Healthy subjects
Conditions
Interventions
Oral ingestion of the test food containing onion extract (3 pills/day
5 days), wash out period (2 days), Oral ingestion of the test food not containing onion extract (3 pills/day
5 days).
Oral ingestion of the test food not containing onion extract (3 pills/day
5 days), wash out period (2 days), Oral ingestion of the test food containing onion extract (3 pills/day
5 days).
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Male and female who don't feel like a good sleep aged 30 to 49 when consent acquisition. (2)Subjects who have a habit of going to bed before 0 a.m. (3)Subjects whose Pittsburgh Sleep Quality Index score is over 6. (4)Subjects who understand the study procedure and agree to participate in the study by giving informed consent prior to the study.
Exclusion criteria
Exclusion criteria: (1)Subjects using medical products. (2)Subjects who have a habit of ingestion medicine, health-promoting foods, foods for specified health uses, health foods that may involve this study. (3)Subjects who have a history of heart failure,liver failure, kidney failure,digestive system disease. (4)Subjects whose hay fever is under treatment. (5)Subjects who use pacemaker. (6)Subjects whose skin is sensitive and develop a rash by adhesive bandage. (7)Females who are pregnant or lactating, or who could become pregnant or lactating during test period. (8)Subjects who excessively take alcohol. (9)Subjects whose eating habits and rhythm of daily life are irregular (Shifts workers, late-night workers). (10)Subjects who have a habit of taking onion over 200g/day. (11)Subjects who have allergy for medicine and foods. (12)Subjects whose BMI is over 30. (13)Subjects who are diagnosed with Sleep apnea syndrome, who are aware of being apena during sleep. (14)Subjects who cannot use Sleep Scope during the test period. (15)Subjects who plan to go on a trip with lodging during the test period. (16)Subjects who cannot give up drinking alcohol during the test period. (17)Subjects who have a history of sleep disorder. (18)Subjects using medical products for sleep disorder. (19)Subjects who plan to participate in other clinical tests. (20)Subjects who are not eligible for this study for some medical reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Electroencephalographic(During 5 day intake), St. Mary's Hospital Sleep Questionnaire(During 5 day intake) | — |
Secondary
| Measure | Time frame |
|---|---|
| Salivary amylase(Day before the start,1 day,5 day, 6day), Sleep diary(From the first day of ingestion of a test food to the last day of the test) | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Plan Sales Department
Outcome results
None listed