UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032592 |
|---|---|
| Receipt number | R000037164 |
| Scientific Title | Effects of polyphenol-enriched extracts from Wakame on muscle atrophy caused by cachexia |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2025/03/19 15:37:08 |
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Basic information
Public title
Effects of polyphenol-enriched extracts from Wakame on muscle atrophy caused by cachexia
Acronym
Effects of polyphenol-enriched Wakame diets on muscle atrophy
Scientific Title
Effects of polyphenol-enriched extracts from Wakame on muscle atrophy caused by cachexia
Scientific Title:Acronym
Effects of polyphenol-enriched Wakame diets on muscle atrophy
Region
| Japan |
Condition
Condition
cachexia
Classification by specialty
| Gastroenterology | Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Cachexia occasionally causes muscle atrophy. This atrophy is mediated by oxidative stress induced with proinflammatory cytokines. Recently polyphenols derived from plants have been reported to have several beneficial effects on cachexia. Wakame contains a lot of polyphenol, especially morin. In this study we will examined anti-muscle atrophy actions of polyphenol-enriched Wakame extracts on patients with cachexia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
muscle volume
Key secondary outcomes
food intake, body weight, tumor size
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are 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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Wakame Extracts with Chinese soup, 1.5 g/day, 28 days;
Interventions/Control_2
flour for control group, 1.5 g/day, 28 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Pre-cachectic condition: In a state deviating from a normal state, weight loss is within 5%, a condition accompanied by anorexia and metabolic abnormality
Key exclusion criteria
Poor oral ingestion, accompanied by systemic inflammation, the condition of cachexia progressed (weight loss is 5% or more; or BMI 20% or less and weight loss 2% or more; or sarcopenia (muscle mass decreased, muscular strength and body function is decreased, BMI less than 18.5) and weight loss is 2% or more)
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
Institute of Medical Biosciences, Department of Nutritional Physiology
Zip code
7708054
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-9248
nikawa@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Nikawa |
Organization
Tokushima University Graduate School
Division name
Institute of Medical Biosciences, Department of Nutritional Physiology
Zip code
7708054
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-9248
Homepage URL
nikawa@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
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
The Ethics Committee of Tokushima University Hospital
Address
2-50-1 Kuramoto-cho, Tokushima
Tel
088-615-8512
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
徳島大学病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | 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
20
Results
Terminated
Results date posted
| 2025 | Year | 03 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Terminated
Participant flow
Terminated
Adverse events
Terminated
Outcome measures
Terminated
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2018 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 14 | Day |
Last modified on
| 2025 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037164
