UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045980 |
|---|---|
| Receipt number | R000052381 |
| Scientific Title | A study to evaluate the effect of food ingredient in healthy adult on the knee discomfort -Placebo-controlled, randomized, double-blind, parallel-group comparative method |
| Date of disclosure of the study information | 2021/11/04 |
| Last modified on | 2021/11/04 16:57:49 |
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Basic information
Public title
A study to evaluate the effect of food ingredient in healthy adult on the knee discomfort -Placebo-controlled, randomized, double-blind, parallel-group comparative method
Acronym
A study to evaluate the effect of food ingredient in healthy adult on the knee discomfort -Placebo-controlled, randomized, double-blind, parallel-group comparative method
Scientific Title
A study to evaluate the effect of food ingredient in healthy adult on the knee discomfort -Placebo-controlled, randomized, double-blind, parallel-group comparative method
Scientific Title:Acronym
A study to evaluate the effect of food ingredient in healthy adult on the knee discomfort -Placebo-controlled, randomized, double-blind, parallel-group comparative method
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of test food intake for 12 consecutive weeks on knee discomfort using placebo as a control
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knee function questionnaire
Key secondary outcomes
Blood test
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
Ingestion of test food (research food)
Interventions/Control_2
Ingestion of placebo
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Japanese adult males and females between 20 and 70 years of age
(2) Subjects who have been judged to be healthy by a physician
(3) Of the above subjects, those who have experienced discomfort in the knee from the past year to the present (at the time of screening)
Key exclusion criteria
(1)Subjects who are taking medication or visiting a hospital
(2)Subjects with a history of serious diseases
(3) Subjects who have participated in other clinical trials within the past month
(4) Subjects who are binge drinkers or have an irregular diet
(5) Subjects who are judged as inappropriate by the physician in charge of the study
(6) Subjects with food allergies or drug allergies
(7) Subjects who have been diagnosed as severe (Grade II or higher) by the Kellgren-Laurence classification
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ryosuke |
| Middle name | |
| Last name | Mastuoka |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
1820002
Address
2-5-7, Sengawa-cho, Chofu-shi, Tokyo
TEL
03-5384-7759
ryosuke_matsuoka@kewpie.co.jp
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | |
| Last name | Tanaka |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
1820002
Address
2-5-7, Sengawa-cho, Chofu-shi, Tokyo
TEL
03-5384-7759
Homepage URL
tomomi_tanaka@kewpie.co.jp
Sponsor or person
Institute
Hokkaido University of Education
Kewpie Corporation
Institute
Department
Personal name
Funding Source
Organization
Kewpie Corporation
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
Hokkaido University of Education Ethics Review Committee
Address
2-34-1, Midorigaoka, Iwamisawa, Hokkaido
Tel
0126-32-0214
iwa-somu@j.hokkyodai.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
| 2021 | Year | 11 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 03 | 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
| 2021 | Year | 11 | Month | 04 | Day |
Last modified on
| 2021 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052381
