N/A (healthy adults)
Conditions
Interventions
2 weeks) >
Washout period (2 weeks) >
Oral intake of the placebo food (1 pill in a day
2 weeks)
Oral intake of the placebo food (1 pill in a day
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Males aged 35-60 years of Postmenopausal females aged 35-60 years. [2]Individuals who are healthy and don't receive treatment. [3]Individuals who fell fatigued, are bad falling asleep, or sleep badly. [4]Individuals whose lights-out and weak-up time is regular, light-out time is before 0 AM, and time of sleeping is over 4 hours. [5]Individuals who work on daytime from Monday to Friday and have Saturdays and Sundays off. [6]Individuals whose written informed consent has been obtained. [7]Individuals judged appropriate for the trial by the principal.
Exclusion criteria
Exclusion criteria: [1]Individuals using medical products. [2]Individuals who use a drug for treatment of disease. [3]Individuals who are suspected patient of, a patient of, or had a history of sleep apnea syndrome. [4]Individuals who have or are suspected patient of nocturia, benign prostatic hyperplasia, overactive bladder. [5]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis). [6]Individuals who have a history of heart failure, kidney failure, hepatitis B or hepatitis C. [7]Individuals who have a history of digestive system disease. [8]Individuals whose BMI is over 25. [9]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day). [10]Individuals who are a smoker. [11]Individuals with serious anemia. [12]Individuals who are sensitive to a test product or other foods, and medical products. [13]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 1 month or will ingest those foods during the test period. [14]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period. [15]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [16]Individuals who participated in other clinical studies in the past 3 months. [17]Individuals who are sensitive to the electrode pad. [18]Individuals who are or whose family is a employee of a health food, functional food, or cosmetic company. [19]Individuals judged inappropriate for the trial by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Electroencephalography measurement with SleepScope (Week 0, 2nd week of the observation period I, 2nd week of the observation period II) [2]OSA sleep inventory (Screening, Week 0, 2nd week of the observation period I, 2nd week of the observation period II) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Safety [1]Blood pressure (Screening, 2nd week of the observation period I, 2nd week of the observation period II) [2]Weight, body fat percentage, BMI (Screening, 2nd week of the observation period I, 2nd week of the observation period II) [3]Doctor's questions (Screening, 2nd week of the observation period I, 2nd week of the observation period II) [4]Subject's diary (From the first day of ingestion of a test material to the last day of the test) *Other indexes [1]Blood test (Screening) [2]Blood biochemical test (Screening) [3]Urine analysis (Screening) [4]Pittsburgh Sleep Quality Index (PSQI-J) (Screening) | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd Administrative Department of Clinical Trials
Outcome results
None listed