UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039586
Receipt number R000045121
Scientific Title Allulose for attenuation of postprandial blood glucose levels in healthy human: a systematic review and a meta-analysis
Date of disclosure of the study information 2020/03/01
Last modified on 2024/02/28 10:04:30

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Basic information

Public title

Allulose for attenuation of blood glucose levels after meal in healthy human

Acronym

Allulose for attenuation of blood glucose levels after meal in healthy human

Scientific Title

Allulose for attenuation of postprandial blood glucose levels in healthy human: a systematic review and a meta-analysis

Scientific Title:Acronym

Allulose for attenuation of postprandial blood glucose levels in healthy human: a systematic review and a meta-analysis

Region

Japan


Condition

Condition

Healthy Human

Classification by specialty

Adult Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To check acute blood glucose levels of healthy humans after meal with and without allulose and see if allulose has a health benefit.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Does allulose intake (<= 10g) attenuate postprandial blood glucose levels in healthy human?

Key secondary outcomes

Does lower intake of allulose (<= 5g) attenuate postprandial blood glucose levels in healthy human? In other words, is there any difference in two different doses?


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

1 days-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The study can be found in full report.
The study conducted in last 50 years.
The study patients are human.
The study patients are healthy.
The study intervention is allulose.
The study patients take some types of meal with the intervention.
The study conducts blood glucose measurements at least 2 hours.
The study measures total Area Under Curve (AUC) of blood glucose levels or could obtain either one of them from authors' group.

Key exclusion criteria

The study is a review or a case study or doesn't report any experiment.
The study with control or placebo group can't be found, so that there is no comparison can be done.
The part of study patients has certain medical conditions and could not obtain data with only healthy patients.
The part of study intervention is allulose and could not obtain data with only allulose intervention.
The study doesn't indicate the level of allulose intake.
The study doesn't measure total AUC of blood glucose levels for 2 hours or could not obtain a data for 2 hours from authors' group.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Yuma
Middle name
Last name Tani

Organization

Matsutani Chemical Industry Co. Ltd.

Division name

Rare Sugar Business Unit

Zip code

664-8508

Address

5-3 Kitaitami, Itami-city, Hyogo, Japan

TEL

072-771-2043

Email

yuma-tani@matsutani.co.jp


Public contact

Name of contact person

1st name Yuma
Middle name
Last name Tani

Organization

Matsutani Chemical Industry Co. Ltd.

Division name

Rare Sugar Business Unit

Zip code

664-8508

Address

5-3 Kitaitami, Itami-city, Hyogo, Japan

TEL

072-771-2043

Homepage URL


Email

yuma-tani@matsutani.co.jp


Sponsor or person

Institute

Matsutani Chemical Industry Co. Ltd.

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Kagawa University, Hokkaido University Hospital, and Izumoring Co. Ltd.

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Matsutani Chemical Industry Co. Ltd.

Address

5-3 Kitaitami, Itami-city, Hyogo, Japan

Tel

072-771-2001

Email

hiroaki-fudaba@matsutani.co.jp


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

松谷化学工業株式会社(兵庫県)
Matsutani Chemical Industry Co. Ltd. (Hyogo)


Other administrative information

Date of disclosure of the study information

2020 Year 03 Month 01 Day


Related information

URL releasing protocol

https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045121

Publication of results

Published


Result

URL related to results and publications

https://doi.org/ 10.1371/journal.pone.0281150

Number of participants that the trial has enrolled

290

Results

The study collected all D-allulose related studies from various databases. A forest plot of the comparison between an allulose intake group and the control group showed both 5g and 10g intake groups have the significantly smaller area under the curve of postprandial blood glucose levels. It means that D-Allulose attenuates postprandial blood glucose concentrations in healthy humans.

Results date posted

2024 Year 02 Month 28 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2023 Year 04 Month 06 Day

Baseline Characteristics

Healthy humans if their change in postprandial blood glucose levels were within a normal range when given a meal.

Participant flow

The study is the Systematic Review and Meta-analysis, and there is no participant flow.

Adverse events

The study is the Systematic Review and Meta-analysis, and there is no adverse event.

Outcome measures

In healthy adults, does 10g or less of allulose, added to a carbohydrate-containing meal, lower postprandial AUC glucose, compared with the same meal without allulose, over the postprandial period in an intervention trial setting?
In healthy adults, does 5g or less of allulose, added to a carbohydrate-containing meal, lower postprandial AUC glucose, compared with the same meal without allulose, over the postprandial period in an intervention trial setting?

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2020 Year 01 Month 31 Day

Date of IRB

2020 Year 02 Month 10 Day

Anticipated trial start date

2020 Year 03 Month 01 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry

2021 Year 03 Month 27 Day

Date trial data considered complete

2022 Year 04 Month 07 Day

Date analysis concluded

2022 Year 05 Month 24 Day


Other

Other related information

-Participants, Intervention, Comparison, and Outcomes (PICO) of the study.
Participants are healthy human.
Intervention is allulose intake.
Comparison is between with and without allulose intake groups.
Outcome is blood glucose levels.
The primary study question is "Does allulose intake (<= 10g) attenuate postprandial blood glucose levels in healthy human?"
The secondary study question is "Does lower intake of allulose (<= 5g) attenuate postprandial blood glucose levels in healthy human?"

-Search methods for identification of studies
We will perform literature search for this study up to a search day of March, 2020 from following databases; US National Library of Medical Database (MEDLINE through PubMed), Cochrane Central Register of Controlled Trials (CENTRAL), Excerpta Medica database (EMBASE), Japan Medical Abstracts Society (ICHUSHI) Web, and Citation Information by National Institute of Informatics (CINII).
Electronic searches will be conducted using following keywords.
"allulose OR psicose OR A-RU-ROH-SU OR PU-SHI-KOH-SU"

-Data collection and analysis
For all studies, two reviewers YT and MT will perform following steps.
exclude duplicates -> 1st screen -> 2nd screen -> data extraction -> risks of bias.
HY act as a tie breaker for the study inclusion as the judge when revewiers have conflicts.
When there is a missing data from the study, contact authors' group for sending those missing data.
Heterogeneity will be checked by Cochrane Q test and I^2 statistic.
The reporting biases will be assessed by the funnel plot.
Meta-analysis will be performed for both random effect model and fixed effect model.
Once analysis is done, then indicate any findings for possible subgroup analysis, and conduct if it's necessary.
Sensitivity analysis will be performed to check the strength of the result.


Management information

Registered date

2020 Year 02 Month 25 Day

Last modified on

2024 Year 02 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045121


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name