N/A (healthy adults)
Conditions
Interventions
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Males and females aged 40-65 years. [2]Individuals who are healthy and don't receive treatment. [3]Individuals whose urinary frequencies in the daytime are 8-14 times and who wake up to urinate during asleep is less than 1 time. [4]Individuals whose lights-out and weak-up time is regular, land time of sleeping is over 5 hours. [5]Individuals whose written informed consent has been obtained. [6]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. [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 whose PSA level is over 4.0 ng/m (1). [13]Individuals who have a drinking habit. [14]Individuals with serious anemia. [15]Individuals who are sensitive to a test product or other foods, and medical products. [16]Individuals who have a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period. [17]Individuals with probable seasonal allergy, such as pollinosis, during the test period. [18]Individuals whose life style will change during the test period. [19]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [20]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months. [21]Individuals who are or whose family is an employee of a health food, functional food, or cosmetic company. [22]Individuals judged inappropriate for the study by the principal. (1)Only male subjects. (2)Only female subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Voiding diary (From the first day of ingestion of a test material to the last day of the test) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary outcomes [1]Indexes on sleeping (Pittsburgh Sleep Quality Index, OSA sleep inventory [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). [2]Indexes on physical condition (Japanese Translation of Profile of Mood States, SF-8 Acute version [Day 0 of Observation Period I, Day 14 of Observation Period I, Day 0 of Observation Period II, Day 14 of Observation Period II]). *Safety [1]Blood pressure, pulsation (Screening, Day 14 of Observation Period II) [2]Weight, body fat percentage, BMI (Screening, Day 14 of Observation Period II) [3]Doctor's questions (Screening, Day 14 of 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]Hematologic test (Screening) [2]Blood biochemical test (Screening) [3]Urine analysis (Screening) [4]Overactive Bladder Symptom Score (Screening) [5]International Prostate Symptom Score (1) (Screening) [6]Simplified Menopausal Index (2) (Screening) (1)Only male subjects. (2)Only female subjects. | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed