Citrus Extract, Sleep and Mental Wellbeing

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

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.

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

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.

Connect with a study center

  • Maastricht University

    Maastricht,
    Netherlands

    Active - Recruiting

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