UMIN-CTR Clinical Trial

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
Email	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
Email	ortho-m.koike@juntendo.ac.jp

Sponsor
Institute	Department of Orthopaedic Surgery, Juntendo Tokyo Koto Geriatric Medical Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028945