Healthy male/female adults
Conditions
Interventions
Consumption of the test food to the subjects, two a day for 2 weeks.
Consumption of the placebo food to the subjects, two a day for 2 weeks.
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy male/female subjects with unsatisfactory sleep, ranging in age from 20 to 64 at informed consent. (2) Subjects having the habit of going to bed by 24 o'clock. (3) Subjects taking in a staple food for dinner every day. (4) During the test period, subjects who can take the test foods daily after fifteen o'clock, two a day. (5) Subjects who can receive the test foods twice a week. (6) Subjects who can give informed consent to participate in this study, after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: Subjects - - (1) taking in sleep-affecting foods, not less than three times a week, (2) who will take medicines which might affect the test (e.g., sleeping pill) during the test period, (3) vaccinated within two weeks before this study, or planning to vaccinate during intaking of test-foods, (4) with not less than 30.0 kg/m2 of BMI, (5) with sleep-apnea syndrome, (6) with previous medical history of sleep disorder, (7) with a continuous medical treatment for sleep disorder, (8) cannot use the sleep-scope during the test period, (9) with an alcohol intake at the measurement of brain waves, (10) with an overnight trip during the test period, (11) with extremely irregular dietary habit/life rhythm, (12) with a serious sleep-affecting rhinitis, (13) with excessive alcohol intake, (14) with the roomer planning to participate in this study, (15) restricting their mealtimes to no more than once a day (not less than once a week), within the last month, (16) with medical history of serious diseases, (17) with pregnancy, possibly one, or lactating, (18) with drug/food allergy (wheat, egg, milk), (19) being fitted with a pacemaker, (20) with sensitive skin, irritating by an adhesive tape, (21) being under another clinical test (medicine or health food), or participated in that within the last 4 weeks, or will join that after the consent, (22) who donated their blood components or blood (0.2 L) within the last month, (23) who donated his blood (0.4 L) within the last 3 months, (24) who donated her blood (0.4 L) within the last 4 months, (25) being collected in total of his blood (1.2 L) within the last 12 months and in this study, (26) being collected in total of her blood (0.8 L) within the last 12 months and in this study, (27) being determined as ineligible for participation by the principal/sub investigator - - .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleeping condition measured by electroencephalograph (sleep-scope) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Oguri-Shirakawa-Azumi sleep inventory ver. MA 2. MOS 36-Item Short-Form Health Survey version2 (acute version) 3. Cortisol and alpha-amylase in saliva | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Clinical Planning Department
Outcome results
None listed