UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of combined intervention of exercise and nutrient on physical function in knee osteoarthritis: a randomized double-blind, placebo-controlled, parallel-group study
Title of the study (Brief title)	Effects of combined intervention of exercise and nutrient on physical function in knee osteoarthritis
Region	Japan

Condition
Condition	Knee osteoarthritis
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of combined intervention of exercise and nutrient on physical function in knee osteoarthritis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	JKOM score, Leg muscular power
Key secondary outcomes	physical performance test, cartilage metabolism markers, skeletal metabolism markers, inflammation markers, blood enzyme activities, blood hormone concentrations, blood metabolite concentrations

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 Device,equipment Behavior,custom
Interventions/Control_1	Placebo drink(350ml/day for 12 weeks)+Daily exercise training for 12 weeks
Interventions/Control_2	Active drink(350ml/day for 12 weeks)+Daily exercise training for 12 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	Not applicable
Gender	Male and Female
Key inclusion criteria	Knee OA subjects with Kellgren-Lawrence grade 2-3 Subjects who can perform muscle exercise Subjects who can take test drinks for 12 weeks Subjects who obtain doctor's permission for participation in this clinical study as a result of the medical examination Subjects who can follow directions of medical workers in this clinical study
Key exclusion criteria	Subjects who had injury of locomotor organ including fracture, tendon rupture,muscle strain,and so on in last 1 year Subjects who are not eligible due to physician's judgment Subjects whose family member is related to the competitor of Kao Corporation.
Target sample size	100

Research contact person
Name of lead principal investigator	Go Omori
Organization	Niigata University of Health and Welfare
Division name	Department of Health and Sports, Faculty of Health and Science
Address	1398-Banchi, Shimami-Cho, Kita-Ku, Niigata City, Niigata, JAPAN
TEL	+81-25-257-4672
Email	omori@nuhw.ac.jp

Public contact
Name of contact person	Takashi Fushimi
Organization	Kao Corporation
Division name	Biological Science Laboratory
Address	2606 Akabane, Ichikai-Machi, Haga-Gun, Tochigi, Japan
TEL	+81-285-68-7769
Homepage URL
Email	fushimi.takashi@kao.co.jp

Sponsor
Institute	Niigata Rehabilitation Hospital
Institute
Department

Funding Source
Organization	Kao Corporation
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	新潟リハビリテーション病院（新潟県）

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 12 Day
Anticipated trial start date	2015 Year 02 Month 21 Day
Last follow-up date	2015 Year 11 Month 24 Day
Date of closure to data entry	2016 Year 07 Month 21 Day
Date trial data considered complete	2016 Year 09 Month 02 Day
Date analysis concluded	2016 Year 10 Month 17 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	-Exercise improved leg muscle power and walking capability, and reduced knee pain and blood oxidative marker. -Nutrient additionally improved walking capability in mild knee OA subjects.
Other related information	Jpn Pharmacol Ther 46(2):237-242. 2018

Management information
Registered date	2015 Year 09 Month 03 Day
Last modified on	2018 Year 03 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021848