UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Trial of the effect of food ingredients on mobility and muscle strength
Title of the study (Brief title)	Trial of the effect of food ingredients on mobility and muscle strength
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effect of food ingredients on mobility and muscle strength
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The stage of the locomotive syndrome risk based on three indices for assessing risk of locomotive syndrome at 8th week, 12th week and 16th week of intake
Key secondary outcomes	Measured value of three indices for assessing risk of locomotive syndrome at 8th week, 12th week and 16th week of intake

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Supplement containing food ingredients such as glucosamine, 16 Weeks
Interventions/Control_2	Supplement not containing food ingredients such as glucosamine, 16 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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) Women and men aged 40 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 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 II-IV 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 disease in locomotor organs affecting the efficacy assessment of this study 7) Presence of history of osseous or articular diseases other than OA within the past 3 months 8) Use of product affecting the data of this study, such as medicine, food for specified health use, supplement, diet 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 previous and present serious disease such as liver disorder, kidney disorder, cardiac affection, lung disorder, digestive disorder, organ disorder, diabetes mellitus, food allergy 14) Investigator's judgment for other reason
Target sample size	110

Research contact person
Name of lead principal investigator	Takayuki Izumo
Organization	Suntory Wellness Limited
Division name	Institute for Health Care Science
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, 619-0284, Japan
TEL	050-3182-0630
Email	Takayuki_Izumo@suntory.co.jp

Public contact
Name of contact person	Noriyuki Kanzaki
Organization	Suntory Wellness Limited
Division name	Institute for Health Care Science
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, 619-0284, Japan
TEL	050-3182-0666
Homepage URL
Email	Noriyuki_Kanzaki@suntory.co.jp

Sponsor
Institute	Suntory Wellness Limited
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	2018 Year 06 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 27 Day
Anticipated trial start date	2016 Year 11 Month 01 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	2016 Year 10 Month 28 Day
Last modified on	2017 Year 11 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028312