Decision-making and Food Intake

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (12)

• Habitual food intake [Срок оценки: On three days before the 1st visit]
• Quantification of epigenetic markers related to appetite, menstrual cycle, and stress [Срок оценки: On 1st and 2nd visit (after approximately 30 days)]
• Depressive mood [Срок оценки: On 1st and 2nd visit (after approximately 30 days)]
• Body image [Срок оценки: On 1st and 2nd visit (after approximately 30 days)]
• Trait food cravings [Срок оценки: On 1st and 2nd visit (after approximately 30 days)]
• Dietary patterns [Срок оценки: Day 2 (after approximately 30 days after day 1 i.e., 1st visit)]
• Intuitive eating [Срок оценки: On 1st and 2nd visit (after approximately 30 days)]
• Food insecurity status [Срок оценки: On 1st and 2nd visit (after approximately 30 days)]
• Restrained eating [Срок оценки: Day 1 (1st visit out of 2)]
• Eating motives [Срок оценки: Day 1 (1st visit out of 2)]
• Family climate [Срок оценки: Day 1 (1st visit out of 2)]
• Attachment styles [Срок оценки: Day 1 (1st visit out of 2)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Фундаментальное исследование

Центры проведения

Германия · 1 центр

• German Institute of Human Nutrition Potsdam-Rehbruecke — Nuthetal

Публикации

• 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

Идентификаторы

NCT: NCT07133529 · Buffet

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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