UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of supplement containing N-acetyl glucosamine, proteoglycan and lutein, on knee joint symptoms. - a randomized, double blind, placebo-controlled study -
Title of the study (Brief title)	Effect of supplement containing N-acetyl glucosamine, proteoglycan and lutein, on knee joint symptoms.
Region	Japan

Condition
Condition	Healthy volunteer
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to evaluate the effect of ingestion of supplement containing N-acetyl glucosamine, proteoglycan and lutein, on knee joint subjective symptoms.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	JKOM and Knee Society Score(ver 2011)
Key secondary outcomes	knee joint subjective symptoms(VAS)

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	Treatment
Type of intervention	Food
Interventions/Control_1	Ingestion of supplement containing N-acetyl glucosamine, proteoglycan complex and lutein for 12 weeks
Interventions/Control_2	Ingestion of placebo without N-acetyl glucosamine, proteoglycan complex and lutein for 12 weeks
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	30 years-old <=
Age-upper limit	64 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Subject, aged from 30 to 65 years Males and females with uncomfortable feeling of knee 2) Subject, be diagnosed KLgrade 0 or 1 3) Subject, upon briefing of the content of the present study, fully understanding and agreeing to its objective; and being able to personally sign a written informed consent
Key exclusion criteria	1)Subjects having a medical history of rheumatism 2)Subjects who have leg pain or numbness 3)Subjects who have injury of semi-lunar disc or the other knee joint disease 4)Subjects receiving treatment for osteoarthritis 5)Subject receiving treatment for serious liver, renal, cardio-vascular, respiratory, endocrine, or metabolic disorders 6)Subject presenting known allergy or history of hypersensitivity to gelatin, crab and salmon 7)For female subject: pregnancy or breast feeding, or possibility of pregnancy, or intention to be pregnant during the study 8)Subject having blood sample of 200 ml or more taken (e.g., donated blood) within 1 month, or 400 ml or more within 3 months prior to the start of the present study 9)Subject who took part in another clinical trial within 3 months prior to the start of the present study or who is currently taking part in another clinical trial 10)Subject deemed unsuitable by the investigator
Target sample size	80

Research contact person
Name of lead principal investigator	Osami Kajimoto
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Medical Science on Fatigue
Address	1-4-3, Asahi-machi, Abeno-ku, Osaka, Osaka
TEL	06-6645-6171
Email	kajimoto@med.osaka-cu.ac.jp

Public contact
Name of contact person	Tomohiro Sugino
Organization	Soiken Inc.
Division name	President & CEO
Address	Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka
TEL	06-6871-8888
Homepage URL
Email	sugino@soiken.com

Sponsor
Institute	Soiken Inc.
Institute
Department

Funding Source
Organization	FANCL Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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	医療法人弘正会ふくだ内科クリニック（大阪府）

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 19 Day
Anticipated trial start date	2016 Year 01 Month 09 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 01 Month 08 Day
Last modified on	2016 Year 08 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023671