UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025163 |
|---|---|
| Receipt number | R000028945 |
| Scientific Title | A Double Blind, Randomized Placebo-Controlled Study of Clinical Efficacy of Melon-GliSODin for the Treatment of Aging-related Dysfunction in Motor Organs |
| Date of disclosure of the study information | 2016/12/09 |
| Last modified on | 2021/02/24 10:33:03 |
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Basic information
Public title
Clinical efficiency of transoral administration of GliSODin against aging-related dysfunction in motor organ.
Acronym
Efficiency of GliSODin
Scientific Title
A Double Blind, Randomized Placebo-Controlled Study of Clinical Efficacy of Melon-GliSODin for the Treatment of Aging-related Dysfunction in Motor Organs
Scientific Title:Acronym
Efficiency of GliSODin
Region
| Japan | Asia(except Japan) |
Condition
Condition
Locomotive Syndrome
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate the preventive effects of transoral intake of GliSODin against age-related dysfunction in motor organ
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Questionnaire on subjective symptoms (Health-related QOL SF-36, Japanese Orthopedic Surgery Association Low Back Pain Disease Questionnaire (JOABPEQ), Japanese Knee Osteoarthritis Measure (JKOM), Locomo 25 Roland-Morris Disability questionnaire (RDQ),disease-specific assessment method for back pain while standing(Oswestry Disability index; ODI), Chalder fatigue Scale,Verbal Rating Scale (VRS), and motility function (grip strength, leg strength, timed up-and go test (TUG), 6-minute walking distance, the two step test, the stand-up test)
Key secondary outcomes
renal function (urea nitrogen (BUN) and serum creatinine (Cre)), liver damage (serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT)), bone formation (procollagen type 1 nitrogenous propeptides (P1NP)), bone resorption (tartrate-resistant acid phosphatase 5b (TRACP5b), osteocalcin (OC), and undercarboxylated osteocalcin (ucOC)), and oxidation (diacron-reactive oxygen metabolites (dROMs) and malondialdehyde (MDA)); antioxidant enzymes (superoxide dismutase (SOD), glutathione peroxidase (GPx), and biological antioxidant potential (BAP)); a marker of glycation (pentosidine); inflammatory cytokines (interleukin-6 (IL6), TNFa, high-sensitivity C-reactive protein (hsCRP), and matrix metalloproteinase 3 (MMP3)). Furthermore, bone density (hip joint Young Adult Mean (YAM), lumbar spine YAM, and whole-body YAM), the Skeletal Muscle Index (SMI), body fat percentage, fat mass, non-fat mass, android (A) fat, gynoid (G) fat; the white blood cell (WBC) count, red blood cell (RBC) count, hemoglobin (Hb), hematocrit (Hct), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean cell hemoglobin concentration (MCHC), and platelet (Plt) count. The biochemical tests comprised serum total protein (TP), albumin (Alb), CK, uric acid (UA) glucose, Zn, Cu, Ca, and Pi
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
GliSODin(1,000 IU/day) for 6 months
Interventions/Control_2
Placebo for 6 months
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
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
Volunteer with low back or knee pain and gait instability caused by motor weakness
Key exclusion criteria
Volunteer with diseases including internal midicine, psychogenic disorders, neuromuscular diseases, postoperative state of orthopaedic surgery, allergy against melon and wheat.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Koike |
Organization
Juntendo Tokyo Koto Geriatric Medical Center
Division name
Department of Orthopaedic Surgery
Zip code
136-0075
Address
3-3-20 Shinsuna, Koto-ku, Tokyo
TEL
03-5632-3111
ortho-m.koike@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Koike |
Organization
Juntendo Tokyo Koto Geriatric Medical Center
Division name
Department of Orthopaedic Surgery
Zip code
136-0075
Address
3-3-20 Shinsuna, Koto-ku, Tokyo
TEL
03-5632-3111
Homepage URL
https://jrct.niph.go.jp/en-latest-detail/jRCTs031180310
ortho-m.koike@juntendo.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Juntendo Tokyo Koto Geriatric Medical Center
Institute
Department
Personal name
Funding Source
Organization
Nutrition Act Co., Ltd.
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
Certified Review Board of Juntendo Tokyo Koto Geriatric Medical Center
Address
3-3-20 Shinsuna, Koto-ku, Tokyo
Tel
03-5632-3111
kubota_kei@juntendo.gmc.ac.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
順天堂東京江東高齢者医療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 09 | 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 | 08 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 06 | Month | 09 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 09 | Day |
Date analysis concluded
| 2020 | Year | 06 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 06 | Day |
Last modified on
| 2021 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028945
