UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063052 |
|---|---|
| Receipt number | R000072182 |
| Scientific Title | The Effect of Pre-meal Consumption of Fermented Food on Postprandial Blood Glucose Levels: A Randomized, Open-Label, Crossover Comparative Trial |
| Date of disclosure of the study information | 2026/09/25 |
| Last modified on | 2026/09/25 13:39:52 |
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Basic information
Public title
The Effect of Pre-meal Consumption of Fermented Food on Postprandial Blood Glucose Levels: A Randomized, Open-Label, Crossover Comparative Trial
Acronym
The Effect of Pre-meal Consumption of Fermented Food on Postprandial Blood Glucose Levels: A Randomized, Open-Label, Crossover Comparative Trial
Scientific Title
The Effect of Pre-meal Consumption of Fermented Food on Postprandial Blood Glucose Levels: A Randomized, Open-Label, Crossover Comparative Trial
Scientific Title:Acronym
The Effect of Pre-meal Consumption of Fermented Food on Postprandial Blood Glucose Levels: A Randomized, Open-Label, Crossover Comparative Trial
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether pre-meal intake of a fermented food suppresses the postprandial blood glucose response in middle-aged men.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incremental area under the postprandial blood glucose curve over 120 min (IAUC120min)
Key secondary outcomes
Secondary outcomes:
Postprandial blood glucose parameters (blood glucose at each time point, Cmax, and Tmax)
VAS (fullness, satiety, and hunger)
Safety outcomes:
Adverse events and adverse reactions
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Taking the test food once before meals -> Washout (7 days) -> Taking the control food (placebo) once before meals
Interventions/Control_2
Taking the control food (placebo) once before meals -> Washout (7 days) -> Taking the test food once before meals
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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
(1) Men aged 40 to under 60 years at the time of consent.
(2) Persons who have received a full explanation of the purpose, content and methods of the study, understand the content of the study, and have given written consent of their own free will.
Key exclusion criteria
(1) Fasting blood glucose level of 126 mg/dL or higher.
(2) HbA1c level of 6.5% or higher.
(3) BMI of 30 kg/m2 or higher.
(4) Use of any medication that may affect glucose metabolism or appetite.
(5) Habitual consumption of Foods for Specified Health Uses, Foods with Function Claims, or other health foods or supplements that may affect glucose metabolism, which cannot be discontinued during the study period.
(6) Current or past history of hepatic, renal, cardiac, pulmonary, gastrointestinal, haematological, endocrine, metabolic, or other serious disease.
(7) Current history of an eating disorder or a taste disorder.
(8) Markedly irregular dietary or lifestyle habits considered inappropriate by the principal or sub-investigator.
(9) Absence of a regular habit of eating three meals per day.
(10) Difficulty in consuming the test food or the standardised meal.
(11) Food allergy to any ingredient of the test food or the standardised meal (milk, wheat, soybean, chicken, or pork).
(12) Skin disorder at the site of continuous glucose monitoring (CGM) sensor placement, or a predisposition to skin injury caused by adhesive tape.
(13) Scheduled clinical examination (radiography, computed tomography, or magnetic resonance imaging), airport baggage screening, treatment, or hospitalisation that may interfere with continuous CGM during the study period.
(14) Blood sampling or blood donation of 400 mL or more within 8 weeks before the date of consent.
(15) Current participation, or planned participation during the study period, in another clinical trial or study.
(16) Any other condition that, in the judgement of the principal or sub-investigator, renders the individual unsuitable for participation on the basis of background characteristics, physical findings, medical interview, physical examination, or laboratory test results.
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0004
Address
Anera Bldg. 8F, 3-3-3 Higashi Nihonbashi, Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Yokoshima |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
Shibaura Omodaka Building 7F, 1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry Co., Ltd.
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
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joto-machi, Maebashi, Gumma, Japan
Tel
027-212-5608
sagawa@mc-connect.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 25 | 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
| 2026 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2027 | Year | 02 | Month | 28 | 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 | 09 | Month | 25 | Day |
Last modified on
| 2026 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072182
