UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047854 |
|---|---|
| Receipt number | R000054559 |
| Scientific Title | Effects of Undaria pinnatifida (Wakame) on postprandial glycaemia: a randomized crossover trial |
| Date of disclosure of the study information | 2022/05/25 |
| Last modified on | 2022/05/25 12:20:05 |
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Basic information
Public title
Effects of Undaria pinnatifida (Wakame) on postprandial glycaemia
Acronym
Effects of Wakame on postprandial glycaemia
Scientific Title
Effects of Undaria pinnatifida (Wakame) on postprandial glycaemia: a randomized crossover trial
Scientific Title:Acronym
Effects of Undaria pinnatifida (Wakame) on postprandial glycaemia: a randomized crossover trial
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
we aimed to investigate the mechanism underlying the influence of ingested wakame on postprandial blood glucose levels and reconfirmation of the effect of wakame on postprandial glycaemia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood glucose levels were measured 15, 30, 45, 60, 90, and 120 min after consuming the test meal.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
ingestion of packed rice with wakame.
Interventions/Control_2
ingestion of packed rice without wakame.
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
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy young Japanese women.
Key exclusion criteria
fasting blood glucose levels >125 mg/dL, excessive alcohol intake, possible allergy to seaweed, use of any medicine for any clinical treatment of disease, and taking oral drugs periodically or supplements that could affect blood glucose levels.
Target sample size
47
Research contact person
Name of lead principal investigator
| 1st name | Rieko |
| Middle name | |
| Last name | Mitamura |
Organization
Fuji women's university
Division name
Faculty of Human Life Sciences
Zip code
0613204
Address
Hanakawa Minami 4-5, Ishikari-shi, Hokkaido, Japan
TEL
0133743111
mitamura@fujijoshi.ac.jp
Public contact
Name of contact person
| 1st name | Rieko |
| Middle name | |
| Last name | Mitamura |
Organization
Fuji Women's University
Division name
Faculty of Human Life Sciences
Zip code
0613204
Address
Hanakawa Minami 4-5, Ishikari-shi, Hokkaido, Japan
TEL
0133743111
Homepage URL
mitamura@fujijoshi.ac.jp
Sponsor or person
Institute
Fuji women's university
Institute
Department
Personal name
Funding Source
Organization
Riken Vitamin Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fuji Womens' University
Address
Hanakawa Minami 4-5, Ishikari-shi, Hokkaido, Japan
Tel
0133743111
mitamura@fujijoshi.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
藤女子大学（北海道）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 25 | 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
47
Results
wakame intake effectively reduced postprandial glucose concentrations in healthy young women. Compared to rice intake alone, blood glucose levels in the early postprandial stage were significantly decreased when wakame was consumed with rice.
Results date posted
| 2022 | Year | 05 | Month | 25 | Day |
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
| 2016 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 25 | Day |
Last modified on
| 2022 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054559
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
