Citrus Extract, Sleep and Mental Wellbeing

The Effect of Citrus Extract on Sleep and Mental Wellbeing

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Disturbance
• Intervention / Treatment: Dietary supplement: Citrus extract; Dietary supplement: Maltodextrin

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yala Stevens, PhD; Phone Number: +31437114555; Email: yala.stevens@maastrichtuniversity.nl

Study Locations

• Netherlands
  • Maastricht, Netherlands
    • Recruiting
    • Maastricht University
    • Contact: Yala Stevens, PhD; Phone Number: +31437114555; Email: yala.stevens@maastrichtuniversity.nl
    • Principal Investigator: Jogchum Plat, Prof
    • Principal Investigator: Tanja Adam, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Citrus extract; Daily Citrus extract supplementation for 8 weeks.	Dietary supplement: Citrus extract; As described in experimental arm
Placebo Comparator: Control; Daily Maltodextrin supplementation for 8 weeks.	Dietary supplement: Maltodextrin; As described in comparator arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in sleep quality scores between the intervention and placebo group	Measured by a sleep quality questionnaire (PSQI)	8 weeks of intervention
Changes in sleep quality between the intervention and placebo group	Measured using actigraphy	8 weeks of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in mental wellbeing between the intervention and placebo group	Measured by mental wellbeing questionnaires	8 weeks of intervention

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: BioActor
• Investigators: Principal Investigator: Jogchum Plat, Maastricht University; Principal Investigator: Tanja Adam, Maastricht University

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 14, 2023
• First Submitted That Met QC Criteria: January 26, 2024
• First Posted (Estimated): February 2, 2024

Study Record Updates

• Last Update Posted (Estimated): February 2, 2024
• Last Update Submitted That Met QC Criteria: January 26, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: 23-012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No