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

NCT06046703 | Not Yet Recruiting

• 1 other identifier: NL84796.068.23
• Study Type: observational
• Target: 256
• Locations: 0 countries
• Sites: N/A

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. 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.

Conditions

Vitamin B 12 Deficiency; Pregnancy; Nutrient Deficiency; Dietary Exposure

Keywords

vegan diet; pregnancy; vitamin b12; omnivorous; nutrition

Outcome Measures

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.

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

Secondary Outcomes (6)

• Nutritional intake

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

• Plasma vitamin B12

  Participants will time the blood draw within 2 weeks after filling out the food diary between 27 en 30 weeks of pregnancy

• Plasma vitamin D

  Participants will time the blood draw within 2 weeks after filling out the food diary between 27 en 30 weeks of pregnancy

• Plasma ferritin

  Participants will time the blood draw within 2 weeks after filling out the food diary between 27 en 30 weeks of pregnancy

• Plasma hemoglobin

  Participants will time the blood draw within 2 weeks after filling out the food diary between 27 en 30 weeks of pregnancy

Study Arms (2)

Vegan

Pregnant women with a strict plant-based diet

Other: Daily nutritional intake

Omnivorous

Pregnant women with an omnivorous diet.

Other: Daily nutritional intake

Interventions

Daily nutritional intake OTHER

Nutritional intake with a focus on vitamin B12, but also other micronutrients and macronutrients

Omnivorous; Vegan

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women from the Netherlands

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

MeSH Terms

Conditions

Vitamin B 12 Deficiency

Condition Hierarchy (Ancestors)

Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Liesbeth Scheepers, Dr.

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deidre Meulenbroeks, Dr.

CONTACT

0031433874768; voedingzwangerschap@mumc.nl

Liesbeth Scheepers, Dr.

CONTACT

0031433874768; hcj.scheepers@mumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 21, 2023
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 13, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share