The Effect of Consumption of Lettuce Extract on the Improvement of Sleep Quality
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0007347
- Lead Sponsor
- niBio
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Terminated
- Sex
- All
- Target Recruitment
- 100
1) Adult men and women aged between 30 and 65 years of age whose satisfaction with sleep quality has decreased
2) PSQI (Pittsburg Sleep Quality Index) above 5 points
3) A person who voluntarily agrees to participate in the test and prepares an informed consent form
1) A person with an Insomnia Severity Index (ISI) of not less than 22 points or not more than 7 points
2) A person who has been diagnosed with or has been treated for sleep disorders
3) A person with a BMI of less than 18.5 kg/m2 or greater than 30.0 kg/m2
4) A person who has been diagnosed with or is being treated for dementia, depression, anxiety disorder, or alcoholism, drug addiction, or mental illness
5) Within one month of the start of the examination, changes that may cause excessive stress (e.g., death of a spouse, family discord, litigation/conflict, sudden living difficulties, immigration, etc.)
6) People with underlying diseases that are likely to cause sleep disorders - snoring, sleep apnea, lower extremity anxiety syndrome, periodic limb movement disorder, narcolepsy, respiratory disease, itching, nighturia, chronic pain or muscle spasms, and other sleep disorders
7) A person who has traveled abroad within the last month due to jet lag or who has plans to travel abroad during the study participation
8) A person engaged in the occupation of day and night shifts
9) Those with a surgical history that can significantly affect their participation in the study within the last 6 months
10) Patients with unregulated hypertension or diabetes (systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg or fasting blood sugar greater than 126 mg/dL)
11) Those with renal dysfunction (more than 1.5 times higher than the normal upper limit of creatine) and liver dysfunction (3 times higher than the normal upper limit of AST, ALT)
12) A person diagnosed with autoimmune disease or thyroid disease
13) A person diagnosed with severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.) or cardiovascular disease (e.g. angina, myocardial infarction, heart failure, arrhythmia, etc.)
14) A person undergoing hormone therapy
15) Pregnant and lactating women
16) A person who is allergic to or overreacted to the components of a human body test product
17) A person who has continuously taken medicine, health functional food or herbal medicine that may affect sleep within one month of the start of the test
18) Those with the following health-related habits - alcohol intake > 140 g/week or smoking > 10 cigarettes/day or caffeine intake > 10 cups/day
19) A person who has participated in another clinical trial or human application test one month before the start of the test
20) A person deemed inappropriate by the research manager to participate in the research
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pittsburgh Sleep Quality Index (PSQI)
- Secondary Outcome Measures
Name Time Method Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), Stanford Sleepiness Scale (SSS);Actigraphy;Sleep Diary;Polysonography;Salivary cortisol Concentration;Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Fatigue Severity Scale (FSS)