An interventional study of Early Time-Restricted Eating and Late Time-Restricted Eating in Time Restricted Eating and Intermittent Fasting, sponsored by German Institute of Human Nutrition. Recruiting at 1 site in Germany. Open to female participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-18.
Sponsored by German Institute of Human Nutrition · Not applicable, Interventional, and Basic science
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).
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.
Exclusion Criteria:
Behavioral: Early Time-Restricted Eating
Behavioral: Late Time-Restricted Eating
Eat between 8:00 and 16:00 for 2 weeks
Also known as: early TRE, eTRE, eTRF
Eat between 13:00 and 21:00 for 2 weeks
Also known as: late TRE, lTRE, lTRF
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)
Time frame: 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
Time frame: 8 weeks
Behaviour: Daily food intake
Self-reported food intake, recorded via FoodApp or handwritten food diary
Time frame: 8 weeks
Large Neutral Amino Acids (LNAAs)
Blood samples
Time frame: 8 weeks
Fasting glucose
Blood samples
Time frame: 8 weeks
Insulin
Blood samples
Time frame: 8 weeks
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
Time frame: 8 weeks
Total Sleep Time (TST)
Assessed through an ActiGraph device
Time frame: 8 weeks
Sleep Efficiency (SE)
Assessed through an ActiGraph device
Time frame: 8 weeks
Wake After Sleep Onset (WASO)
Assessed through an ActiGraph device Sleep Onset Latency (SOL), Sleep Fragmentation Index
Time frame: 8 weeks
Sleep Onset Latency (SOL)
Assessed through an ActiGraph device
Time frame: 8 weeks
Sleep Fragmentation Index
Assessed through an ActiGraph device
Time frame: 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
Time frame: 8 weeks
Total movement
24h activity, assessed using an ActiGraph device
Time frame: 8 weeks
Moderate to Vigorous Physical Activity (MVPA)
24h activity, assessed using an ActiGraph device
Time frame: 8 weeks
Non-sedentary Time
24h activity, assessed using an ActiGraph device
Time frame: 8 weeks
Step Count
24h activity, assessed using an ActiGraph device
Time frame: 8 weeks
Energy Expenditure
24h activity, assessed using an ActiGraph device
Time frame: 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)
Time frame: 8 weeks
Questionnaires assessing chronotype
Munich Chronotype Questionnaire (MCTQ, Roenneberg et al. 2003), Morningness Eveningness Questionnaire (MEQ, Horne et al.1976)
Time frame: 8 weeks
Questionnaire assessing risk-taking behaviour
Domain Specific Risk-Taking (DOSPERT, Johnson et al. 2004)
Time frame: 8 weeks
Questionnaire assessing stress
Perceived Stress Questionnaire (PSQ, Fliege et al. 2001)
Time frame: 8 weeks
Questionnaire assessing intuitive eating
Intuitive Eating Scale (IES-2, Ruzanska et al. 2017)
Time frame: 8 weeks
Questionnaire assessing emotional eating
Salzburg Emotional Eating Questionnaire (SEES, Meule et al. 2018)
Time frame: 8 weeks
Questionnaire assessing food cravings
Food Cravings Questionnaire (FCQ, Meule et al. 2012)
Time frame: 8 weeks
Questionnaire assessing impulsive behaviour
Barratt Impulsivity Scale (BIS, Meule et al. 2011)
Time frame: 8 weeks
Questionnaire assessing momentary impulsive behaviour
Momentary Impulsivity Assessment (Tomko et al., 2014)
Time frame: 8 weeks
Questionnaire assessing behavioural inhibition and activation
Behavioural Inhibition and Activation (BIS/BAS, Strobel et al. 2001)
Time frame: 8 weeks
Questionnaire assessing mood
Positive and Negative Affect Scale (PANAS, Janke et al. 2014)
Time frame: 8 weeks
Questionnaire assessing interoception
Multidimension Assessment of Interoceptive Awareness (MAIA-2, Mehling et al. 2018)
Time frame: 8 weeks
Questionnaire assessing social decision-making
Social Value Orientation (SVO, Murphy et al. 2011)
Time frame: 8 weeks
Questionnaire assessing wellbeing
Warwick Edinburgh Mental Wellbeing Scale (WEMWBS, Lang et al. 2017)
Time frame: 8 weeks
Gut microbiome composition
Collection of stool samples before and after each intervention to assess gut microbiome composition including alpha and beta diversity
Time frame: 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).
Time frame: 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
Time frame: 8 weeks
Cortisol
Blood samples
Time frame: 8 weeks
Progesterone
Blood samples
Time frame: 8 weeks
Estradiol
Blood samples
Time frame: 8 weeks
Ghrelin
Blood samples
Time frame: 8 weeks
Plan to share: Yes — Only anonymized data will be shared with the scientific community by making the anonymized data available via public servers (for example, Open Science Framework) when requested.
Supporting information: Sap
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German Institute of Human Nutrition