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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000044258
Receipt No. R000050551
Scientific Title Effects of consumption of the test food on the discomfort of the knee joint in healthy subjects: a randomized, double-blind placebo-controlled trial
Date of disclosure of the study information 2021/05/19
Last modified on 2021/09/07

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Basic information
Public title Effects of consumption of the test food on the discomfort of the knee joint in healthy subjects
Acronym Effects of consumption of the test food on the discomfort of the knee joint in healthy subjects
Scientific Title Effects of consumption of the test food on the discomfort of the knee joint in healthy subjects: a randomized, double-blind placebo-controlled trial
Scientific Title:Acronym Effects of consumption of the test food on the discomfort of the knee joint in healthy subjects
Region
Japan

Condition
Condition Healthy Japanese subjects
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the discomfort of the knee joint after continuous consumption of the test food for 12 weeks in healthy subjects
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The measured values of the total score of Japanese Knee Osteoarthritis Measure (JKOM) at 12 weeks after consumption (12w)
Key secondary outcomes 1. The measured values of the total score of JKOM at 4 and 8 weeks after consumption (4, 8w)

2. The amounts of changes of the total score of JKOM between screening (before consumption; Scr) and 4w, 8w, or 12w

3. The measured values at 4w, 8w and 12w and amounts of changes between Scr and 4w, 8w, or 12w of the following items:

3-1. JKOM
visual analogue scale (VAS), the scores of pain and stiffness in knees, conditions in daily life, general activities, and health conditions

3-2. Japanese Orthopaedic Association (JOA) score
JOA score [average of both foot (right and left), left foot, and right foot], pain on walking [average of both foot (right and left), left foot, and right foot], pain on ascending or descending stairs [average of both foot (right and left), left foot, and right foot], range of motion [average of both foot (right and left), left foot, and right foot], joint effusion [average of both foot (right and left), left foot, and right foot]

3-3. Interleukin 1 beta (IL-1beta)

3-4. Interleukin 6 (IL-6)

3-5. High sensitivity C-reactive protein (CRP)

3-6. Procollagen II C-Terminal Propeptide (PIICP)

3-7. Collagen Type I and II Cleavage (C1,2C)

4. The values of the individual items of the JKOM questionnaire and the JOA score at 4w, 8w and 12w


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

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Duration: 12 weeks
Test food: Food containing methyl sulfonyl methane
Administration: Take ten tablets per day with water, five tablets each at breakfast and dinner

* If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2 Duration: 12 weeks
Test food: Placebo
Administration: Take ten tablets per day with water, five tablets each at breakfast and dinner

* If you forget to take the test food, take it 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. Japanese

2. Men or women

3. Subjects aged 20 or more

4. Healthy subjects

5. Subjects who are experiencing discomfort in the knee joint

6. Subjects who are judged as eligible to participate in the study by the physician

7. Subjects who are judged in the Kellgren-Lawrence grade (KL grade) either 0 or 1 in X-ray at screening (before consumption; Scr)

8. Subjects whose JKOM score are relatively high at Scr
Key exclusion criteria 1. Subjects who have at least one previous medical history of malignant tumor, heart failure or myocardial infarction

2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Subjects who are undergoing medical treatment of knee disease such as knee osteoarthritis

4. Subjects who are currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases

5. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use

6. Subjects who currently taking or using medicines (include herbal medicines, cold patch and topical medication) and supplements

7. Subjects who are allergic to medicines and/or the test food related products

8. Subjects who are pregnant, breast-feeding, or planning to become pregnant

9. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial

10. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Tsuyoshi
Middle name
Last name Takara
Organization Medical Corporation Seishinkai, Takara Clinic
Division name Director
Zip code 141-0022
Address 9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL 03-5793-3623
Email t-takara@takara-clinic.com

Public contact
Name of contact person
1st name Naoko
Middle name
Last name Suzuki
Organization ORTHOMEDICO Inc.
Division name R&D Department
Zip code 112-0002
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL 03-3818-0610
Homepage URL
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization CIC FRONTIER Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address 9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel 03-5793-3623
Email IRB@takara-clinic.com

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)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information
2021 Year 05 Month 19 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 88
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 No longer recruiting
Date of protocol fixation
2021 Year 05 Month 12 Day
Date of IRB
2021 Year 05 Month 12 Day
Anticipated trial start date
2021 Year 05 Month 19 Day
Last follow-up date
2021 Year 12 Month 25 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 05 Month 19 Day
Last modified on
2021 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050551

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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