UMIN-CTR Clinical Trial

Public title

Safety evaluation of execessive consumption of proteoglycan complex 80 from salmon nasal cartilage - a randomized, double blind, placebo-controlled study -

Acronym

Safety evaluation of execessive consumption of proteoglycan complex 80 from salmon nasal cartilage

Scientific Title

Safety evaluation of execessive consumption of proteoglycan complex 80 from salmon nasal cartilage - a randomized, double blind, placebo-controlled study -

Scientific Title:Acronym

Safety evaluation of execessive consumption of proteoglycan complex 80 from salmon nasal cartilage

Region

Japan

Condition

Healthy volunteer

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the safety of excessive consumption of proteoglycan complex 80 for 4 weeks

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Bloodchemistry, hematology and urine analysis at 2-week, 4-week consumption and 2-week after consumption period

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 proteoglycan complex 80 for 4 weeks

Interventions/Control_2

Ingestion of placebo without proteoglycan complex 80 for 4 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

20

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

1.Healthy male and female age 20 to 65 inclusive at the time of informed consent, BMI >30 inclusive.
2.Subjects who received an enough explanation of the test objectives and detail, who have consent ability, who are willing to participate with well understandings and who have signed the informed consent document.

Key exclusion criteria

1.Subjects who have been continuously treated by medicine.
2.Subjects who have a history of renal, hepatic, cardiac, respiratory, endocrine, or other metabolic disease or who have been treated for those diseases.
3.Subjects who have been regularly used medicine (Including antiflatulent and laxative)
4.Subjects who cannot stop taking supplement/health food (Including Special Health Food, Foods with "Function Claims")
5.Subjects who declared having an allergy for component of test tablet
6.Subjects who have a past surgical history or a history of digestive disease which affects digestion.
7.Subjects who are pregnant, willing to be pregnant or breast feeding.
8.Subjects with a history of drug dependence or alcohol dependence or past history of drug dependence or alcohol dependence
9.Subjects who made a blood component donation or whole blood donation more than 200mL within 4 weeks before the test starts
10.Subjects who have shift work or night shift work.
11.Subjects who have been participated in any other food or medicine intake clinical trial, cosmetic and medicine application trial or participated in any other clinical trial within 1 month after consent obtain, or who is willing to participate.
12.Any who is judged as unsuitable to participate in this clinical trial through by principal investigator or sub-investigator.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Yasuo Kobuna

Organization

Kobuna orthopedic surgery

Division name

Medical office

Zip code

Address

311-2, Gokanmachi, Maebashi, Gunma

TEL

027-261-7600

Email

info@kobunaseikei.jp

Name of contact person

1st name
Middle name
Last name	Yoshika Komori

Organization

KSO Corporation

Division name

Sales department

Zip code

Address

1-9-7 Shibaura, Minato-ku, Tokyo

TEL

03-3452-7733

Homepage URL

Email

yoshi@kso.co.jp

Institute

KSO Corporation

Institute

Department

Personal name

Organization

Nihon Pharmaceutical

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

2017

Year

06

Month

01

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

Preinitiation

Date of protocol fixation

2017

Year

02

Month

14

Day

Date of IRB

Anticipated trial start date

2017

Year

03

Month

06

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

03

Month

03

Day

Last modified on

2017

Year

03

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030300