UMIN-CTR Clinical Trial

Public title

The efficacy evaluation of proteoglycan on cartilage biomarkers in subjects with knee joints discomfort.

Acronym

Efficacy evaluation of proteoglycan on knee joints discomfort.

Scientific Title

The efficacy evaluation of proteoglycan on cartilage biomarkers in subjects with knee joints discomfort.

Scientific Title:Acronym

Efficacy evaluation of proteoglycan on knee joints discomfort.

Region

Japan

Condition

Healthy volunteer

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the efficacy of proteoglycan on knee joints discomfort.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

C2C, PIICP, CTX-II, CTX-II/PIICP, C1,2C, CS846, COMP, C1,2C/PIICP

Key secondary outcomes

Visual Analogue Scale (VAS), Japanese Knee Osteoarthritis Measure (JKOM), Japanese Orthopaedic Association score (JOA score)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Blocking

Concealment

Numbered container method

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Proteoglycan capsules are ingested for 16 consecutive weeks at 10mg.

Interventions/Control_2

Placebo capsules (no proteoglycan) are ingested for 16 consecutive 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

35

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. Males and females at the ages of 35 to 75
2. Subjects who confirmed pain of knee joint by JKOM and VAS.
3. Subjects who are classified into 0-II grade on the basis of the Kellgren-Lawrence classification. (Subjects who undiagnosed with Knee Osteoarthritis by physician)

Key exclusion criteria

1. Subjects who exceeded the value of knee pain more than the sum VAS value of other joint pain
2. Subjects who are confirmed 30-points by JOA score, the degree of knee pain and walk ability
3. Subjects who are suspected gouty attack with hyperuricemia
4. Subjects who have positive rheumatoid factors on the screening test or may have rheumatic pain
5. Subjects who have performed arthroplasty or need it
6. Subjects who regularly take health food containing proteoglycan or related to bone and joint wellness from three month before the screening test to the end of the study
7. Subjects who regularly take medicine, except in the case of permission to take anti-pain and anti-inflammatory drug by physician
8. Subjects who take medicine more than three days a week or plan to do them in study period
9. Subjects who have been performed intra-articular hyaluronic acid or steroid drug injection within a year before the screening test
10. Subjects who get an intense exercise to make excessive load on the joints
11. 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
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 raw material in test diet
15. Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
16. Subjects who take warfarin
17. Subjects who have participated in other clinical study within a month before the screening test or who intend to participate in study period
18. Subjects who intend to become pregnant or lactating
19. Subjects who are judged as unsuitable for this study by physician

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Kumie Ito

Organization

Yaesu Sakura dori Clinic

Division name

Internal Medicine

Zip code

Address

1-6-6 yaesu, chuo-ku, Tokyo

TEL

03-6214-1285

Email

k-ito@y-sakuradoori.jp

Name of contact person

1st name
Middle name
Last name	Takashi Nakagawa

Organization

TTC Co., Ltd.

Division name

Clinical Research Planning Department

Zip code

Address

1-20-2 Ebisunishi, shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL

Email

ttcpwr2001@ttc-tokyo.co.jp

Institute

TTC Co., Ltd.

Institute

Department

Personal name

Organization

ICHIMARU PHARCOS Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

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

Date of disclosure of the study information

2016

Year

10

Month

31

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5488639/pdf/etm-14-01-0115.pdf

Number of participants that the trial has enrolled

Results

Evaluation of the effect of salmon nasal proteoglycan on biomarkers for cartilage metabolism in individuals with knee joint discomfort: A randomized double-blind placebo-controlled clinical study.

Abstract
A randomized double-blind placebo-controlled clinical trial was conducted to evaluate the chondroprotective action of salmon nasal cartilage proteoglycan on joint health. The effect of oral administration of proteoglycan (10 mg/day) on cartilage metabolism was evaluated in individuals with knee joint discomfort but without diagnosis of knee osteoarthritis. The average age of patients was 52.6 +/- 1.1 years old. The effect of proteoglycan was evaluated by analyzing markers for type II collagen degradation (C1,2C) and synthesis (PIICP), and the ratio of type II collagen degradation to synthesis. The results indicated that the change in C1,2C levels significantly differed in the proteoglycan group compared with the placebo group following 16 weeks intervention among subjects with high levels of knee pain and physical dysfunction (total score of Japan Knee Osteoarthritis Measure more than 41) and subjects with constant knee pain (both P<0.05). There was a greater increase in PIICP levels in the proteoglycan group than the placebo group following intervention, although this difference was not significant in both sets of patients. Thus, the C1,2C/PIICP ratios decreased in the proteoglycan group, whereas they slightly increased in the placebo group following the intervention. Furthermore, no test supplement-related adverse events were observed during the intervention. Therefore, oral administration of salmon nasal cartilage proteoglycan at a dose of 10 mg/day may exert a chondroprotective action in subjects with knee joint discomfort. This effect was achieved by improving cartilage metabolism (reducing type II collagen degradation and enhancing type II collagen synthesis), without causing apparent adverse effects.

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

2015

Year

01

Month

23

Day

Date of IRB

Anticipated trial start date

2015

Year

02

Month

08

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

02

Month

07

Day

Last modified on

2017

Year

08

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019129