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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039586
Receipt No. 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 2020/08/26

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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
Institute Matsutani Chemical Industry Co. Ltd.
Institute
Department

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 Unpublished

Result
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

Progress
Recruitment status No longer recruiting
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
Date trial data considered complete
Date analysis concluded
2020 Year 12 Month 31 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
2020 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.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


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