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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025863
Receipt No. R000029738
Scientific Title Investigation of blood kinetics at the time of ingestion of coating processed glucosamine hydrochloride
Date of disclosure of the study information 2017/01/26
Last modified on 2018/09/05

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Basic information
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
Condition Healthy male
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
Primary outcomes Area under the curve of plasma glucosamine levels
Key secondary outcomes maximum plasma glucosamine levels, glucosamine concentration at each time point

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute TTC Co., Ltd
Institute
Department

Funding Source
Organization NOF CORPORATION
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 26 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
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
Other related information

Management information
Registered date
2017 Year 01 Month 26 Day
Last modified on
2018 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029738

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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