UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033045 |
|---|---|
| Receipt number | R000037623 |
| Scientific Title | The effect of salacia-derived salacinol on the postprandial hyperglycemia suppression - A systematic review. |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2019/03/05 10:15:50 |
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Basic information
Public title
The effect of salacia-derived salacinol on the postprandial hyperglycemia suppression - A systematic review.
Acronym
A systematic review of salacia-derived salacinol.
Scientific Title
The effect of salacia-derived salacinol on the postprandial hyperglycemia suppression - A systematic review.
Scientific Title:Acronym
A systematic review of salacia-derived salacinol.
Region
| Japan |
Condition
Condition
Healthy adult volunteers with a fasting blood glucose level in the normal range or the boundary range (less than 126 mg/dL).
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The object of this review is to evaluate the suppressive effect on the postprandial hyperglycemia of food containing salacia-derived salacinol by performing a systematic review.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the suppression effect on the postprandial hyperglycemia (ref1).
Specifically, it is taken as the blood glucose level after ingestion of carbohydrate or a meal containing carbohydrate.
(ref1)
Since the fluctuation of blood glucose level after meals varies depending on the types or contents of carbohydrates loaded, such as a drink containing sucrose or a steamed rice, the primary outcome will be evaluated comprehensively using the Cmax and/or the area under the curve (AUC) of postprandial blood glucose level.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Systematic literature search using scientific databases and registered databases for clinical trials and systematic review will be performed.
Key inclusion criteria as follows:
Participants: Healthy adult volunteers with a fasting blood glucose level in the normal range or the boundary range (less than 126 mg/dL).
Intervention: Intake the foods containing salacia-derived salacinol more than 0.02 mg/meal.
Comparison: Intake the foods not containing salacia-derived salacinol.
Outcome: The suppression effects of postprandial hyperglycemia (see above outcome column)
Study design: Adopt randomized, quasi-randomized and non-randomized (parallel group or cross over) comparison test.
Key exclusion criteria
The literature which does not meet the key inclusion criteria will be excluded. Intervention tests without a placebo intake group are excluded.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akifumi Nagatomo |
Organization
Morishita Jintan Co. Ltd.
Division name
Health Care Product Department
Zip code
Address
11-1, Tsudayamate 2-Chome, Hirakata-City, Osaka 573-0128, Japan
TEL
072-800-1044
a-nagatomo@jintan.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiki Sakaino |
Organization
Association for Salacia Promotion
Division name
Office
Zip code
Address
c/o Life Science Division, 26-30, Nishiazabu 2-Chome Minatoku, Tokyo 106-8620, Japan
TEL
03-6418-9130
Homepage URL
http://www.salacia-association.jp/index.html
yoshiki.sakaino@fujifilm.com
Sponsor or person
Institute
Association for Salacia Promotion
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Review team
Mr. Kenji Ikeda, Fujifilm Corporation
Dr. Yuriko Oda, Fujifilm Corporation
Dr.. Eriko Kishino, Ensuikou Sugar Refining Co. Ltd.
Research Collaborator
Professor Horoharu Kamioka, Tokyo University of Agriculuture
Dr. Takahiro Yoshizaki, Toyo University
Ms. Mari Makishi, Toho University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.salacia-association.jp/index.html
Publication of results
Published
Result
URL related to results and publications
http://www.salacia-association.jp/index.html
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
| 2018 | Year | 05 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 12 | Month | 18 | Day |
Other
Other related information
(Searches)
A librarian (Research Collaborator F) will search 11 databases for studies from the beginning of each databases to the search date.
Moreover, both reviewer A and B will search 3 journals for studies on their hands.
(Studies extraction)
In order to make the final selection of studies for the review, two reviewers (A and B) will independently apply all criteria to the full text of articles. Disagreement and uncertainties will be resolved by discussion with other reviewers. More over, reviewer C will confirm the final judgment.
Based on the selected studies, two reviewers (C and D) will independently extract data with outcome. Disagreement and uncertainties will be resolved by discussion with other reviewers. More over, reviewer A will confirm the final judgment.
(Risk of bias assessment)
Three reviewers (A, B and C) will independently assess the quality of articles based on the rule of 8 items.
(Indirectness evaluation)
Two reviewers (A and B) will independently evaluate the indirectness of articles. Disagreement and uncertainties will be resolved by discussion with other reviewers. More over, reviewer C will confirm the final judgment.
(Inconsistency evaluation )
We will evaluate inconsistency of evidence according to the value of I2 and by a statistical test for heterogeneity of effect estimates in a meta-analysis. If we would not evaluate inconsistency with meta-analysis, it will be evaluated other criteria.
(Imprecision assessment)
We will assess imprecision based on the total number of participants in all included studies.
(Meta-analysis)
Only when we will not find heterogeneity in randomized controlled trials and confirm no missing data, research collaborator E will conduct a meta-analysis by using RevMan5.
Management information
Registered date
| 2018 | Year | 06 | Month | 19 | Day |
Last modified on
| 2019 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037623
