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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012483
Receipt No. R000011985
Scientific Title The effect of reducing internal exposure by continuous intake of apple pectin
Date of disclosure of the study information 2013/12/04
Last modified on 2014/01/07

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Basic information
Public title The effect of reducing internal exposure
by continuous intake of apple pectin
Acronym The effect of reducing internal exposure
by apple pectin
Scientific Title The effect of reducing internal exposure
by continuous intake of apple pectin
Scientific Title:Acronym The effect of reducing internal exposure
by apple pectin
Region
Japan

Condition
Condition general people with internal exposure
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Establishing the way of decreasing internal exposure
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The decrease of radioactive Cs
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 Treatment
Type of intervention
Food
Interventions/Control_1 Intake the jelly with apple-pectin for 4 weeks.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Those who were 20Bq/kg or more in the whole-body counter
Key exclusion criteria (1) Those who show an allergic reaction to test meal
(2) Those who have excised the digestive organ
(3) Those who are under pregnancy or breast-feeding
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoyoshi Oikawa
Organization Minamisoma-city general hospital
Division name cranial nerve surgery
Zip code
Address Honmachi 2 chome, Haramachi-ku, Minamisoma
TEL 0244-22-3181
Email minamisoma-kyukyu@bz04.plala.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsu Kinoshita
Organization Community SHIN Science Co., Ltd.
Division name Social Epidemiology Institute
Zip code
Address 160-4 Kishimachi, Matsuyama-city, Ehime
TEL 089-904-7811
Homepage URL
Email tetsu.prospective@gmail.com

Sponsor
Institute Minamisoma-city general hospital
Institute
Department

Funding Source
Organization Sunny Health Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Organization of weight control popularization
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
2013 Year 12 Month 04 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
2012 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 06 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
2013 Year 12 Month 04 Day
Last modified on
2014 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=R000011985

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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