UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025660 |
|---|---|
| Receipt number | R000029475 |
| Scientific Title | A study of milk-derived components on joint function -A Randomized, Double-blind, Placebo-controlled Study- |
| Date of disclosure of the study information | 2017/07/31 |
| Last modified on | 2019/07/19 09:53:03 |
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Basic information
Public title
A study of milk-derived components on joint function
-A Randomized, Double-blind, Placebo-controlled Study-
Acronym
A study of milk-derived components on joint function
Scientific Title
A study of milk-derived components on joint function
-A Randomized, Double-blind, Placebo-controlled Study-
Scientific Title:Acronym
A study of milk-derived components on joint function
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate improvements in mobility of knee and waist-joints, and physical performance in healthy adults those consuming milk-derived tablets for 8 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
JKOM, JLEQ, VAS of knee- and waist- pain at rest, walking and stair-climbing, Questionnaires about motion of knee- and waist- joints, Passive range of movement of knee- and waist- joints, 10-m walking (normal- and maximum-speed), Obstacle walking, Ascending and descending stairs, Open-close stepping counts, One-leg standing duration (when eye-opened and -closed)
Key secondary outcomes
Hyaluronic acid (HA), Cartilage oligomeric matrix protein (COMP), Collagen type II Cleavage (C2C), Procollagen type II C-Propeptide(CP2), C-terminal telopeptides of type II collagen (CTX-2), MMP-3, MP-9, MMP-13, IL-1, IL-2, IL-4, IL-6, IL-8, IL-10, IL-17, IL-18, Urine- C-terminal telopeptides of type II collagen(CTX-2)/U-Cre, Questionnaires about tablets
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of milk-derived components and glucosamine for 8 weeks
Interventions/Control_2
Ingestion of glucosamine for 8 weeks
Interventions/Control_3
Ingestion of placebo for 8 weeks
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
| 60 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy male and female who are 60 years old and more, and less than 75 years old when taking informed consent.
2. Those who have knee- and waist- pain
3. Those who can come to the designated hospital on scheduled date
4. Those who can write life record correctly
5. Those who understand objectives and protocol of this study with written consent
Key exclusion criteria
1. Patients with OA, RA and/or goat
2. Those who have difficulty to participate in this study because of conditions i.e., liver, kidney, or cardiac disease, breathing, endocrinology, metabolism, nervous, or conscious disorder, diabetes (determined by JDA), and other diseases.
3. Those with history of cardiovascular diseases
4. Those who use medicines, health foods and supplements (including "Food for specified health uses", "Foods with function claims" and "Food with nutrient function claims") constantly, excepting those who can stop them at taking of informed consent.
5. Those who have allergies of test tablets (including dairy product and crustacean)
6. Those who have had bad feeling after blood collection
7. Those who are participating in other tests or who participated in last 4 weeks.
8. Heavy drinker of alcohol and/or heavy smoker
9. Those who have extremely irregular eating and living habits
10. Those who do not agree with the intent of this study explained beforehand
11. Those who are judged as inappropriate for the subject of this test by clinical investigator
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Kato |
Organization
Jikoukai Medical Corporation
Division name
Kouki Medical Clinic
Zip code
064-0823
Address
1-22, Kita 3-jo Nisi 24, Chuo-ku, Sapporo-shi, Hokkaido
TEL
011-611-2711
suzuki-jikoukai@e-mail.jp
Public contact
Name of contact person
| 1st name | Yoshiko |
| Middle name | |
| Last name | Yanagisawa |
Organization
Kao Corporation
Division name
Health Care Food Research Center
Zip code
131-8501
Address
2-1-3 Bunka, Sumida-ku, Tokyo
TEL
03-5630-7456
Homepage URL
yanagisawa.yoshiko@kao.co.jp
Sponsor or person
Institute
Jikoukai Medical Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao 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
Fukuzumi Internal Medicine Clinic Ethics Review Committee
Address
Fukuzumi, Toyohira-ku, Sapporo, Hokkaido
Tel
011-836-3531
inaba-jikoukai@e-mail.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
医療法人社団 慈昂会 昂希内科クリニック
Jikoukai Medical Corporation, Kouki Medical Clinic
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 31 | 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
| 2016 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 15 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 21 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 13 | Day |
Last modified on
| 2019 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029475
| 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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