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Search / Trial NCT06095232

Pilot Study to Investigate Dietary Changes During Pregnancy

Launched by GERMAN INSTITUTE OF HUMAN NUTRITION · Oct 18, 2023

Trial Information

Current as of August 22, 2025

Recruiting

Keywords

Pregnancy Menstrual Cycle Nutrition Cognition

ClinConnect Summary

This clinical trial is studying how dietary choices during pregnancy and the natural changes in hormones can affect women's cognitive performance and gut health. The researchers will look at both pregnant women and those who are not pregnant but have regular menstrual cycles. They want to understand how diet, mood, and sleep relate to brain function and the variety of bacteria in the gut.

To participate, women aged 18 to 35 who are either pregnant with their first child or not planning to get pregnant within the next year may be eligible. They should have a healthy weight, be in good physical and mental health, and speak German fluently. Participants will complete online tasks, answer questionnaires about their diet and well-being, keep a food diary for three days, and provide a stool sample to analyze gut bacteria. This is a great opportunity for women to contribute to important research while learning more about their health during pregnancy.

Gender

FEMALE

Eligibility 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).

About German Institute Of Human Nutrition

The German Institute of Human Nutrition (DIfE) is a renowned research institution dedicated to advancing the understanding of nutrition and its impact on human health. Located in Potsdam-Rehbrücke, DIfE conducts interdisciplinary research that integrates molecular biology, nutrition science, and public health to address pressing dietary challenges and promote optimal health outcomes. As a clinical trial sponsor, DIfE is committed to rigorous scientific methodologies and ethical standards, facilitating innovative studies that explore the relationships between diet, metabolism, and disease prevention. Through its collaborative efforts with academic and industry partners, DIfE aims to translate research findings into practical dietary guidelines and interventions that improve public health.

Locations

Nuthetal, Brandenburg, Germany

Patients applied

0 patients applied

Trial Officials

Soyoung Q Park, Prof. Dr.

Principal Investigator

German Institute of Human Nutrition

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported