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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Citrus flavonoid | Experimental | Citrus flavonoid |
|
| Citrus flavonoid formulation | Experimental | Citrus flavonoid formulation |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lozenge containing citrus flavonoid | Dietary Supplement |
| ||
| Lozenge containing citrus flavonoid formulation |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris Van der Grinten | Department: lung diseases MUMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center (MUMC) | Maastricht | 6229 | Netherlands |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Dietary Supplement |
|
| Identical looking placebo | Dietary Supplement |
|