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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025660
Receipt No. 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

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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
Email 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
Email yanagisawa.yoshiko@kao.co.jp

Sponsor
Institute Jikoukai Medical Corporation
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029475

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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