Diet Quality of Pregnant Women With a Strict Plant-based Diet Versus an Omnivorous Diet
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMaastricht University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Pregnant women from the Netherlands
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Daily nutritional intake
Other interventionNutritional intake with a focus on vitamin B12, but also other micronutrients and macronutrients
Treatment groups
256 Participants
are divided into 2 treatment groupsGroup A: Vegan1 intervention
Group B: Omnivorous1 intervention
Trial outcomes
Primary outcomes
1
Vitamin B12 intake in mcg/day
Participants will fill out a three-day food diary in an app. The vitamin B12 intake will be extracted from this.
Time frame
Participants will fill out the food diary between 27 and 30 weeks of pregnancySecondary outcomes
1
Nutritional intake
Participants will fill out a three-day food diary in an app. The intake of micronutrients and macronutrients will be extracted from this app and displayed as a percentage of the daily recommended nutritional intake.
Time frame
Participants will fill out the food diary between 27 and 30 weeks of pregnancy2
Plasma vitamin B12
Obtaining blood samples from pregnant women for hemoglobin testing is a routine part of clinical practice between 27 and 30 weeks of pregnancy, and not specifically for this study. For study purposes, 10 milliliter (mL) of additional blood will be sampled per participant during this blood withdrawal. Plasma vitamin B12 will be shown in pmol/L.
Time frame
Participants will time the blood draw within 2 weeks after filling out the food diary between 27 en 30 weeks of pregnancy3
Plasma vitamin D
Obtaining blood samples from pregnant women for hemoglobin testing is a routine part of clinical practice between 27 and 30 weeks of pregnancy, and not specifically for this study. For study purposes, 10mL of additional blood will be sampled per participant during this blood withdrawal. Plasma vitamin D will be shown in nmol/L.
Time frame
Participants will time the blood draw within 2 weeks after filling out the food diary between 27 en 30 weeks of pregnancy4
Plasma ferritin
Obtaining blood samples from pregnant women for hemoglobin testing is a routine part of clinical practice between 27 and 30 weeks of pregnancy, and not specifically for this study. For study purposes, 10mL of additional blood will be sampled per participant during this blood withdrawal. Plasma ferritin will be shown in µg/L.
Time frame
Participants will time the blood draw within 2 weeks after filling out the food diary between 27 en 30 weeks of pregnancyLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: