None listed
Conditions
Interventions
Dietary Supplement : - Lettuce extract or placebo
- Capsules, 500 mg/capsule
- 2 capsules/time, once a day, Oral administration for 4 weeks (1,000 mg as lettuce extract)
- Take 2 capsules with water 3
Sponsors
UniBio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index (PSQI) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Korea, Republic of
Contacts
Public ContactMiji Lee
Research Institute of Medical Nutrition
Outcome results
None listed