The Sleep Improving Effects of Orange Phenolics

Study Overview
=================
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.

Official Title
-----------------
Determination of the Sleep Improving Effects of Phenolics From an Orange Peel Extract

Conditions
-----------------
Polyphenols, Sleep, Fatigue

Intervention / Treatment
-----------------
* Dietary Supplement: Lozenge containing citrus flavonoid
* Dietary Supplement: Lozenge containing citrus flavonoid formulation
* Dietary Supplement: Identical looking placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Citrus flavonoid<br>Citrus flavonoid | Dietary Supplement: Lozenge containing citrus flavonoid<br> <br> |
| Experimental: Citrus flavonoid formulation<br>Citrus flavonoid formulation | Dietary Supplement: Lozenge containing citrus flavonoid formulation<br> <br> |
| Placebo Comparator: Placebo<br>Placebo | Dietary Supplement: Identical looking placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep quality as assessed objectively by means of a portable sleep monitoring system (ZEO) | • 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. | 9 test nights (up to 9 days) | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Polyphenols, Orange, Sleep, Fatigue