UMIN-CTR Clinical Trial

Public title

Investigation of blood kinetics at the time of ingestion of coating processed glucosamine hydrochloride

Acronym

Investigation of blood kinetics at the time of ingestion of coating processed glucosamine hydrochloride

Scientific Title

Investigation of blood kinetics at the time of ingestion of coating processed glucosamine hydrochloride

Scientific Title:Acronym

Investigation of blood kinetics at the time of ingestion of coating processed glucosamine hydrochloride

Region

Japan

Condition

Healthy male

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Comparison of blood kinetics of coating processed glucosamine hydrochloride and no coating processed glucosamine hydrochloride

Basic objectives2

Pharmacokinetics

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Area under the curve of plasma glucosamine levels

Key secondary outcomes

maximum plasma glucosamine levels, glucosamine concentration at each time point

Study type

Interventional

Basic design

Cross-over

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

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of coating processed glucosamine hydrochloride

Interventions/Control_2

Intake of no coating processed glucosamine hydrochloride

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

64

years-old

>=

Gender

Male

Key inclusion criteria

Healthy males from 20 to 64 years of age

Key exclusion criteria

(1) Subjects routinely taking medicine or health food that may affect the evaluation of the study
(2) Subjects who has under treatment or a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease)
(3) Subjects having possibilities for emerging allergy related to the current study
(4) Subjects who are under medication or having a history of serious diseases for which medication was required
(5) Subjects taking warfarin (product name: Warfarin, Warin, Alephrine, Warfarin K etc) for cerebral infarction or heart disease etc., those who need to take warfarin during the research period
(6) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
(7) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(8) Subjects who are judged as unsuitable for the current study based on the results of clinical and physical preliminary examination
(9) Subjects judged as unsuitable for the study by the investigator for other reasons

Target sample size

6

Name of lead principal investigator

1st name
Middle name
Last name	Atsunori Miyazaki

Organization

NOF CORPORATION

Division name

Functional Foods Research Lab.

Zip code

Address

3-3, Chidori-cho, Kawasaki-ku, Kawasaki, Kanagawa

TEL

044-281-2502

Email

atsunori_miyazaki@nof.co.jp

Name of contact person

1st name
Middle name
Last name	Shinsuke Tsuji

Organization

TTC Co., Ltd

Division name

Clinical Research Planning Department

Zip code

Address

Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL

Email

s.tsuji@ttc-tokyo.co.jp

Institute

TTC Co., Ltd

Institute

Department

Personal name

Organization

NOF CORPORATION

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

01

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

There was no significant difference in AUC 0 - 10 h, which is the main evaluation item before ingestion, and Cmax of the secondary evaluation item.
In the blood glucosamine concentration at each time point, the control food showed a significantly higher value (p = 0.001) than the test food at the glucosamine concentration after 1 hour of ingestion, and After 2 hours of ingestion, the control food was higher than the test food.
However, on the contrary, after 3 hours and 4 hours of ingestion, since the test food was higher than that of the control food, it is considered that the absorption slowed down due to the coating.
Although there was no significant difference in this study, the average value of AUC 0 - 10 h, Cmax based on pre - ingestion was higher than that of the control food when ingesting the test food.
Regarding safety, no adverse events occurred under this research condition, and it was confirmed that there was no problem in the safety of the research food.

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

2017

Year

01

Month

26

Day

Date of IRB

Anticipated trial start date

2017

Year

01

Month

27

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

01

Month

26

Day

Last modified on

2018

Year

09

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029738