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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029735
Receipt No. R000033974
Scientific Title A study of the effect of the food ingredients on muscle strength in human lower limb.
Date of disclosure of the study information 2019/06/29
Last modified on 2019/02/07

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Basic information
Public title A study of the effect of the food ingredients on muscle strength in human lower limb.
Acronym A study of the effect of the food ingredients on muscle strength in human lower limb.
Scientific Title A study of the effect of the food ingredients on muscle strength in human lower limb.
Scientific Title:Acronym A study of the effect of the food ingredients on muscle strength in human lower limb.
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of the food ingredients on muscle strength in human lower limb.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The stage of the locomotive syndrome risk based on the stand-up test at the 12th week of intake.
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 Prevention
Type of intervention
Food
Interventions/Control_1 Supplement containing food
ingredients such as glucosamine, 12 weeks.
Interventions/Control_2 Supplement not containing food
ingredients such as glucosamine, 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
55 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 1) Women and men aged 55 to 74 years at the time of acquisition of agreement in participating in this study
2) Presence of knee pain
3) Person who begins declining in mobility, especially who begins declining muscle strength in lower limb and deteriorating physical condition and lifestyles
4) Person who can come to the medical organization for the measurement at the date of visiting
5) Person who can understand the purpose and content of this study and agree in writing to participate in this study
Key exclusion criteria 1) Kellgren - Lawrence grades 2-4
2) Presence of hyperuricemia
3) Presence of rheumatoid arthritis that may cause joint pain
4) Surgical treatment of knee joint(s) needed or undergone
5) Need for pharmacological articular treatments during the study period
6) Presence of history of osseous or articular diseases other than OA within the past 3 months
7) Presence of disease in locomotor organs that affects the efficacy assessment of this study
8) Use of product affecting the data of this study, such as medicine, food for specified health use, or health food
9) Daily use of a cane or a supporter
10) Daily use of hot spa or massage therapy
11) Daily or occasional vigorous exercise
12) Female in pregnancy, lactation and scheduled pregnancy period
13) With present heart disorder, liver disorder, kidney disorder, diabetes mellitus, or obesity, with previous or present cardiac disorder, or with allergy to the study foods
14) Investigator's judgment for other reason
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junichi Nakamura
Organization Suntory MONOZUKURI Expert Limited
Division name R&D Support Department HE Center
Zip code
Address 2-3-3 Daiba, Minato-ku, Tokyo, Japan
TEL 03-5579-1277
Email Junichi_Nakamura@suntory.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akifumi Maeda
Organization Suntory MONOZUKURI Expert Limited
Division name R&D Support Department HE Center
Zip code
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL 050-3182-0719
Homepage URL
Email Akifumi_Maeda@suntory.co.jp

Sponsor
Institute Suntory MONOZUKURI Expert Limited
Institute
Department

Funding Source
Organization Suntory Wellness Limited
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

Other administrative information
Date of disclosure of the study information
2019 Year 06 Month 29 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 Completed
Date of protocol fixation
2017 Year 11 Month 09 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 27 Day
Last modified on
2019 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033974

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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