Fatigue Clinical Trial
Official title:
Determination of the Sleep Improving Effects of Phenolics From an Orange Peel Extract
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.
Status | Completed |
Enrollment | 77 |
Est. completion date | September 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Netherlands | Maastricht University Medical Center (MUMC) | Maastricht |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | No |
Secondary | 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 | No |
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