N/A(healthy adults)
Conditions
Interventions
Observation Period I: Oral intake of the test food A (5 days) >
Washout period (1 week) >
Observation Period II: Oral intake of the test food B (5 days) >
Observation Period III: Oral intake of the placebo food (5 days)
Observation Period I: Oral intake of the test food A (5 days) >
Observation Period II: Oral intake of the placebo food (5 days) >
Observation Period III: Oral intake of the test food B (5 days)
Observation Period I: Oral intake of the test food B (5 days) >
Observation Period II: Oral intake of the test food A (5 days) >
Observation Period III: Oral intake of the placebo food (5 days)
Observation Period I: Oral intake of the test food B (5 days) >
Observation Period III: Oral intake of the test food A (5 days)
Observation Period I: Oral intake of the placebo food (5 days) >
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Males aged 20-64 years of postmenopausal females aged 20-64 years. [2]Individuals who are healthy and don't receive treatment. [3]Individuals who fell fatigued, are bad falling asleep, or sleep badly. [4]Individuals whose Pittsburgh Sleep Quality Index (PSQI-J) score is over 6 points. [5]Individuals whose lights-out and weak-up time is regular, light-out time is before 0 AM, and time of sleeping is over 4 hours. [6]Individuals who sleep alone. [7]Individuals who work on daytime from Monday to Friday and have Saturdays and Sundays off. [8]Individuals whose written informed consent has been obtained. [9]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 BMI is over 30. [9]Individuals whose systolic and diastolic blood pressures are over 140mmHg and 90mmHg, respectively. [10]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day). [11]Individuals who cannot restrict to taking coffee and tea less than 2 cups in a day. [12]Individuals who are a smoker. [13]Individuals with serious anemia. [14]Individuals who are sensitive to a test product or other foods, and medical products. [15]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, energy drinks, 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, such as conducting a long-term travel, during the test period. [18]Individuals whose sleep situation will be different according to circumstances like sleepover. [19]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [20]Individuals who participated in other clinical studies in the past 3 months. [21]Individuals who are sensitive to the electrode pad. [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 trial by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Electroencephalography measurement with SleepScope (Day 0, 5 days of the observation period I, 5 days of the observation period II, 5 days of the observation period III) [2]OSA sleep inventory (Screening, Day 0, 5 days of the observation period I, 5 days of the observation period II, 5 days of the observation period III) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary outcomes [1]Epworth Sleepiness Scale (ESS) (Screening, Day 0, 5th day of the observation period I, 5th day of the observation period II, 5th day of the observation period III) [2]Visual analogue scale for exhilarating feeling upon waking (Screening, Day 0, 5th day of the observation period I, 5th day of the observation period II, 5th day of the observation period III) [3]Visual analogue scale for conditions in the daytime (Screening, Day 0, 5th day of the observation period I, 5th day of the observation period II, 5th day of the observation period III) *Safety [1]Blood pressure (Screening, Day 0, 5th day of the observation period I, 5th day of the observation period II, 5th day of the observation period III) [2]Weight, body fat percentage, BMI (Day 0, 5th day of the observation period I, 5th day of the observation period II, 5th day of the observation period III) [3]Doctor's questions (Day 0, 5th day of the observation period I, 5th day of the observation period II, 5th day of the observation period III) [4]Subject's diary (From the first day of ingestion of a test material to the last day of the test) *Other indexes [1]Blood test (Screening) [2]Blood biochemical test (Screening) [3]Urine analysis (Screening) [4]Pittsburgh Sleep Quality Index (PSQI-J) (Screening) | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed