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NCT Number: NCT06508255

Time-restricted Eating and Cognition

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).

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

German Institute of Human Nutrition (DIfE)

Nuthetal, Germany

Location status: Recruiting

Location contact

Bianca Weigel

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early time-restricted eating

Behavioral

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

Other names: early TRE, eTRE, eTRF

Late time-restricted eating

Behavioral

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

Other names: late TRE, lTRE, lTRF

Primary outcomes

  1. 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)

  2. 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

  3. Behaviour: Daily food intake

    Time frame: 8 weeks

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

  4. Large Neutral Amino Acids (LNAAs)

    Time frame: 8 weeks

    Blood samples

  5. Fasting glucose

    Time frame: 8 weeks

    Blood samples

  6. Insulin

    Time frame: 8 weeks

    Blood samples

Secondary outcomes

  1. 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

  2. Total Sleep Time (TST)

    Time frame: 8 weeks

    Assessed through an ActiGraph device

  3. Sleep Efficiency (SE)

    Time frame: 8 weeks

    Assessed through an ActiGraph device

  4. Wake After Sleep Onset (WASO)

    Time frame: 8 weeks

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

  5. Sleep Onset Latency (SOL)

    Time frame: 8 weeks

    Assessed through an ActiGraph device

  6. Sleep Fragmentation Index

    Time frame: 8 weeks

    Assessed through an ActiGraph device

  7. 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. Total movement

    Time frame: 8 weeks

    24h activity, assessed using an ActiGraph device

  9. Moderate to Vigorous Physical Activity (MVPA)

    Time frame: 8 weeks

    24h activity, assessed using an ActiGraph device

  10. Non-sedentary Time

    Time frame: 8 weeks

    24h activity, assessed using an ActiGraph device

  11. Step Count

    Time frame: 8 weeks

    24h activity, assessed using an ActiGraph device

  12. Energy Expenditure

    Time frame: 8 weeks

    24h activity, assessed using an ActiGraph device

  13. 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)

  14. Questionnaires assessing chronotype

    Time frame: 8 weeks

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

  15. Questionnaire assessing risk-taking behaviour

    Time frame: 8 weeks

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

  16. Questionnaire assessing stress

    Time frame: 8 weeks

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

  17. Questionnaire assessing intuitive eating

    Time frame: 8 weeks

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

  18. Questionnaire assessing emotional eating

    Time frame: 8 weeks

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

  19. Questionnaire assessing food cravings

    Time frame: 8 weeks

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

  20. Questionnaire assessing impulsive behaviour

    Time frame: 8 weeks

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

  21. Questionnaire assessing momentary impulsive behaviour

    Time frame: 8 weeks

    Momentary Impulsivity Assessment (Tomko et al., 2014)

  22. Questionnaire assessing behavioural inhibition and activation

    Time frame: 8 weeks

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

  23. Questionnaire assessing mood

    Time frame: 8 weeks

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

  24. Questionnaire assessing interoception

    Time frame: 8 weeks

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

  25. Questionnaire assessing social decision-making

    Time frame: 8 weeks

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

  26. Questionnaire assessing wellbeing

    Time frame: 8 weeks

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

  27. 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

  28. 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).

  29. 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

  30. Cortisol

    Time frame: 8 weeks

    Blood samples

  31. Progesterone

    Time frame: 8 weeks

    Blood samples

  32. Estradiol

    Time frame: 8 weeks

    Blood samples

  33. Ghrelin

    Time frame: 8 weeks

    Blood samples

Study contacts

Contact information is provided by the study sponsor or research team.

Lara Ryan

CONTACT

[email protected]

33 200 88 - 2511 ext. + 49

Sponsors and collaborators

Lead sponsor

German Institute of Human Nutrition

Other

Collaborators

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

Registry information

Official study title

Time-restricted Eating and Cognition (ChronoBEAT)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 18, 2024
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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