Status:
RECRUITING
Time-restricted Eating and Cognition
Lead Sponsor:
German Institute of Human Nutrition
Collaborating Sponsors:
Prof. Dr. Olga Ramich (German Institute of Human Nutrition)
Freie Universität Berlin
Conditions:
Time Restricted Eating
Intermittent Fasting
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief 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,...
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 st...
Eligibility Criteria
Inclusion
- right-handed
- legally competent
- physically and mentally healthy
- BMI: 19-35 kg/m²
- fluent in reading and speaking German
Exclusion
- 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
Key Trial Info
Start Date :
May 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06508255
Start Date
May 17 2024
End Date
March 1 2025
Last Update
July 18 2024
Active Locations (1)
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1
German Institute of Human Nutrition (DIfE)
Nuthetal, Germany