BehaviorBuffetNCT07133529
Decision-making and Food Intake
A study testing Perceived food uncertainty and Perceived food certainty in people with Behavior and Hormones, run by German Institute of Human Nutrition at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- What is being tested?
- Perceived food uncertainty and Perceived food certainty
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- 4 Aug 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 23Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
German Institute of Human Nutrition Potsdam-Rehbruecke
Nuthetal, Brandenburg, 14558
Recruitment officer, +4933200882752, Buffet-studie@dife.de
About this study
Official title: Decision-making and Food Intake ("Buffet Study")
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.
Read the detailed description
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
- Behavior, Hormones, Stress, Cognition, Food Intake
- Being tested
- Perceived food uncertainty, Perceived food certainty
- Keywords
- Decision-making, Food intake, Food uncertainty
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perceived food uncertaintyBehavioural
Participants remain unaware of both the scheduled time and the length of the next meal.
Perceived food certaintyBehavioural
Participants are aware of both the scheduled time and the length of the next meal.
| Study group | Role | What they receive |
|---|---|---|
| Perceived food uncertainty | Experimental | Not described Receives: Behavioral: Perceived food uncertainty |
| Perceived food certainty | Experimental | Not described Receives: Behavioral: Perceived food certainty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: On 1st and 2nd visit (after approximately 30 days)
Glucose levels
Glucose levels will be measured multiple times throughout the visit via blood sampling.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: on 1st and 2nd visit (after approximately 30 days)
Secondary outcomes (13)
Habitual food intake
Self-reported habitual food intake (i.e., all food and drinks consumed) is assessed via an app and/or through additional handwritten food diaries on three consecutive days.
Measured: On three days before the 1st visit
Quantification of epigenetic markers related to appetite, menstrual cycle, and stress
Epigenetic markers associated with appetite regulation, menstrual function, and stress response will be measured in blood samples. Site-specific epigenetic modifications (e.g., DNA methylation or histone modifications) will be quantified using validated molecular assays.
Measured: On 1st and 2nd visit (after approximately 30 days)
Depressive mood
Depressive mood is assessed using the German version of the Beck Depression Inventory (BDI; Kühner et al., 2007). The questionnaire measures the severity of depressive symptoms experienced over the past two weeks. Higher total scores indicate more pronounced depressive symptomatology.
Measured: On 1st and 2nd visit (after approximately 30 days)
Body image
Body image is assessed using the Body Shape Questionnaire (BSQ; Pook et al., 2008), which measures concerns related to body shape commonly associated with eating disorders. Participants rate how frequently they experience body-related thoughts and feelings. Higher scores indicate greater body shape concern.
Measured: On 1st and 2nd visit (after approximately 30 days)
Trait food cravings
Food cravings are measured using the trait version of the Food Cravings Questionnaire (FCQ-T; Meule et al., 2012). Responses are given on a six-point scale from "never/not applicable" to "always," with higher scores indicating more frequent and intense cravings.
Measured: On 1st and 2nd visit (after approximately 30 days)
Dietary patterns
Dietary patterns are assessed using a food frequency questionnaire (Haftenberger et al., 2018), which captures the frequency and quantity of consumption across various foods and food groups over the past month. Participants indicate how often they consumed specific items and in which quantity, allowing for an overview of habitual dietary intake and eating patterns.
Measured: Day 2 (after approximately 30 days after day 1 i.e., 1st visit)
Intuitive eating
Intuitive eating is assessed using the Intuitive Eating Scale-2 (van Dyck et al., 2019), which evaluates individuals' tendency to rely on physical hunger and satiety cues to guide decisions about when, what, and how much to eat. Participants respond on a five-point scale ranging from "strongly disagree" to "strongly agree." Higher scores reflect a greater inclination toward intuitive eating behaviors.
Measured: On 1st and 2nd visit (after approximately 30 days)
Food insecurity status
Food insecurity status is assessed using the Food Insecurity Experience Scale (FIES; Depa et al., 2018), which evaluates individuals' access to food by addressing factors such as financial constraints, availability, and dietary quality. Response options include "yes," "no," "refused," and "don't know." Higher scores reflect greater severity of food insecurity.
Measured: On 1st and 2nd visit (after approximately 30 days)
Restrained eating
Restrained eating is assessed using the "Cognitive Restraint of Eating" subscale from the Three-Factor Eating Questionnaire (TFEQ; Pudel \& Westenhöfer, 1989). The subscale includes both true/false items and statements rated on a four-point Likert scale ranging from 1 ("always") to 4 ("never"). Higher total scores indicate greater cognitive restraint in eating behavior.
Measured: Day 1 (1st visit out of 2)
Eating motives
Eating motives will be assessed using the Eating Motives Survey (TEMS; Renner et al., 2012). Items are rated on a 7-point Likert scale, ranging from "never" to "always". Higher scores on TEMS subscales indicate a greater reliance on those eating motives when making food or eating choices.
Measured: Day 1 (1st visit out of 2)
Family climate
Family climate is measured using the Familien Klima Skale (FKS; Roth, 2003). Items are rated on a 5-point Likert scale ranging from 1) "does not apply at all," 2) "applies little," 3) "applies moderately," 4) "applies predominantly," to 5) "applies almost completely." Higher total scores indicate a better family climate.
Measured: Day 1 (1st visit out of 2)
Attachment styles
Attachment styles will be assessed using the Adult Attachment Scale (AAS; Schmidt et al., 2004). Items are rated on a five-point Likert scale ranging from "not at all true" to "exactly true." Higher scores on each subscale indicate a stronger endorsement of the corresponding attachment dimension. The subscales/attachment styles assessed are secure, avidant, anxious.
Measured: Day 1 (1st visit out of 2)
Gut Microbiome
To assess the relationship between the gut microbiome and participants' food intake during the ad libitum meal, fecal samples will be collected prior to the first visit, during the observational phase in which participants record their habitual dietary intake.
Measured: 1 to three days before the 1st visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start4 Aug 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Institute of Human Nutrition
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Soyoung Q Park, German Institute of Human Nutrition
- Investigators
- Soyoung Q Park, Prof. Dr., Principal investigator, German Institute of Human Nutrition Potsdam-Rehbruecke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133529
- Sponsor's protocol ID
- Buffet
- Acronym
- Buffet
- Status last verified
- Aug 2025
- First submitted
- 29 Jul 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 20840739Langenbach 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.
PubMed 31554883Teslovich 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.
PubMed 24909971Schmidt 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.
PubMed 15343479Renner 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.
PubMed 22521515Depa 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.
PubMed 29527460Meule 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.
PubMed 21983051Pook 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.
PubMed 18037499Kuhner 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.
PubMed 16832698Eggart 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.
PubMed 34170963Schneider 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.
PubMed 32550857Meule 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.
PubMed 28986162Gueguen 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.
PubMed 38101503Liu 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.
PubMed 33722669Eisenstein 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.
PubMed 26192187
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision-making and Food Intake ("Buffet Study")
- ClinicalTrials.gov ID
- NCT07133529
- Acronym / sponsor ID
- Buffet / Buffet
- Conditions
- Behavior, Hormones, Stress, Cognition, Food Intake
- Keywords
- Decision-making, Food intake, Food uncertainty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- German Institute of Human NutritionUniversity, hospital or other
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 21 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perceived food uncertainty | Experimental | Behavioral: Perceived food uncertainty |
| Perceived food certainty | Experimental | Behavioral: Perceived food certainty |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (23 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perceived food uncertaintyParticipants remain unaware of both the scheduled time and the length of the next meal. | Behavioural | Perceived food uncertainty |
| Perceived food certaintyParticipants are aware of both the scheduled time and the length of the next meal. | Behavioural | Perceived food certainty |
Primary outcome
Laboratory food intake
Time frame: On 1st and 2nd visit (after approximately 30 days)
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.
Food-specific inhibitory control
Time frame: On 1st and 2nd visit (after approximately 30 days)
Food-specific inhibitory control measured by a go/no-go task adapted from Teslovich et al., 2014.
Risk propensity on a decision-making task
Time frame: On 1st and 2nd visit (after approximately 30 days)
In this task, participants decide between a risky/gamble or safe option, based on a paradigm by Liu et al., 2021.
Delay Discounting behavior in a computerized task
Time frame: On 1st and 2nd visit (after approximately 30 days)
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.
Range adaptation in reinforcement learning
Time frame: On 1st and 2nd visit (after approximately 30 days)
Range adaptation in the context of a reinforcement learning task is assessed using a paradigm described by Gueguen et al., 2024.
Behavioral economic paradigm
Time frame: On 1st and 2nd visit (after approximately 30 days)
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.
Heart rate
Time frame: On 1st and 2nd visit (after approximately 30 days)
Resting-state and task-based heart rate, measured with a three-point electrocardiogram (ECG)
Heart-rate variability
Time frame: On 1st and 2nd visit (after approximately 30 days)
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.
Electrodermal activity
Time frame: On 1st and 2nd visit (after approximately 30 days)
Resting-state and task-based skin conductance measured with two electrodermal activity electrodes placed on the fingers of the non-dominant hand.
Subjective stress levels
Time frame: On 1st and 2nd visit (after approximately 30 days)
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.
Subjective hunger levels
Time frame: On 1st and 2nd visit (after approximately 30 days)
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.
Subjective fullness levels
Time frame: On 1st and 2nd visit (after approximately 30 days)
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.
Subjective satiety levels
Time frame: On 1st and 2nd visit (after approximately 30 days)
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.
Subjective food cravings
Time frame: On 1st and 2nd visit (after approximately 30 days)
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.
Levels of diverse hormones
Time frame: On 1st and 2nd visit (approximately 30 days later)
Levels of different hormones (e.g., estradiol, progesteron, testosterone, ghrelin, leptin) will be measured via blood sampling.
Levels of cortisol
Time frame: On 1st and 2nd visit (approximately 30 day later)
Cortosol levels will be assessed multiple times throughout the visit as an objective measure of stress.
Insulin levels
Time frame: On 1st and 2nd visit (after approximately 30 days)
Levels of insulin will be measured multiple times throughout the visit via blood sampling.
Glucose levels
Time frame: On 1st and 2nd visit (after approximately 30 days)
Glucose levels will be measured multiple times throughout the visit via blood sampling.
Stress eating
Time frame: On 1st and 2nd visit (after approximately 30 days)
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.
Reward-related behavioral activation and inhibition
Time frame: On 1st and 2nd visit (after approximately 30 days)
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.
Impulsivity
Time frame: On 1st and 2nd visit (after approximately 30 days)
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.
Mood
Time frame: On 1st and 2nd visit (after approximately 30 days)
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.
Emotion regulation
Time frame: On 1st and 2nd visit (after approximately 30 days)
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.
Perceived stress
Time frame: On 1st and 2nd visit (after approximately 30 days)
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.
State anxiety
Time frame: On 1st and 2nd visit (after approximately 30 days)
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.
Interoceptive awareness
Time frame: On 1st and 2nd visit (after approximately 30 days)
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.
Loss of control over eating
Time frame: on 1st and 2nd visit (after approximately 30 days)
Participants will rate their subjective loss of control over eating during the ad lib buffet task. Higher values indicate greater loss of control.
13 secondary outcomes
Habitual food intake
Time frame: On three days before the 1st visit
Quantification of epigenetic markers related to appetite, menstrual cycle, and stress
Time frame: On 1st and 2nd visit (after approximately 30 days)
Depressive mood
Time frame: On 1st and 2nd visit (after approximately 30 days)
Body image
Time frame: On 1st and 2nd visit (after approximately 30 days)
Trait food cravings
Time frame: On 1st and 2nd visit (after approximately 30 days)
Dietary patterns
Time frame: Day 2 (after approximately 30 days after day 1 i.e., 1st visit)
Intuitive eating
Time frame: On 1st and 2nd visit (after approximately 30 days)
Food insecurity status
Time frame: On 1st and 2nd visit (after approximately 30 days)
Restrained eating
Time frame: Day 1 (1st visit out of 2)
Eating motives
Time frame: Day 1 (1st visit out of 2)
Family climate
Time frame: Day 1 (1st visit out of 2)
Attachment styles
Time frame: Day 1 (1st visit out of 2)
Gut Microbiome
Time frame: 1 to three days before the 1st visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Background: PubMed 20840739Haftenberger 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.
- Background: PubMed 31554883Langenbach 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.
- Background: PubMed 24909971Teslovich 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.
- Background: PubMed 15343479Schmidt 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.
- Background: PubMed 22521515Renner 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.
- Background: PubMed 29527460Depa 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.
- Background: PubMed 21983051Meule 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.
- Background: PubMed 18037499Pook 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.
- Background: PubMed 16832698Kuhner 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.
- Background: PubMed 34170963Eggart 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.
- Background: PubMed 32550857Schneider 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.
- Background: PubMed 28986162Meule 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.
- 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.Link provided by the sponsor.
- Janke, S., \& Glöckner-Rist, A. (2012). Deutsche Version der Positive and Negative Affect Schedule (PANAS). Zusammenstellung sozialwissenschaftlicher Items und Skalen (ZIS).Link provided by the sponsor.
- Grimm, Jürgen (Hg.) (2009): State-Trait-Anxiety Inventory nach Spielberger. Deutsche Lang- und Kurzversion.- Methodenforum der Universität Wien. MF-Working Paper 2009/02Link provided by the sponsor.
- 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: ZPILink provided by the sponsor.
- Pudel V., Westenhöfer, J. (1989): Fragebogen zum Essverhalten. F-E-V, Hogrefe, Göttingen.Link provided by the sponsor.
- Roth, M.(2003). Kurzform der Familienklimaskalen für Jugendliche. Zusammenstellung sozialwissenschaftlicher Items und Skalen (ZIS).Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Soyoung Q Park, Prof. Dr. principal investigator
German Institute of Human Nutrition Potsdam-Rehbruecke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perceived food uncertainty and Perceived food certainty in people with Behavior and Hormones, run by German Institute of Human Nutrition at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renée Sophie Cuntz, MSc (+49 33 200 88 2519, Renee.Cuntz@dife.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laboratory food intake (time frame: On 1st and 2nd visit (after approximately 30 days)). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07133529, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.