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
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
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
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
