UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study to confirm the food functionality against the joints and limbs or the like
Title of the study (Brief title)	Study to confirm the food functionality against the joints and limbs or the like
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the functionality and safety of the test product for the healthy adult men and women with a sense of discomfort in the joints and limbs or the like.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the questionare for joints and limbs or the like
Key secondary outcomes	1.QOL 2.Safety

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	8 weeks , soft capsules containing test food
Interventions/Control_2
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.20 years of age or older men and women 2.Subjects with a sense of discomfort in the joints and limbs or the like
Key exclusion criteria	1.Subjects who are udergoing treatment which may influence the outcome of the study 2.Subjects who are taking drugs and supplements which may influence the outcome of the st udy 3.Subjects who received the surgery in the past for related the study 4.Subjects who are pregnant or lactating and have these plans 5.Subjects with food allergies 6.Subjects who are judged as unsuitable for the stury by the investigator for the other reason
Target sample size	60

Research contact person
Name of lead principal investigator	Masatomo Najima
Organization	Japan clinical trial assosiation
Division name	N.A.
Address	8F, 5-27-3 sendagaya, shibuyaku, Tokyo
TEL	03-6457-4666
Email	info@yakujihou.org

Public contact
Name of contact person	Hirohisa Kojima
Organization	Japan clinical trial assosiation
Division name	N.A.
Address	8F, 5-27-3 sendagaya, shibuyaku, Tokyo
TEL	03-6457-4666
Homepage URL
Email	info@yakujihou.org

Sponsor
Institute	Japan clinical trial assosiation
Institute
Department

Funding Source
Organization	Ajinomoto Co., Inc.
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	2016 Year 10 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 17 Day
Anticipated trial start date	2016 Year 10 Month 04 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 04 Day
Last modified on	2017 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027944