Effects of citrus extract on sleep and mental wellbeing
The Effect of Citrus Extract on Sleep and Mental Wellbeing
NA · Maastricht University Medical Center · NCT06239168
This study is testing if taking citrus extract every day can help healthy people with minor sleep problems feel better and sleep more soundly.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 40 Years to 70 Years |
| Sex | All |
| Sponsor | Maastricht University Medical Center (other) |
| Locations | 1 site (Maastricht) |
| Trial ID | NCT06239168 on ClinicalTrials.gov |
What this trial studies
This trial investigates the impact of daily citrus extract administration on sleep quality and mental wellbeing in healthy individuals experiencing minor sleep disturbances. It employs a randomized, double-blind, placebo-controlled, cross-over design to ensure robust results. Participants will alternate between receiving the citrus extract and a placebo, allowing for direct comparison of effects. The study aims to fill the gap in human evidence regarding the benefits of citrus extract for sleep-related issues.
Who should consider this trial
Good fit: Ideal candidates are healthy individuals aged 40-70 with minor sleep disturbances and a BMI between 18.5 and 30 kg/m2.
Not a fit: Patients with chronic sleep disorders or major psychiatric conditions are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a natural and effective intervention for improving sleep quality and mental wellbeing.
How similar studies have performed: While pre-clinical studies have shown promise, human studies on citrus extract's effects on sleep are limited, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 * 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
Where this trial is running
Maastricht
- Maastricht University — Maastricht, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Jogchum Plat — Maastricht University
- Study coordinator: Yala Stevens, PhD
- Email: yala.stevens@maastrichtuniversity.nl
- Phone: +31437114555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sleep Disturbance