The Effect of Citrus Extract on Sleep and Mental Wellbeing
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sleep Disturbance
- Sponsor
- Maastricht University Medical Center
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Changes in sleep quality between the intervention and placebo group
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Changes in sleep quality between the intervention and placebo group
Time Frame: 8 weeks of intervention
Measured using actigraphy
Changes in sleep quality scores between the intervention and placebo group
Time Frame: 8 weeks of intervention
Measured by a sleep quality questionnaire (PSQI)
Secondary Outcomes
- Changes in mental wellbeing between the intervention and placebo group(8 weeks of intervention)