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Time Restricted EatingNCT06508255

Time-restricted Eating and Cognition

A study testing Early Time-Restricted Eating and Late Time-Restricted Eating in people with Time Restricted Eating and Intermittent Fasting, run by German Institute of Human Nutrition at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for
Time Restricted Eating, Intermittent Fasting
What is being tested?
Early Time-Restricted Eating and Late Time-Restricted Eating
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteGermany
Study dates
17 May 2024to Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 36Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Lara Ryan contact

33 200 88 - 2511 ext. + 49

lara.ryan@dife.de

Germany1 site, 1 recruiting

  • German Institute of Human Nutrition (DIfE)

    Nuthetal

    Bianca Weigel, DNN-Studie@dife.de

    Recruiting

Other trials in Germany

About this study

Official title: 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).

Read the 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.

Being tested
Early Time-Restricted Eating, Late Time-Restricted Eating
Keywords
Time-restricted eating, Time-restricted feeding, Cognition, Decision-making, Behaviour, Brain Activity, Food Intake, Diet, Microbiome, Sleep, Physical Activity
Medical subject headings
Intermittent Fasting, Behavior, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early Time-Restricted EatingBehavioural

    Also called early TRE, eTRE, eTRF

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

  • Late Time-Restricted EatingBehavioural

    Also called late TRE, lTRE, lTRF

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

Study groups in NCT06508255
Study groupRoleWhat they receive
Early Time-Restricted EatingExperimentalNot described
Receives: Behavioral: Early Time-Restricted Eating
Late Time-Restricted EatingExperimentalNot described
Receives: Behavioral: Late Time-Restricted Eating

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 8 weeks

  2. 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

    Measured: 8 weeks

  3. Behaviour: Daily food intake

    Self-reported food intake, recorded via FoodApp or handwritten food diary

    Measured: 8 weeks

  4. Large Neutral Amino Acids (LNAAs)

    Blood samples

    Measured: 8 weeks

  5. Fasting glucose

    Blood samples

    Measured: 8 weeks

  6. Insulin

    Blood samples

    Measured: 8 weeks

Secondary outcomes (33)

  1. 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

    Measured: 8 weeks

  2. Total Sleep Time (TST)

    Assessed through an ActiGraph device

    Measured: 8 weeks

  3. Sleep Efficiency (SE)

    Assessed through an ActiGraph device

    Measured: 8 weeks

  4. Wake After Sleep Onset (WASO)

    Assessed through an ActiGraph device Sleep Onset Latency (SOL), Sleep Fragmentation Index

    Measured: 8 weeks

  5. Sleep Onset Latency (SOL)

    Assessed through an ActiGraph device

    Measured: 8 weeks

  6. Sleep Fragmentation Index

    Assessed through an ActiGraph device

    Measured: 8 weeks

  7. 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

    Measured: 8 weeks

  8. Total movement

    24h activity, assessed using an ActiGraph device

    Measured: 8 weeks

  9. Moderate to Vigorous Physical Activity (MVPA)

    24h activity, assessed using an ActiGraph device

    Measured: 8 weeks

  10. Non-sedentary Time

    24h activity, assessed using an ActiGraph device

    Measured: 8 weeks

  11. Step Count

    24h activity, assessed using an ActiGraph device

    Measured: 8 weeks

  12. Energy Expenditure

    24h activity, assessed using an ActiGraph device

    Measured: 8 weeks

  13. 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)

    Measured: 8 weeks

  14. Questionnaires assessing chronotype

    Munich Chronotype Questionnaire (MCTQ, Roenneberg et al. 2003), Morningness Eveningness Questionnaire (MEQ, Horne et al.1976)

    Measured: 8 weeks

  15. Questionnaire assessing risk-taking behaviour

    Domain Specific Risk-Taking (DOSPERT, Johnson et al. 2004)

    Measured: 8 weeks

  16. Questionnaire assessing stress

    Perceived Stress Questionnaire (PSQ, Fliege et al. 2001)

    Measured: 8 weeks

  17. Questionnaire assessing intuitive eating

    Intuitive Eating Scale (IES-2, Ruzanska et al. 2017)

    Measured: 8 weeks

  18. Questionnaire assessing emotional eating

    Salzburg Emotional Eating Questionnaire (SEES, Meule et al. 2018)

    Measured: 8 weeks

  19. Questionnaire assessing food cravings

    Food Cravings Questionnaire (FCQ, Meule et al. 2012)

    Measured: 8 weeks

  20. Questionnaire assessing impulsive behaviour

    Barratt Impulsivity Scale (BIS, Meule et al. 2011)

    Measured: 8 weeks

  21. Questionnaire assessing momentary impulsive behaviour

    Momentary Impulsivity Assessment (Tomko et al., 2014)

    Measured: 8 weeks

  22. Questionnaire assessing behavioural inhibition and activation

    Behavioural Inhibition and Activation (BIS/BAS, Strobel et al. 2001)

    Measured: 8 weeks

  23. Questionnaire assessing mood

    Positive and Negative Affect Scale (PANAS, Janke et al. 2014)

    Measured: 8 weeks

  24. Questionnaire assessing interoception

    Multidimension Assessment of Interoceptive Awareness (MAIA-2, Mehling et al. 2018)

    Measured: 8 weeks

  25. Questionnaire assessing social decision-making

    Social Value Orientation (SVO, Murphy et al. 2011)

    Measured: 8 weeks

  26. Questionnaire assessing wellbeing

    Warwick Edinburgh Mental Wellbeing Scale (WEMWBS, Lang et al. 2017)

    Measured: 8 weeks

  27. Gut microbiome composition

    Collection of stool samples before and after each intervention to assess gut microbiome composition including alpha and beta diversity

    Measured: 8 weeks

  28. 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).

    Measured: 8 weeks

  29. 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

    Measured: 8 weeks

  30. Cortisol

    Blood samples

    Measured: 8 weeks

  31. Progesterone

    Blood samples

    Measured: 8 weeks

  32. Estradiol

    Blood samples

    Measured: 8 weeks

  33. Ghrelin

    Blood samples

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2024
  2. Study start17 May 2024
  3. Primary completionMar 2025 (estimated)
  4. Study completionMar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06508255
Sponsor's protocol ID
ChronoBEAT
Status last verified
Jul 2024
First submitted
30 May 2024
Last updated
18 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 34869534

  • 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.

    PubMed 33722669

  • 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.

    PubMed 12568247

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

    PubMed 1027738

  • 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.

  • 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.

    PubMed 1947597

  • 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.

    PubMed 29467700

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

  • 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, 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.

    PubMed 21983051

  • 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.

    PubMed 34170963

  • 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.

    PubMed 28645751

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

Questions about this trial

What is this clinical trial studying?

A study testing Early Time-Restricted Eating and Late Time-Restricted Eating in people with Time Restricted Eating and Intermittent Fasting, run by German Institute of Human Nutrition at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lara Ryan (33 200 88 - 2511 ext. + 49, lara.ryan@dife.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Behaviour: risk propensity on a decision-making task (time frame: 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06508255, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.

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