Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
77 participants
INTERVENTIONAL
2014-03-31
2014-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Citrus flavonoid
Citrus flavonoid
Lozenge containing citrus flavonoid
Citrus flavonoid formulation
Citrus flavonoid formulation
Lozenge containing citrus flavonoid formulation
Placebo
Placebo
Identical looking placebo
Interventions
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Lozenge containing citrus flavonoid
Lozenge containing citrus flavonoid formulation
Identical looking placebo
Eligibility Criteria
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Inclusion Criteria
* Non-smoking
* Healthy
* Lightly disturbed sleep for at least six months, on a regular basis
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Chris Van der Grinten
Role: PRINCIPAL_INVESTIGATOR
Department: lung diseases MUMC
Locations
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Maastricht University Medical Center (MUMC)
Maastricht, , Netherlands
Countries
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Other Identifiers
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NL43845.068.13
Identifier Type: -
Identifier Source: org_study_id