A Study on the Effect of Test Food on Lower Back Problems -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-

UMIN ID: UMIN000054270

Registered date:26/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: No
• Date of first enrollment: 2024/04/26
• Target sample size: 66
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Active food, 8 weeks consumption
Placebo food, 8 weeks consumption

Outcome(s)

• Primary Outcome: assessment of lower back problems
• Secondary Outcome: Questionnaire

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: Subjects (who) 1) are currently attending hospital or have a current medical history of a disease that could affect the study. 2)underwent surgery for chronic pain in joints, ligament injury or meniscus injury. 3)with artificial joints, etc. 4)take joint related medicines (such as poultices, liniments, and/or analgesics, etc.) three or more times a week. 5)can't stop using drugs and/or supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting joints during the study period. 6) are pregnant or planning to become pregnant or breastfeed during the study period. 7)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). 8)have allergy to ingredients of test foods. 9)are participating or intend to participate in other clinical trials that may affect the study at the time of commencement of the study. 10)are judged as unsuitable for the current study by the investigator for other reasons.

Related Information

• Primary Sponsor: TOYO SHINYAKU Co., Ltd.
• Source(s) of Monetary Support: TOYO SHINYAKU Co., Ltd.