Investigating dietary changes during pregnancy
Pilot Study to Investigate Dietary Changes During Pregnancy
This study is trying to see how the changing hormones during pregnancy and the menstrual cycle affect the eating habits and mental well-being of first-time pregnant women and those who aren't pregnant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 156 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | German Institute of Human Nutrition Academic / other |
| Locations | 1 site (Nuthetal, Brandenburg) |
| Trial ID | NCT06095232 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to explore the dietary choices and nutritional composition of pregnant women while examining the influence of fluctuating sex hormones during the menstrual cycle. The study will involve primiparous pregnant women and nulliparous women with regular menstrual cycles, assessing them during different hormonal phases and across various stages of pregnancy. Participants will complete online tasks related to cognitive performance and log their daily food intake, while also filling out questionnaires on mood, sleep, and mental well-being. The study seeks to identify patterns in food intake and cognitive performance throughout pregnancy and the menstrual cycle.
Who should consider this trial
Good fit: Ideal candidates include healthy women aged 18-35 who are either primiparous and pregnant or nulliparous with regular menstrual cycles and no pregnancy intentions.
Not a fit: Patients with current or former mental health issues, cardiovascular diseases, gastrointestinal disorders, or other specified health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how dietary choices during pregnancy affect cognitive performance and gut microbiome diversity.
How similar studies have performed: While there is ongoing research into dietary impacts on pregnancy, this specific approach focusing on cognitive performance and gut microbiome diversity is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: 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).
Where this trial is running
Nuthetal, Brandenburg
- German Institute of Human Nutrition — Nuthetal, Brandenburg, Germany (Recruiting)
Study contacts
- Principal investigator: Soyoung Q Park, Prof. Dr. — German Institute of Human Nutrition
- Study coordinator: Elisa Rehbein, Dr.
- Email: elisa.rehbein@dife.de
- Phone: +4933200882525
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.