None listed
Conditions
Interventions
Dietary Supplement : Participants will take 1 capsule (300 mg) once daily, 30 minutes before bedtime, for 4 weeks (28 days).
The test and control products will be manufactured to be visually and physi
Sponsors
Nutra-it
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) men and women aged 19 to 65 2) Those with a Pittsburgh Sleep Quality Index (PSQI) score of 5 or higher 3) A person who agrees to participate in this study and signs a written consent form
Exclusion criteria
Exclusion criteria: 1) Those with extreme sleep disorders (Insomnia severity index = 22 points, or = 7 points factor) 2) Those who have the following conditions (including mental illness) that cause sleep disorders : Sleep apnea (sleep apnea), restless leg syndrome, periodic limb movement disorder (periodic limb movement during sleep), depression, narcolepsy (dyspathy) 3) Changes that may cause excessive stress within 2 weeks of the first visit : : Death of spouse, family feud, litigation/dispute, sudden difficulty in living, immigration, etc 4) Those who are taking medicines that may affect their sleep within one month of their first visit 5) A person undergoing hormone therapy 6) Those who usually drink too much alcohol (>280g/week, about 5 bottles/weeks of soju) 7) Those who smoke excessively (> 10 cigarettes/day) 8) Those who consume more than 400mg of caffeine daily (ex. those who consume 8 cups of mixed coffee, 3 cups of americano, and 8 cups of green tea or more) 9) A night shift worker or a person whose bedtime is irregular due to his/her usual job, etc 10) A person who has traveled long distances to a country with a different time difference within one month of his/her first visit 11) Body mass index (BMI) is 18kg/m2 or less or 35kg/m2 or more 12) A person who has continuously consumed health functional food or herbal medicine within one month of his/her first visit 13) A person who participated in a clinical trial within one month of the first visit 14) Pregnant women and nursing mothers 15) If the researcher deems it inappropriate to participate in this test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep efficiency (SE);sleep incubation period (SL);total sleep time (TST);wake-up time (WASO);Delta power | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh sleep quality assessment questionnaire (PSQI);Leeds Sleep Evaluation Questionnaire (LSEQ);VAS (Visual Analogue Scale) questionnaire;SSSStanford Sleepness Scale questionnaire;Changes in blood levels of cortisol, hs-CRP, IL-6, and TNF-a | — |
Countries
Korea, Republic of
Contacts
Public ContactMUN HYUK SEONG
Seroul Health Care
Outcome results
None listed