UMIN-CTR Clinical Trial

Public title

Effect of supplement containing lutein on knee joint symptoms. -a randomized, double blind, placebo-controlled study-

Acronym

Effect of supplement containing lutein on knee joint symptoms.

Scientific Title

Effect of supplement containing lutein on knee joint symptoms. -a randomized, double blind, placebo-controlled study-

Scientific Title:Acronym

Effect of supplement containing lutein on knee joint symptoms.

Region

Japan

Condition

Healthy volunteer

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

JKOM and Knee Society Score(ver 2011)

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Tsuyoshi Yamato

Organization

Medical Corporation Kouwakai Kouwa Clinic

Division name

Director

Zip code

Address

6-33-17, komagome, toshima-ku, Tokyo, Japan

TEL

03-3917-8105

Email

kouwa.clinic@gmail.com

Name of contact person

1st name
Middle name
Last name	Toshiki Kataoka

Organization

HUMA R&D CORP

Division name

Business Promotion Division

Zip code

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

Institute

HUMA R&D CORP

Institute

Department

Personal name

Organization

FANCL Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人社団幸和会　幸和クリニック
（Medical Corporation Kouwakai Kouwa Clinic）

Date of disclosure of the study information

2016

Year

08

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2016

Year

01

Month

15

Day

Date of IRB

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

Other related information

Registered date

2016

Year

02

Month

19

Day

Last modified on

2016

Year

08

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024342