UMIN-CTR Clinical Trial

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

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, lutein, salmon nasal cartilage extract (containing proteoglycan and type 2 collagen) and N-acetyl glucosamine for 12 weeks
Interventions/Control_2	Ingestion of placebo without lutein, salmon nasal cartilage extract (containing proteoglycan and type 2 collagen) and N-acetyl glucosamine 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	74 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Males and females aged from 30 to 74 years 2) Healthy subjects who feel pain of knee 3) Subject who is diagnosed KLgrade 0 or 1 4) Subject's score in the "pain, walking ability" of the JOA decision is less than 26 points
Key exclusion criteria	1) Subjects receiving treatment for pain of knee 2) Subjects receiving drug treatment 3) Subject receiving treatment for hyperuricemia 4) Subject receiving treatment or having a medical history for serious disease such as diabetes, cardiovascular disease, liver disease, kidney disease and heart disease 5) Subjects having rheumatism 6) Subjects having surgery of the knee or those who need knee surgery 7) Subjects having drug treatment plan for joint, during the test period 8) Subjects who has carried out the intra-articular injection of hyaluronic acid within two weeks, or the intra-articular injection of steroids within three months prior to the start of the present study 9) Subject having a medical history for disease related to bone and joints, such as fracture or sprain within three months 10) Subject taking lutein, salmon cartilage extract, proteoglycan, type 2 collagen, N-acetyl glucosamine, and other health food (hyaluronic acid, glucosamine, chondroitin sulfate, etc.) that might affect the evaluation of the test 11) Subject taking pharmaceutical products(especially glucosamine, chondroitin sulfate, vitamin D, containing amino acid, the drug treatment of osteoporosis) 12) Subject using a cane, routinely 13) Subject taking warfarin 14) Subject presenting known allergy to food or drug 15) For female subject: pregnancy or breast feeding, or possibility of pregnancy, or intention to be pregnant during the study 16) Subject deemed unsuitable by the investigator or test sharing doctor
Target sample size	88

Research contact person
Name of lead principal investigator	Tsuyoshi Yamato
Organization	Medical Corporation Kouwakai Kouwa Clinic
Division name	Director
Address	6-33-17, komagome, toshima-ku, Tokyo, Japan
TEL	03-3917-8105
Email	kouwa.clinic@gmail.com

Public contact
Name of contact person	Toshiki Kataoka
Organization	HUMA R&D CORP
Division name	Business Promotion Division
Address	RBM hamamatsucho Bld, 9F, 1-27-12, Hamamatsucho, Minato-ku, Tokyo, Japan
TEL	03-3431-1260
Homepage URL
Email	kataoka@huma-c.co.jp

Sponsor
Institute	HUMA R&D CORP
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	医療法人社団幸和会　幸和クリニック （Medical Corporation Kouwakai Kouwa Clinic）

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 15 Day
Anticipated trial start date	2016 Year 02 Month 22 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 02 Month 19 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=R000024342