Human study for investigating the safety and effectiveness of lactium on the sleep quality
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0001867
- Lead Sponsor
- Ewha Womans University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 48
1) Participants who give informed consent before the start
2) 20~65 years, healthy men and women (men : women = 1 : 1)
3) Subject with poor sleep quality (Pittsburgh Sleep Quality Index > 5)
1) Subject with severe sleep disorder (Insomnia severity index = 22)
2) Subject with snoring, sleep apnea, restless legs syndrome, periodic limb movement during sleep and narcolepsy
3) Subject who has experienced excessive stress within 2 weeks prior to the first visit (death of spouse, family discord, immigration, etc.)
4) Subject who took drugs that could have effect on sleeping within one month prior to the first visit
5) Subject receiving hormone therapy
6) Subject who consumes alcohol more than 140g per week (soju about 2.5 bottles/week, about 2.5 glasses/day)
7) Excessive smoking (> 20 cigarettes/day)
8) Subject who consumes excessive caffeine (> 10 cup of coffee/day)
9) Night-shift workers or subject who has irregular bedtime
10) Subject who took extended trip to foreign country within 4 weeks prior to the first visit
11) Body mass index(BMI) = 18 kg/m2 or = 35 kg/m2
12) Subjects who consumed functional foods or oriental medicine within one month prior to first visit
13) Subject sensitive to experimental materials or dairy products
14) Subject who participated in other human studies within one month prior to first visit
15) Pregnant or lactating women
16) Subject unable to use smartphone
17) Any condition that the principal investigator believes may put the subject at undue risk
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sleep health questionnaire;Polysomnography
- Secondary Outcome Measures
Name Time Method Actigraph;Salivary cortisol, sIgA ,melatonin