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| Name | Class |
|---|---|
| BioActor | INDUSTRY |
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This is a randomized, double-blind, placebo-controlled, cross-over trial investigating the effects of daily administration of citrus extract on sleep and mental wellbeing.
Based on epidemiological data, a substantial number of people report to have sleeping problems. This is of major concern, as poor sleep quality has been associated with impaired mental and physical health. Several pre-clinical studies have shown promising results, but evidence from human studies is still limited. Therefore, the aim of the present study is to investigate the effect of a citrus extract on sleep and mental wellbeing in healthy subjects with (minor) sleep disturbance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Citrus extract | Experimental | Daily Citrus extract supplementation for 8 weeks. |
|
| Control | Placebo Comparator | Daily Maltodextrin supplementation for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Citrus extract | Dietary Supplement | As described in experimental arm |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in sleep quality scores between the intervention and placebo group | Measured by a sleep quality questionnaire (PSQI) | 8 weeks of intervention |
| Changes in sleep quality between the intervention and placebo group | Measured using actigraphy | 8 weeks of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in mental wellbeing between the intervention and placebo group | Measured by mental wellbeing questionnaires | 8 weeks of intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yala Stevens, PhD | Contact | +31437114555 | yala.stevens@maastrichtuniversity.nl |
| Name | Affiliation | Role |
|---|---|---|
| Jogchum Plat | Maastricht University | Principal Investigator |
| Tanja Adam | Maastricht University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University | Recruiting | Maastricht | Netherlands |
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| ID | Term |
|---|---|
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000716707 | grapefruit seed extract |
| C008315 | maltodextrin |
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| Maltodextrin |
| Dietary Supplement |
As described in comparator arm |
|