UMIN-CTR Clinical Trial

Public title

A Systematic Review of the effect of intake of functional ingredients of barley-derived beta glucan in reducing postprandial Blood Glucose rise

Acronym

SR of the effect of Barley-derived beta glucan in reducing postprandial Blood Glucose rise

Scientific Title

A Systematic Review of the effect of intake of functional ingredients of barley-derived beta glucan in reducing postprandial Blood Glucose rise

Scientific Title:Acronym

SR of the effect of Barley-derived beta-glucan in reducing postprandial Blood Glucose rise

Region

Japan

Condition

Male and female adults whose fasting or postprandial blood glucose in borderline or high levels, and healthy male and female adults. Those who are planning to become pregnant, expectant or nursing mothers, and breastfeeding women are excluded.

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The object is to investigate whether the intake of barley-derived beta-glucan affects to improve fasting or postprandial blood glucose in borderline or high levels' male and female adults, and healthy male and female adults based on a Systematic Review.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The effect of intake of barley-derived beta-glucan on Area under the blood concentration curve (AUC) and the postprandial blood glucose levels

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

(PICOS)
P (Participant): Male and female adults whose fasting or postprandial blood glucose level: 110-125 mg/dl, 75gOGTT 2 hour after value: 110-125 mg/dl, casual blood glucose level: 140-199 mg/dl, and healthy male and female adults. Minors, pregnant women (including those planning pregnant), lactating mothers, patients with diabetes mellitus, BMI less than 18.5, 30 or above are excluded.
I (Intervention): Foods containing barley-derived beta-glucan (regardless of food form) should be taken orally. The duration of intake is one time. Studies with unknown barley-derived beta-glucan content are excluded.
C (Comparison): Comparison target, Intake of barley-derived beta-glucan-free placebo
O (Outcome measurement): The primary outcome is the evaluated value of the effect of intake of barley-derived beta-glucan on Area under the blood concentration curve (AUC) and the postprandial blood glucose levels.
S (Study design): Randomised controlled trials are conducted. A significant difference test is performed on the test results by statistical analysis. The test arm must contain a food or beverage containing barley-derived beta-glucan. Intervention trials without a placebo group and studies using foods with multiple ingredients other than barley-derived beta-glucan as functional components are not included. Only peer-reviewed original papers are eligible.

Key exclusion criteria

Trials that include women who are pregnant or breastfeeding, women who are planning to become pregnant, or people who are being treated for hypertension
Studies with unknown barley-derived beta-glucan content
Papers citing the test results of the original paper, explanatory papers, abstracts of conference presentations, conference proceedings

Target sample size

Name of lead principal investigator

1st name	Kuniyoshi
Middle name
Last name	Shimizu

Organization

Faculty of Agriculture, Graduate school of Kyushu University

Division name

Laboratory of Systematic Forest and Forest Products Science

Zip code

819-0395

Address

19-0395 744 Motooka, Nishiku-Fukuoka City

TEL

092-802-4675

Email

shimizu.kuniyoshi.381@m.kyushu-u.ac.jp

Name of contact person

1st name	Seiichi
Middle name
Last name	Hattori

Organization

Kurume Research Park Co., Ltd.

Division name

Bio Project Division

Zip code

839-0864

Address

1-1 Hyakunenkoen,Kurume City, Fukuoka

TEL

0942-37-6124

Homepage URL

Email

fbv@kurume-rp.co.jp

Institute

Kyushu University

Institute

Department

Personal name

Kuniyoshi Shimizu

Organization

Kurume Research Park Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Evaluation Center of Health and Nutrition Inc.
Kenichi Kakino

Name of secondary funder(s)

Organization

N/A

Address

N/A

Tel

N/A

Email

N/A

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

2025

Year

01

Month

31

Day

URL releasing protocol

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

Preinitiation

Date of protocol fixation

2024

Year

11

Month

11

Day

Date of IRB

Anticipated trial start date

2025

Year

01

Month

31

Day

Last follow-up date

2025

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

The research process involves a team of three experienced individuals, A, B, and C, who independently conduct searches using academic article databases and clinical trial registries, as well as the Foods with Functional Claims Notification Database. In cases where their findings do not align, discussions are held, and if necessary, a fourth member, C, will make the final decision on the acceptance or rejection of results.
The selection of studies and data extraction is similarly conducted independently by A, B, and C, with a structured approach to resolving discrepancies through consultation and, if needed, confirmation by C. The evaluation of bias risk in research papers is performed using established guidelines, and any uncertainties in the data are addressed by contacting the authors directly.
To assess the reliability of studies, the team evaluates various factors such as indirectness, inaccuracy, and publication bias, referencing specific clinical practice guidelines.
In synthesizing results, studies with similar designs and high PICO item similarity are pooled, while those with high bias risk are excluded. Missing data is addressed by reaching out to authors, and if unresponsive, it is treated as a missing value. Meta-analysis is conducted using statistical software, with subgroup analyses performed in cases of high heterogeneity.
The certainty of the evidence is quantified based on the evaluation of indirectness, inaccuracy, inconsistency, and publication bias, with a scoring system that categorizes the evidence into high, medium, low, and very low certainty levels. This structured approach ensures a comprehensive and rigorous evaluation of the research findings.

Registered date

2025

Year

01

Month

28

Day

Last modified on

2025

Year

03

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064927