Health TrialsbyHealthPanel

Time-restricted Eating and Cognition

ConditionsTime Restricted EatingIntermittent Fasting
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorGerman Institute of Human Nutrition

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

right-handed

legally competent

physically and mentally healthy

BMI: 19-35 kg/m²

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Early Time-Restricted Eating

    Behavioral

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

  • Late Time-Restricted Eating

    Behavioral

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

Treatment groups

35 Participants
are divided into 2 treatment groups
Group A: Early Time-Restricted EatingExperimental treatment 1 intervention
Group B: Late Time-Restricted EatingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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)

Time frame
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

Time frame
8 weeks
3

Behaviour: Daily food intake

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

Time frame
8 weeks
4

Large Neutral Amino Acids (LNAAs)

Blood samples

Time frame
8 weeks

Secondary outcomes

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

Time frame
8 weeks
2

Total Sleep Time (TST)

Assessed through an ActiGraph device

Time frame
8 weeks
3

Sleep Efficiency (SE)

Assessed through an ActiGraph device

Time frame
8 weeks
4

Wake After Sleep Onset (WASO)

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

Time frame
8 weeks

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

German Institute of Human Nutrition (DIfE)Recruiting NuthetalGermanyGermany

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

German Institute of Human Nutrition

Lead sponsor

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

Collaborator

Freie Universität Berlin

Collaborator

German Center for Diabetes Research

Collaborator

Charite University, Berlin, Germany

Collaborator

Source ClinicalTrials.gov
Apply now