UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050725 |
|---|---|
| Receipt number | R000057336 |
| Scientific Title | A test to assess blood glucose responses after intake of frozen desserts. |
| Date of disclosure of the study information | 2023/05/01 |
| Last modified on | 2023/03/30 14:19:32 |
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Basic information
Public title
A test to assess blood glucose responses after intake of frozen desserts.
Acronym
A test to assess blood glucose responses after intake of frozen desserts.
Scientific Title
A test to assess blood glucose responses after intake of frozen desserts.
Scientific Title:Acronym
A test to assess blood glucose responses after intake of frozen desserts.
Region
| Japan |
Condition
Condition
borderline diabetics
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the postprandial blood glucose of the test foods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
the postprandial blood glucose level
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
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
Ingestion of test foods (research foods 1)
Interventions/Control_2
Ingestion of test foods (research foods 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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Japanese male and female between 20 and 59 years of age.
2. borderline diabetics or fasting blood glucose level is 110 mg/dL to 125 mg/dL or HbA1c level is 6.0% to 6.5%
3. Written informed is required.
Key exclusion criteria
1. Subjects who are allergic to the test food's products
2. Patients under treatment, or on medication
3. Subjects having cardiac arrhyhmia, or severe anemia
4. Subjectsl taking antipertensive drugs, etc
5. Subjects who regularly have symptoms such as dizziness, lightheadedness, palpitations, headache, shortness of breath, etc
6. Subjects who have donated more than 200 mL of blood within the last 2 months or more than 400 mL within the last 3 months
7. Subjects with a history of diabetes in the past
8. Subjects with a history of serious diseases (liver disorder, renal disorder, heart disease, etc.) in the past
9. Subjects with a history of digestive disorders in the past
10. Subjects with a history of hepatitis in the past or having hepatitis now
11. Alcoholic patients
12. Subjects who are pregnant, lactating, or planning to become pregnant during this trial
13. Subjects taking antidiabetic drug or health foods that claim to affect blood sugar levels
14. Subjects in ohther clinical trial
Target sample size
13
Research contact person
Name of lead principal investigator
| 1st name | Nobuo |
| Middle name | |
| Last name | Yasuda |
Organization
Ezaki Glico Co., Ltd
Division name
Health Innovation Business Headquarter
Zip code
5558502
Address
4-6-5 Utajima, Nishi-Yodogawa-ku, Osaka, Japan
TEL
090-8570-0969
nobuo.yasuda@glico.com
Public contact
Name of contact person
| 1st name | Takayoshi |
| Middle name | |
| Last name | Machida |
Organization
Ezaki Glico Co., Ltd
Division name
Health Innovation Business Headquarter
Zip code
5558502
Address
4-6-5 Utajima, Nishi-Yodogawa-ku, Osaka, Japan
TEL
080-8932-0881
Homepage URL
takayoshi.machida@glico.com
Sponsor or person
Institute
Ezaki Glico Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Ezaki Glico 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
Shiba Palace Clinic
Address
1-9-10, Hamamatsucho, Minato-ku, Tokyo
Tel
03-5408-1599
jimukyoku@mail.souken-r.com
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
| 2023 | Year | 05 | 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
13
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
Completed
Date of protocol fixation
| 2023 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2023 | 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
| 2023 | Year | 03 | Month | 30 | Day |
Last modified on
| 2023 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057336
