Decision-making and Food Intake
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorGerman Institute of Human Nutrition
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Perceived food uncertainty
BehavioralParticipants remain unaware of both the scheduled time and the length of the next meal.
Perceived food certainty
BehavioralParticipants are aware of both the scheduled time and the length of the next meal.
Treatment groups
45 Participants
are divided into 2 treatment groupsGroup A: Perceived food uncertaintyExperimental treatment 1 intervention
Group B: Perceived food certaintyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
On 1st and 2nd visit (after approximately 30 days)2
Food-specific inhibitory control
Food-specific inhibitory control measured by a go/no-go task adapted from Teslovich et al., 2014.
Time frame
On 1st and 2nd visit (after approximately 30 days)3
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.
Time frame
On 1st and 2nd visit (after approximately 30 days)4
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.
Time frame
On 1st and 2nd visit (after approximately 30 days)Secondary outcomes
1
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.
Time frame
On three days before the 1st visit2
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.
Time frame
On 1st and 2nd visit (after approximately 30 days)3
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.
Time frame
On 1st and 2nd visit (after approximately 30 days)4
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.
Time frame
On 1st and 2nd visit (after approximately 30 days)Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
German Institute of Human Nutrition Potsdam-RehbrueckeRecruiting14558, Nuthetal, Brandenburg
Germany
GermanySponsors and contacts
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Source ClinicalTrials.gov