UMIN-CTR Clinical Trial

Public title

A systematic review on the suppression of postprandial blood glucose elevation by Salacia-derived salacinol (updated version)

Acronym

A systematic review of Salacia-derived salacinol (updated version)

Scientific Title

A systematic review on the suppression of postprandial blood glucose elevation by Salacia-derived salacinol (updated version)

Scientific Title:Acronym

A systematic review of Salacia-derived salacinol (updated version)

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) are included. Those who are planning to become pregnant, expectant or nursing mothers, and breastfeeding women are excluded.

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 based on literature information in accordance with the "Guidelines on Notification of Foods with Functional Claims" issued from Consumer Affairs Agency.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The primary outcome will measure the effect on blood glucose levels after eating carbohydrates or carbohydrate-containing meals. Specifically, the postprandial blood glucose level and the area under the blood glucose curve (AUC) of postprandial blood glucose. Both outcomes will be evaluated comprehensively.

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 will be performed using databases for scientific articles, clinical trials, and systematic reviews, as well as handsearching. Inclusion criteria as follows:
Participants (P): Healthy adult volunteers with a fasting blood glucose level in the normal range or the boundary range (less than 126 mg/dL) are included. Those who are planning to become pregnant, expectant or nursing mothers, and breastfeeding women are excluded.
Intervention (I): Intake the foods (tablets, granules, beverages, processed foods) containing Salacia-derived salacinol. The lower limit of Salacia-derived salacinol is 0.02 mg/dose.
Comparison (C): Intake the foods not containing Salacia-derived salacinol.
Outcome (O): The primary outcome will measure the effect on blood glucose levels after eating carbohydrates or carbohydrate-containing meals. Specifically, the postprandial blood glucose level and the area under the blood glucose curve (AUC). Both outcomes will be evaluated comprehensively.
Study design (S): Adopt randomized, quasi-randomized, and non-randomized controlled trials (parallel-group or crossover trials).

Key exclusion criteria

Studies that do not meet the inclusion criteria, such as intervention trials without a placebo group, are excluded.

Target sample size

100

Name of lead principal investigator

1st name	Akifumi (Reviewer C)
Middle name
Last name	Nagatomo

Organization

Morishita Jintan Co.,Ltd.

Division name

Business Management Headquarters, Research and Development Department

Zip code

573-0128

Address

11-1, Tsudayamate 2-Chome, Hirakata-City, Osaka, Japan

TEL

072-800-1044

Email

a-nagatomo@jintan.co.jp

Name of contact person

1st name	Koji
Middle name
Last name	Kimura

Organization

Association for Salacia Promotion

Division name

Office

Zip code

103-0014

Address

1-38-12, Nihonbashi-kakigaracho, Chuo-Ku, Tokyo, Japan

TEL

03-5642-3700

Homepage URL

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

Email

salacia.office@fast.or.jp

Institute

Association for Salacia Promotion

Institute

Department

Personal name

Organization

Association for Salacia Promotion

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Review team
Mr. Kenji Ikeda (reviewer A), Fujifilm Corporation
Dr. Eriko Kishino (reviewer D), Tokyo Metropolitan Technology Research Institute
Ms. Ruka Yugawa (reviewer B), Morishita Jintan Co.,Ltd.

Research Collaborator
Professor Hiroharu Kamioka (HK), Tokyo University of Agriculture
Ms. Mari Makishi (MM), Toho University, Librarian
Ms. Satoko Sayama (SS), Librarian

Name of secondary funder(s)

Organization

N/A

Address

N/A

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

2023

Year

12

Month

01

Day

URL releasing protocol

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

Publication of results

Unpublished

URL related to results and publications

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

2023

Year

11

Month

29

Day

Date of IRB

2023

Year

11

Month

29

Day

Anticipated trial start date

2023

Year

12

Month

04

Day

Last follow-up date

2024

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

(Searches)
The search strategy will be developed by MM (librarian), an external collaborator skilled in clinical research searches and with extensive experience in search tasks in systematic reviews, and will be peer reviewed by SS, also a librarian. MM will search the scientific article and clinical study databases from the beginning of each database to the date of the search.

(Studies extraction)
Based on PICOS, independent screening will be performed by reviewers A and B. If there is a discrepancy, the result will be decided through discussion, but if it is difficult to make a decision, reviewer C will make a decision.
Reviewers C and D will independently extract data with outcome from the selected studies. Disagreement and uncertainties will be resolved by discussion with another reviewer. If the data in the selected studies is unclear or missing, the principal investigator C will confirm with the corresponding author by e-mail.

(Risk of bias assessment)
Evaluation of the validity and reliability of the selected studies was conducted independently by reviewers A and B for each of the items "risk of bias", "indirectness", "imprecision", "inconsistency", and "publication bias". The degree of matching and the Kappa coefficient will be calculated.

(Meta-analysis)
Only when we will not find heterogeneity in randomized controlled trials and confirm no missing data, reviewer C will conduct a meta-analysis by using EZR 1.61.

(Certainty assessment)
Regarding the certainty of the evidence, RoB, indirectness, imprecision, inconsistency, and the publication bias will be rated as "Low (0)", "Medium (-1)", and "High (-2)", respectively. If the sum of each item will be 0 or -1, then the certainly of evidence for an outcome will be evaluated as "High", -2~-4 as "Moderate", -5~-7 as "Low", and -8 or less as "Very Low".

Registered date

2023

Year

12

Month

01

Day

Last modified on

2024

Year

12

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060412