Decision-making and Food Intake

Official title

Decision-making and Food Intake ("Buffet Study")

Overview

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.

Interventions

• Behavioral Perceived food uncertainty
  Participants remain unaware of both the scheduled time and the length of the next meal.
• Behavioral Perceived food certainty
  Participants are aware of both the scheduled time and the length of the next meal.

Primary outcome measures

• Laboratory food intake [Time frame: On 1st and 2nd visit (after approximately 30 days)]
• Food-specific inhibitory control [Time frame: On 1st and 2nd visit (after approximately 30 days)]
• Risk propensity on a decision-making task [Time frame: On 1st and 2nd visit (after approximately 30 days)]
• Delay Discounting behavior in a computerized task [Time frame: On 1st and 2nd visit (after approximately 30 days)]
• Range adaptation in reinforcement learning [Time frame: On 1st and 2nd visit (after approximately 30 days)]
• Behavioral economic paradigm [Time frame: On 1st and 2nd visit (after approximately 30 days)]
• Heart rate [Time frame: On 1st and 2nd visit (after approximately 30 days)]
• Heart-rate variability [Time frame: On 1st and 2nd visit (after approximately 30 days)]
• Electrodermal activity [Time frame: On 1st and 2nd visit (after approximately 30 days)]
• Subjective stress levels [Time frame: On 1st and 2nd visit (after approximately 30 days)]

Secondary outcome measures (12)

• 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)]

Eligibility criteria

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:

• 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
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Basic science

Study locations

Germany · 1 center

• German Institute of Human Nutrition Potsdam-Rehbruecke — Nuthetal

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. PMID 20840739
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07133529 · Buffet

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗