUITING
Diet Quality of Pregnant Women With a Strict Plant-based Diet Versus an Omnivorous Diet
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Vitamin B 12 Deficiency
Pregnancy
Eligibility:
FEMALE
18+ years
Brief 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....
Detailed Description
The number of people adhering to a strict plant-based diet is increasing globally. Adequate maternal nutrition during pregnancy is essential for fetal development, as deficiencies in macro- and micron...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT06046703
Start Date
January 1 2025
End Date
July 1 2027
Last Update
March 13 2024
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