Time-restricted Eating and Cognition
- Conditions
- Intermittent FastingTime Restricted Eating
- Registration Number
- NCT06508255
- Lead Sponsor
- German Institute of Human Nutrition
- Brief 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).
- Detailed Description
This study aims to investigate the effects of different time-restricted eating (TRE) interventions on decision-making, brain activity and related processes in an all female cohort over 8 weeks. The study will have a within-subjects, randomised, crossover design, involving two TRE interventions with a comparable feeding and fasting window of 8:16h respectively- early TRE (eating window: 08:00-16:00) and late TRE (eating window: 13:00-21:00). After completing a screening visit, participants will complete a two-week observational phase in which they record their habitual food intake, as well as sleep and physical activity assessment. After this observational phase, participants will be randomly assigned to one of two study arms (early TRE/late TRE or late TRE/early TRE). Here they will complete both TRE interventions for two weeks each, separated by a washout phase of two weeks. During these phases they will record their food intake and physical activity and sleep will be assessed. The participants will be invited for 4 laboratory study visits during this time, at the beginning and end of each TRE intervention.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 35
- right-handed
- legally competent
- physically and mentally healthy
- BMI: 19-35 kg/m²
- fluent in reading and speaking German
- weight change >5% of body weight during the last 3 months
- pregnancy or breastfeeding
- allergies (inclusion possible after consultation with study doctor)
- history of cardiovascular disease (myocardial infarction, stroke, hypertension, hypotension) in the last year
- severe psychiatric condition, including drug addiction and depression
- impaired renal or liver function
- dementia or other severely debilitating cognitive disease
- history of or current eating disorders (e.g., Bulimia nervosa, Anorexia nervosa, Orthorexia nervosa, Binge-Eating disorder)
- chronic diseases (e.g., Morbus Crohn, Colitis Ulcerosa)
- metabolic disorders (e.g., metabolic syndrome, diabetes type 1 or 2)
- hormonal imbalances (e.g., thyroid gland diseases)
- consuming diseases (e.g., cancer, kachexie) in the last 2 years
- surgical removal (partial removal) of the digestive organs (e.g., gastrectomy) or history of bariatric surgery
- Autoimmune conditions or current infection
- Blood clotting disorders (e.g., haemophilia)
- Severe anemia
- severe claustrophobia
- blood donation four weeks prior to study entry
- glucocorticoid therapy (oral)
- anticoagulant medication (inclusion possible if medication can be paused)
- taking medications that require regular eating
- any medications or supplements known to affect sleep, circadian rhythms, immune activity or metabolism
- taking weight loss, lipid or glucose-lowering medications (any medications that affects metabolism) i.e. metformin
- pacemaker or other electrical implant
- vaccination during the study course or in the two weeks' prior
- immunosuppressive premedication
- currently on a diet/fasting regime (or within 1 month)
- professional athletes
- nicotine consumption
- drug abuse
- alcohol consumption per week more than 14 beers (0,3l)/ wine (0,125l)/ sparkling wine (0,1l)/Schnaps (4cl)
- shift work
- poor sleep quality (PSQI score > 10 at medical screening)
- travel across more than one time zone one month before study or during study period
- non-removable metallic implants
- fear of blood draw
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Behaviour: risk propensity on a decision-making task 8 weeks The choice (accept/reject) between a risk/gamble or safe option, based on a task paradigm by Liu et al. (2021)
Behaviour: Daily food intake 8 weeks Self-reported food intake, recorded via FoodApp or handwritten food diary
Brain: blood-oxygen-level-dependent (BOLD) signal changes 8 weeks BOLD signal changes on a whole-brain level and in predefined regions of interest assessed using fMRI
Fasting glucose 8 weeks Blood samples
Insulin 8 weeks Blood samples
Large Neutral Amino Acids (LNAAs) 8 weeks Blood samples
- Secondary Outcome Measures
Name Time Method Sleep Efficiency (SE) 8 weeks Assessed through an ActiGraph device
Wake After Sleep Onset (WASO) 8 weeks Assessed through an ActiGraph device Sleep Onset Latency (SOL), Sleep Fragmentation Index
Sleep Fragmentation Index 8 weeks Assessed through an ActiGraph device
Moderate to Vigorous Physical Activity (MVPA) 8 weeks 24h activity, assessed using an ActiGraph device
Step Count 8 weeks 24h activity, assessed using an ActiGraph device
Questionnaire assessing stress 8 weeks Perceived Stress Questionnaire (PSQ, Fliege et al. 2001)
Progesterone 8 weeks Blood samples
Total Sleep Time (TST) 8 weeks Assessed through an ActiGraph device
Total movement 8 weeks 24h activity, assessed using an ActiGraph device
Non-sedentary Time 8 weeks 24h activity, assessed using an ActiGraph device
Energy Expenditure 8 weeks 24h activity, assessed using an ActiGraph device
Sleep Onset Latency (SOL) 8 weeks Assessed through an ActiGraph device
Questionnaire assessing impulsive behaviour 8 weeks Barratt Impulsivity Scale (BIS, Meule et al. 2011)
Gut microbiome composition 8 weeks Collection of stool samples before and after each intervention to assess gut microbiome composition including alpha and beta diversity
Cortisol 8 weeks Blood samples
Estradiol 8 weeks Blood samples
Questionnaire assessing sleep quality 8 weeks 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
Glucose tolerance 8 weeks 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
Questionnaire assessing risk-taking behaviour 8 weeks Domain Specific Risk-Taking (DOSPERT, Johnson et al. 2004)
Questionnaire assessing momentary impulsive behaviour 8 weeks Momentary Impulsivity Assessment (Tomko et al., 2014)
Questionnaire assessing behavioural inhibition and activation 8 weeks Behavioural Inhibition and Activation (BIS/BAS, Strobel et al. 2001)
Ghrelin 8 weeks Blood samples
Questionnaires assessing chronotype 8 weeks Munich Chronotype Questionnaire (MCTQ, Roenneberg et al. 2003), Morningness Eveningness Questionnaire (MEQ, Horne et al.1976)
Questionnaire assessing emotional eating 8 weeks Salzburg Emotional Eating Questionnaire (SEES, Meule et al. 2018)
Questionnaire assessing social decision-making 8 weeks Social Value Orientation (SVO, Murphy et al. 2011)
Questionnaire assessing wellbeing 8 weeks Warwick Edinburgh Mental Wellbeing Scale (WEMWBS, Lang et al. 2017)
Decision-making 8 weeks 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
Daily questions monitoring intervention effects 8 weeks 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)
Questionnaire assessing intuitive eating 8 weeks Intuitive Eating Scale (IES-2, Ruzanska et al. 2017)
Questionnaire assessing food cravings 8 weeks Food Cravings Questionnaire (FCQ, Meule et al. 2012)
Questionnaire assessing mood 8 weeks Positive and Negative Affect Scale (PANAS, Janke et al. 2014)
Questionnaire assessing interoception 8 weeks Multidimension Assessment of Interoceptive Awareness (MAIA-2, Mehling et al. 2018)
Trial Locations
- Locations (1)
German Institute of Human Nutrition (DIfE)
🇩🇪Nuthetal, Germany
German Institute of Human Nutrition (DIfE)🇩🇪Nuthetal, GermanyBianca WeigelContactDNN-Studie@dife.de