Healthy subjects with self-reported poor sleep
Conditions
Interventions
Group 1: Intervention group - time-restricted eating for 4 weeks (eating window max. 10 h, last meal before 8:30 pm). Questionnaires at baseline, weekly, post-intervention, and optionally 4 weeks afte
Sponsors
Stiftung Leibniz Universität Hannover (LUH), Institute of Food and One Health
Eligibility
Sex/Gender
All
Age
30 Years to 65 Years
Inclusion criteria
Inclusion criteria: - BMI 18.5 - 35.0 kg/m² - Self-reported poor sleep quality (PSQI score >5) - Ability and willingness to follow the instructions of the study coordinators. This particularly concerns compliance with the study conditions and the associated dietary changes - Late eating habits and calorie intake (habitually after 8:30 pm) - Usual calorie intake window =12 hours - Documented consent of the participants after detailed written information about the content, requirements, and risks of the study
Exclusion criteria
Exclusion criteria: - Manifest chronical diseases: diabetes, cardiovascular diseases, kidney diseases (eg, renal failure, urinary tract diseases), gastrointestinal diseases, liver diseases (eg, hepatitis, cirrhosis), cancer within the last two years, untreated thyroid dysfunction and other endocrine diseases, psychiatric conditions, neurological diseases - Medically diagnosed mental illness or eating disorder (e.g. depression, anxiety disorder, bulimia nervosa, anorexia nervosa) with current treatment - Chronic diseases involving the immune system (i.e., Crohn’s disease, ulcerative colitis, rheumatoid arthritis, multiple sclerosis) - Oral health issues: infections, diseases, or recent surgeries - Diagnosed sleep disorder and sleep apnoea - Use of medication and dietary supplements affecting sleep (hypnotic drugs, antidepressants, anticonvulsants, antipsychotics, H1 antagonists, supplements of melatonin, magnesium, tryptophan, glycine, or L-theanine and plant extracts) - Medications reducing saliva production (salivary sampling) - Ongoing therapeutic treatments in connection with sleep disorders (e.g. cognitive behavioural therapy, relaxation techniques, psychotherapy). - Following a specific diet (e.g. ketogenic diet, intermittent fasting, low-carb) - Permanent use of immunosuppressants and corticoids - Abuse of alcohol and drugs - Caffeine Consumption: =4 cups of coffee or caffeine drinks or equivalent per day and caffeine consumption after 4pm - Consumption of tobacco/nicotine within 4 hours before bedtime - Reproductive Status: Pregnant, breastfeeding, or intention to become pregnant during the study - Night shift workers - External Sleep Disruptors: affected by factors like awakenings by infants, noise, snoring partners, or chronic pain - Upcoming surgery or travel: individuals with surgeries or travel (including jetlag) planned within the next three months - Participation in another clinical study within the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in self-reported sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI) Time points: t0, t4, t8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep quality (PSQI global score and subscales) Time points: t0, t2, t4, t6, t8 (t2/t6 exploratory) Method: Pittsburgh Sleep Quality Index (PSQI), self-report Sleep quality (Single-Item Sleep Quality Scale, SQS) Time points: t0, t1, t2, t3, t4, t5, t6, t7, t8 Method: Single-Item Sleep Quality Scale (SQS), self-report Sleep parameters and derived metrics Time points: t0, t4, t8 Method: Munich ChronoType Questionnaire (MCTQ), self-report Mental well-being Time points: t0, t4, t8 Method: Depression Anxiety and Stress Scale – 21 (DASS-21), self-report Dietary habits Time points: t0, t4, t8 Method: Food Frequency Questionnaire (FFQ) and items of the Chrononutrition Profile Questionnaire, self-report Salivary cortisol Time points: t0, t4, t8 Method: Saliva sample Gut microbiome composition Time points: t0, t4, t8 Method: Microbiome analysis (16S rRNA sequencing), stool sample (optional) Note: The exact time points of the PSQI and SQS assessments depend on group allocation. | — |
Countries
Germany
Contacts
Public ContactJulius Schuster
Stiftung Leibniz Universität Hannover (LUH), Institute of Food and One Health
Outcome results
None listed