Decrease in sleep quality
Conditions
Interventions
Test food or placebo intake period: 14 days in each of the first and second cycles (Test food and placebo are interchanged in the first and second cycles). -Cycle 1: 7 days of pre-treatment and 7 day
Sponsors
AMINO UP Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: -Healthy adult male -Day shift workers from Monday to Friday (excluding those who work the early or late shift or other on-duty days) -Those who are able to take oral intake adequately. -Persons who have been fully informed of the study and who have given their free and voluntary written consent based on a thorough understanding of the study.
Exclusion criteria
Exclusion criteria: -BMI of 25 or higher (body mass index of 1 or higher) and Epworth sleepiness scale (evaluation of sleepiness) of 11 or higher. -Those who have good sleep phase, quality, and quantity (phase: 9 points or more, quality: 11 points or more, quantity: 9 points or more) on the 3D Sleep Scale (3DSS), and who score less than 6 points for sleep disturbance on the Pittsburgh Sleep Questionnaire (PSQI-J). -Morningness/eveningness diagnosis (morning/evening type) with a clear morningness (70-86 points) or clear eveningness (16-30 points). -Those who have an excessive*1 smoking habit. -Heavy drinker of alcohol*2 -Heavy drinkers*3 of caffeine-containing beverages and those who habitually consume caffeine-containing beverages within 4 hours before bedtime. -Those who have severe anemia, circulatory disease, respiratory disease, liver disease, renal disease, gastrointestinal disease, diabetes, rheumatoid arthritis, acute infectious disease, psychiatric disease, cerebrovascular disease, benign prostatic hyperplasia, frequent urination at night, symptoms of overactive bladder, etc. -Those who are receiving treatment for insomnia or sleep disorders. -Persons with serious drug or food allergies -Patients who are regularly using medications prescribed by a physician that are thought to affect sleep. -Persons enrolled in other clinical trials. -Other subjects deemed unsuitable by the principal investigator. *1: More than 20 cigarettes per day on average *2: Alcohol: An average of more than 60 g of the equivalent of pure alcohol per day, for example, 3 medium beer bottles (about 3 long cans 500 mL x 3), a little less than 3 gou of sake (180 mL x 3), 1+1/2 glasses (about 300 mL) of 25% shochu, 3 double glasses (about 180 mL) of whiskey, a little less than 6 glasses (about 600 mL) of wine, 3 cans (about 350 mL x 3) of canned chuhai with 7% alcohol *3: Coffee: An average of more than 3 cups (237 mL/cup x 3) in a mug per day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep electroencephalogram measurement -Sleep quality related indexes: sleep efficiency, arousal index, sleep onset latency, wake time after sleep onset -Sleep status: lights-out time, lights-on time, total recording time, sleep-onset time, sleep-median time, final wake-up, time on the floor after final wake-up, total sleep time, sleep stage duration, sleep stage occurrence rate, and REM latency. | — |
Secondary
| Measure | Time frame |
|---|---|
| -Sleep Questionnaire: OSA-MA, Pre-Sleep Questionnaire (PSQ) -HSP-70 expression in blood cells -Adverse events -Subjects' logbooks | — |
Countries
Japan
Contacts
Public ContactTsukasa Takahashi
AMINO UP Co., Ltd. Business Development Division
Outcome results
None listed