Citrus Extract, Sleep and Mental Wellbeing

Sleep Disturbance Clinical Trial

Official title:

The Effect of Citrus Extract on Sleep and Mental Wellbeing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06239168
• Other study ID #: 23-012
• Status: Recruiting
• Phase: N/A
• Start date: November 8, 2023
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Maastricht University Medical Center
• Contact: Yala Stevens, PhD
• Phone: +31437114555
• Email: yala.stevens[@]maastrichtuniversity.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep Disturbance

Intervention

Dietary Supplement:
• Citrus extract
As described in experimental arm
• Maltodextrin
As described in comparator arm

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	BioActor

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in sleep quality scores between the intervention and placebo group	Measured by a sleep quality questionnaire (PSQI)	8 weeks of intervention
Primary	Changes in sleep quality between the intervention and placebo group	Measured using actigraphy	8 weeks of intervention
Secondary	Changes in mental wellbeing between the intervention and placebo group	Measured by mental wellbeing questionnaires	8 weeks of intervention