Determination of the Sleep Improving Effects of Phenolics From an Orange Peel Extract
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Polyphenols
- Sponsor
- Maastricht University Medical Center
- Enrollment
- 77
- Locations
- 1
- Primary Endpoint
- Sleep quality as assessed objectively by means of a portable sleep monitoring system (ZEO)
- Status
- Completed
- Last Updated
- 10 years ago
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18-75
- •Non-smoking
- •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
Outcomes
Primary Outcomes
Sleep quality as assessed objectively by means of a portable sleep monitoring system (ZEO)
Time Frame: 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 Outcomes
- 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)