Unique ID issued by UMIN | UMIN000033891 |
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Receipt number | R000038653 |
Scientific Title | Evaluation of physical function in elderly subjects by botanical extract-formulated food: a randomized, double-blind, placebo-controlled study |
Date of disclosure of the study information | 2018/09/03 |
Last modified on | 2019/07/09 16:42:13 |
Evaluation of physical function in elderly subjects by botanical extract-formulated food: a randomized, double-blind, placebo-controlled study
Evaluation of physical function in elderly subjects by botanical extract -formulated food
Evaluation of physical function in elderly subjects by botanical extract-formulated food: a randomized, double-blind, placebo-controlled study
Evaluation of physical function in elderly subjects by botanical extract -formulated food
Japan |
Not applicable
Not applicable |
Others
NO
To evaluate the effect of intake of botanical extract-formulated food for 8 weeks on physical function in elderly subjects aged 65-74.
Efficacy
Not applicable
6-Minute Walk Test
Timed Up and Go Test
Chair stand Test
Handgrip strength Test
Sit and Reach Test
Profile of Mood States 2nd Edition
Borg scale
VAS (Visual analogue scale)
Clinical examination
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Intake of test food for 8 weeks
Intake of placebo food for 8 weeks
65 | years-old | <= |
74 | years-old | >= |
Male and Female
1. Males and females aged 65-74 years
2. Subjects who can carry out"Timed Up and Go Test"
3. Subjects who can carry out"6-Minute Walk Test"
4. Subjects who can visit the medical institution at the scheduled visit date
5. Subjects who recognize the object and contents of the study and submit the written informed consent
1. Subjects with heart disease
2. Subjects with serious diseases (diabetes,hypertension, hyperlipidemia, liver disease, or kidney damage)
3. Subjects with respiratory diseases
4. Subjects who have experienced dizziness, syncope, and transient sight loss
5. Subjects with musculoskeletal disorders limiting physical activities
6. Subjects who take medicine affecting heart rate
7. Subjects who have allergy related to the test foods
8. Subjects who had a habit to ingest medicine, foods for specified health uses, and foods with function claims
9. Subjects who are difficult to swallow
10. Subjects who are ineligible due to physician's judgment
34
1st name | Hiromi |
Middle name | |
Last name | Miyawaki |
Miyawaki Orthopedic Clinic
Hospital director
061-1431
3-1-6 Ariake, Eniwa, Hokkaido, Japan
0123-33-4026
Miyawaki1571@north-wind.ne.jp
1st name | Shimpei |
Middle name | |
Last name | Tomita |
New drug research center, Inc.
Clinical Research Dept.
061-1445
452-1Toiso,Eniwa-shi,Hokkaido, Japan
0123-34-0412
s-tomita@ndrcenter.co.jp
Maruzen Pharmaceuticals Co., Ltd.
Maruzen Pharmaceuticals Co., Ltd.
Profit organization
Miyawaki Orthopedic Clinic Clinical Trial Review Committee
3-1-6 Ariakecho, Eniwa City, Hokkaido
0123-33-4026
d-kameda@mediffom.co.jp
NO
2018 | Year | 09 | Month | 03 | Day |
Unpublished
34
Completed
2018 | Year | 07 | Month | 09 | Day |
2018 | Year | 07 | Month | 09 | Day |
2018 | Year | 09 | Month | 04 | Day |
2018 | Year | 11 | Month | 09 | Day |
2018 | Year | 08 | Month | 25 | Day |
2019 | Year | 07 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038653
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Research case data specifications | |
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Research case data | |
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