UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058907 |
|---|---|
| Receipt number | R000067130 |
| Scientific Title | Effect of test food consumption on postprandial blood glucose levels in healthy subjects |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/08/06 13:58:54 |
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Basic information
Public title
Effect of test food consumption on postprandial blood glucose levels in healthy subjects
Acronym
Effect of test food consumption on postprandial blood glucose levels in healthy subjects
Scientific Title
Effect of test food consumption on postprandial blood glucose levels in healthy subjects
Scientific Title:Acronym
Effect of test food consumption on postprandial blood glucose levels in healthy subjects
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of single dose consumption of the test meal on blood glucose elevation at the next meal in Japanese men and women between the ages 20-65 years.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood glucose levels
The incremental area under the curve for postprandial blood glucose levels(iAUC)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single intake of active food - Washout period - Non-intake
Interventions/Control_2
Non-intake - Washout period - Single intake of active food
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Japanese male and female subjects between the ages of 20 and 65 at the time of written consent.
2.Subjects who are blood glucose levels are within the normal range (less than 126 mg/dL at fasting) at the time of health chack up.
3. Subjects who have received a full explanation of the purpose and content of the study, have the ability to consent, understand the study well, and have volunteered to participate in the study and have agreed to participate in the study in writing.
Key exclusion criteria
1.Subjects who are taking medication or under medical treatment.
2.Subjects who are under exercise therapy or dietetic therapy.
3.Subjects who have developed allergies as for the foods test.
4.Subjects with current or history of drug dependence or alcohol dependence.
5.Subjects who are hospitalized for mental disorders (depression, etc.) or sleep disorders(insomnia, sleep apnea, etc.), or have a history of mental disorders in the past.
6.Subjects with irregular life rhythms due to night shifts or shift work.
7.Subjects with extremely irregular lifestyle habits such as eating and sleeping.
8.Subjects who have an extremely unbalanced diet.
9.Subjects who have or have had serious diseases such as brain diseases, malignant tumors, immune diseases, diabetes, diabetes mellitus, liver diseases (hepatitis), kidney diseases, heart diseases, etc., thyroid diseases, adrenal diseases, and other metabolic diseases.
10.Subjects with a body mass index (BMI) exceeding 30.
11.Subjects who use health foods and medicines that contain ingredients that affect the trial
12.Subjects who have participated in other clinical trials (research) within 3 months retrospectively from the date of obtaining consent, or those who have plans to participate in other clinical trials (research) during the study period.
13.Subjects who have collected more than 200 mL of blood within 1 month or 400 mL within 3 months prior to the date of obtaining consent.
14.Subjects who are currently pregnant or breastfeeding. or who are likely to become so during the study period.
15.Subjects who are judged to be inappropriate as subjects based on clinical laboratory test values and measured values at the time of SCR.
16.Subjects who are considered as an inappropriate candidate by the doctor in charge.
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | Takamasa |
| Middle name | |
| Last name | Yamamoto |
Organization
Japan Frito-Lay Ltd.
Division name
Development Division, M&S Headquarters
Zip code
306-0221
Address
819-3 Kitatone, Koga-shi, Ibaraki , Japan
TEL
070-2497-5636
t.yamamoto@fritolay.co.jp
Public contact
Name of contact person
| 1st name | Natsuna |
| Middle name | |
| Last name | Takezawa |
Organization
Japan Frito-Lay Ltd.
Division name
Development Division, M&S Headquarters
Zip code
306-0221
Address
819-3 Kitatone, Koga-shi, Ibaraki , Japan
TEL
07048407264
Homepage URL
n.takezawa@fritolay.co.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, Takahashi Internal Medicine Clinic
Address
101 Chisaka Daiichi Building, 6-2-6 Higashikoi-kubo, Kokubunji-shi,Tokyo,Japan
Tel
03-6869-4145
jimukyoku@medireco.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
| 2025 | Year | 09 | 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 | 07 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 27 | Day |
Last modified on
| 2025 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067130
