None listed
Conditions
Interventions
Active food, 12 weeks consumption
Placebo food, 12 weeks consumption
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Males and females aged 40 to 74 years-old with discomfort of knee joints. 2)Subjects whose knee joints are judged to be not diseased by the investigator according to the Kellgren-Lawrence grade (KL grade) in X-ray at screening tests. 3)Subjects whose BMI are less than 30. 4)Subjects who are judged not suffering from a disease by the investigator. 5)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Exclusion criteria
Exclusion criteria: 1)have a history of and/or contract rheumatoid arthritis, or are suspected to have rheumatoid arthritis by screening tests. 2)underwent surgery for chronic pain in joints, ligament injury or meniscus injury. 3)with knee artificial joints, etc. 4)take joint related medicines (such as poultices, liniments, and/or analgesics, etc.) three or more times a week. 5)have a history of and/or contract serious diseases (eg, liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, metabolic disease and/or joint disease). 6)can't stop using drugs and/or supplements affecting joints during the study period. 7)have allergy to ingredients of test foods. 8)are under treatment for or have a history of drug addiction and/or alcoholism. 9)have excessive alcohol intake more than approximately 20 g/day of pure alcohol equivalent or habit of drinking not less than 5 days a week. 10)can't stop drinking from 2 days before the screening measurement and each measurement. 11)are shift worker or mid-night worker. 12)with extremely irregular dietary habit. 13)plan to travel abroad, including overseas trip, during test periods. 14)are pregnant or planning to become pregnant or breastfeed during the study period. 15)have donated over 200 mL of blood and/or blood components within the last one month or over 400 mL of blood and/or blood components within the last three months prior to screening tests. 16)had participated in other clinical studies (measurement) within the last one month prior to the current study and/or are planning to participate in other clinical studies (measurement) during the current study. 17)are judged as unsuitable for the current study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS and JKOM score after 12 weeks of intake | — |
Countries
Japan
Contacts
Public ContactYoshika Komori
KSO Corporation Clinical Trial Management department
Outcome results
None listed