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Evaluation of sleep-improving effects of a food

Not Applicable
Conditions
Healthy subjects
Registration Number
JPRN-UMIN000031122
Lead Sponsor
CPCC Company Limited
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
30
Inclusion Criteria

Not provided

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Electroencephalographic(During 5 day intake), St. Mary's Hospital Sleep Questionnaire(During 5 day intake)
Secondary Outcome Measures
NameTimeMethod
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)
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