Decision-making and Food Intake

NCT07133529 | Recruiting

• 1 other identifier: Buffet
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Behavior; Hormones; Stress; Cognition; Food Intake

Keywords

Decision-making; Food intake; Food uncertainty

Outcome Measures

Primary Outcomes (27)

• Laboratory food intake

  Food consumed during a laboratory ad libitum buffet task, in which participants are able to order and consume different foods from a menu of their own liking.

  On 1st and 2nd visit (after approximately 30 days)

• Food-specific inhibitory control

  Food-specific inhibitory control measured by a go/no-go task adapted from Teslovich et al., 2014.

  On 1st and 2nd visit (after approximately 30 days)

• Risk propensity on a decision-making task

  In this task, participants decide between a risky/gamble or safe option, based on a paradigm by Liu et al., 2021.

  On 1st and 2nd visit (after approximately 30 days)

• Delay Discounting behavior in a computerized task

  In this task, participants are asked to choose between an immediate and delayed monetary reward, based on a task paradigm by Eisenstein et al., 2015.

  On 1st and 2nd visit (after approximately 30 days)

• Range adaptation in reinforcement learning

  Range adaptation in the context of a reinforcement learning task is assessed using a paradigm described by Gueguen et al., 2024.

  On 1st and 2nd visit (after approximately 30 days)

• Behavioral economic paradigm

  In this task, participants manage a shared resource by deciding how much to extract from a common pool over multiple rounds. Based on their individual extraction, participants receive a monetary reward, which is reduced once the group exceeds a predefined extraction limit. Adapted from Lagenbach et al., 2019.

  On 1st and 2nd visit (after approximately 30 days)

• Heart rate

  Resting-state and task-based heart rate, measured with a three-point electrocardiogram (ECG)

  On 1st and 2nd visit (after approximately 30 days)

• Heart-rate variability

  Resting-state and task-based heart-rate variability measured with a three-point electrocardiogram (ECG). Respiratory activity will also be recorded using a breathing belt to correct for breathing-related artifacts.

  On 1st and 2nd visit (after approximately 30 days)

• Electrodermal activity

  Resting-state and task-based skin conductance measured with two electrodermal activity electrodes placed on the fingers of the non-dominant hand.

  On 1st and 2nd visit (after approximately 30 days)

• Subjective stress levels

  Subjective stress levels are measured on a semi-continous scale from 1 (not at all) to 100 (extremely) repeatedly during each visit to assess stress responses to perceived food availability. Higher scores indicate greater stress.

  On 1st and 2nd visit (after approximately 30 days)

• Subjective hunger levels

  Subjective hunger levels are measured on a semi-continous scale from 1 (not at all) to 100 (extremely) repeatedly during each visit to assess changes in subjective hunger ratings in response to perceived food availability. Higher scores indicate greater hunger.

  On 1st and 2nd visit (after approximately 30 days)

• Subjective fullness levels

  Subjective fullness levels are measured on a semi-continous scale from 1 (not at all) to 100 (extremely) repeatedly during each visit to assess changes in subjective fullness ratings in response to perceived food availability. Higher scores indicate greater fullness.

  On 1st and 2nd visit (after approximately 30 days)

• Subjective satiety levels

  Subjective satiety levels are measured on a semi-continous scale from 1 (not at all) to 100 (extremely) repeatedly during each visit to assess changes in subjective satiety ratings in response to perceived food availability. Higher scores indicate greater satiation.

  On 1st and 2nd visit (after approximately 30 days)

• Subjective food cravings

  Subjective cravings for sweet, salty, and fatty foods are measured on a semi-continous scale from 1 (not at all) to 100 (extremely) repeatedly during each visit to assess changes in subjective food craving ratings in response to perceived food availability. Higher scores indicate stronger food craving.

  On 1st and 2nd visit (after approximately 30 days)

• Levels of diverse hormones

  Levels of different hormones (e.g., estradiol, progesteron, testosterone, ghrelin, leptin) will be measured via blood sampling.

  On 1st and 2nd visit (approximately 30 days later)

• Levels of cortisol

  Cortosol levels will be assessed multiple times throughout the visit as an objective measure of stress.

  On 1st and 2nd visit (approximately 30 day later)

• Insulin levels

  Levels of insulin will be measured multiple times throughout the visit via blood sampling.

  On 1st and 2nd visit (after approximately 30 days)

• Glucose levels

  Glucose levels will be measured multiple times throughout the visit via blood sampling.

  On 1st and 2nd visit (after approximately 30 days)

• Stress eating

  Changes in food intake related to stress is assessed with the Salzburg Stress Eating Scale (SSES; Meule et al., 2018). Higher Scores indicate increased food intake in response to stress, while lower scores indicate reduced food intake when experiencing stress.

  On 1st and 2nd visit (after approximately 30 days)

• Reward-related behavioral activation and inhibition

  Reward-related behavioral activation and inhibition are assessed using the Behavioral Inhibition System/Behavioral Activation System questionnaire (BIS/BAS; Strobel et al., 2001). Participants respond on a four-point Likert scale: "strongly disagree," "disagree," "agree," and "strongly agree." Higher scores on the BIS scale indicate greater behavioral inhibition, while higher scores on the BAS scale reflect stronger behavioral activation.

  On 1st and 2nd visit (after approximately 30 days)

• Impulsivity

  Impulsivity is assessed using the Barratt Impulsiveness Scale (BIS; Meule et al., 2011). Participants respond using a four-point scale: "rarely," "occasionally," "often," and "almost always." Higher scores indicate greater impulsivity.

  On 1st and 2nd visit (after approximately 30 days)

• Mood

  Mood is measured twice during each visit before and after the ad libitum meal using the Positive and Negative Affect Schedule (PANAS; Janke \& Glöckner-Rist, 2014). Participants respond to 20 mood adjectives-10 reflecting positive affect and 10 reflecting negative affect-using a five-point scale: "not at all," "very slightly," "moderately," "quite a bit," and "extremely." Higher scores on the positive affect scale indicate stronger positive mood, while higher scores on the negative affect scale indicate stronger negative mood.

  On 1st and 2nd visit (after approximately 30 days)

• Emotion regulation

  Emotion regulation is assessed using the Emotion Regulation Questionnaire (ERQ; Abler \& Kessler, 2009), which captures individual differences in the use of two distinct strategies to regulate emotions (cognitive reappraisal and expressive suppression). Participants rate their agreement with each item on a seven-point Likert scale, ranging from "strongly disagree" to "strongly agree." Higher scores on each subscale indicate more frequent use of the corresponding regulation strategy.

  On 1st and 2nd visit (after approximately 30 days)

• Perceived stress

  Perceived stress is assessed using the Perceived Stress Scale (PSS-10; Schneider et al., 2020), which aptures the extent to which individuals perceive their lives as unpredictable, uncontrollable, and overwhelming over the past month. Participants respond to general statements using a five-point scale ranging from "never" to "very often." Higher scores indicate greater perceived stress.

  On 1st and 2nd visit (after approximately 30 days)

• State anxiety

  State anxiety is assessed twice during each visit before and after the ad lib meal using the state version of the State-Trait Anxiety Inventory (STAI; Grimm, 2009); which captures the current intensity of anxiety as experienced at the moment of assessment. Response options include "almost never". "a little", "moderately", and "very much". Higher scores indicate higher levels of state anxiety.

  On 1st and 2nd visit (after approximately 30 days)

• Interoceptive awareness

  Interoceptive awareness is assessed using the Multidimensional Assessment of Interoceptive Awareness (MAIA; Eggart et al., 2021). The questionnaire measures various aspects of the awareness of internal bodily sensations. Participants respond to statements using a six-point scale: "never," "very rarely," "rarely," "occasionally," "frequently," and "always." Higher scores reflect greater awareness of bodily sensations.

  On 1st and 2nd visit (after approximately 30 days)

• Loss of control over eating

  Participants will rate their subjective loss of control over eating during the ad lib buffet task. Higher values indicate greater loss of control.

  on 1st and 2nd visit (after approximately 30 days)

Secondary Outcomes (13)

• Habitual food intake

  On three days before the 1st visit

• Quantification of epigenetic markers related to appetite, menstrual cycle, and stress

  On 1st and 2nd visit (after approximately 30 days)

• Depressive mood

  On 1st and 2nd visit (after approximately 30 days)

• Body image

  On 1st and 2nd visit (after approximately 30 days)

• Trait food cravings

  On 1st and 2nd visit (after approximately 30 days)

Study Arms (2)

Perceived food uncertainty

EXPERIMENTAL

Behavioral: Perceived food uncertainty

Perceived food certainty

EXPERIMENTAL

Behavioral: Perceived food certainty

Interventions

Perceived food uncertainty BEHAVIORAL

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

Perceived food uncertainty

Perceived food certainty BEHAVIORAL

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

Perceived food certainty

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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)
• Heart or blood circulation/cardiovascular disease (myocardial infarction, stroke, hypertension, hypotension, having a pacemaker)
• 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)
• Other serious health problems or current severe mental or physical stress.
• Blood clotting disorder
• Fear of drawing blood
• Severe anemia
• Previously diagnosed hypoglycemia episodes

Sponsors & Collaborators

• German Institute of Human Nutrition: lead

Study Sites (1)

German Institute of Human Nutrition Potsdam-Rehbruecke

Nuthetal, Brandenburg, 14558, Germany

RECRUITING

Related Publications (15)

• 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.

  PMID: 20840739 BACKGROUND

• 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.

  PMID: 31554883 BACKGROUND

• 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.

  PMID: 24909971 BACKGROUND

• 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.

  PMID: 15343479 BACKGROUND

• 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.

  PMID: 22521515 BACKGROUND

• 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.

  PMID: 29527460 BACKGROUND

• 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.

  PMID: 21983051 BACKGROUND

• 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.

  PMID: 18037499 BACKGROUND

• 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.

  PMID: 16832698 BACKGROUND

• 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.

  PMID: 34170963 BACKGROUND

• 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.

  PMID: 32550857 BACKGROUND

• 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.

  PMID: 28986162 BACKGROUND

• 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.

  PMID: 38101503 BACKGROUND

• 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.

  PMID: 33722669 BACKGROUND

• 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.

  PMID: 26192187 BACKGROUND

Related Links

• 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.
• Janke, S., \& Glöckner-Rist, A. (2012). Deutsche Version der Positive and Negative Affect Schedule (PANAS). Zusammenstellung sozialwissenschaftlicher Items und Skalen (ZIS).
• Grimm, Jürgen (Hg.) (2009): State-Trait-Anxiety Inventory nach Spielberger. Deutsche Lang- und Kurzversion.- Methodenforum der Universität Wien. MF-Working Paper 2009/02
• 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
• Pudel V., Westenhöfer, J. (1989): Fragebogen zum Essverhalten. F-E-V, Hogrefe, Göttingen.
• Roth, M.(2003). Kurzform der Familienklimaskalen für Jugendliche. Zusammenstellung sozialwissenschaftlicher Items und Skalen (ZIS).

MeSH Terms

Conditions

Behavior

Study Officials

• Soyoung Q Park, Prof. Dr.

  German Institute of Human Nutrition Potsdam-Rehbruecke

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renée Sophie Cuntz, MSc

CONTACT

+49 33 200 88 2519; Renee.Cuntz@dife.de

Elisa Rehbein, Dr.

CONTACT

+49 33 200 88 - 2525; elisa.rehbein@dife.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 21, 2025
• Study Start: August 4, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

DE (1)