Effects of Consumption of the Test Food on Sleep Quality, Fatigue and Quality of Life.
- Conditions
- o
- Registration Number
- JPRN-UMIN000048981
- Lead Sponsor
- TES Holdings Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 12
Not provided
[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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method OSA sleep inventory (Screening, 2nd week of the observation period I: 8 days, and 2nd week of the observation period II: 8 days.)
- Secondary Outcome Measures
Name Time Method