UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048912 |
|---|---|
| Receipt number | R000055731 |
| Scientific Title | Effect and safety evaluation on knees and low back by ingestion of test food for adult men and women |
| Date of disclosure of the study information | 2022/09/12 |
| Last modified on | 2023/09/15 09:51:15 |
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Basic information
Public title
Effect and safety evaluation on knees and low back by ingestion of test food for adult men and women
Acronym
Effect and safety evaluation on knees and low back by ingestion of test food for adult men and women
Scientific Title
Effect and safety evaluation on knees and low back by ingestion of test food for adult men and women
Scientific Title:Acronym
Effect and safety evaluation on knees and low back by ingestion of test food for adult men and women
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects and safety on the knees and low back for 12 weeks on continuous ingestion of the test food as a placebo control.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
JKOM at before, 6 and 12 weeks
Key secondary outcomes
JKOOS, JOA, knee range of motion, VAS (knee pain at rest, walking, climbing stairs), at before, 6 and 12 weeks and JLEQ, high-sensitivity CRP, MMP-1, MMP-3, MMP-13, IL-1beta, TNF-alpha, IL-6, PGE2, and HO-1 at before and 12 weeks
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
Intake of test food for 12 weeks
Interventions/Control_2
Intake of placebo for 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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Males and females from 40 to 74 years of age
(2)Subjects who have knee joint pain
(3)Subjects who can understand the purpose and content of this study and agree in writing to participate in this study
Key exclusion criteria
(1)Subjects who are classified into II, III or IV grade on the basis of the KL classification
(2)Subjects which knee join pain is weaker than pain in other joints
(3)Subjects who are confirmed 30-points by JOA score, the degree of knee pain and walk ability
(4)Subjects who are suspected gout attack with hyperuricemia
(5)Subjects who have positive rheumatoid factors on the screening test or may have rheumatic pain
(6)Subjects who have performed arthroplasty or need it
(7)Subjects who regularly take health food containing bone, cartilage, joint from three month before the screening test to the end of the study and regular users
(8)Subjects who regularly use the involved ingredients at least 3 times a week.
(9)Subjects who regularly take medicine
(10)Subjects who have been performed intra-articular hyaluronic acid or steroid drug injection within a year before the screening test
(11)Subjects who get an intense exercise to make excessive load on the joints
(12)Subjects who have a history of the disorder related to bone and joint such as fracture and sprain within a year before the screening test
(13)Subjects who regularly use a stick or supporter
(14)Subjects who periodically conduct actions that may affect on the efficacy evaluation
(15)Subjects who get a diagnosis of malignancy, are under treatment for cranial nerve disease, cardiac disease, renal disease, diabetes and thyroid dysfunction, and have a history of serious disorder such as hepatic disease
(16)Subjects who drink alcohol in large quantities
(17)Subjects who have at risk of developing allergies related to the test food
(18)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(19)Subjects who have participated in other clinical study within a month before the screening test or who intend to participate in study period
(20)Subjects who intend to become pregnant or lactating
(21)Subjects who are judged as unsuitable for this study by physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiro |
| Middle name | |
| Last name | Shiba |
Organization
Ina Food Industry Co., Ltd.
Division name
R&D Division
Zip code
399-4498
Address
5074 Nishiharuchika, Ina City, Nagano Prefecture
TEL
0265-78-1121
kshiba@kantenpp.co.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Nakagawa |
Organization
EP Mediate Co., Ltd.
Division name
Foods Department, Clinical Research Planning Department
Zip code
162-0821
Address
7F, Kagurazaka AK Building, 1-8 Tukudo-cho, Shinjuku-ku, Tokyo
TEL
080-7710-1146
Homepage URL
nakagawa.takashi768@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Ina Food Industry Co., Ltd.
Shionogi Healthcare 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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguroku, Tokyo
Tel
03-6452-2712
nakagawa.akiko297@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 | 09 | Month | 12 | 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
50
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
| 2022 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 12 | Day |
Last modified on
| 2023 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055731
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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