Actively Recruiting

Phase Not Applicable
Age: 18Years - 35Years
FEMALE
Healthy Volunteers
ID07133529

Decision-making and Food Intake (Buffet Study)

Led by German Institute of Human Nutrition · Updated on 2025-08-21

45

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how the expectation of food availability affects eating behavior, mood, body awareness, and food consumption in healthy women with natural menstrual cycles. This randomized crossover study focuses on understanding how knowing or not knowing meal timing influences decisions, hormone levels, and stress. Participants attend two afternoon sessions after fasting overnight. In one session, meal timing and duration are clearly shared ("certain" condition), while in the other, this information is withheld ("uncertain" condition). Each visit includes cognitive and behavioral tests followed by a buffet meal where women can eat freely. Blood samples are taken at six specific times to measure hormones like ghrelin, leptin, insulin, glucose, and cortisol. Additionally, participants track their food intake using a smartphone app for three days before the first visit. During the study visits, researchers measure food intake, decision-making skills, mood, stress, body signals, and hormone fluctuations. They also assess heart rate, skin responses, and self-reported hunger, fullness, and cravings. The study monitors behavioral and metabolic responses about 30 days apart, gathering detailed data on eating patterns and emotional states. This comprehensive monitoring helps explore how perceived meal certainty impacts various physical and psychological factors.

CONDITIONS

Brief Title

Decision-making and Food Intake

Who Can Participate

Age: 18Years - 35Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Nulliparous women aged 18 to 35 years with a regular menstrual cycle of 25 to 32 days
  • Legally competent and able to consent to participate
  • Fluent German speaker (native or fluent)
  • Physically and mentally healthy
  • Body mass index (BMI) between 18.5 and 30 kg/m2
Not Eligible

You will not qualify if you...

  • Current or use of hormonal contraceptives in the past 6 months
  • Current use of hormonal intra-uterine devices (IUDs)
  • Previous or current pregnancy
  • Diagnosed psychological or metabolic disorders
  • History or presence of brain or mental illnesses including anxiety, depression, eating or personality disorders, substance dependence, neurological disorders except occasional headache, psychiatric or neurological abnormalities
  • History or presence of heart or cardiovascular diseases including myocardial infarction, stroke, hypertension, hypotension, or having a pacemaker
  • Gastrointestinal disorders such as colon diseases, irritable bowel syndrome, or Crohn's disease
  • Endocrine disorders like thyroid problems
  • Serious past or present medical conditions including metabolic syndrome or diabetes
  • Other serious health problems or severe mental or physical stress
  • Blood clotting disorders
  • Fear of blood draws
  • Severe anemia
  • Previously diagnosed hypoglycemia episodes
  • Regular use of medications such as antidepressants or anti-anxiety drugs
  • Blood donation within 4 weeks before study appointment
  • Use of anticoagulant medications
  • Illegal drug use
  • Smoking or nicotine use
  • Extreme athletes
  • Vegetarian, vegan, or any dietary restrictions due to allergies or intolerances
  • Shift workers

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - 3 days

Participants log all food intake using a smartphone app for three days before the initial session to capture real-world eating patterns.

Self-monitoring using app

Outpatient Treatment

Duration - 2 appointments spaced approximately 30 days apart

Participants attend two afternoon appointments about 30 days apart. During each appointment, they undergo cognitive and behavioral tests, sample food from a buffet under different instructions (either certain or uncertain meal timing and duration), and provide blood samples at six fixed intervals.

2 visits (in-person)

Trial Site Locations

Total: 1 location

1

German Institute of Human Nutrition Potsdam-Rehbruecke

Nuthetal, Brandenburg, Germany, 14558

Actively Recruiting

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Research Team

R

Renée Sophie Cuntz, MSc

E

Elisa Rehbein, Dr.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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Published Research Related To This Trial

Relative validation of a food frequency questionnaire for national health and nutrition monitoring.

Marjolein Haftenberger, Thorsten Heuer, Christin Heidemann...

https://pubmed.ncbi.nlm.nih.gov/20840739

Prevalence of food insecurity among food bank users in Germany and its association with population characteristics.

Julia Depa, Fiona Gyngell, Annalena Müller...

https://pubmed.ncbi.nlm.nih.gov/29527460

Food cravings discriminate differentially between successful and unsuccessful dieters and non-dieters. Validation of the Food Cravings Questionnaires in German.

Adrian Meule, Annika Lutz, Claus Vögele...

https://pubmed.ncbi.nlm.nih.gov/21983051

Validation of the Multidimensional Assessment of Interoceptive Awareness (MAIA-2) questionnaire in hospitalized patients with major depressive disorder.

Michael Eggart, Jennifer Todd, Juan Valdés-Stauber

https://pubmed.ncbi.nlm.nih.gov/34170963