UMIN-CTR Clinical Trial

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

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

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

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

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Association for Salacia Promotion

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

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)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

10

Month

01

Day

URL releasing protocol

http://www.salacia-association.jp/index.html

Publication of results

Published

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

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 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.

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