UMIN-CTR Clinical Trial

Basic information
Public title	Combination effect of knee braces with food ingredients on knee joint functions in healthy Japanese subjects: an open-label, single-arm study (SWE-2020-06-HBLOCO)
Acronym	Combination effect of knee braces with food ingredients on knee joint functions
Scientific Title	Combination effect of knee braces with food ingredients on knee joint functions in healthy Japanese subjects: an open-label, single-arm study
Scientific Title:Acronym	Combination effect of knee braces with food ingredients on knee joint functions
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 food ingredients and knee braces on knee joint functions
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The total score of Japanese Orthopaedic Association (JOA)
Key secondary outcomes

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	Prevention
Type of intervention	Food Device,equipment
Interventions/Control_1	Supplementation of food ingredient and knee support (4 weeks)
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	40 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Healthy men and women aged 40 to 64 years. (2) Presence of knee pain. (3) Person who can understand the purpose and content of this study and agree in writing to participate in this study.
Key exclusion criteria	(1) Presence of disease in locomotor organs affecting the efficacy assessment of this study. (2) Person whose keep irregular hours such as shift work. (3) Use of product affecting the data of this study, such as food for specified health use, food with function claims, and medicine. (4) Presence of previous and present serious disease such as cardiac affection, liver disorder, kidney disorder, cardiovascular disorder, lung disorder, diabetes mellitus. (5) Investigator's judgment for other reason.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Takayuki Middle name Last name Izumo
Organization	Suntory Wellness Limited
Division name	Institute For Health Care Science
Zip code	619-0284
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	1st name Saori Middle name Last name Ohmae
Organization	Suntory Wellness Limited
Division name	Institute For Health Care Science
Zip code	619-0284
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto. 619-0284, Japan.
TEL	050-3182-8180
Homepage URL
Email	Saori_Omae@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)

IRB Contact (For public release)
Organization	Medical Station Clinic Research Ethics Committee
Address	3-12-8, Takaban, Meguroku, Tokyo
Tel	03-6452-2712
Email	saito876@eps.co.jp

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	2022 Year 06 Month 01 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	2021 Year 06 Month 24 Day
Date of IRB	2021 Year 06 Month 24 Day
Anticipated trial start date	2021 Year 07 Month 12 Day
Last follow-up date	2021 Year 09 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 06 Month 30 Day
Last modified on	2021 Year 12 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051074