An interventional study of Lozenge containing citrus flavonoid and Lozenge containing citrus flavonoid formulation in Polyphenols, Sleep and Fatigue, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-11-20.
Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Supportive care
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.
1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.
This study's enrollment of 77 is above the median of 54 across 1,440 interventional studies indexed under Fatigue.
Browse Fatigue studies →Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Citrus flavonoid
Dietary Supplement: Lozenge containing citrus flavonoid
Citrus flavonoid formulation
Dietary Supplement: Lozenge containing citrus flavonoid formulation
Placebo
Dietary Supplement: Identical looking placebo
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.
Time frame: 9 test nights (up to 9 days)
Subjective sleep quality ratings and fitness, tiredness and cognitive ratings, obtained from questionnaires
Leeds Sleep Evaluation Questionnaire
Time frame: up to 9 days. Questionnaires are filled out the morning after every test night
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Maastricht University Medical Center