Time-restricted Eating and Cognition

July 17, 2024 updated by: Prof. Dr. Soyoung Q Park, German Institute of Human Nutrition

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Nuthetal, Germany
        • Recruiting
        • German Institute of Human Nutrition (DIfE)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Behaviour: risk propensity on a decision-making task
Time Frame: 8 weeks
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
Time Frame: 8 weeks
BOLD signal changes on a whole-brain level and in predefined regions of interest assessed using fMRI
8 weeks
Behaviour: Daily food intake
Time Frame: 8 weeks
Self-reported food intake, recorded via FoodApp or handwritten food diary
8 weeks
Large Neutral Amino Acids (LNAAs)
Time Frame: 8 weeks
Blood samples
8 weeks
Fasting glucose
Time Frame: 8 weeks
Blood samples
8 weeks
Insulin
Time Frame: 8 weeks
Blood samples
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Questionnaire assessing sleep quality
Time Frame: 8 weeks
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)
Time Frame: 8 weeks
Assessed through an ActiGraph device
8 weeks
Sleep Efficiency (SE)
Time Frame: 8 weeks
Assessed through an ActiGraph device
8 weeks
Wake After Sleep Onset (WASO)
Time Frame: 8 weeks
Assessed through an ActiGraph device Sleep Onset Latency (SOL), Sleep Fragmentation Index
8 weeks
Sleep Onset Latency (SOL)
Time Frame: 8 weeks
Assessed through an ActiGraph device
8 weeks
Sleep Fragmentation Index
Time Frame: 8 weeks
Assessed through an ActiGraph device
8 weeks
Glucose tolerance
Time Frame: 8 weeks
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
Time Frame: 8 weeks
24h activity, assessed using an ActiGraph device
8 weeks
Moderate to Vigorous Physical Activity (MVPA)
Time Frame: 8 weeks
24h activity, assessed using an ActiGraph device
8 weeks
Non-sedentary Time
Time Frame: 8 weeks
24h activity, assessed using an ActiGraph device
8 weeks
Step Count
Time Frame: 8 weeks
24h activity, assessed using an ActiGraph device
8 weeks
Energy Expenditure
Time Frame: 8 weeks
24h activity, assessed using an ActiGraph device
8 weeks
Daily questions monitoring intervention effects
Time Frame: 8 weeks
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
Time Frame: 8 weeks
Munich Chronotype Questionnaire (MCTQ, Roenneberg et al. 2003), Morningness Eveningness Questionnaire (MEQ, Horne et al.1976)
8 weeks
Questionnaire assessing risk-taking behaviour
Time Frame: 8 weeks
Domain Specific Risk-Taking (DOSPERT, Johnson et al. 2004)
8 weeks
Questionnaire assessing stress
Time Frame: 8 weeks
Perceived Stress Questionnaire (PSQ, Fliege et al. 2001)
8 weeks
Questionnaire assessing intuitive eating
Time Frame: 8 weeks
Intuitive Eating Scale (IES-2, Ruzanska et al. 2017)
8 weeks
Questionnaire assessing emotional eating
Time Frame: 8 weeks
Salzburg Emotional Eating Questionnaire (SEES, Meule et al. 2018)
8 weeks
Questionnaire assessing food cravings
Time Frame: 8 weeks
Food Cravings Questionnaire (FCQ, Meule et al. 2012)
8 weeks
Questionnaire assessing impulsive behaviour
Time Frame: 8 weeks
Barratt Impulsivity Scale (BIS, Meule et al. 2011)
8 weeks
Questionnaire assessing momentary impulsive behaviour
Time Frame: 8 weeks
Momentary Impulsivity Assessment (Tomko et al., 2014)
8 weeks
Questionnaire assessing behavioural inhibition and activation
Time Frame: 8 weeks
Behavioural Inhibition and Activation (BIS/BAS, Strobel et al. 2001)
8 weeks
Questionnaire assessing mood
Time Frame: 8 weeks
Positive and Negative Affect Scale (PANAS, Janke et al. 2014)
8 weeks
Questionnaire assessing interoception
Time Frame: 8 weeks
Multidimension Assessment of Interoceptive Awareness (MAIA-2, Mehling et al. 2018)
8 weeks
Questionnaire assessing social decision-making
Time Frame: 8 weeks
Social Value Orientation (SVO, Murphy et al. 2011)
8 weeks
Questionnaire assessing wellbeing
Time Frame: 8 weeks
Warwick Edinburgh Mental Wellbeing Scale (WEMWBS, Lang et al. 2017)
8 weeks
Gut microbiome composition
Time Frame: 8 weeks
Collection of stool samples before and after each intervention to assess gut microbiome composition including alpha and beta diversity
8 weeks
Decision-making
Time Frame: 8 weeks
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
Time Frame: 8 weeks
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
Time Frame: 8 weeks
Blood samples
8 weeks
Progesterone
Time Frame: 8 weeks
Blood samples
8 weeks
Estradiol
Time Frame: 8 weeks
Blood samples
8 weeks
Ghrelin
Time Frame: 8 weeks
Blood samples
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
German Institute of Human Nutrition

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Charite University, Berlin, Germany
Freie Universität Berlin
German Center for Diabetes Research
Prof. Dr. Olga Ramich (German Institute of Human Nutrition)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Soyoung Q Park, Prof. Dr., German Institute of Human Nutrition

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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