UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033045
Receipt No. 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

* 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 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
Email 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
Email yoshiki.sakaino@fujifilm.com

Sponsor
Institute Association for Salacia Promotion
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037623

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.