Decision-making and Food Intake

NCT ID: NCT07133529

Last Updated: 2025-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-04

Study Completion Date

2026-07-31

Brief Summary

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The study will investigate how the expectation of food availability impacts the response to food cues, mood, interoceptive awareness, and consumption of food intake in healthy, naturally cycling women.

Detailed Description

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In this within-subjects, randomized crossover study, we will probe how perceived meal availability shapes eating behavior, cognition, and metabolic markers in healthy, naturally cycling women. Each woman attends two appointments in the afternoon (starting at 12 pm after an overnight fast): one in which meal timing and duration are fully disclosed ("certain" condition) and one in which that information is intentionally withheld ("uncertain" condition). During each appointment, participants first undergo a set of cognitive and behavioral tests, then are invited to sample ad libitum from a 30-item buffet under the respective certainty or uncertainty instructions. Venous blood is collected at six fixed intervals to measure fluctuations in ghrelin, leptin, insulin, glucose, and cortisol. To capture real-world eating patterns, participants also log all intake in a smartphone food-tracking app for three days leading up to the initial session.

Conditions

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Behavior Hormones Stress Cognition Food Intake

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Perceived food uncertainty

Group Type EXPERIMENTAL

Perceived food uncertainty

Intervention Type BEHAVIORAL

Participants remain unaware of both the scheduled time and the length of the next meal.

Perceived food certainty

Group Type EXPERIMENTAL

Perceived food certainty

Intervention Type BEHAVIORAL

Participants are aware of both the scheduled time and the length of the next meal.

Interventions

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Perceived food uncertainty

Participants remain unaware of both the scheduled time and the length of the next meal.

Intervention Type BEHAVIORAL

Perceived food certainty

Participants are aware of both the scheduled time and the length of the next meal.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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German Institute of Human Nutrition

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Soyoung Q Park

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Soyoung Q Park, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

German Institute of Human Nutrition Potsdam-Rehbruecke

Locations

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German Institute of Human Nutrition Potsdam-Rehbruecke

Nuthetal, Brandenburg, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Renée Sophie Cuntz, MSc

Role: CONTACT

+49 33 200 88 2519

Elisa Rehbein, Dr.

Role: CONTACT

+49 33 200 88 - 2525

Facility Contacts

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Recruitment officer

Role: primary

+4933200882752

References

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Haftenberger M, Heuer T, Heidemann C, Kube F, Krems C, Mensink GB. Relative validation of a food frequency questionnaire for national health and nutrition monitoring. Nutr J. 2010 Sep 14;9:36. doi: 10.1186/1475-2891-9-36.

Reference Type BACKGROUND
PMID: 20840739 (View on PubMed)

Langenbach BP, Baumgartner T, Cazzoli D, Muri RM, Knoch D. Inhibition of the right dlPFC by theta burst stimulation does not alter sustainable decision-making. Sci Rep. 2019 Sep 25;9(1):13852. doi: 10.1038/s41598-019-50322-w.

Reference Type BACKGROUND
PMID: 31554883 (View on PubMed)

Teslovich T, Freidl EK, Kostro K, Weigel J, Davidow JY, Riddle MC, Helion C, Dreyfuss M, Rosenbaum M, Walsh BT, Casey BJ, Mayer L. Probing behavioral responses to food: development of a food-specific go/no-go task. Psychiatry Res. 2014 Sep 30;219(1):166-70. doi: 10.1016/j.psychres.2014.04.053. Epub 2014 May 10.

Reference Type BACKGROUND
PMID: 24909971 (View on PubMed)

Schmidt S, Strauss B, Hoger D, Brahler E. [The Adult Attachment Scale (AAS) - psychometric evaluation and normation of the German version]. Psychother Psychosom Med Psychol. 2004 Sep-Oct;54(9-10):375-82. doi: 10.1055/s-2003-815000. German.

Reference Type BACKGROUND
PMID: 15343479 (View on PubMed)

Renner B, Sproesser G, Strohbach S, Schupp HT. Why we eat what we eat. The Eating Motivation Survey (TEMS). Appetite. 2012 Aug;59(1):117-28. doi: 10.1016/j.appet.2012.04.004. Epub 2012 Apr 19.

Reference Type BACKGROUND
PMID: 22521515 (View on PubMed)

Depa J, Gyngell F, Muller A, Eleraky L, Hilzendegen C, Stroebele-Benschop N. Prevalence of food insecurity among food bank users in Germany and its association with population characteristics. Prev Med Rep. 2018 Jan 28;9:96-101. doi: 10.1016/j.pmedr.2018.01.005. eCollection 2018 Mar.

Reference Type BACKGROUND
PMID: 29527460 (View on PubMed)

Meule A, Lutz A, Vogele C, Kubler A. Food cravings discriminate differentially between successful and unsuccessful dieters and non-dieters. Validation of the Food Cravings Questionnaires in German. Appetite. 2012 Feb;58(1):88-97. doi: 10.1016/j.appet.2011.09.010. Epub 2011 Sep 29.

Reference Type BACKGROUND
PMID: 21983051 (View on PubMed)

Pook M, Tuschen-Caffier B, Brahler E. Evaluation and comparison of different versions of the Body Shape Questionnaire. Psychiatry Res. 2008 Feb 28;158(1):67-73. doi: 10.1016/j.psychres.2006.08.002. Epub 2007 Nov 26.

Reference Type BACKGROUND
PMID: 18037499 (View on PubMed)

Kuhner C, Burger C, Keller F, Hautzinger M. [Reliability and validity of the Revised Beck Depression Inventory (BDI-II). Results from German samples]. Nervenarzt. 2007 Jun;78(6):651-6. doi: 10.1007/s00115-006-2098-7. German.

Reference Type BACKGROUND
PMID: 16832698 (View on PubMed)

Eggart M, Todd J, Valdes-Stauber J. Validation of the Multidimensional Assessment of Interoceptive Awareness (MAIA-2) questionnaire in hospitalized patients with major depressive disorder. PLoS One. 2021 Jun 25;16(6):e0253913. doi: 10.1371/journal.pone.0253913. eCollection 2021.

Reference Type BACKGROUND
PMID: 34170963 (View on PubMed)

Schneider EE, Schonfelder S, Domke-Wolf M, Wessa M. Measuring stress in clinical and nonclinical subjects using a German adaptation of the Perceived Stress Scale. Int J Clin Health Psychol. 2020 May-Aug;20(2):173-181. doi: 10.1016/j.ijchp.2020.03.004. Epub 2020 May 22.

Reference Type BACKGROUND
PMID: 32550857 (View on PubMed)

Meule A, Reichenberger J, Blechert J. Development and preliminary validation of the Salzburg Stress Eating Scale. Appetite. 2018 Jan 1;120:442-448. doi: 10.1016/j.appet.2017.10.003. Epub 2017 Oct 3.

Reference Type BACKGROUND
PMID: 28986162 (View on PubMed)

Gueguen MCM, Anllo H, Bonagura D, Kong J, Hafezi S, Palminteri S, Konova AB. Recent Opioid Use Impedes Range Adaptation in Reinforcement Learning in Human Addiction. Biol Psychiatry. 2024 May 15;95(10):974-984. doi: 10.1016/j.biopsych.2023.12.005. Epub 2023 Dec 13.

Reference Type BACKGROUND
PMID: 38101503 (View on PubMed)

Liu L, Artigas SO, Ulrich A, Tardu J, Mohr PNC, Wilms B, Koletzko B, Schmid SM, Park SQ. Eating to dare - Nutrition impacts human risky decision and related brain function. Neuroimage. 2021 Jun;233:117951. doi: 10.1016/j.neuroimage.2021.117951. Epub 2021 Mar 12.

Reference Type BACKGROUND
PMID: 33722669 (View on PubMed)

Eisenstein SA, Gredysa DM, Antenor-Dorsey JA, Green L, Arbelaez AM, Koller JM, Black KJ, Perlmutter JS, Moerlein SM, Hershey T. Insulin, Central Dopamine D2 Receptors, and Monetary Reward Discounting in Obesity. PLoS One. 2015 Jul 20;10(7):e0133621. doi: 10.1371/journal.pone.0133621. eCollection 2015.

Reference Type BACKGROUND
PMID: 26192187 (View on PubMed)

Related Links

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https://doi.org/10.23668/psycharchives.6497

Abler, B. \& Kessler, H. (2011). ERQ. Emotion Regulation Questionnaire \[Verfahrensdokumentation aus PSYNDEX Tests-Nr. 9006192 und Fragebogen\]. In Leibniz-Zentrum für Psychologische Information und Dokumentation (ZPID) (Hrsg.), Elektronisches Testarchiv.

https://doi.org/10.6102/zis146

Janke, S., \& Glöckner-Rist, A. (2012). Deutsche Version der Positive and Negative Affect Schedule (PANAS). Zusammenstellung sozialwissenschaftlicher Items und Skalen (ZIS).

https://empcom.univie.ac.at/fileadmin/user_upload/p_empcom/pdfs/Grimm2009_StateTraitAngst_MFWorkPaper2009-02.pdf

Grimm, Jürgen (Hg.) (2009): State-Trait-Anxiety Inventory nach Spielberger. Deutsche Lang- und Kurzversion.- Methodenforum der Universität Wien. MF-Working Paper 2009/02

https://doi.org/10.23668/psycharchives.15697

Van Dyck, Z., Herbert, B. M., Happ, C., Kleveman, G. V., \& Vögele, C. (2019). IES-2. Deutsche Version der Intuitive Eating Scale 2 \[Verfahrensdokumentation und Fragebogen\]. In Leibniz-Institut für Psychologie (ZPID) (Hrsg.), Open Test Archive. Trier: ZPI

https://www.testzentrale.de/shop/fragebogen-zum-essverhalten.html

Pudel V., Westenhöfer, J. (1989): Fragebogen zum Essverhalten. F-E-V, Hogrefe, Göttingen.

https://doi.org/10.6102/zis195

Roth, M.(2003). Kurzform der Familienklimaskalen für Jugendliche. Zusammenstellung sozialwissenschaftlicher Items und Skalen (ZIS).

Other Identifiers

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Buffet

Identifier Type: -

Identifier Source: org_study_id

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