UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of salacia-derived salacinol on the postprandial hyperglycemia suppression - A systematic review.
Title of the study (Brief title)	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	Akifumi Nagatomo
Organization	Morishita Jintan Co. Ltd.
Division name	Health Care Product Department
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	Yoshiki Sakaino
Organization	Association for Salacia Promotion
Division name	Office
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 05 Month 21 Day
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

Related information
URL releasing protocol	http://www.salacia-association.jp/index.html
Publication of results	Published
URL releasing results	http://www.salacia-association.jp/index.html
Results
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