Time-restricted Eating and Cognition
NCT Number: NCT06508255
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Time Restricted Eating|Intermittent Fasting
Interventions: BEHAVIORAL: Early Time-Restricted Eating|BEHAVIORAL: Late Time-Restricted Eating
Sponsor: German Institute of Human Nutrition
Collaborators: Prof. Dr. Olga Ramich (German Institute of Human Nutrition)|Freie Universität Berlin|German Center for Diabetes Research|Charite University, Berlin, Germany
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-05-17
Completion Date: 2025-03
Locations: German Institute of Human Nutrition (DIfE), Nuthetal, Germany

Summary:
This study aims to investigate how time-restricted eating (TRE), more specifically TRE at different times (early vs late in the day), influences brain activity, behavior, decision-making, food intake, physical activity, the gut microbiome and metabolic processes. The study intervention procedure is a replication of that described in Peters et al. (2021).

Primary Outcome Measures: Behaviour: risk propensity on a decision-making task, The choice (accept/reject) between a risk/gamble or safe option, based on a task paradigm by Liu et al. (2021), 8 weeks|Brain: blood-oxygen-level-dependent (BOLD) signal changes, BOLD signal changes on a whole-brain level and in predefined regions of interest assessed using fMRI, 8 weeks|Behaviour: Daily food intake, Self-reported food intake, recorded via FoodApp or handwritten food diary, 8 weeks|Large Neutral Amino Acids (LNAAs), Blood samples, 8 weeks|Fasting glucose, Blood samples, 8 weeks|Insulin, Blood samples, 8 weeks
Secondary Outcome Measures: Questionnaire assessing sleep quality, Assessed by the Pittsburgh Sleep Quality Index (PSQI, Buysse et al. 1991). The questionnaire is scored between 0-21, with a higher value indicating worse sleep quality, 8 weeks|Total Sleep Time (TST), Assessed through an ActiGraph device, 8 weeks|Sleep Efficiency (SE), Assessed through an ActiGraph device, 8 weeks|Wake After Sleep Onset (WASO), Assessed through an ActiGraph device Sleep Onset Latency (SOL), Sleep Fragmentation Index, 8 weeks|Sleep Onset Latency (SOL), Assessed through an ActiGraph device, 8 weeks|Sleep Fragmentation Index, Assessed through an ActiGraph device, 8 weeks|Glucose tolerance, Assessed using an Oral Glucose Tolerance Test (OGTT). 5 blood samples will be carried out (fasted, 30 minutes, 60 minutes 120 minutes, 180 minutes after glucose consumption). Using these 5 values, area under curve (AUC) will be calculated to determine glucose tolerance, 8 weeks|Total movement, 24h activity, assessed using an ActiGraph device, 8 weeks|Moderate to Vigorous Physical Activity (MVPA), 24h activity, assessed using an ActiGraph device, 8 weeks|Non-sedentary Time, 24h activity, assessed using an ActiGraph device, 8 weeks|Step Count, 24h activity, assessed using an ActiGraph device, 8 weeks|Energy Expenditure, 24h activity, assessed using an ActiGraph device, 8 weeks|Daily questions monitoring intervention effects, Daily self-report questions of experience during intervention, level of physical activity, sleep quality, hunger and appetite levels, sleep and physical activity using Visual Analog Scales (VAS with a scale of 1-100, where higher values correspond to stronger e.g. hunger), 8 weeks|Questionnaires assessing chronotype, Munich Chronotype Questionnaire (MCTQ, Roenneberg et al. 2003), Morningness Eveningness Questionnaire (MEQ, Horne et al.1976), 8 weeks|Questionnaire assessing risk-taking behaviour, Domain Specific Risk-Taking (DOSPERT, Johnson et al. 2004), 8 weeks|Questionnaire assessing stress, Perceived Stress Questionnaire (PSQ, Fliege et al. 2001), 8 weeks|Questionnaire assessing intuitive eating, Intuitive Eating Scale (IES-2, Ruzanska et al. 2017), 8 weeks|Questionnaire assessing emotional eating, Salzburg Emotional Eating Questionnaire (SEES, Meule et al. 2018), 8 weeks|Questionnaire assessing food cravings, Food Cravings Questionnaire (FCQ, Meule et al. 2012), 8 weeks|Questionnaire assessing impulsive behaviour, Barratt Impulsivity Scale (BIS, Meule et al. 2011), 8 weeks|Questionnaire assessing momentary impulsive behaviour, Momentary Impulsivity Assessment (Tomko et al., 2014), 8 weeks|Questionnaire assessing behavioural inhibition and activation, Behavioural Inhibition and Activation (BIS/BAS, Strobel et al. 2001), 8 weeks|Questionnaire assessing mood, Positive and Negative Affect Scale (PANAS, Janke et al. 2014), 8 weeks|Questionnaire assessing interoception, Multidimension Assessment of Interoceptive Awareness (MAIA-2, Mehling et al. 2018), 8 weeks|Questionnaire assessing social decision-making, Social Value Orientation (SVO, Murphy et al. 2011), 8 weeks|Questionnaire assessing wellbeing, Warwick Edinburgh Mental Wellbeing Scale (WEMWBS, Lang et al. 2017), 8 weeks|Gut microbiome composition, Collection of stool samples before and after each intervention to assess gut microbiome composition including alpha and beta diversity, 8 weeks|Decision-making, Delay discounting task: the task involves making choices between receiving two hypothetical monetary amounts: an immediate but smaller sum of money or a larger sum of money at a delayed, future point in time. The task paradigm is based on Wan et al. (2023) and Eisenstein et al. (2015)., 8 weeks|Decision-making, Go/no-go task: the task involves responding to specific visual cues (go trial; press button) or inhibiting a response (no-go trial; don't press button) as fast as possible, assessing inhibitory control and impulsiveness, 8 weeks|Cortisol, Blood samples, 8 weeks|Progesterone, Blood samples, 8 weeks|Estradiol, Blood samples, 8 weeks|Ghrelin, Blood samples, 8 weeks