UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018757
Receipt No. R000021700
Scientific Title A study on the blood concentration of carnosine after ingestion of carnosine in human
Date of disclosure of the study information 2015/08/25
Last modified on 2016/01/07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A study on the blood concentration of carnosine after ingestion of carnosine in human
Acronym A study on the blood concentration of carnosine after ingestion of carnosine in human
Scientific Title A study on the blood concentration of carnosine after ingestion of carnosine in human
Scientific Title:Acronym A study on the blood concentration of carnosine after ingestion of carnosine in human
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the effect of plant-derived components on the blood concentration of carnosine after ingestion of carnosine. To confirm the safety of oral intake of plant-derived components.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Efficacy : Area under the curve of blood carnosine level after ingestion of carnosine
Safety : Adverse effects
Key secondary outcomes Efficacy : Blood carnosine level at each blood sampling time after ingestion of carnosine
Safety : Adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Day0, 1 day oral intake of 900mg of Carnosine.
Day1-6, Oral intake of 1g of plant-derived components everyday.
Day7, 1day oral intake of 900mg of Carnosine & 1g of plant-derived components.
Interventions/Control_2
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
60 years-old >
Gender Male and Female
Key inclusion criteria 1)Healthy males and females aged 20 to less than 60 years old.
2)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria 1)Subjects who take continuous medical treatment.
2)Subjects who are contracting with diabetic nephropathy
3)Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses) affecting the test results.
4)Subjects who have contracted or are contracting heart disease, liver disease, kidney disease and digestive disease.
5)Subjects who have contracted with cancer
6)Subjects who are pregnant or have possibility to bocome pregnant or planning to become pregnant during the study or breast-feeding woman.
7)Subjects who drink alcohol a lot
8)Subjects who have an extremely irregular diet habit or alternative work schedule or work on midnight shift
9)Subjects who have allergic reaction to drug medicine and food.
10)Subjects who have systolic blood pressure less than 90 mmHg.
11)Subjects who donated 200 mL of blood and/or blood components within the last one month prior to the current study.
12)Male subjects who donated 400 mL of blood within the last three months prior to the current study.
13)Female subjects who donated 400 mL of blood within the last four months prior to the current study.
14)Male subjects whose blood was collected more than 1200 mL within the last twelve months when the amount of blood sampling in the current study is added.
15)Female subjects whose blood was collected more than 800 mL within the last twelve months when the amount of blood sampling in the current study is added.
16)Subjects who are participating in other clinical studies for drug medicine or food, or who finished clinical study within four weeks, or who are planning to participate in other clinical study.
17)Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junichi Nakamura
Organization Suntory Global Innovation Center Ltd.
Division name Research Institute
Zip code
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan
TEL 050-3182-0460
Email Junichi_Nakamura@suntory.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Watanabe
Organization Suntory Global Innovation Center Ltd.
Division name Innovation Development Department
Zip code
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan
TEL 050-3182-0593
Homepage URL
Email H_Watanabe@suntory.co.jp

Sponsor
Institute Suntory Global Innovation Center Ltd.
Institute
Department

Funding Source
Organization Suntory Global Innovation Center Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 チヨダパラメディカルケアクリニック(東京都)

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 25 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
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
2015 Year 08 Month 18 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 01 Day
Last follow-up date
2015 Year 09 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 08 Month 21 Day
Last modified on
2016 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021700

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.