Time-restricted Eating and Cognition

Time-restricted Eating and Cognition (ChronoBEAT)

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).

Study Overview

• Status: Recruiting
• Conditions: Intermittent Fasting; Time Restricted Eating
• Intervention / Treatment: Behavioral: Early Time-Restricted Eating; Behavioral: Late Time-Restricted Eating

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.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lara Ryan; Phone Number: + 49 33 200 88 - 2511; Email: lara.ryan@dife.de

Study Locations

• Germany
  • Nuthetal, Germany
    • Recruiting
    • German Institute of Human Nutrition (DIfE)
    • Contact: Bianca Weigel; Email: DNN-Studie@dife.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Time-Restricted Eating	Behavioral: Early Time-Restricted Eating; Eat between 8:00 and 16:00 for 2 weeks; Other Names: eTRF; eTRE; early TRE
Experimental: Late Time-Restricted Eating	Behavioral: Late Time-Restricted Eating; Eat between 13:00 and 21:00 for 2 weeks; Other Names: lTRF; late TRE; lTRE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: German Institute of Human Nutrition
• Collaborators: Charite University, Berlin, Germany; Freie Universität Berlin; German Center for Diabetes Research; Prof. Dr. Olga Ramich (German Institute of Human Nutrition)
• Investigators: Principal Investigator: Soyoung Q Park, Prof. Dr., German Institute of Human Nutrition

Publications and helpful links

General Publications

• 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. Erratum In: Sleep 1992 Feb;15(1):83.
• Horne JA, Ostberg O. A self-assessment questionnaire to determine morningness-eveningness in human circadian rhythms. Int J Chronobiol. 1976;4(2):97-110.
• 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.
• 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
• Meule, A., Vögele, C. & Kübler, A. Psychometrische Evaluation der deutschen Barratt Impulsiveness Scale - Kurzversion (BIS-15). Diagnostica 57, 126-133 (2011).
• 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.
• 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.
• 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
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Murphy, R. O., Ackermann, K. A., & Handgraaf, M. J. (2011). Measuring social value orientation. Judgment and Decision making, 6(8), 771-781.
• 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.
• 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. Erratum In: PLoS One. 2016 Jan 08;11(1):e0147063. doi: 10.1371/journal.pone.0147063.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Physical Activity; Microbiome; Sleep; Diet; Cognition; Food Intake; Decision-making; Brain Activity; Time-restricted feeding; Behaviour; Time-restricted eating
• Other Study ID Numbers: ChronoBEAT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Fully anonymised data will be available after publication of results when requested.
• IPD Sharing Access Criteria: the anonymized data will be available via public servers (for example, Open Science Framework) when requested.
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No