Time-restricted Eating and Cognition

NCT06508255 | Recruiting

• 1 other identifier: ChronoBEAT
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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).

Conditions

Time Restricted Eating; Intermittent Fasting

Keywords

Time-restricted eating; Time-restricted feeding; Cognition; Decision-making; Behaviour; Brain Activity; Food Intake; Diet; Microbiome; Sleep; Physical Activity

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (33)

• Questionnaire assessing sleep quality

  8 weeks

• Total Sleep Time (TST)

  8 weeks

• Sleep Efficiency (SE)

  8 weeks

• Wake After Sleep Onset (WASO)

  8 weeks

• Sleep Onset Latency (SOL)

  8 weeks

Study Arms (2)

Early Time-Restricted Eating

EXPERIMENTAL

Behavioral: Early Time-Restricted Eating

Late Time-Restricted Eating

EXPERIMENTAL

Behavioral: Late Time-Restricted Eating

Interventions

Early Time-Restricted Eating BEHAVIORAL

Eat between 8:00 and 16:00 for 2 weeks

Also known as: early TRE, eTRE, eTRF

Early Time-Restricted Eating

Late Time-Restricted Eating BEHAVIORAL

Eat between 13:00 and 21:00 for 2 weeks

Also known as: late TRE, lTRE, lTRF

Late Time-Restricted Eating

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• right-handed
• legally competent
• physically and mentally healthy
• BMI: 19-35 kg/m²
• fluent in reading and speaking German

You may not qualify if:

• weight change \>5% of body weight during the last 3 months
• pregnancy or breastfeeding
• 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

Sponsors & Collaborators

• German Institute of Human Nutrition: lead
• Prof. Dr. Olga Ramich (German Institute of Human Nutrition): collaborator
• Freie Universität Berlin: collaborator
• German Center for Diabetes Research: collaborator
• Charite University, Berlin, Germany: collaborator

Study Sites (1)

German Institute of Human Nutrition (DIfE)

Nuthetal, Germany

RECRUITING

Related Publications (19)

• 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.

  PMID: 34869534 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.

  PMID: 33722669 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.

  PMID: 12568247 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.

  PMID: 1027738 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.

  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.

  PMID: 1947597 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.

  PMID: 29467700 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

  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.

  PMID: 21983051 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.

  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.

  PMID: 34170963 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.

  PMID: 28645751 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.

  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.

  PMID: 26192187 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.

  PMID: 24274047 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.

  PMID: 37001683 BACKGROUND

MeSH Terms

Conditions

Intermittent Fasting; Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior

Study Officials

• Soyoung Q Park, Prof. Dr.

  German Institute of Human Nutrition

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lara Ryan

CONTACT

33 200 88 - 2511; lara.ryan@dife.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Soyoung Q Park (Principal Investigator)

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: July 18, 2024
• Study Start: May 17, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Fully anonymised data will be available after publication of results when requested.
• Access Criteria: the anonymized data will be available via public servers (for example, Open Science Framework) when requested.

Locations

DE (1)