None listed
Conditions
Interventions
Others(Health Functional Food) : Participants will be randomly assigned to either Group A (test product followed by control product) or Group B (control product followed by test product). During each
Sponsors
Ewha Womans University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women aged 19 to under 65 years old at the time of screening. 2) Individuals who experience one or more of the following symptoms at least once per week: difficulty initiating or maintaining sleep, early morning awakening with an inability to return to sleep, or non-restorative sleep (feeling unrefreshed despite sleeping). 3) Individuals with a total score >5 on the Pittsburgh Sleep Quality Index (PSQI), indicating poor sleep quality. 4) Individuals who voluntarily provide written informed consent to participate in this study and are able to understand and comply with the study procedures and requirements.
Exclusion criteria
Exclusion criteria: 1) Individuals who, based on an assessment using a structured diagnostic instrument, have major depressive disorder, bipolar disorder, alcohol dependence, or schizophrenia requiring treatment. 2) Individuals with an Insomnia Severity Index (ISI) total score of 22 or higher, indicating severe insomnia. 3) Individuals with an Epworth Sleepiness Scale (ESS) total score of 16 or higher, indicating severe daytime sleepiness. 4) Individuals who are currently receiving treatment for, or require treatment for, any of the following conditions that may cause sleep disturbances: sleep apnea, restless legs syndrome, periodic limb movement disorder, or narcolepsy. 5) Individuals with a body mass index (BMI) of 18.5 kg/m² or lower or 30 kg/m² or higher. 6) Individuals with medical conditions that are not adequately controlled with medication, such as hypertension, diabetes mellitus, thyroid dysfunction, or renal failure. 7) Individuals with a history of traumatic brain injury accompanied by loss of consciousness or seizures. 8) Individuals currently taking medications known to commonly cause sleep disturbances. 9) Individuals who have taken sleeping pills, tranquilizers, psychotropic medications, herbal medicines, or health functional foods that may affect sleep within 1 month before the screening visit. 10) Individuals who are unable to undergo brain magnetic resonance imaging (MRI) or polysomnography (PSG), including those with claustrophobia or implanted metallic medical devices. 11) Individuals who work night shifts or have irregular habitual bedtimes because of their occupation or for other reasons. 12) Individuals who have traveled long distances across time zones within 1 month before the screening visit. 13) Women who are pregnant or breastfeeding, or who plan to become pregnant during the study period. 14) Individuals whose average daily caffeine intake exceeds 300 mg/day, equivalent to approximately three cups of Americano coffee or five cups of instant coffee mix. 15) Individuals who have continuously consumed any ingredient contained in the test product for one month or longer. 16) Individuals with hypersensitivity, allergies, or adverse reactions to any ingredient contained in the test product or control product. 17) Individuals who have participated in other clinical trials (including human trials) within 1 month before the screening visit or who plan to participate in another study during the study period. 18) Individuals whom the investigator considers unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep Health Questionnaire;Sleep habits(Actigraphy, Sleep diary, Polysomnography) | — |
Secondary
| Measure | Time frame |
|---|---|
| Brain imaging;Neuropsychological test (Cambridge Neuropsychological Test Automated Battery, paper-and-pencil tests);Safety-related indicators (vital signs, laboratory tests, adverse event) | — |
Countries
Korea, Republic of
Contacts
Public ContactSuji Lee
Ewha Womans University
Outcome results
None listed