Tokyo, Nov. 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059885) titled 'A study for the efficacy of test food on knee joint discomfort -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-' on Nov. 26.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - KSO Corporation

Condition: Condition - Healthy adult Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate effects of test food on knee joint discomfort for 12 weeks Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intake of test food for 12 weeks Interventions/Control_2 - Intake of placebo for 12 weeks

Eligibility: Age-lower limit - 40 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Males and females aged 40 years old or older at the time of informed consent. 2) Subject with discomfort or pain of knee joints. 3) Subjects diagnosed as grade 0 or I according to the Kellgren- Lawrence grade (KL grade). 4) Subjects whose BMI are less than 30. 5) Subjects who can make self-judgment and are voluntarily giving written informed consent. Key exclusion criteria - 1) have a history of and/or contract rheumatoid arthritis, or are suspected to have rheumatoid arthritis by screening tests. 2) Subjects who are judged suffering from knee osteoarthritis by the investigator. 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) with knee joint diseases such as chronic joint pain, ligament injury, or meniscal injury, or those currently under treatment for such conditions. 6) 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). 7) can't stop using drugs and/or supplements affecting joints during the study period. 8) have allergies to ingredients of test foods. 9) are under treatment for or have a history of drug addiction and/or alcoholism. 10) are pregnant or planning to become pregnant or breastfeed during the study period. 11) 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. 12) are judged as unsuitable for the current study by the investigator for other reasons. Target Size - 80

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 09 Month 04 Day Date of IRB - 2025 Year 09 Month 04 Day Anticipated trial start date - 2025 Year 11 Month 26 Day Last follow-up date - 2026 Year 04 Month 13 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068489

Disclaimer: Curated by HT Syndication.