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| Name | Class |
|---|---|
| Prof. Dr. Olga Ramich (German Institute of Human Nutrition) | UNKNOWN |
| Freie Universität Berlin | OTHER |
| German Center for Diabetes Research | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Time-Restricted Eating | Experimental |
| |
| Late Time-Restricted Eating | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Time-Restricted Eating | Behavioral | Eat between 8:00 and 16:00 for 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | 8 weeks |
| Behaviour: Daily food intake | Self-reported food intake, recorded via FoodApp or handwritten food diary | 8 weeks |
| Large Neutral Amino Acids (LNAAs) | Blood samples | 8 weeks |
| Fasting glucose | Blood samples | 8 weeks |
| Insulin | Blood samples | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 8 weeks |
| Total Sleep Time (TST) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lara Ryan | Contact | 33 200 88 - 2511 | + 49 | lara.ryan@dife.de |
| Name | Affiliation | Role |
|---|---|---|
| Soyoung Q Park, Prof. Dr. | German Institute of Human Nutrition | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| German Institute of Human Nutrition (DIfE) | Recruiting | Nuthetal | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34869534 | Background | Peters B, Koppold-Liebscher DA, Schuppelius B, Steckhan N, Pfeiffer AFH, Kramer A, Michalsen A, Pivovarova-Ramich O. Effects of Early vs. Late Time-Restricted Eating on Cardiometabolic Health, Inflammation, and Sleep in Overweight and Obese Women: A Study Protocol for the ChronoFast Trial. Front Nutr. 2021 Nov 15;8:765543. doi: 10.3389/fnut.2021.765543. eCollection 2021. | |
| 33722669 |
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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.
Fully anonymised data will be available after publication of results when requested.
the anonymized data will be available via public servers (for example, Open Science Framework) when requested.
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| ID | Term |
|---|---|
| D000093763 | Intermittent Fasting |
| D001519 | Behavior |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D005215 | Fasting |
| D005247 | Feeding Behavior |
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| Charite University, Berlin, Germany |
| OTHER |
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| Late Time-Restricted Eating | Behavioral | Eat between 13:00 and 21:00 for 2 weeks |
|
|
Assessed through an ActiGraph device
| 8 weeks |
| Sleep Efficiency (SE) | Assessed through an ActiGraph device | 8 weeks |
| Wake After Sleep Onset (WASO) | Assessed through an ActiGraph device Sleep Onset Latency (SOL), Sleep Fragmentation Index | 8 weeks |
| Sleep Onset Latency (SOL) | Assessed through an ActiGraph device | 8 weeks |
| Sleep Fragmentation Index | Assessed through an ActiGraph device | 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 | 8 weeks |
| Total movement | 24h activity, assessed using an ActiGraph device | 8 weeks |
| Moderate to Vigorous Physical Activity (MVPA) | 24h activity, assessed using an ActiGraph device | 8 weeks |
| Non-sedentary Time | 24h activity, assessed using an ActiGraph device | 8 weeks |
| Step Count | 24h activity, assessed using an ActiGraph device | 8 weeks |
| Energy Expenditure | 24h activity, assessed using an ActiGraph device | 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) | 8 weeks |
| Questionnaires assessing chronotype | Munich Chronotype Questionnaire (MCTQ, Roenneberg et al. 2003), Morningness Eveningness Questionnaire (MEQ, Horne et al.1976) | 8 weeks |
| Questionnaire assessing risk-taking behaviour | Domain Specific Risk-Taking (DOSPERT, Johnson et al. 2004) | 8 weeks |
| Questionnaire assessing stress | Perceived Stress Questionnaire (PSQ, Fliege et al. 2001) | 8 weeks |
| Questionnaire assessing intuitive eating | Intuitive Eating Scale (IES-2, Ruzanska et al. 2017) | 8 weeks |
| Questionnaire assessing emotional eating | Salzburg Emotional Eating Questionnaire (SEES, Meule et al. 2018) | 8 weeks |
| Questionnaire assessing food cravings | Food Cravings Questionnaire (FCQ, Meule et al. 2012) | 8 weeks |
| Questionnaire assessing impulsive behaviour | Barratt Impulsivity Scale (BIS, Meule et al. 2011) | 8 weeks |
| Questionnaire assessing momentary impulsive behaviour | Momentary Impulsivity Assessment (Tomko et al., 2014) | 8 weeks |
| Questionnaire assessing behavioural inhibition and activation | Behavioural Inhibition and Activation (BIS/BAS, Strobel et al. 2001) | 8 weeks |
| Questionnaire assessing mood | Positive and Negative Affect Scale (PANAS, Janke et al. 2014) | 8 weeks |
| Questionnaire assessing interoception | Multidimension Assessment of Interoceptive Awareness (MAIA-2, Mehling et al. 2018) | 8 weeks |
| Questionnaire assessing social decision-making | Social Value Orientation (SVO, Murphy et al. 2011) | 8 weeks |
| Questionnaire assessing wellbeing | Warwick Edinburgh Mental Wellbeing Scale (WEMWBS, Lang et al. 2017) | 8 weeks |
| Gut microbiome composition | Collection of stool samples before and after each intervention to assess gut microbiome composition including alpha and beta diversity | 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). | 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 | 8 weeks |
| Cortisol | Blood samples | 8 weeks |
| Progesterone | Blood samples | 8 weeks |
| Estradiol | Blood samples | 8 weeks |
| Ghrelin | Blood samples | 8 weeks |
| Background |
| Liu L, Artigas SO, Ulrich A, Tardu J, Mohr PNC, Wilms B, Koletzko B, Schmid SM, Park SQ. Eating to dare - Nutrition impacts human risky decision and related brain function. Neuroimage. 2021 Jun;233:117951. doi: 10.1016/j.neuroimage.2021.117951. Epub 2021 Mar 12. |
| 12568247 | Background | Roenneberg T, Wirz-Justice A, Merrow M. Life between clocks: daily temporal patterns of human chronotypes. J Biol Rhythms. 2003 Feb;18(1):80-90. doi: 10.1177/0748730402239679. |
| 1027738 | Background | Horne JA, Ostberg O. A self-assessment questionnaire to determine morningness-eveningness in human circadian rhythms. Int J Chronobiol. 1976;4(2):97-110. |
| Background | Johnson, J., Wilke, A., & Weber, E. U. (2004). Beyond a trait view of risk taking: A domain-specific scale measuring risk perceptions, expected benefits, and perceived-risk attitudes in German-speaking populations. Polish Psychological Bulletin, 35, 153-172 |
| Background | Fliege, H., Rose, M., Arck, P., Levenstein, S., & Klapp, B. F. (2001). Validierung des "perceived stress questionnaire"(PSQ) an einer deutschen Stichprobe. Diagnostica, 47(3), 142-152. |
| 1947597 | Background | Buysse DJ, Reynolds CF 3rd, Monk TH, Hoch CC, Yeager AL, Kupfer DJ. Quantification of subjective sleep quality in healthy elderly men and women using the Pittsburgh Sleep Quality Index (PSQI). Sleep. 1991 Aug;14(4):331-8. |
| 29467700 | Background | Meule A, Reichenberger J, Blechert J. Development and Preliminary Validation of the Salzburg Emotional Eating Scale. Front Psychol. 2018 Feb 6;9:88. doi: 10.3389/fpsyg.2018.00088. eCollection 2018. |
| Background | Meule, A., Vögele, C. & Kübler, A. Psychometrische Evaluation der deutschen Barratt Impulsiveness Scale - Kurzversion (BIS-15). Diagnostica 57, 126-133 (2011). |
| Background | Janke, S., & Glöckner-Rist, A. (2014). "Deutsche Version der Positive and Negative Affect Schedule (PANAS)" in Zusammenstellung sozialwissenschaftlicher Items und Skalen, GESIS (Mannheim, Germany). doi.org/10.6102/zis146 |
| 21983051 | Background | Meule A, Lutz A, Vogele C, Kubler A. Food cravings discriminate differentially between successful and unsuccessful dieters and non-dieters. Validation of the Food Cravings Questionnaires in German. Appetite. 2012 Feb;58(1):88-97. doi: 10.1016/j.appet.2011.09.010. Epub 2011 Sep 29. |
| Background | Strobel, A., Beauducel, A., Debener, S., & Brocke, B. (2001). Eine deutschsprachige version des BIS/BAS-Fragebogens von carver und white. Zeitschrift für Differentielle und diagnostische Psychologie. |
| 34170963 | Background | Eggart M, Todd J, Valdes-Stauber J. Validation of the Multidimensional Assessment of Interoceptive Awareness (MAIA-2) questionnaire in hospitalized patients with major depressive disorder. PLoS One. 2021 Jun 25;16(6):e0253913. doi: 10.1371/journal.pone.0253913. eCollection 2021. |
| 28645751 | Background | Ruzanska UA, Warschburger P. Psychometric evaluation of the German version of the Intuitive Eating Scale-2 in a community sample. Appetite. 2017 Oct 1;117:126-134. doi: 10.1016/j.appet.2017.06.018. Epub 2017 Jun 21. |
| Background | Murphy, R. O., Ackermann, K. A., & Handgraaf, M. J. (2011). Measuring social value orientation. Judgment and Decision making, 6(8), 771-781. |
| Background | Lang, G., & Bachinger, A. (2017). Validation of the German Warwick-Edinburgh mental well-being scale (WEMWBS) in a community-based sample of adults in Austria: a bi-factor modelling approach. Journal of Public Health, 25, 135-146. |
| 26192187 | Background | Eisenstein SA, Gredysa DM, Antenor-Dorsey JA, Green L, Arbelaez AM, Koller JM, Black KJ, Perlmutter JS, Moerlein SM, Hershey T. Insulin, Central Dopamine D2 Receptors, and Monetary Reward Discounting in Obesity. PLoS One. 2015 Jul 20;10(7):e0133621. doi: 10.1371/journal.pone.0133621. eCollection 2015. |
| 24274047 | Background | Tomko RL, Solhan MB, Carpenter RW, Brown WC, Jahng S, Wood PK, Trull TJ. Measuring impulsivity in daily life: the momentary impulsivity scale. Psychol Assess. 2014 Jun;26(2):339-49. doi: 10.1037/a0035083. Epub 2013 Nov 25. |
| 37001683 | Background | Wan H, Myerson J, Green L. Individual differences in degree of discounting: Do different procedures and measures assess the same construct? Behav Processes. 2023 May;208:104864. doi: 10.1016/j.beproc.2023.104864. Epub 2023 Mar 30. |