Time-restricted Eating and Cognition

NCT ID: NCT06508255

Last Updated: 2024-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-17

Study Completion Date

2025-03-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Time Restricted Eating Intermittent Fasting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Early Time-Restricted Eating

Group Type EXPERIMENTAL

Early Time-Restricted Eating

Intervention Type BEHAVIORAL

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

Late Time-Restricted Eating

Group Type EXPERIMENTAL

Late Time-Restricted Eating

Intervention Type BEHAVIORAL

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

Interventions

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Early Time-Restricted Eating

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

Intervention Type BEHAVIORAL

Late Time-Restricted Eating

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

Intervention Type BEHAVIORAL

Other Intervention Names

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early TRE eTRE eTRF late TRE lTRE lTRF

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Prof. Dr. Olga Ramich (German Institute of Human Nutrition)

UNKNOWN

Sponsor Role collaborator

Freie Universität Berlin

OTHER

Sponsor Role collaborator

German Center for Diabetes Research

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role collaborator

German Institute of Human Nutrition

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Soyoung Q Park

Prof. Dr. Soyoung Q Park (Principal Investigator)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Soyoung Q Park, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

German Institute of Human Nutrition

Locations

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German Institute of Human Nutrition (DIfE)

Nuthetal, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Lara Ryan

Role: CONTACT

33 200 88 - 2511 ext. + 49

Facility Contacts

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Bianca Weigel

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 34869534 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33722669 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12568247 (View on PubMed)

Horne JA, Ostberg O. A self-assessment questionnaire to determine morningness-eveningness in human circadian rhythms. Int J Chronobiol. 1976;4(2):97-110.

Reference Type BACKGROUND
PMID: 1027738 (View on PubMed)

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

Reference Type 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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 1947597 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29467700 (View on PubMed)

Meule, A., Vögele, C. & Kübler, A. Psychometrische Evaluation der deutschen Barratt Impulsiveness Scale - Kurzversion (BIS-15). Diagnostica 57, 126-133 (2011).

Reference Type 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

Reference Type 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.

Reference Type BACKGROUND
PMID: 21983051 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 34170963 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28645751 (View on PubMed)

Murphy, R. O., Ackermann, K. A., & Handgraaf, M. J. (2011). Measuring social value orientation. Judgment and Decision making, 6(8), 771-781.

Reference Type 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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 26192187 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24274047 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37001683 (View on PubMed)

Other Identifiers

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ChronoBEAT

Identifier Type: -

Identifier Source: org_study_id

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