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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034361
Receipt No. R000039162
Scientific Title A study for evaluating the elution of component from test food. An open trial.
Date of disclosure of the study information 2018/10/09
Last modified on 2019/04/08

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Basic information
Public title A study for evaluating the elution of component from test food. An open trial.
Acronym A study for evaluating the elution of component from test food.
Scientific Title A study for evaluating the elution of component from test food. An open trial.
Scientific Title:Acronym A study for evaluating the elution of component from test food.
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the elution rate of component from test food to oral cavity.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Elution rate of component from test food
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Ingestion of test food
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) Males and Females from 20 to 59 years of age
(2) Subjects giving written informed consent
Key exclusion criteria (1) Individuals who have symptoms affecting ingestion of test food
(2) Individuals who are taking antihypertensive drug or herb, or who are currently suffering from some disease and undergoing drug treatment
(3) Individuals presenting known food allergy
(4) Individuals who are pregnant or breast-feeding, or have the will of pregnancy during the study period
(5) Individuals who are judged as unsuitable for the study by the investigator
Target sample size 8

Research contact person
Name of lead principal investigator
1st name Satoko
Middle name
Last name Okuyama
Organization Lotte Co., Ltd.
Division name Central Laboratory,Food science development section
Zip code 336-8601
Address 1-1, Numakage-3chome, Minami-ku, Saitama
TEL 048-837-0170
Email okuyama_satoko@lotte.co.jp

Public contact
Name of contact person
1st name Satoko
Middle name
Last name Okuyama
Organization Lotte Co., Ltd.
Division name Central Laboratory,Food science development section
Zip code 336-8601
Address 1-1, Numakage-3chome, Minami-ku, Saitama
TEL 048-837-0170
Homepage URL
Email okuyama_satoko@lotte.co.jp

Sponsor
Institute Lotte Co., Ltd.
Institute
Department

Funding Source
Organization Lotte Co., Ltd.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Shiba Palace Clinic institutional review board
Address 6F DaiwaA Hamamatsucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel 03-5408-1599
Email jimukyoku@mail.souken-r.com

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
2018 Year 10 Month 09 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 Preinitiation
Date of protocol fixation
2018 Year 09 Month 13 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 31 Day
Last follow-up date
2018 Year 11 Month 22 Day
Date of closure to data entry
2018 Year 11 Month 30 Day
Date trial data considered complete
2018 Year 11 Month 30 Day
Date analysis concluded
2018 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date
2018 Year 10 Month 02 Day
Last modified on
2019 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039162

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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