Intermittent Fasting, Time Restricted Eating
Conditions
Keywords
Time-restricted eating, Time-restricted feeding, Cognition, Decision-making, Behaviour, Brain Activity, Food Intake, Diet, Microbiome, Sleep, Physical Activity
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.
Interventions
BEHAVIORALEarly Time-Restricted Eating
Eat between 8:00 and 16:00 for 2 weeks
BEHAVIORALLate Time-Restricted Eating
Eat between 13:00 and 21:00 for 2 weeks
Sponsors
Prof. Dr. Olga Ramich (German Institute of Human Nutrition)
Freie Universität Berlin
German Center for Diabetes Research
Charite University, Berlin, Germany
German Institute of Human Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
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) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| Behaviour: Daily food intake | 8 weeks | Self-reported food intake, recorded via FoodApp or handwritten food diary |
| Large Neutral Amino Acids (LNAAs) | 8 weeks | Blood samples |
| Fasting glucose | 8 weeks | Blood samples |
| Insulin | 8 weeks | Blood samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| Gut microbiome composition | 8 weeks | Collection of stool samples before and after each intervention to assess gut microbiome composition including alpha and beta diversity |
| Decision-making | 8 weeks | 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). |
| Cortisol | 8 weeks | Blood samples |
| Progesterone | 8 weeks | Blood samples |
| Estradiol | 8 weeks | Blood samples |
| Ghrelin | 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 |
| Total Sleep Time (TST) | 8 weeks | Assessed through an ActiGraph device |
| Sleep Efficiency (SE) | 8 weeks | Assessed through an ActiGraph device |
| Questionnaire assessing intuitive eating | 8 weeks | Intuitive Eating Scale (IES-2, Ruzanska et al. 2017) |
| Sleep Onset Latency (SOL) | 8 weeks | Assessed through an ActiGraph device |
| Sleep Fragmentation Index | 8 weeks | Assessed through an ActiGraph device |
| 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 |
| Total movement | 8 weeks | 24h activity, assessed using an ActiGraph device |
| Moderate to Vigorous Physical Activity (MVPA) | 8 weeks | 24h activity, assessed using an ActiGraph device |
| Non-sedentary Time | 8 weeks | 24h activity, assessed using an ActiGraph device |
| Step Count | 8 weeks | 24h activity, assessed using an ActiGraph device |
| Energy Expenditure | 8 weeks | 24h activity, assessed using an ActiGraph device |
| 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) |
| Questionnaires assessing chronotype | 8 weeks | Munich Chronotype Questionnaire (MCTQ, Roenneberg et al. 2003), Morningness Eveningness Questionnaire (MEQ, Horne et al.1976) |
| Questionnaire assessing risk-taking behaviour | 8 weeks | Domain Specific Risk-Taking (DOSPERT, Johnson et al. 2004) |
| Questionnaire assessing stress | 8 weeks | Perceived Stress Questionnaire (PSQ, Fliege et al. 2001) |
| Wake After Sleep Onset (WASO) | 8 weeks | Assessed through an ActiGraph device Sleep Onset Latency (SOL), Sleep Fragmentation Index |
| Questionnaire assessing emotional eating | 8 weeks | Salzburg Emotional Eating Questionnaire (SEES, Meule et al. 2018) |
| Questionnaire assessing food cravings | 8 weeks | Food Cravings Questionnaire (FCQ, Meule et al. 2012) |
| Questionnaire assessing impulsive behaviour | 8 weeks | Barratt Impulsivity Scale (BIS, Meule et al. 2011) |
| 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) |
Countries
Germany
Contacts
Primary ContactLara Ryan
Outcome results
None listed