Time-restricted Eating and Cognition (ChronoBEAT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Behaviour: risk propensity on a decision-making task
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •right-handed
- •legally competent
- •physically and mentally healthy
- •BMI: 19-35 kg/m²
- •fluent in reading and speaking German
排除标准
- •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
结局指标
主要结局
Behaviour: risk propensity on a decision-making task
时间窗: 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
时间窗: 8 weeks
Self-reported food intake, recorded via FoodApp or handwritten food diary
Brain: blood-oxygen-level-dependent (BOLD) signal changes
时间窗: 8 weeks
BOLD signal changes on a whole-brain level and in predefined regions of interest assessed using fMRI
Fasting glucose
时间窗: 8 weeks
Blood samples
Insulin
时间窗: 8 weeks
Blood samples
Large Neutral Amino Acids (LNAAs)
时间窗: 8 weeks
Blood samples
次要结局
- 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)
- 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)
- Decision-making(8 weeks)
研究者
Prof. Dr. Soyoung Q Park
Prof. Dr. Soyoung Q Park (Principal Investigator)
German Institute of Human Nutrition