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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031558
Receipt No. R000036033
Scientific Title Effects of nutrient in Japanese subjects with knee pain: a randomized, double-blind, placebo-controlled, parallel pilot study.
Date of disclosure of the study information 2018/03/02
Last modified on 2018/05/08

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Basic information
Public title Effects of nutrient in Japanese subjects with knee pain: a randomized, double-blind, placebo-controlled, parallel pilot study.
Acronym Effects of nutrient in Japanese subjects with knee pain
Scientific Title Effects of nutrient in Japanese subjects with knee pain: a randomized, double-blind, placebo-controlled, parallel pilot study.
Scientific Title:Acronym Effects of nutrient in Japanese subjects with knee pain
Region
Japan

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

Objectives
Narrative objectives1 To investigate the effect of nutrient intake on knee pain.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes VAS score of knee pain, JKOM score
Key secondary outcomes Blood metabolite concentrations, Blood enzyme activities

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 NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Active supplement (continuous intake for 12W)
Interventions/Control_2 Placebo supplement (continuous intake for 12W)
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
45 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria -Subjects who have high scores of JKOM(II-V)
Key exclusion criteria -Subjects who have therapeutic history for at least 2 year for knee joint pain
-Subjects who suffer from articular rheumatism
-Subjects who suffer from liver or kidney disease
-Subjects who have therapeutic history for serious liver, kidney or heart disease
-Subjects who have medication for knee joint pain (anodyne, anti-inflammation)
-Subjects who have therapeutic history for at least 1 year for serious locomotor system (for example, a fracture, a tendon rapture, a pulled muscle)
-Subjects who take excess alcohol
-Subjects who take supplement including chondroitin sulfate or glucosamine for knee joint pain in daily
-Subjects who are not eligible due to physician's judgment
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shingo Kakuo
Organization Kao Corporation
Division name Biological Science Laboratory
Zip code
Address 2606 Akabane, Ichikai-Machi, Haga-Gun, Tochigi
TEL +81-285-68-7440
Email kakuo.shingo@kao.com

Public contact
Name of contact person
1st name
Middle name
Last name Shingo Kakuo
Organization Kao Corporation
Division name Biological Science Laboratory
Zip code
Address 2606 Akabane, Ichikai-Machi, Haga-Gun, Tochigi
TEL +81-285-68-7440
Homepage URL
Email kakuo.shingo@kao.com

Sponsor
Institute SOUKEN Laboratories
Institute
Department

Funding Source
Organization Kao Corporation
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
Address
Tel
Email

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 芝パレスクリニック (Shiba Palace Clinic)(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 02 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://doi.org/10.1007/s40520-018-0953-6
Number of participants that the trial has enrolled
Results
-Continuous intake of active nutrient significantly lowered VAS score of knee pain.
-Continuous intake of active nutrient significantly relieved knee pain and stiffness.
Aging Clinical and Experimental Research
 (https://doi.org/10.1007/s40520-018-0953-6)



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 Completed
Date of protocol fixation
2011 Year 09 Month 28 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2012 Year 05 Month 22 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 02 Day
Last modified on
2018 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036033

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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