UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy evaluation of Saccharomyces cerevisiae SM-10 on the joints
Title of the study (Brief title)	Efficacy evaluation of Saccharomyces cerevisiae SM-10 on the joints
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of SM-10 supplements on the functions of movement, cartilage metabolism and liver
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Levels of change in locomotive syndrome risk test at 6 and 12 weeks.
Key secondary outcomes	Levels of change in JKOM, JHEQ, JLEQ, JOA, VAS (knee pain), COMP, liver function (AST, ALT, gamma-GTP). Levels of change in knee joint stiffness.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	SM-10 supplements are ingested for 12 consecutive weeks at 600 mg.
Interventions/Control_2	Placebo are ingested for 12 consecutive.
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	45 years-old <=
Age-upper limit	64 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Males and females at the ages of 45 to 64 2. Subjects who confirmed pain of knee joint by JKOM and VAS. 3. Subjects who are judged as stage 1 in locomotive syndrome risk test 4. Subjects who are classified into 0-I grade on the basis of the Kellgren-Lawrence classification. (Subjects who undiagnosed with Knee Osteoarthritis by physician)
Key exclusion criteria	1. Subjects who are confirmed 30-points by JOA score, the degree of knee pain and walk ability 2. Subjects who are suspected gouty attack with hyperuricemia 3. Subjects who have positive rheumatoid factors on the screening test or may have rheumatic pain 4. Subjects who have performed arthroplasty or need it 5. Subjects who regularly take health food containing bone, joint, muscle wellness from three month before the screening test to the end of the study 6. Subjects who regularly take medicine 7. Subjects who have been performed intra-articular hyaluronic acid or steroid drug injection within a year before the screening test 8. Subjects who get an intense exercise to make excessive load on the joints 9. Subjects who have a history of the disorder related to bone and joint such as fracture and sprain within a year before the screening test 10. Subjects who regularly use a stick or supporter 11. Subjects who routinely exert an influence on the efficacy evaluation 12. Subjects who get a diagnosis of malignancy, are under treatment for hypertension, cardiac disease, renal disease and thyroid dysfunction, and have a history of serious disorder such as hepatic disease 13. Subjects who consume an excess amounts of alcohol 14. Subjects who have possibility of allergy symptoms onset by the test supplement 15. Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire 16. Subjects who have participated in other clinical study within a month before the screening test or who intend to participate in study period 17. Subjects who intend to become pregnant or lactating 18. Subjects who are judged as unsuitable for this study by physician
Target sample size	60

Research contact person
Name of lead principal investigator	hiroyuki kimura
Organization	Horus Co., Ltd.
Division name	Academic Planning Department
Address	3-3-5 Nakano Nakano-ku Tokyo
TEL	03-5328-9331
Email	kimura.hiroyuki@horus-jnl.co.jp

Public contact
Name of contact person	Sayuri Fujita
Organization	Horus Co., Ltd.
Division name	Academic Planning Department
Address	3-3-5 Nakano Nakano-ku Tokyo
TEL	03-5328-9331
Homepage URL	http://horus-jnl.com/
Email	gakujutu.mail@horus-jnl.co.jp

Sponsor
Institute	TTC CO., LTD.
Institute
Department

Funding Source
Organization	Horus Co., Ltd.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 14 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 05 Month 26 Day
Anticipated trial start date	2016 Year 06 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	Jpn Pharmacol Ther 2017, 45 (6), 1031-44
Other related information

Management information
Registered date	2016 Year 06 Month 14 Day
Last modified on	2017 Year 08 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026198