Sleep Disturbance
Conditions
Brief summary
This is a randomized, double-blind, placebo-controlled, cross-over trial investigating the effects of daily administration of citrus extract on sleep and mental wellbeing.
Detailed description
Based on epidemiological data, a substantial number of people report to have sleeping problems. This is of major concern, as poor sleep quality has been associated with impaired mental and physical health. Several pre-clinical studies have shown promising results, but evidence from human studies is still limited. Therefore, the aim of the present study is to investigate the effect of a citrus extract on sleep and mental wellbeing in healthy subjects with (minor) sleep disturbance.
Interventions
DIETARY_SUPPLEMENTCitrus extract
As described in experimental arm
DIETARY_SUPPLEMENTMaltodextrin
As described in comparator arm
Sponsors
BioActor
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy individuals with (minor) sleep disturbance * Age 40-70 years * BMI 18.5 - 30 kg/m2 * Willingness to give up being a blood donor from 4 weeks before the start of the study, during the study and for 4 weeks after completion of the study
Exclusion criteria
* Excessive caffeine use * Major psychiatric/mental health disorders . * Chronic sleep disorders * Severe sleep disturbance for more than 1 year * Other clear causes for poor sleep quality or mental wellbeing * Use of medication or supplements that can affect outcomes * Nonpharmacological treatment for sleep disorders * Flight from a time-zone with \>3 h difference ≤1 week before an intervention period * Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study * Use of pre-, pro- or synbiotics within 1 month prior to the start of the study * Reported weight loss or weight gain of \>3 kg in the month prior to pre-study screening * Smoking * Abuse of products * Known allergy to citruses * Known pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in sleep quality scores between the intervention and placebo group | 8 weeks of intervention | Measured by a sleep quality questionnaire (PSQI) |
| Changes in sleep quality between the intervention and placebo group | 8 weeks of intervention | Measured using actigraphy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in mental wellbeing between the intervention and placebo group | 8 weeks of intervention | Measured by mental wellbeing questionnaires |
Countries
Netherlands
Contacts
Primary ContactYala Stevens, PhD
Outcome results
None listed