Tokyo, April 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000056585) titled 'Undenatured Type II Collagen Long-term Intake Study' on April 30.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Kyowa Trial Co., Ltd.
Condition:
Condition - N/A (healthy adults)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the improvement in knee joint and the associated motor functions following the oral administration of the study foods for 12 weeks continuously in healthy male and female
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Intake the test food (capsules containing undenatured type II collagen) for 12 weeks
Interventions/Control_2 - Intake the control food (capsules without undenatured type II collagen) for 12 weeks
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1)Japanese male and female aged 20 to <75 years at the time of obtaining the consent for trial participation
2)Healthy participants who are not currently receiving treatment for any serious disease
3)Participants who do not have OA or RA but have discomfort in their knees
4)Participants with JKOM pain VAS 20mm or more (preferably 50mm or less)
5)Participants who can visit the designated facility on the scheduled visit date
6)Participants who provided their consent in writing after having fully understood the purpose and content of the trial
Key exclusion criteria - 1)Participants with OA (knee OA , grade II or higher according to the KL classification), RA , and gout
2)Participants with gait velocity of 1.0m/s or more at 10m walk (maximal velocity walk) during the pretest
3)Participants with body mass index 25.0 or more at the time of preliminary examination
4)Participants undergoing outpatient treatment for knee arthralgia
5)Participants who have difficulty in participating in the study due to liver, kidney, and heart diseases, respiratory disorder, endocrine disorder, metabolic disorder, neuropathy, consciousness disorder, diabetes mellitus (according to the criteria established by the Japanese Diabetes Association), and other diseases
6)Participants with a history of cardiovascular disease
7)Participants who regularly use drugs or health foods/supplements (including food for specified uses, food with function claims, and food with nutrient function claims) that may affect this study (but who can stop using them at the time informed consent was obtained is not applicable)
8)Participants with allergies related to test foods (collagen)
9)Participants who have weakness or deterioration in physical condition due to previous blood sampling
10)Participants who have donated blood (200mL or more) from the month before the start of the study to the start of the study or who are scheduled to donate blood during the study period
11)Participants participating in other clinical trials or who are within 4 weeks of completion of the study
12)Participants with alcohol polydipsia and persons who smoke excessively
13)Participants who have extremely irregular eating habits
14)Participants who do not agree with the purpose of the test, which was explained in advance
15)Participants who are determined by the principal investigator as not suitable for participation in this study
Target Size - 88
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2024 Year 10 Month 16 Day
Date of IRB - 2024 Year 11 Month 05 Day
Anticipated trial start date - 2025 Year 01 Month 20 Day
Last follow-up date - 2025 Year 05 Month 02 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064490
Disclaimer: Curated by HT Syndication.
