UMIN-CTR Clinical Trial

Basic information
Public title	A Study on the Effect of Test Food on Joint Function -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Acronym	A Study on the Effect of Test Food on Joint Function
Scientific Title	A Study on the Effect of Test Food on Joint Function -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Scientific Title:Acronym	A Study on the Effect of Test Food on Joint Function
Region	Japan

Condition
Condition	No
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the effect of test food on joint function
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	assessment of joint function
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Active food, 12 weeks consumption
Interventions/Control_2	Placebo food, 12 weeks consumption
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	1)Males and females aged 40 to 74 years-old with discomfort of 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 can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria	Subjects (who) 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 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 pregnant or planning to become pregnant or breastfeed during the study period. 9)have donated over 200 mL of blood and/or blood components within the last one month prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to screening tests. 10)had participated in other clinical studies within the last one month prior to the current study and/or are planning to participate in other clinical studies during the current study. 11)are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Naoya Middle name Last name Sekiguchi
Organization	Urayasu Sekiguchi Clinic
Division name	Director
Zip code	279-0004
Address	5-17-27 Nekozane, Urayasu-shi, Chiba
TEL	047-306-3557
Email	scfira@royal.ocn.ne.jp

Public contact
Name of contact person	1st name Yoshika Middle name Last name Komori
Organization	KSO Corporation
Division name	Sales department
Zip code	105-0023
Address	1-9-7 Shibaura, Minato-ku, Tokyo
TEL	03-3452-7733
Homepage URL
Email	eigyou27@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	TOYO SHINYAKU Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethical Committee of Nihonbashi Cardiology Clinic
Address	Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel	03-5641-4133
Email	niho-jimucho@well-sleep.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 01 Month 07 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2021 Year 12 Month 21 Day
Date of IRB
Anticipated trial start date	2022 Year 01 Month 09 Day
Last follow-up date	2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 01 Month 06 Day
Last modified on	2022 Year 01 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053106