Effect of the Test Food on Stress, Fatigue, Sleeping and Voiding.
- Conditions
- /A (healthy adults)
- Registration Number
- JPRN-UMIN000036476
- 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
- 24
Not provided
[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. [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 score of the Overactive Bladder Symptom Score in Question 3 is over 3 points and total points are over 2(1). [9]Individuals whose score of the International Prostate Symptom Score is over 8 points (1). [10]Individuals whose score of the Simplified Menopausal Index is over 50 points (2). [11]Individuals whose BMI is over 30. [12]Individuals who can not prohibit alcohol intake during the observation period. [13]Individuals who are sensitive to a test product or other foods, and medical products. [14]Individuals who have a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 1 months or will ingest those foods during the test period. [15]Individuals with probable seasonal allergy, such as pollinosis, during the test period. [16]Individuals whose life style will change during the test period. [17]Individuals who are pregnant, nursing or possibly pregnant. [18]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months. [19]Individuals who are or whose family is an employee of a health food, functional food, or cosmetic company. [20]Individuals judged inappropriate for the study by the principal. (1)Only male subjects. (2)Only female subjects.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method [1]Indexes on stress and fatigue and indexes on sleeping (Japanese Translation of Profile of Mood States, VAS and Pittsburgh Sleep Quality Index [Screening, Day 0 of observation Period I, Day 14 of Observation Period I, Day 0 of Observation Period II, Day 14 of Observation Period II]).
- Secondary Outcome Measures
Name Time Method *Secondary outcomes [1]Indexes on physical condition (King's HealthQuestionnaire [Day 0 of Observation Period I, Day 14 of Observation Period I, Day 0 of Observation Period II, Day 14 of Observation Period II]). [2]Voiding diary (From the first day of ingestion of a test material to the last day of the test). *Safety [1]Blood pressure, pulsation (Screening, Day 14 of Observation Period I, Day 14 of Observation Period II). [2]Weight, body fat percentage, BMI (Screening, Day 14 of Observation Period I, Day 14 of Observation Period II). [3]Doctor's questions (Screening, Day 14 of Observation Period I, Day 14 of Observation Period II). [4]Subject's diary (From three days ago of ingestion of a test material to the last day of the test).