UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052028 |
|---|---|
| Receipt number | R000059325 |
| Scientific Title | Effects of test food on joint discomfort, pain, and motor function. |
| Date of disclosure of the study information | 2023/08/28 |
| Last modified on | 2024/07/03 16:25:20 |
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Basic information
Public title
Effects of test food on joint discomfort, pain, and motor function.
Acronym
Effects of test food on joint discomfort, pain, and motor function.
Scientific Title
Effects of test food on joint discomfort, pain, and motor function.
Scientific Title:Acronym
Effects of test food on joint discomfort, pain, and motor function.
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine effects of test food on joint discomfort, pain, and motor function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
JKOM(The Japanese Knee Osteoarthrtis Measure)
Key secondary outcomes
[1]Range of motion (extension and flexion) of the knee joint
[2]Leg extensor strength
[3]Grip strength
[4]Trunk flexibility
[5]10 m walking speed
[6]30 seconds chair-stand test
[7]The Japanese Orthopaedic Society's criteria for the treatment of osteoarthritis and knee joint disease (JOA)
[8]Visual Analog Scale (VAS) questionnaire
[9]Body composition (height, weight, body mass index, fat mass (percentage of body fat), lean weight, muscle mass, body water content)
[10]Time up go test
[11]Functional reach test
*Safety
[1]Subject's diary
[2]Adverse events
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
Test food (1 time in a day; 12 weeks)
Interventions/Control_2
Placebo food(1 time in a day; 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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
[1]Males and females aged 40 years or older at the time of obtaining informed consent and having a feeling of discomfort or pain in the knee joint
[2]Subjects who are fully informed of the purpose and content of the study, who are competent to give consent, who voluntarily volunteer to participate in the study with a thorough understanding, and who can agree in writing to participate in the study
[3]Subjects who are judged by the investigator to have no health problems when participating in the study
Key exclusion criteria
[1]Subjects with a past history of serious diseases (liver disorder, renal disorder, cardiovascular disorder, cerebrovascular disorder, respiratory disorder, etc.)
[2]Subjects with a history or present medical history of rheumatoid arthritis, and subjects with a history of rheumatoid arthritis as a result of a preliminary examination
[3]Subjects with knee joint disease such as meniscus injury, and those undergoing treatment
[4]Subjects with knee osteoarthritis or other joint-related diseases
[5]Subjects with a knee prosthesis
[6]Subjects who regularly use knee joint medicines, supplements, or health foods, such as compresses, applicants, and pain medications
[7]Subjects with chronic knee pain who had previously undergone surgery
[8]Subjects with mental illness or dementia
[9]Subjects with allergy to food ingredients contained in test food
[10]Subjects who are pregnant, lactating, or possibly pregnant
[11]Subjects who need to take antiplatelet drugs or anticoagulants (warfarin, etc.) during the study period
[12]Subjects currently participating in other human clinical trials or less than 3 months after participation in other human clinical trials
[13]Other subjects who are judged ineligible by the investigator
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Norio |
| Middle name | |
| Last name | Hotta |
Organization
Chubu University
Division name
Department of Lifelong Sports and Health Sciences, College of Life and Health Sciences
Zip code
487-8501
Address
1200 Matsumoto, Kasugai, Aichi
TEL
0568-51-9667
horinori@isc.chubu.ac.jp
Public contact
Name of contact person
| 1st name | Norio |
| Middle name | |
| Last name | Hotta |
Organization
Chubu University
Division name
Department of Lifelong Sports and Health Sciences, College of Life and Health Sciences
Zip code
487-8501
Address
1200 Matsumoto, Kasugai, Aichi
TEL
0568-51-9667
Homepage URL
horinori@isc.chubu.ac.jp
Sponsor or person
Institute
Chubu University
Institute
Department
Personal name
Funding Source
Organization
Rohto Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Chubu University
Address
1200 Matsumoto, Kasugai, Aichi
Tel
0568-51-4424
gakuji@office.chubu.ac.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
| 2023 | Year | 08 | Month | 28 | 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
| 2023 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 29 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 28 | Day |
Last modified on
| 2024 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059325
