UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033193 |
|---|---|
| Receipt number | R000037847 |
| Scientific Title | Confirmation of correlation between improvement of knee pain and food-derived peptide in blood by dietary supplement intake |
| Date of disclosure of the study information | 2018/06/30 |
| Last modified on | 2021/03/31 15:51:53 |
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Basic information
Public title
Confirmation of correlation between improvement of knee pain and food-derived peptide in blood by dietary supplement intake
Acronym
Confirmation of correlation between improvement of knee pain and food-derived peptide in blood by dietary supplement intake
Scientific Title
Confirmation of correlation between improvement of knee pain and food-derived peptide in blood by dietary supplement intake
Scientific Title:Acronym
Confirmation of correlation between improvement of knee pain and food-derived peptide in blood by dietary supplement intake
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of the dietary supplement of single and consecutive ingestion for 12 weeks in vivo dynamics of food-derived peptide in blood and on the knee pain
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Food-derived peptide in blood (plasma levels before and after ingestion, AUC, Cmax)
Correlation between food-derived peptide in blood (AUC or Cmax) and JKOM
Key secondary outcomes
Food-derived peptide in urine
JKOM
Cartilage marker
JOA
Joint pain
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
A single and consecutive ingestion for 12 weeks of test food
Interventions/Control_2
A single and consecutive ingestion for 12 weeks of placebo food
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)Males and females at the ages of 40 to 74
(2)Subjects who have knee joint pain
Key exclusion criteria
(1)Subjects who are classified into 0 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 which JOA category I score are 30-points on both knee join
(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
(8)Subjects who regularly take medicine with some exceptions
(9)Subjects who have been performed intra-articular hyaluronic acid or steroid drug injection within a year before the screening test
(10)Subjects who get an intense exercise to make excessive load on the joints
(11)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
(12)Subjects who regularly use a cane or supporter
(13)Subjects who periodically conduct actions that may affect the evaluation of effectiveness
(14)Subjects who are biased in eating habits
(15)Subjects who get a diagnosis of malignancy, are under treatment for cardiac disease, renal disease 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 food allergies
(18)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(19)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(20)Subjects who have participated in other clinical study within a month before the screening test or who intend to participate in study period
(21)Subjects who intend to become pregnant or lactating
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukie Ito |
Organization
Q'SAI Co., LTD.
Division name
Research and Development Department
Zip code
Address
1-7-16 Kusagae, Chuo-ku, Fukuoka-shi, Japan 810-8606
TEL
092-724-0855
kurokawa@kyusai.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Nakagawa |
Organization
TTC Co.,Ltd
Division name
Clinical Research Planning Department
Zip code
Address
Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL
03-5459-5329
Homepage URL
t.nakagawa@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co.,Ltd
Institute
Department
Personal name
Funding Source
Organization
Q'SAI 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
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 30 | 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
| 2018 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 22 | 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 | 06 | Month | 29 | Day |
Last modified on
| 2021 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037847
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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