Last updated: January 26, 2024
Sponsor: Maastricht University Medical Center
Overall Status: Active - Recruiting
Phase
N/A
Condition
Narcolepsy
Insomnia
Restless Leg Syndrome
Treatment
Citrus extract
Maltodextrin
Clinical Study ID
NCT06239168
23-012
Ages 40-70 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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
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 scientificintervention 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
Study Design
Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Citrus extract
Phase:
Study Start date:
November 08, 2023
Estimated Completion Date:
December 31, 2024
Study Description
Connect with a study center
Maastricht University
Maastricht,
NetherlandsActive - Recruiting
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