UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of the effect of the food ingredients on muscle strength in human lower limb.
Title of the study (Brief title)	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	Junichi Nakamura
Organization	Suntory MONOZUKURI Expert Limited
Division name	R&D Support Department HE Center
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	Akifumi Maeda
Organization	Suntory MONOZUKURI Expert Limited
Division name	R&D Support Department HE Center
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 11 Month 09 Day
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

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Publication of results	Unpublished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