UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028201
Receipt No. R000032280
Scientific Title Inhibitory effects of polyphenol-rich extracts from Wakame on cachexia: an experiment checking the safety dose in human
Date of disclosure of the study information 2017/09/01
Last modified on 2017/07/12

* 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 Inhibitory effects of polyphenol-rich extracts from Wakame on cachexia: an experiment checking the safety dose in human
Acronym Effects of Wakame polyphenol on cacexia
Scientific Title Inhibitory effects of polyphenol-rich extracts from Wakame on cachexia: an experiment checking the safety dose in human
Scientific Title:Acronym Effects of Wakame polyphenol on cacexia
Region
Japan

Condition
Condition cachexia
Classification by specialty
Hematology and clinical oncology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We will check the safety and side-effects of the dietary wakame polyphenol-rich extracts in healthy Japanese people.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes No significant side-effects after one month
Key secondary outcomes Increase in muscle volume

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 yogurt(75g), 30 days
Interventions/Control_2 Polyphenol-rich extracts from Wakame, 3g/day, 30 days
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
80 years-old >
Gender Male and Female
Key inclusion criteria 20-80 years old
gender-free
desk worker
informed consent
Key exclusion criteria patients with DM or chronic kidney diseases
person who do not like eat wakame
person daily getting supplements containing polyphenols
person with allergy against club or shrimp
person with thyroid dysfunction
pregnant women
person with claustrophobia or pace-maker
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Nikawa
Organization Tokushima University Graduate School
Division name Institutes of Biomedical Science
Zip code
Address 3-18-15 Kuramoto-cho, Tokushima
TEL 088-633-9248
Email nikawa@tokusima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Nikawa
Organization Tokushima University Graduate School
Division name Institutes of Biomedical Science
Zip code
Address 3-18-15 Kuramoto-cho, Tokushima
TEL 088-633-9248
Homepage URL
Email nikawa@tokusima-u.ac.jp

Sponsor
Institute Department of Nutritional Physiology, Institutes of Biomedical Science, Tokushima University Graduate School
Institute
Department

Funding Source
Organization Cross-Ministerial Strategic Innovation Promotion Program (SIP)
Organization
Division
Category of Funding Organization Japanese Governmental office
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

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 01 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
2017 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 01 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 07 Month 12 Day
Last modified on
2017 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032280

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.