UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052712 |
|---|---|
| Receipt number | R000060149 |
| Scientific Title | Effects of test food intake on knee joints, muscle strength, and bones in healthy adults |
| Date of disclosure of the study information | 2023/11/07 |
| Last modified on | 2024/11/01 18:12:16 |
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Basic information
Public title
Effects of test food intake on knee joints, muscle strength, and bones in healthy adults
Acronym
Effects of test food intake on knee joints, muscle strength, and bones in healthy adults
Scientific Title
Effects of test food intake on knee joints, muscle strength, and bones in healthy adults
Scientific Title:Acronym
Effects of test food intake on knee joints, muscle strength, and bones in healthy adults
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the knee joints, muscle strength, and bones efficacy of ingestion of test food for 12 weeks
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
JKOM
Key secondary outcomes
Locomo25, JKOOS, JOA, knee range of motion, VAS, JLEQ, 6m walk test, knee extension strength, muscle mass, bone density, P1NP, TRACP-5b, osteocalcin
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food daily for 12 weeks
Interventions/Control_2
Intake of placebo daily 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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Healthy males and females from 40 to 74 years of age
(2)Subject who feels discomfort in their joints due to aging
(3)Subject who experiences a decline in walking and muscle strength due to aging
(4)Subjects who confirmed pain of knee joint by JKOM VAS and have low muscle mass
(5)Subjects who can understand the purpose and content of this study and voluntarily agree 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 use health foods that may affect the evaluation of the study
(8)Subjects who regularly use pharmaceuticals
(9)Subjects who have been performed intra-articular hyaluronic acid or steroid drug injection within a year before the screening test
(10)Subjects who exercise excessively
(11)Subjects with a history of locomotory disease within 1 year before the screening examination
(12)Subjects who use canes or supporters
(13)Subjects who periodically conduct actions that may affect the evaluation of effectiveness
(14)Subjects who have or have a history of severe diseases
(15)Subjects who taking warfarin or those who need to take warfarin during the study period
(16)Subjects who diagnosed with hypertension
(17)Subjects who have unsteady lifestyle or who work manual labor
(18)Subjects who drink alcohol in large quantities
(19)Subjects who have at risk of developing allergies related to the test food
(20)Subjects who are judged as unsuitable due to lifestyle questionnaire
(21)Subjects who cannot carry out the test as instructed
(22)Subjects who have participated in other clinical study within a month before the screening test or who intend to participate in the study period
(23)Subjects who are in a pregnancy or lactation period in the study period
(24)Subjects who are judged as unsuitable for the study by investigator for other reasons
Target sample size
58
Research contact person
Name of lead principal investigator
| 1st name | Tatsuji |
| Middle name | |
| Last name | Takahashi |
Organization
ICHIMARU PHARCOS Co., Ltd.
Division name
Product Development 3
Zip code
501-0475
Address
318-1 Asagi, Motosu-Shi, Gifu
TEL
000-000-0000
xxx@xxx
Public contact
Name of contact person
| 1st name | Akane |
| Middle name | |
| Last name | Morimoto |
Organization
EP Mediate Co., Ltd.
Division name
Foods Department Trial Planning Section
Zip code
162-0821
Address
Kagurazaka AK Bldg., 1-8 Tsukudocho, Shinjuku-ku, Tokyo
TEL
070-7079-8489
Homepage URL
morimoto.akane003@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
ICHIMARU PHARCOS Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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, Meguro-ku, 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
社会福祉法人新栄会 滝野川病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 07 | 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 | 10 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 24 | 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 | 11 | Month | 07 | Day |
Last modified on
| 2024 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060149
