Time-restricted Eating and Cognition (ChronoBEAT)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Time Restricted Eating
- Sponsor
- German Institute of Human Nutrition
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Behaviour: risk propensity on a decision-making task
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Prof. Dr. Soyoung Q Park
Prof. Dr. Soyoung Q Park (Principal Investigator)
German Institute of Human Nutrition
Eligibility Criteria
Inclusion Criteria
- •right-handed
- •legally competent
- •physically and mentally healthy
- •BMI: 19-35 kg/m²
- •fluent in reading and speaking German
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Behaviour: risk propensity on a decision-making task
Time Frame: 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
Time Frame: 8 weeks
Self-reported food intake, recorded via FoodApp or handwritten food diary
Brain: blood-oxygen-level-dependent (BOLD) signal changes
Time Frame: 8 weeks
BOLD signal changes on a whole-brain level and in predefined regions of interest assessed using fMRI
Fasting glucose
Time Frame: 8 weeks
Blood samples
Insulin
Time Frame: 8 weeks
Blood samples
Large Neutral Amino Acids (LNAAs)
Time Frame: 8 weeks
Blood samples
Secondary Outcomes
- Sleep Efficiency (SE)(8 weeks)
- Wake After Sleep Onset (WASO)(8 weeks)
- Sleep Fragmentation Index(8 weeks)
- Moderate to Vigorous Physical Activity (MVPA)(8 weeks)
- Step Count(8 weeks)
- Questionnaire assessing stress(8 weeks)
- Progesterone(8 weeks)
- Total Sleep Time (TST)(8 weeks)
- Total movement(8 weeks)
- Non-sedentary Time(8 weeks)
- Energy Expenditure(8 weeks)
- Sleep Onset Latency (SOL)(8 weeks)
- Questionnaire assessing impulsive behaviour(8 weeks)
- Gut microbiome composition(8 weeks)
- Cortisol(8 weeks)
- Estradiol(8 weeks)
- Questionnaire assessing sleep quality(8 weeks)
- Glucose tolerance(8 weeks)
- Questionnaire assessing risk-taking behaviour(8 weeks)
- Questionnaire assessing momentary impulsive behaviour(8 weeks)
- Questionnaire assessing behavioural inhibition and activation(8 weeks)
- Ghrelin(8 weeks)
- Questionnaires assessing chronotype(8 weeks)
- Questionnaire assessing emotional eating(8 weeks)
- Questionnaire assessing social decision-making(8 weeks)
- Questionnaire assessing wellbeing(8 weeks)
- Decision-making(8 weeks)
- Daily questions monitoring intervention effects(8 weeks)
- Questionnaire assessing intuitive eating(8 weeks)
- Questionnaire assessing food cravings(8 weeks)
- Questionnaire assessing mood(8 weeks)
- Questionnaire assessing interoception(8 weeks)