None listed
Conditions
Interventions
[1] Oral ingestion of a test food (1 pill in a day
2 weeks). [2] Observation. [3] Washout (2 weeks) [4] Oral ingestion of a placebo food (1 pill in a day
2 weeks). [5] Observation.
[1] Oral ingestion of a placebo food (1 pill in a day
2 weeks). [2] Observation. [3] Washout (2 weeks) [4] Oral ingestion of a test food (1 pill in a day
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Males and females aged 20-59 years. [2] Individuals who are healthy and have no chronic physical disease. [3] Individuals who are easily fatigued in daily life and are dissatisfied with their sleep. [4] Individuals who go to bed (lights off) and wake up at regular times, go to bed (lights out) before midnight, and have a habit of sleeping for 4 hours or more. [5] Individuals who sleep alone. [6] Individuals who work five days a week during the daytime and have weekends off; who are full-time housewives but their cohabitants (spouse, children under high school age) work five days a week during the day or commute to school or work on weekdays, and have a regular lifestyle (ex. waking and sleeping times). [7] Individuals who do not have a habit of drinking. [8] Individuals whose written informed consent has been obtained after explanation of this study. [9] Individuals who can have an examination on a designated check day. [10] Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: [1] Individuals who are placed in an environment that interferes with sleep at bedtime. [2] Individuals using medical products. [3] Individuals who use a drug for treatment of disease. [4] Individuals who are suspected patient of, a patient of, or had a history of sleep apnea syndrome. [5] Individuals who have or are suspected patient of nocturia, benign prostatic hyperplasia, overactive bladder. [6] Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [7] Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. [8] Individuals who are a patient or have a history of or endocrine disease. [9] Individuals who used a drug to treat a disease in the past 1 month. [10] Individuals with drug and food allergies. [11] Individuals whose BMI is over 30 kg/m2. [12] Individuals who consume 2 or more cups of coffee or tea a day (14 or more cups per week; excepting those who can limit their intake during the EEG measurement period). [13] Individuals who are a smoker. [14] Individuals with serious anemia. [15] Individuals who had a habit to ingest Food with Health Claims, health foods, or supplements in the past 1 month or will ingest those foods during the test period. [16] Individuals with probable seasonal allergy, such as pollinosis, during the test period. [17] Individuals with possible changes of life style during the test period. [18] Individuals who may have different sleeping conditions during the EEG measurement period. [19] Individuals who may cause skin irritation due to the electrode adhesive pad. [20] Individuals who are pregnant, nursing or possibly pregnant. [21] Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months. [22] Individuals who are or whose family is an employee of a health food, functional food, or cosmetic company. [23] Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OSA sleep inventory (Screening, 2nd week of the observation period I: 8 days, and 2nd week of the observation period II: 8 days.) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary indexes [1] Electroencephalography measurement during sleep with SleepScope.(1) [2] St. Mary's Hospital Sleep Questionnaire.(2) [3] Japanese Edition of Profile of Mood States.(2) [4] Visual Analogue Scale.(3) [5] Activity survey (Subject's diary).(4) *Safety [1] Blood pressure, pulsation.(2) [2] Weight, body fat percentage, BMI.(2) [3] Doctor's questions/ Side effects/ Adverse events.(2) [4] Subject's diary.(4) *Other indexes [1] Baseline characteristics.(5) [2] Hematologic test.(5) [3] Blood biochemical test.(5) [4] Urine analysis.(5) [5] Height measurement.(5) [6] Waist girth, hip girth.(5) [7] Pittsburgh Sleep Quality Index (PSQI-J).(5) [8] Munich ChronoType Questionnaire-Japanese version.(5) (1): Screening, 2nd week of the observation period I: 5days, 2nd week of the observation period II: 5days. (2): Screening, 2nd week of the observation period I, 2nd week of the observation period II. (3): Screening, 2nd week of the observation period I: 3days, 2nd week of the observation period II: 3days. (4): Every day from the day before the observation period I to the day before the observation period II. (5): Screening. | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed