UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045809 |
|---|---|
| Receipt number | R000052288 |
| Scientific Title | Effects of consumption of the test food on walking function in healthy Japanese women aged 50 or more: an open-label trial |
| Date of disclosure of the study information | 2021/10/22 |
| Last modified on | 2022/12/21 15:18:55 |
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Basic information
Public title
Effects of consumption of the test food on walking function in healthy Japanese women aged 50 or more
Acronym
Effects of consumption of the test food on walking function in healthy Japanese women aged 50 or more
Scientific Title
Effects of consumption of the test food on walking function in healthy Japanese women aged 50 or more: an open-label trial
Scientific Title:Acronym
Effects of consumption of the test food on walking function in healthy Japanese women aged 50 or more
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of consumption of the test food on walking function in healthy Japanese women aged 50 or more
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Walking time in 10-meter walking test at 12 weeks after consumption (12w)
Key secondary outcomes
1. The number of steps, stride length, waking rate, the number of times of standing up from the chair for 30 seconds, evaluation scores in the step test, evaluation items of Japanese knee osteoarthritis measure (JKOM) {visual analog scale (VAS) and the score of JKOM, pain and stiffness in knees, conditions in daily life, general activities, and health conditions}, evaluation items of Japan low back pain evaluation questionnaire (JLEQ) (VAS, and the score of JLEQ, low back pain related to activity of daily living, problems due to low back pain, and health and psychological condition of a month living), and high sensitivity C-reactive protein at 12w
2. Individual items of the JKOM and JLEQ questionnaire at 12w
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test food: Food containing shark cartilage extract, fish meat extract, and rosemary extract
Administration: Take two packs (four tablets per one pack) with water without chewing at any time during the day
* Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Japanese
2. Women
3. Subjects aged 50 or more
4. Healthy subjects
5. Subjects who are aware of the decline in their walking ability due to 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 Scr
8. Subjects whose walking time is long in the 10-meter walking test at Scr
Key exclusion criteria
Subjects who
1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. are undergoing or need to undergo treatment for knee disease such as knee osteoarthritis
4. have undergone or need to undergo knee or back surgery
5. may experience rheumatic pain
6. are attending an orthopedic or osteopathic clinic
7. are intensely exercising to make excessive load on the body
8. currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, bronchial asthma, coagulation disorder, prostate cancer, glaucoma, hypercholesterolemia, gastric ulcer, gout, hemophilia, hypoprothrombinemia, photosensitivity, hemorrhagic disease, convulsive disorder, aspirin sensitivity, vitamin B12 deficiency, psoriasis, hereditary eye disease such as Leber disease, red blood cell abnormality such as megaloblastic anemia or polycythemia vera, or other chronic diseases
9. have high serum calcium levels
10. plan to undergo a surgical operation between two weeks before first consumption and two weeks after last consumption
11. take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use
12. currently taking medications (including herbal medicines) and supplements
13. are allergic to medicines and/or the test food related products
14. have allergic reactions to nonsteroidal anti-inflammatory drugs, cobalt or cobalamin
15. are pregnant, breast-feeding, and plan to become pregnant after participate in the study
16. suffer from COVID-19
17. have been enrolled in other clinical trials within the last three month before the agreement to participate in this trial or plan to participate another trial during this trial
18. are judged as ineligible to participate in the study by the physician
Target sample size
17
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
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
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
NAGASE BeautyCare 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
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 | 10 | Month | 22 | 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
19
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
| 2021 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 04 | 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
| 2021 | Year | 10 | Month | 20 | Day |
Last modified on
| 2022 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052288
