Status:
UNKNOWN
Pilot Study to Investigate Dietary Changes During Pregnancy
Lead Sponsor:
German Institute of Human Nutrition
Conditions:
Pregnancy Related
Eligibility:
FEMALE
18-35 years
Brief Summary
The aim of this pilot study is to investigate dietary choices and composition during pregnancy and fluctuating sex hormones during the natural menstrual cycle in women. In particular, the investigator...
Detailed Description
Before the beginning of the study, participants will undergo a screening process related to inclusion and exclusion criteria. Upon successful study inclusion the procedure for each study session and b...
Eligibility Criteria
Inclusion
- 18-35 year old healthy women
- Primiparous pregnant women experiencing a singleton pregnancy or nulliparous women who have no pregnancy intention within the next year with a regular menstrual cycle (25-35 days) and no use of hormonal contraceptives in the previous 6 months
- Legally competent/Consent to participate
- Language proficiency in German (native speaker, fluent)
- Physically and mentally healthy
- Body mass index (BMI) of 18.5 - 30 kg/m2 (pre-pregnancy)
Exclusion
- Former or current illnesses of:
- Brain or mind (including anxiety disorders, depression, eating disorders, personality disorders, alcohol, drugs or drug dependence, neurological disorders other than occasional headache, psychiatric or neurological abnormalities)
- Heart or blood circulation/cardiovascular disease (myocardial infarction, stroke, hypertension, hypotension)
- Gastro-intestinal disorders (e.g. colon diseases, irritable bowel syndrome, Crohn's disease)
- endocrine disorders (e.g. thyroid disorders)
- Other serious past or present medical conditions (for example, metabolic syndrome, diabetes).
Key Trial Info
Start Date :
August 19 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT06095232
Start Date
August 19 2023
End Date
August 1 2025
Last Update
October 23 2023
Active Locations (1)
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1
German Institute of Human Nutrition
Nuthetal, Brandenburg, Germany, 14558