Healthy adults
Conditions
Interventions
Consume the test food at a low dose once a day for 2 weeks.
Consume the test food at a high dose once a day for 2 weeks.
Consume placebo food once a day for 2 weeks.
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Healthy Japanese men and women aged 20 and over but under 65 at informed consent. 2)Subjects who feel temporary fatigue in daily life. 3)Subjects who with a Pittsburgh Sleep Quality Index score of 6 or higher. 4)Subjects who have received a sufficient explanation of the purpose and content of the study, have the ability to consent, voluntarily applied to participate in the study after a good understanding, and have agreed to participate in the study in writing.
Exclusion criteria
Exclusion criteria: Subjects who 1)are suffering from or have a history of serious liver disease, kidney disease, gastrointestinal disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal gland disease, or other metabolic disease 2)at high risk of suffering from idiopathic chronic fatigue or chronic fatigue syndrome based on self-report 3)are presumed to be at high risk of suffering from depression based on CES-D scores or other questionnaires 4)with a history of treatment for sleep disorders or current medical history 5)have been diagnosed with sleep apnea syndrome, or suspected of having it 6)are taking medication or consuming supplements (including functional food products) related to sleep and fatigue recovery 7)have digestive disease or a history of digestive surgery 8)have allergy to the research food 9)are pregnant, lactating, or planning to get pregnant 10)with an infant under one year old in a household 11)sleeps with multiple individuals on a single bedding 12)living with someone requiring long-term care 13)have excessive alcohol intake more than approximately 20g/day of pure alcohol equivalent or habit of drinking more than 4 days a week 14)cannot stop drinking from 2 days before each measurement 15)have an experience of drug dependence or alcohol dependence or current illness 16)smokes more than 20 cigarettes a day or cannot to stop smoking from the time they wake up on the measurement day until the end of the measurement 17)are Shift workers, late-night workers, or with irregular working days and holidays 18)regularly engage in strenuous exercise or work 19)have donated blood or blood components exceeding 200 mL within one month prior to the consent date or 400 mL within three months prior to the consent date 20)plan to participate in other clinical study during study periods or had participated in other clinical study within the last 1 month 21)are judged by the principal investigator to be inappropriate as study subjects for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OSA-MA | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) VAS for waking up 2) VAS for fatigue | — |
Countries
Japan
Contacts
Public ContactYoshika Komori
KSO Corporation Clinical Trial Management department
Outcome results
None listed