UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination on an influence of a test food product on knee joint pain
Title of the study (Brief title)	Examination on an influence of a test food product on knee joint pain
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Orthopedics Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine an influence of a test food product on knee joint pain by selecting males and females of Japanese nationality aged 40 and over, below 75 who are aware of knee pain but have not received orthopedic treatment as subjects and assigning them to take the test food product on a continuous basis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	JKOM survey
Key secondary outcomes	VAS survey

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	6-week intake of the test food
Interventions/Control_2	6-week intake of the placebo food
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.Subjects giving written informed consent 2.To examine an influence of a test food product on knee joint pain by selecting males and females of Japanese nationality aged 40 and over, below 75 who are aware of knee pain but have not received orthopedic treatm
Key exclusion criteria	1.Currently seeing a doctor for treatment of knee joint pain 2.Currently in treatment with medication 3.Presence or previous history of allergy to medication and/or food (especially, shrimps and crabs) 4.Presence or previous history of a severe disorder(s) such as diabetes, a circulatory disease, a hepatic disease, a renal disease, or a cardiac disease 5.Currently in treatment of rheumatism 6.Previous history of knee surgery 7.Plan to undergo medical treatment on knees during the study 8.Underwent an intraarticular injection of hyaluronic acid within two weeks before the selection or intraarticular injection of steroids within three months before the selection 9.Diagnosed with a bone or joint-related diseases such as a bone fracture or a sprain within the past three months 10.Regular intake of a health food product that contains hyaluronic acid, glucosamine, chondroitin sulfate, quercetin glycoside, vitamin D, or amino-acid formulation, and the intention of consuming the product during the study 11.Regular intake of medication with an influence on the evaluation of this study (particularly, a pharmaceutical product that contains glucosamine, chondroitin sulfate, vitamin D, or amino-acid formulation, or a pharmaceutical product for treatment of osteoporosis) 12.Regular use of an assistive cane 13.Regular intake of warfarin (product names: Warfarin, Warin, Arefarin, Warfarin, etc.) for treatment of cerebral infarction, a cardiac disease, or the like 14.Nursing or pregnant, or desired to become pregnant during the study 15.Presence or previous history of psychiatric visits for depression, a sleep disorder, etc. 16.Determined by the investigator to be unsuitable for enrollment in this study
Target sample size	200

Research contact person
Name of lead principal investigator	Ochitani Daisuke
Organization	Clinical Development Division
Division name	Clinical Development Division
Address	Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	81-3-3431-1260
Email	ochitani@huma-c.co.jp

Public contact
Name of contact person	Ochitani Daisuke
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Address	Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	81-3-3431-1260
Homepage URL
Email	ochitani@huma-c.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	MYCARE Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

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	2017 Year 06 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 05 Month 12 Day
Anticipated trial start date	2017 Year 06 Month 12 Day
Last follow-up date	2017 Year 08 Month 07 Day
Date of closure to data entry	2017 Year 08 Month 25 Day
Date trial data considered complete	2017 Year 08 Month 25 Day
Date analysis concluded	2017 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 06 Month 23 Day
Last modified on	2018 Year 02 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031968