UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060741 |
|---|---|
| Receipt number | R000069500 |
| Scientific Title | easurement of the Glycemic Index of Pasta Containing Glucomannan |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/02/24 23:28:59 |
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Basic information
Public title
Measurement of the Glycemic Index of Pasta Containing Glucomannan
Acronym
Measuring the GI of Pasta
Scientific Title
easurement of the Glycemic Index of Pasta Containing Glucomannan
Scientific Title:Acronym
Measuring the GI of Pasta
Region
| Japan |
Condition
Condition
Healthy adults with normal food habit
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify whether pasta containing glucomannan lowers the GI and suppresses blood sugar spikes in healthy individuals.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Glycemic Index(GI)
Key secondary outcomes
Blood glucose increase at each time point, maximum blood glucose increase for each person
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Commercial pasta
Interventions/Control_2
Pasta with glucomannan
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants who voluntarily express their intent to join the trial and meet the following criteria:
(1) Adult men and women aged 20 years or older but under 50 years at the time of consent acquisition
(2) Individuals with a BMI of 30 or below
(3) Individuals who have received prior explanation of the clinical trial, understand the content including informed consent in accordance with the Declaration of Helsinki, agree with its purpose, and can provide written consent themselves
Key exclusion criteria
(1) Individuals taking diabetes medication
(2) Individuals receiving insulin therapy
(3) Individuals with wheat allergies
(4) Individuals with a history of digestive tract surgery that affects digestion and absorption
(5) Individuals who are pregnant, may be pregnant, or are breastfeeding
(6) Individuals who regularly consume dietary fiber supplements (products containing dietary fiber derived from seaweed, konjac, psyllium, etc.) or whole grains (including whole wheat, brown rice, rye, barley, etc.)
(7) Individuals currently participating in other drug or health supplement clinical trials, those within 4 weeks of completing such a trial, or those planning to participate in another clinical trial after giving consent for this trial
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Seiichiro |
| Middle name | |
| Last name | Aoe |
Organization
Otsuma Women's University
Division name
Faculty of Home Economics, Department of Food Science
Zip code
102-8357
Address
12 Sanban-cho, Chiyoda-ku, Tokyo
TEL
+81-3-5275-6048
s-aoe@otsuma.ac.jp
Public contact
Name of contact person
| 1st name | Seiichiro |
| Middle name | |
| Last name | Aoe |
Organization
Otsuma Women's University
Division name
Faculty of Home Economics, Department of Food Science
Zip code
102-8357
Address
12 Samban-cho, Chiyoda-ku, Tokyo
TEL
+81-3-5275-6048
Homepage URL
s-aoe@otsuma.ac.jp
Sponsor or person
Institute
Otsuma Women's University, Faculty of Home Economics, Department of Food Science
Institute
Department
Personal name
Funding Source
Organization
Showa Sangyo Co., Ltd
Research Center for Fundamental Technologies
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Life Science Research Ethics Committee, Otsuma Women's University
Address
12 Samban-cho, Chiyoda-ku, Tokyo
Tel
03-5275-6408
kenkyu.s@ml.otsuma.ac.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
大妻女子大学（東京都）/ Otsuma Women's University (Tokyo)
昭和産業株式会社（千葉県）/ Showa Sangyo Co., Ltd. (Chiba)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 24 | Day |
Last modified on
| 2026 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069500
