UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033446 |
|---|---|
| Receipt number | R000038134 |
| Scientific Title | Effects of consumption of the test food in healthy Japanese with discomfort in the knee joint: a randomized, double-blind, placebo-controlled, parallel-group trial |
| Date of disclosure of the study information | 2018/07/19 |
| Last modified on | 2021/05/27 11:05:56 |
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Basic information
Public title
Effects of consumption of the test food in healthy Japanese with discomfort in the knee joint: a randomized, double-blind, placebo-controlled, parallel-group trial
Acronym
Effects of consumption of the test food in healthy Japanese with discomfort in the knee joint
Scientific Title
Effects of consumption of the test food in healthy Japanese with discomfort in the knee joint: a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym
Effects of consumption of the test food in healthy Japanese with discomfort in the knee joint
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects on discomfort in the knee joint with the test food for 12 weeks in healthy Japanese adult subjects with discomfort in the knee joint
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The total score of Japanese Knee Osteoarthritis Measure (JKOM)
* Compare the amount of change between screening (before consumption) and 12 weeks after consumption
Key secondary outcomes
1. JKOM
Assess the total score of JKOM and the scores of visual analogue scale (VAS), pain and stiffness in knees, conditions in daily life, general activities, and health conditions
2. The Japanese Orthopaedic Association score for osteoarthritic knees (JOA)
Assess JOA scores (the average in both legs, right leg, and left leg)
3. Subjective symptoms related to knee pains (VAS)
4. The 30-second chair stand test
Assess the number of times of standing up from the chair for 30 seconds
5. The 10-meter walking test
Assesse walking speed, the number of steps, stride length, and waking rate (the number of steps per time)
6. Blood test
Assess high sensitivity C-reactive protein, cleavage of type II collagen, and myoglobin
*1-6 Assess the items at screening (before consumption) and 4, 8, and 12 weeks after consumption and calculate the amount of change or rate of change. However, the total score of JKOM assesses only the value and rate of change at 12 weeks after consumption.
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
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test Material: Active tablets
Dosage: Take 6 tablets with water or warm water after breakfast
* If you forget to take the tablets, take tablets as soon as you remember within the day.
Interventions/Control_2
Duration: 12 weeks
Test Material: Placebo tablets
Dosage: Take 6 tablets with water or warm water after breakfast
* If you forget to take the tablets, take tablets as soon as you remember within the day.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Healthy Japanese adult subjects
2. Subjects who are experiencing discomfort in the knee joint; however, subjects who are not diagnosed with any diseases by a physician
3. Subjects who are judged as eligible to participate in the study by the physician
4. Within the subjects who met the 1st to 3rd inclusion criteria, subjects who are judged in the Kellgren-Lawrence grade (KL grade) either 0 or 1 in X-ray at screening (before consumption)
5. Within the subjects who met the 4th inclusion criteria, subjects whose total scores of JKOM are relatively high at screening (before consumption)
Key exclusion criteria
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
2. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
3. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily
4. Subjects who are currently taking medications (including herbal medicines) and supplement
* Particularly taking anticoagulants such as warfarin
5. Subjects who experience palpitations when they walk fast
6. Subjects who are allergic to medicines and/or the test food related products
7. Subjects who are pregnant, breast-feeding, or planning to become pregnant
8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial
9. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo YAMAMOTO |
Organization
ORTHOMEDICO Inc.
Division name
CEO
Zip code
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
kazu@orthomedico.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoko SUZUKI |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
DHC Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 19 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Published
Result
URL related to results and publications
http://www.pieronline.jp/content/article/0386-3603/47120/2007
Number of participants that the trial has enrolled
66
Results
Kageyama M, Kobashi R, Tomobe H, Nakajima Y, Akiyoshi K, Ohmori R, Yamada A, Takahashi Y, Takara T. Effects of consumption of the test food containing glucosamine hydrochloride, methylsulfonylmethane, boswellia serrata extract, and olive extract in healthy Japanese subjects with knee joint discomfort: a randomized, double-blinded, placebo-controlled, parallel-group study. Jpn Pharmacol Ther. 2019; 47(12): 2007-2029
Results date posted
| 2021 | Year | 05 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 01 | Month | 08 | Day |
Baseline Characteristics
Refer to the paper
Participant flow
Refer to the paper
Adverse events
Refer to the paper
Outcome measures
Refer to the paper
Plan to share IPD
Undecided
IPD sharing Plan description
To require consultation among related companies
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 19 | Day |
Last modified on
| 2021 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038134
