None listed
Conditions
Interventions
Dietary Supplement : Test product (EHAE1): Take 2 tablets once daily with sufficient water, 30 minutes before bedtime (each 600 mg tablet contains 250 mg of EHAE1).
Placebo: Take 2 tablets once daily
Sponsors
N Biotech Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults aged between 19 and 65 years 2) Individuals with a PSQI-K (Korean Version of the Pittsburgh Sleep Quality Index) score of 5 or higher 3) Individuals with an ISI-K (Korean Version of the Insomnia Severity Index) score between 8 and 21 (inclusive) 4) Individuals who voluntarily agree to participate in the study and sign the written informed consent form before the start of the trial
Exclusion criteria
Exclusion criteria: 1) Individuals currently being treated for serious diseases of the cardiovascular, immune, respiratory, gastrointestinal/hepatic and biliary, renal and urogenital, nervous, musculoskeletal systems, infectious diseases, or malignancies 2) Individuals with conditions or factors that may interfere with sleep, such as nocturia or frequent urination 3) Individuals currently being treated for major depressive disorder, generalized anxiety disorder, post-traumatic stress disorder, obsessive-compulsive disorder, as defined by DSM-V 4) Individuals with a history or current diagnosis of psychiatric disorders such as schizophrenia or bipolar disorder 5) Individuals with cognitive impairments due to conditions such as dementia (per DSM-V criteria) or Parkinson’s disease 6) Individuals who have received treatment or intervention for sleep disorders (e.g., insomnia, narcolepsy, obstructive sleep apnea, restless legs syndrome, periodic limb movement disorder) within one month prior to Visit 1 7) Individuals with a BMI =18.5 kg/m² or =35 kg/m² at Visit 1 8) Individuals experiencing withdrawal symptoms from alcohol or smoking 9) Individuals who smoke excessively (=20 cigarettes/day) 10) Individuals who consume excessive caffeine (>3 cups/day) 11) Individuals with a history of alcohol abuse or those who chronically consume alcohol *Defined as an average daily intake =40 g for men (=280 g/week), or =20 g for women (=140 g/week) 12) Individuals with irregular sleep patterns due to shift work or night work within one month prior to Visit 1 13) Individuals who have experienced acute stress (e.g., death of a family member, imprisonment, divorce, separation, debt, runaway, delinquency, infidelity, business failure, serious illness, remarriage, etc.) within one month prior to Visit 1 14) Individuals who have traveled across time zones within one month prior to Visit 1 15) Individuals who have taken oral corticosteroids or hormone therapies within one month prior to Visit 1 16) Individuals who have used medications that affect sleep within one month prior to Visit 1 (e.g., antipsychotics [anticonvulsants, antidepressants, anxiolytics, sleeping pills, stimulants], melatonin, beta-blockers, antihistamines) 17) Individuals who have taken sleep-related functional health foods within one month prior to Visit 1 (e.g., L-glutamic acid fermented GABA powder, Ecklonia cava extract, rice bran alcohol extract, Ashwagandha extract, milk protein hydrolysate [Lactium], etc.) 18) Individuals with uncontrolled hypertension (systolic BP =140 mmHg or diastolic BP =90 mmHg after resting for 10 minutes) 19) Individuals with uncontrolled diabetes mellitus (HbA1c > 7.0%) 20) Individuals with TSH =0.1 µIU/mL or =10 µIU/mL 21) Individuals with eGFR <60 mL/min/1.73 m² 22) Individuals with AST (GOT) or ALT (GPT) levels =3 times the upper limit of normal 23) Individuals who participated in another interventional clinical trial (including human studies) within one month prior to Visit 1, or plan to participate in one during this study 24) Pregnant or breastfeeding women, or those planning to become pregnant during the study period 25) Individuals with hypersensitivity or allergy to any component of the investigational product 26) Individuals deemed unsuitable for participation by the investigator for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSQI-K (Pittsburgh Sleep Quality Index-Korean version) | — |
Secondary
| Measure | Time frame |
|---|---|
| ISI-K (Insomnia Severity Index-Korean version);KESS (Korean version of Epworth Sleepiness Scale);Sleep diary;Actigraphy;PSG (Polysomnography) | — |
Countries
Korea, Republic of
Contacts
Public ContactWonchul Shin
Kyung Hee University Hospital at Gangdong
Outcome results
None listed