Healthy adults
Conditions
Interventions
Consume foods containing crocetin once a day just before bedtime for 1 week.
Consume a placebo food containing no crocetin once a day just before bedtime for 1 week.
Sponsors
Calbee, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Healthy males and females aged 45 to 74 years-old. -Subjects who are a manager or higher and have some sleep complaints or have no sleep complaints according to the pre-sleep questionnaire. -Subjects who can make self-judgment and arevoluntarily giving written informed consent.
Exclusion criteria
Exclusion criteria: -Subjects who have taken, or will take during the study period, drugs (e.g., antiallergic drugs, sleep inducing drugs, sleep aids, etc.) that may affect the study one month prior to the start of intake of the study foods. -Subjects who regularly consume food for specified health use, functional foods, supplements, or health foods that may affect the study more than 3 times a week, and those who are unable to limit their intake during the study period. -Subjects who with a history or current history of serious heart, liver, kidney, or gastrointestinal diseases. -Subjects who suspected chronic or acute serious infectious diseases. -Subjects who are scheduled to be vaccinated during the study period. -Subjects who are pregnant or planning to become pregnant or breastfeed during the study period. -Subjects who have excessive alcohol. -Subjects who with extremely irregular eating habits. -Subjects who has a BMI of 30 or higher. -Subjects who plan to change their lifestyle drastically during the study period. -Subjects whose sleep may be disturbed by external factors (e.g., roommates or pets). -Subjects who allergic to food. -Subjects who are currently participating in a clinical study of another drug or health food and who plan to participate in another clinical study within one month after the completion of the study or after giving consent to participate in the study. -Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Indexes on sleeping | — |
Secondary
| Measure | Time frame |
|---|---|
| Questionnaire | — |
Countries
Japan
Contacts
Public ContactYusuke Osuka
Calbee, Inc. Functional Research Section Research Department Research & Development Division
Outcome results
None listed