UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy evaluation of the knee subjective symptoms and motor function by collagen containing drink
Title of the study (Brief title)	The efficacy evaluation of the knee subjective symptoms and motor function by collagen containing drink
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of collagen containing drink on the knee subjective symptoms and motor function for 12 weeks.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	locomotive syndrome risk test, JKOM before and 6, 12 weeks after the intervention with the test drink
Key secondary outcomes	JOA, levels of change in knee joint stiffness, VAS, handgrip before and 6, 12 weeks after the intervention with the test drink

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	Prevention
Type of intervention	Food
Interventions/Control_1	Collagen containing drink are ingested for 12 consecutive weeks
Interventions/Control_2	Collagen free drink are ingested for 12 consecutive weeks
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	74 years-old >=
Gender	Male and Female
Key inclusion criteria	(1)Males and females at the ages of 40 to 74 (2)Subjects who are judged as stage 1 in locomotive syndrome risk test (3)Subjects who confirmed pain of knee joint by JKOM and VAS (4)Subjects who are classified into 0-I grade on the basis of the Kellgren-Lawrence classification. (Subjects who undiagnosed with Knee Osteoarthritis by physician)
Key exclusion criteria	(1)Subjects who exceeded the value of knee pain on JKOM, question-I : the degree of pain, more than the sum VAS value of other joint pain (e.g., ankle, elbow, finger, shoulder, back and hip) (2)Subjects who are confirmed 30-points by JOA score, the degree of knee pain and walk ability (3)Subjects who are suspected gouty attack with hyperuricemia (4)Subjects who have positive rheumatoid factors on the screening test or may have rheumatic pain (5)Subjects who have performed arthroplasty or need it (6)Subjects who regularly take health food containing bone, joint, muscle wellness from three month before the screening test to the end of the study (7)Subjects who regularly take medicine (8)Subjects who have been performed intra-articular hyaluronic acid or steroid drug injection within a year before the screening test (9)Subjects who get an intense exercise to make excessive load on the joints (10)Subjects who have a history of the disorder related to bone and joint such as fracture and sprain within a year before the screening test (11)Subjects who regularly use a stick or supporter (12)Subjects who routinely exert an influence on the efficacy evaluation (13)Subjects who get a diagnosis of malignancy, are under treatment for hypertension, cardiac disease, renal disease and thyroid dysfunction, and have a history of serious disorder such as hepatic disease (14)Subjects who consume an excess amounts of alcohol (15)Subjects who have possibility of allergy symptoms onset by the test supplement (16)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (17)Subjects who have participated in other clinical study within a month before the screening test or who intend to participate in study period (18)Subjects who intend to become pregnant or lactating (19)Subjects who are judged as unsuitable for this study by physician
Target sample size	30

Research contact person
Name of lead principal investigator	Sadao Mori
Organization	Morinaga & Co.,Ltd
Division name	Health and Wellness Headquarters
Address	2-1-1, Shimodueyoshi, Tsurumi-ku, Yokohama
TEL	070-3864-8266
Email	s-mori-ab@morinaga.co.jp

Public contact
Name of contact person	Noriko Watanabe
Organization	TTC Co.,Ltd
Division name	Clinical Research Planning Department
Address	Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	n.watanabe@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co.,Ltd
Institute
Department

Funding Source
Organization	Morinaga & Co.,Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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 09 Day

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

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

Management information
Registered date	2017 Year 06 Month 09 Day
Last modified on	2018 Year 06 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031730