The Sleep Improving Effects of Orange Phenolics

Not Applicable

Completed

• Conditions: Fatigue; Polyphenols; Sleep
• Interventions: Dietary Supplement: Identical looking placebo; Dietary Supplement: Lozenge containing citrus flavonoid; Dietary Supplement: Lozenge containing citrus flavonoid formulation

• Registration Number: NCT02209103
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

This study aims to determine whether a citrus flavonoid or a citrus flavonoid formulation can improve objective sleep duration and/or quality, and/or improve perceived sleep quality and feelings of rest.

Participants will complete a total of 9 test nights, which consist of sleeping with the sleep monitoring system after ingestion of the test product or a placebo, and filling out sleep-related questionnaires.

The study has a crossover design, meaning that all participants receive all three interventions (citrus flavonoid, citrus flavonoid formulation, placebo) three times, in a randomized order.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Status Verified: 2014-08
• Study First Submitted: 2014-08-04
• Study First Submitted QC: 2014-08-04
• Study First Posted: 2014-08-05
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Last Update Submitted: 2015-11-19
• Last Update Posted: 2015-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

• Age 18-75
• Non-smoking
• Healthy
• Lightly disturbed sleep for at least six months, on a regular basis

Exclusion Criteria

• Severe sleep disorders (sleep apnea, restless legs syndrome)
• An apparent cause for the sleep disorders (pain, etc.)
• Clinically significant abnormal liver functioning
• Clinically significant abnormal serum creatinine
• BMI lower than 18 or higher than 30 kg/m2
• Use of concomitant medications or supplements

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Identical looking placebo	Placebo
Citrus flavonoid	Lozenge containing citrus flavonoid	Citrus flavonoid
Citrus flavonoid formulation	Lozenge containing citrus flavonoid formulation	Citrus flavonoid formulation

Primary Outcome Measures

Name	Time	Method
Sleep quality as assessed objectively by means of a portable sleep monitoring system (ZEO)	9 test nights (up to 9 days)	• The primary endpoint for this study is the determination of sleep quality, as assessed objectively with the portable sleep monitoring system ZEO, which is based on EEG/EMG (electromyography) coupled with an automatic sleep phase classifier. Sleep stages are classified as deep sleep, light sleep, REM (rapid eye movement) sleep or awake. The sleep patterns of the participants after ingestion of the two different test products will be compared to each other and to placebo.

Secondary Outcome Measures

Name	Time	Method
Subjective sleep quality ratings and fitness, tiredness and cognitive ratings, obtained from questionnaires	up to 9 days. Questionnaires are filled out the morning after every test night	Leeds Sleep Evaluation Questionnaire

Trial Locations

Locations (1)

Maastricht University Medical Center (MUMC); 🇳🇱 Maastricht, Netherlands