UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053454 |
|---|---|
| Receipt number | R000061004 |
| Scientific Title | Test to confirm the effect of a single intake of the test food on the suppression of postprandial blood glucose elevation(Placebo-controlled, randomized, double-blind, crossover study) |
| Date of disclosure of the study information | 2024/02/04 |
| Last modified on | 2024/01/26 16:31:51 |
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Basic information
Public title
Test to confirm the effect of a single intake of the test food on the suppression of postprandial blood glucose elevation
Acronym
Test to confirm the suppression of postprandial blood glucose elevation by ingestion of test food
Scientific Title
Test to confirm the effect of a single intake of the test food on the suppression of postprandial blood glucose elevation(Placebo-controlled, randomized, double-blind, crossover study)
Scientific Title:Acronym
Test to confirm the effect of a single intake of the test food on the suppression of postprandial blood glucose elevation
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirmation of suppression of postprandial blood glucose elevation by ingestion of test food
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area under the blood concentration curve (AUC) and change over time, Cmax, deltaCmax for glucose
Key secondary outcomes
Area under the blood concentration curve (AUC) and change over time, Cmax, deltaCmax of insulin
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test food to Control food: Beverage
Intake: 125 ml/dose
Loaded meal: Commercial aseptic white rice (200g)
Transition from the test food to the control food with a 2-week pause
Interventions/Control_2
Control food to Test food: Beverage
Intake: 125 ml/dose
Loading food: commercially sterile white rice (200 g)
Blood collection: Yes
Transition from the control food to the test food with a 2-week pause
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)Healthy Japanese men and women who are between 20 and 65 years of age at the time of consent acquisition.
2)Those whose glucose level is between 100 mg/dL and 125 mg/dL or whose HbA1c (NGSP) level is between 5.6% and 6.5% as a result of screening test.
3)Persons who have been fully informed of the purpose and content of the research,have the capacity to consent,have voluntarily volunteered to participate based on a good understanding of the purpose and content of the research,and have agreed to participate in the research in writing.
Key exclusion criteria
1)Those suffering from or undergoing treatment for serious renal or hepatic disease, cardiac, respiratory, endocrine, or other metabolic diseases.
2)Persons with chronic diseases and regular users of medicines.
3)Persons with gastrointestinal diseases affecting digestion and absorption and a history of gastrointestinal surgery (excluding appendicitis)
4)Persons taking medicines that may affect blood glucose levels.
5)Those who cannot stop taking supplements or health foods (including foods for specified health uses and foods with functional claims) that may affect blood glucose levels, blood lipids, or body fat during the study period.
6)Persons with a history or current medical history of drug or alcohol dependence.
7)Those who are unable to abstain from alcohol for 2 days prior to each examination.
8)Persons who are judged by the principal investigator to be unsuitable as research subjects based on blood tests performed during the screening test.
9)Those who are diagnosed as anemic by screening tests and are not suitable for frequent blood sampling.
10)Persons who developed diarrhea within 1 week prior to the screening test date, or who are normally prone to diarrhea.
11)Persons who have donated more than 200 mL of blood or component blood within 1 month or 400 mL within 3 months prior to the date of obtaining consent.
12)Those who have declared that they are allergic to the components of the research food (fruits) or to the load food (sesame).
13)Persons who are participating, or intend to participate, in studies (trials) involving the ingestion of other foods or the use of medicines, or the application of cosmetics and medicines.
14)Pregnant, intending to become pregnant during the study period, possibly pregnant, or breastfeeding.
15)Other persons deemed inappropriate as research subjects by the principal investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Tokushima |
Organization
Maebashi North Hospital
Division name
Director
Zip code
371-0054
Address
692 Shimohosoi-machi,Maebashi-shi,Gumma
TEL
027-235-3333
sagawa@mc-connect.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numazu |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
1-9-7, Shibaura, Minato-ku, Tokyo The 7th floor of Shibaura omodaka building
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Ezaki Glico Co.Ltd
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
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joto-machi, Maebashi-shi, Gumma
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
| 2024 | Year | 02 | Month | 04 | 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
| 2024 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2024 | Year | 01 | Month | 26 | Day |
Last modified on
| 2024 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061004
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
