UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044718 |
|---|---|
| Receipt number | R000051074 |
| Scientific Title | Combination effect of knee braces with food ingredients on knee joint functions in healthy Japanese subjects: an open-label, single-arm study |
| Date of disclosure of the study information | 2022/06/01 |
| Last modified on | 2021/12/23 16:24:44 |
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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
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
Saori_Omae@suntory.co.jp
Sponsor or person
Institute
Suntory Wellness Limited
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051074
