Clinical trial NCT06508255: Time-restricted Eating and Cognition
Official title: Time-restricted Eating and Cognition (ChronoBEAT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: German Institute of Human Nutrition
Sponsor class: OTHER
Collaborators: name: Prof. Dr. Olga Ramich (German Institute of Human Nutrition)
name: Freie Universität Berlin
name: German Center for Diabetes Research
name: Charite University, Berlin, Germany
First posted: 2024-07-18
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Behaviour: risk propensity on a decision-making task
timeFrame: 8 weeks
measure: Brain: blood-oxygen-level-dependent (BOLD) signal changes
timeFrame: 8 weeks
measure: Behaviour: Daily food intake
timeFrame: 8 weeks
measure: Large Neutral Amino Acids (LNAAs)
timeFrame: 8 weeks
measure: Fasting glucose
timeFrame: 8 weeks
measure: Insulin
timeFrame: 8 weeks
Secondary outcomes:
measure: Questionnaire assessing sleep quality
timeFrame: 8 weeks
measure: Total Sleep Time (TST)
timeFrame: 8 weeks
measure: Sleep Efficiency (SE)
timeFrame: 8 weeks
measure: Wake After Sleep Onset (WASO)
timeFrame: 8 weeks
measure: Sleep Onset Latency (SOL)
timeFrame: 8 weeks
measure: Sleep Fragmentation Index
timeFrame: 8 weeks
measure: Glucose tolerance
timeFrame: 8 weeks
measure: Total movement
timeFrame: 8 weeks
measure: Moderate to Vigorous Physical Activity (MVPA)
timeFrame: 8 weeks
measure: Non-sedentary Time
timeFrame: 8 weeks
measure: Step Count
timeFrame: 8 weeks
measure: Energy Expenditure
timeFrame: 8 weeks
measure: Daily questions monitoring intervention effects
timeFrame: 8 weeks
measure: Questionnaires assessing chronotype
timeFrame: 8 weeks
measure: Questionnaire assessing risk-taking behaviour
timeFrame: 8 weeks
measure: Questionnaire assessing stress
timeFrame: 8 weeks
measure: Questionnaire assessing intuitive eating
timeFrame: 8 weeks
measure: Questionnaire assessing emotional eating
timeFrame: 8 weeks
measure: Questionnaire assessing food cravings
timeFrame: 8 weeks
measure: Questionnaire assessing impulsive behaviour
timeFrame: 8 weeks
measure: Questionnaire assessing momentary impulsive behaviour
timeFrame: 8 weeks
measure: Questionnaire assessing behavioural inhibition and activation
timeFrame: 8 weeks
measure: Questionnaire assessing mood
timeFrame: 8 weeks
measure: Questionnaire assessing interoception
timeFrame: 8 weeks
measure: Questionnaire assessing social decision-making
timeFrame: 8 weeks
measure: Questionnaire assessing wellbeing
timeFrame: 8 weeks
measure: Gut microbiome composition
timeFrame: 8 weeks
measure: Decision-making
timeFrame: 8 weeks
measure: Decision-making
timeFrame: 8 weeks
measure: Cortisol
timeFrame: 8 weeks
measure: Progesterone
timeFrame: 8 weeks
measure: Estradiol
timeFrame: 8 weeks
measure: Ghrelin
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Nuthetal
country: Germany
facility: German Institute of Human Nutrition (DIfE)
Study officials:
affiliation: German Institute of Human Nutrition
name: Soyoung Q Park, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Horne JA, Ostberg O. A self-assessment questionnaire to determine morningness-eveningness in human circadian rhythms. Int J Chronobiol. 1976;4(2):97-110.
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: Meule, A., Vögele, C. & Kübler, A. Psychometrische Evaluation der deutschen Barratt Impulsiveness Scale - Kurzversion (BIS-15). Diagnostica 57, 126-133 (2011).
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Murphy, R. O., Ackermann, K. A., & Handgraaf, M. J. (2011). Measuring social value orientation. Judgment and Decision making, 6(8), 771-781.
citation: 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.
citation: 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.
citation: 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.
citation: 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.