How expected meal availability changes eating and decision-making in young women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In a within-subjects randomized crossover design, healthy, nulliparous women attend two afternoon sessions after an overnight fast: one where meal timing and duration are fully disclosed (certain) and one where that information is withheld (uncertain). During each visit participants complete cognitive and behavioral tests, provide venous blood samples at six fixed intervals to measure ghrelin, leptin, insulin, glucose, and cortisol, and are invited to sample ad libitum from a 30-item buffet under the assigned instructions. Participants also log all food intake in a smartphone app for three days before the first session to capture real-world eating patterns. The design compares hormonal, cognitive, mood, interoceptive, and consumption outcomes between the certainty and uncertainty conditions within the same individuals.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Nulliparous women (age: 18-35 years) with a regular menstrual cycle (25-32 days)
* 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

Exclusion Criteria:

* Current or use of hormonal contraceptives in the previous 6 months
* Current use of hormonal intra-uterine devices (IUDs)
* Previous or current pregnancy
* Diagnosed psychological or metabolic disorder
* Former or current illnesses of:

  1. Brain or mind (including anxiety disorders, depression, eating disorders, personality disorders, alcohol, drugs or drug or non-substance dependence, neurological disorders other than occasional headache, psychiatric or neurological abnomalities)
  2. Heart or blood circulation/cardiovascular disease (myocardial infarction, stroke, hypertension, hypotension, having a pacemaker)
  3. Gastro-intestinal disorders (e.g. colon diseases, irritable bowel syndrome, Crohn's disease)
  4. Endocrine disorders (e.g. thyroid disorders)
  5. Other serious past or present medical conditions (for example, metabolic syndrome, diabetes)
* Other serious health problems or current severe mental or physical stress.
* Blood clotting disorder
* Fear of drawing blood
* Severe anemia
* Previously diagnosed hypoglycemia episodes
* Regular intake of medication (e.g. Antidepressant/anti-anxiety medication)
* Blood donation within 4 weeks before the study appointment
* Intake of anticoagulant medications
* illegal drug consumption
* smoking or nicotine consumption
* extreme athletes
* vegetarians or vegans or any other dietary restrictions due to allergies or intolerances
* shift workers

Where it's running

• German Institute of Human Nutrition Potsdam-Rehbruecke
  Nuthetal, Brandenburg, Germany Recruiting

Study contacts

• Principal investigator: Soyoung Q Park, Prof. Dr. — German Institute of Human Nutrition Potsdam-Rehbruecke
• Study coordinator: Renée Sophie Cuntz, MSc
• Email: Renee.Cuntz@dife.de
• Phone: +49 33 200 88 2519

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.