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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010822
Receipt No. R000012673
Scientific Title Safety and efficacy of polyphenols derived from Japanese chestnut peel
Date of disclosure of the study information 2013/05/28
Last modified on 2013/11/28

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Basic information
Public title Safety and efficacy of polyphenols derived from Japanese chestnut peel
Acronym Safety and efficacy of polyphenols derived from Japanese chestnut peel
Scientific Title Safety and efficacy of polyphenols derived from Japanese chestnut peel
Scientific Title:Acronym Safety and efficacy of polyphenols derived from Japanese chestnut peel
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study is to evaluate safety and efficacy of polyphenols derived from Japanese chestnut peel for weight-management.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary endpoint is evaluation of safety as phase I trial. An evaluation of adverse events.
Key secondary outcomes Efficacy for body composition as phase II study.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 An extract containing polyphenols derived from Japanese chestnut peel is administered for 8 weeks. Placebo controlled trial.
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 - Age: more than or equal to 20 years at the time of providing informed consent

- Individuals who have never experienced psychological and critical diseases.

- Individuals who have the ability to provide written informed consent.
Key exclusion criteria - Subjects who have an inappropriate clinical history for efficacy and safety assessment in the study (such as drug abuse, alcoholism, and the disease of heart, liver, kidney, lungs, eye, blood etc.) and who is taking any drugs.

- Subjects judged to be inappropriate for the study by the investigator.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seika Kamohara MD, PhD
Organization DHC Corporation
Division name Division of Research Adviser
Zip code
Address Minami-azabu 2-7-1, Minato-ku, Tokyo
TEL 03-5442-3945
Email kamohara@dhc.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Seika Kamohara MD, PhD
Organization DHC Corporation
Division name Division of Research Adviser
Zip code
Address Minami-azabu 2-8-12, Minato-ku, Tokyo
TEL 03-5442-3945
Homepage URL
Email kamohara-seika@umin.ac.jp

Sponsor
Institute DHC Corporation
Institute
Department

Funding Source
Organization DHC Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Suidobashi Medical Clinic, Tokyo, Japan.
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 05 Month 28 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
2013 Year 04 Month 26 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 29 Day
Last follow-up date
2013 Year 12 Month 31 Day
Date of closure to data entry
2014 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 05 Month 28 Day
Last modified on
2013 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012673

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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