slaap night rest sleep
Conditions
Interventions
Participants will ingest daily before dinner, in random order, 500 mg of citrus
extract or placebo (maltodextrin) capsules for 8 weeks, separated by a 4-week
wash-out.
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: men and women, 40-70 years old, BMI 18,5-30 kg/m2, (mild) sleep disturbance (PSQI score >5), willingness to give up being a blood donor from 4 weeks before the start of the study until 4 weeks after completion of the study.
Exclusion criteria
Exclusion criteria: • Excessive caffeine use ( >400 mg/day) • Major psychiatric/mental health disorders (e.g. major depression, post-traumatic stress disorder, bipolar disorder, schizophrenia). • Chronic sleep disorders (e.g. sleep apnea, restless leg syndrome, periodic limb movement disorder) • Severe sleep disturbance for more than 1 year • Other clear causes for poor sleep quality, stress, depression or anxiety (e.g. stressful situation or life event, excessive noise, snoring partner, infants/children regularly awakening, shift-work, chronic/acute pain) • Use of medication or supplements that can affect outcomes (e.g. anti-depression medication, sleeping pills, melatonin) • Use of medication that can be affected by intake of grapefruit (juice) • Nonpharmacological treatment for sleep disorders (cognitive behavioural therapy, relaxation therapy) • Flight from a time-zone with >3 h difference 3 kg in the month prior to pre-study screening, or intention to lose weight during the study period • Smoking • Abuse of products (> 20 alcoholic consumptions per week and drug usage) • Current use of (antioxidant) dietary supplements and not willing to quit for the duration of the study duration • Known allergy to citruses • Known pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to assess the effect of 8 weeks of supplementing daily 500 mg citrus extract rich in the flavonoids hesperidin and naringin on parameters of sleep quality. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are to study the effects on mental wellbeing (depression, anxiety and stress outcomes). Exploratory study objectives are to study the effect on faecal microbiota composition, faecal short-chain fatty acid (SCFA) concentrations, blood biomarkers related to mental wellbeing (BDNF, dopamine, serotonin) and blood biomarkers of metabolic health (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, CRP, glucose, insulin and HOMA-IR). | — |
Countries
Netherlands
Outcome results
None listed