Fatigue, Polyphenols, Sleep
Conditions
Keywords
Polyphenols, Orange, Sleep, Fatigue
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTLozenge containing citrus flavonoid
DIETARY_SUPPLEMENTLozenge containing citrus flavonoid formulation
DIETARY_SUPPLEMENTIdentical looking placebo
Sponsors
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep quality as assessed objectively by means of a portable sleep monitoring system (ZEO) | 9 test nights (up to 9 days) | • 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective sleep quality ratings and fitness, tiredness and cognitive ratings, obtained from questionnaires | up to 9 days. Questionnaires are filled out the morning after every test night | Leeds Sleep Evaluation Questionnaire |
Countries
Netherlands
Outcome results
None listed