Time-restricted Eating and Cognition

German Institute of Human Nutrition

Status

Enrolling

Conditions

Time Restricted Eating

Intermittent Fasting

Treatments

Behavioral: Late Time-Restricted Eating

Behavioral: Early Time-Restricted Eating

Study type

Interventional

Funder types

Other

Identifiers

NCT06508255

ChronoBEAT

Details and patient eligibility

About

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).

Full 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.

Enrollment

35 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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