UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028201 |
|---|---|
| Receipt number | 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 | 2025/05/12 15:21:51 |
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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 | Takeshi |
| Middle name | |
| Last name | Nikawa |
Organization
Tokushima University Graduate School
Division name
Institutes of Biomedical Science
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-9248
nikawa@tokusima-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Nikawa |
Organization
Tokushima University Graduate School
Division name
Institutes of Biomedical Science
Zip code
770-8054
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-9248
Homepage URL
nikawa@tokusima-u.ac.jp
Sponsor or person
Institute
Department of Nutritional Physiology, Institutes of Biomedical Science, Tokushima University Graduate School
Institute
Department
Personal name
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
Clinical Trial Center for Developmental Therapeutics
Address
3-18-15 Kuramoto-cho, Tokushima
Tel
088-633-9294
awachiken@tokushima-u.ac.jp
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
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
0
Results
There are no results because the exam was canceled.
Results date posted
| 2025 | Year | 05 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
There are no baseline characteristics because the exam was canceled.
Participant flow
There are no baseline characteristics because the exam was canceled.
Adverse events
None
Outcome measures
No adverse events occurred after one month of administration.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2017 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 13 | Day |
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
| 2025 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032280
