healthy humans
Conditions
Interventions
Oral ingestion of the test food once a day for 4 weeks
Oral ingestion of the placebo control food once a day for 4 weeks
Sponsors
Miura Clinic, Medical Corporation Kanonkai
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) 40<=Age<64 of healty men and women (2) Subjects in menopause (3) Subjects with reduced sleep quality (4) Subjects not taking drugs such as sleeping pills (5) Subjects who received a sufficient explanation of the purpose and details of the examination, voluntarily participate in voluntary participation after having a good understanding, understanding well and agreeing to participate in the examination in writing
Exclusion criteria
Exclusion criteria: (1) Subjects with diabetes, liver disease, kidney disease, gastrointestinal disease, peripheral vascular disease, or medical history for severe diseases (2) Subjects who are diagnosed with heart disease and are restricted from daily extreme exercise (3) Subjects using implantable medical electrical devices (pacemakers, implantable defibrillators, etc.) that are susceptible to electromagnetic interference (4) Subjects using wearable medical electrical devices (electrocardiographs, pacemakers, etc.) (5) Subjects who indicate abnormal parameter in liver or kidney function (6) Subjects with a disease under treatment now (7) Subjects with drug or food allergy (8) Subjects who play high intensity sports or are on a diet (9) Subjects who can not stop taking health foods (including food for specified health uses, foods with function claimss) or designated quasi drugs during the examination period (10) Subjects taking continuous medication (including OTC, prescription drugs) (11) Subjects taking health foods, quasi-drugs, medicines (including OTC, prescription medicine) expected to improve insomnia (12) Subjects using sleep-promoting bedding / equipment (13) Subjects who have used Healthtron or other electric potential therapy devices at present or in the past (14) Subjects who consume excess alcohol or who can not abstain from the day before the test to the day during the sleep brain wave measurement period (15) Subject who has been pregnant or subject who have a plan to become pregnant or breast feed during the study period (16) Subjects who is participating in the other study or planning to participate during the study period (17) Subjects deemed unsuitable by the investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Brain waves during sleep | — |
Secondary
| Measure | Time frame |
|---|---|
| OSA sleep inventory MA version Visual Analogue Scale | — |
Countries
Japan
Contacts
Public ContactMakoto Terashima
Oneness Support Co., Ltd. Clinical Trial Division
Outcome results
None listed