Unique ID issued by UMIN | UMIN000053973 |
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Receipt number | R000061597 |
Scientific Title | A study for the effects of intake of test food on aging care in healthy adults |
Date of disclosure of the study information | 2024/03/26 |
Last modified on | 2024/04/02 14:42:32 |
A study for the effects of intake of test food on aging care in healthy adults
A study for the effects of intake of test food on aging care in healthy adults
A study for the effects of intake of test food on aging care in healthy adults
A study for the effects of intake of test food on aging care in healthy adults
Japan |
Healthy adult
Not applicable | Adult |
Others
NO
To investigate the aging care efficacy of intake of test food for 12 weeks
Efficacy
Confirmatory
Not applicable
Physical function test
JKOM, VAS, JOA, knee range of motion
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
YES
No need to know
2
Prevention
Food |
Intake of test food daily for 12 weeks
Intake of placebo daily for 12 weeks
50 | years-old | <= |
80 | years-old | > |
Male and Female
(1) Healthy males and females from 50 to 79 years of age
(2) Subjects who can understand the purpose and content of this study and voluntarily agree to participate in this study
(3) Subjects who are classified into 1 or 2 grade on the basis of the locomotive syndrome risk test on the screening test
(4) Subjects who are selected on the basis of VAS scale of JKOM and legs strength on the screening test
(5) Subjects who don't have diseases related to knee joints
(1) Subjects which knee join pain is weaker than pain in other joints
(2) Subjects who are confirmed 30-points by JOA score, the degree of knee pain and walk ability
(3) Subjects who are suspected gout attack with hyperuricemia
(4) Subjects who have positive rheumatoid factors on the screening test or may have rheumatic pain
(5) Subjects who have performed arthroplasty or need it
(6) Subjects who regularly use health foods that may affect the evaluation of the study
(7) Subjects who regularly use pharmaceuticals
(8) Subjects who have been performed intra-articular hyaluronic acid or steroid drug injection within a year before the screening test
(9) Subjects who exercise excessively
(10) Subjects with a history of locomotory disease within 1 year before the screening examination
(11) Subjects who use canes or supporters
(12) Subjects who periodically conduct actions that may affect the evaluation of effectiveness
(13) Subjects who have or have a history of severe diseases
(14) Subjects who diagnosed with hypertension
(15) Subjects who have unsteady lifestyle or who work manual labor
(16) Subjects who drink alcohol in large quantities
(17) Subjects who have at risk of developing allergies related to the test food
(18) Subjects who are judged as unsuitable due to lifestyle questionnaire
(19) Subjects who cannot carry out the test as instructed
(20) Subjects who have participated in other clinical study within a month before the screening test or who intend to participate in the study period
(21) Subjects who are in a pregnancy or lactation period in the study period
(22) Subjects who are judged as unsuitable for the study by investigator for other reasons
60
1st name | Satoshi |
Middle name | |
Last name | Hayakawa |
Q'SAI CO., LTD.
Marketing Division Product Development Department
810-0022
1-1-1 Yakuin, Chuo-ku, Fukuoka-shi, Japan
092-724-0855
shayakawa@kyusai.co.jp
1st name | Kei |
Middle name | |
Last name | Yasui |
EP Mediate Co., Ltd.
R&D Support Center Foods Department Section 2
162-0821
Kagurazaka AK Bldg., 1-8 Tsukudocho, Shinjuku-ku, Tokyo
080-7710-1158
yasui.kei475@eps.co.jp
EP Mediate Co., Ltd.
Q'SAI CO., LTD.
Profit organization
Japan
Medical Station Clinic Research Ethics Committee
3-12-8, Takaban, Meguro-ku, Tokyo
03-6452-2712
nakagawa.akiko297@eps.co.jp
NO
社会福祉法人新栄会 滝野川病院(東京都)
2024 | Year | 03 | Month | 26 | Day |
Unpublished
No longer recruiting
2024 | Year | 02 | Month | 22 | Day |
2024 | Year | 02 | Month | 22 | Day |
2024 | Year | 04 | Month | 01 | Day |
2024 | Year | 08 | Month | 29 | Day |
2024 | Year | 03 | Month | 26 | Day |
2024 | Year | 04 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061597
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