N/A (healthy adults)
Conditions
Interventions
Oral intake of Test Food A (3 capsules in a day
8 weeks).
Oral intake of Test Food B (3 capsules in a day
8 weeks).
Oral intake of the placebo (3 capsules in a day
8 weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: [1]Japanese males aged 40-69 years. [2]Individuals who are healthy and have no chronic physical disease. [3]Individuals whose urinary frequencies in the daytime are 8-14 times and who wake up more than 5 days in a week to urinate after sleeping and before waking up. [4]Individuals who are aware of mild sleep disorders such as a nocturnal awakening, an early morning awakening and a deep sleep disorder. [5]Individuals who work on daytime from Monday to Friday and have Saturdays and Sundays off. [6]Individuals whose lights-out and wake-up time is regular, and who have a habit of sleeping more than 5 hours. [7]Individuals who sleep alone. [8]Individuals who do not have a habit of drinking. [9]Individuals whose written informed consent has been obtained. [10]Individuals judged appropriate for the study 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 whose OABSS score is over 2 point in the Q. 3 and over 3 points in the total score of the OABSS, and OABSS score is over 6 points. [6]Individuals whose IPSS score is over 8 points. [7]Individuals who used a drug to treat a disease in the past 1 month. [8]Individuals who have a history of heart failure, kidney failure, hepatitis B or hepatitis C. [9]Individuals who have a history of digestive system disease. [10]Individuals whose BMI is over 30kg/m2. [11]Individuals who cannot stop drinking. [12]Individuals who are sensitive to a test product or other foods, and medical products. [13]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. [14]Individuals with probable seasonal allergy, such as pollinosis, during the test period. [15]Individuals whose life style will change during the test period. [16]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months. [17]Individuals who are or whose family is an employee of a health food, functional food, or cosmetic company. [18]Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Indexes for urination (Overactive Bladder-questionnaire (1), Nocturia-Quality of Life (1), urinary survey (2)). (1): Screening, Week 0, Week 4, Week 8. (2): Everyday From the seven days before the first day of ingestion of a test material to the last day of the test. | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary indexes [1]Indexes for sleeping (The Japanese version of the Pittsburgh Sleep Quality Index(1), OSA sleep inventory MA version (2)). [2]Indexes for QOL(SF-8TM standard version (1)). (1): Screening, Week 0, Week 4, Week 8. (2): Screening, Week 0 (for 5 days), Week 4 (for 5 days), Week 8 (for 5 days). *Safety indexes [1]Blood pressure, pulsation (1). [2]Weight, body fat percentage, BMI (1). [3]Blood test(1). [4]Blood biochemical test(1). [5]Urine analysis(1). [6]Doctor's questions (1). (1): Screening, Week 0, Week 8. | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed