UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050020 |
|---|---|
| Receipt number | R000056970 |
| Scientific Title | A verification study of suppressive effect on the postprandial blood glucose level by sugar-restricted diet |
| Date of disclosure of the study information | 2023/01/12 |
| Last modified on | 2023/07/13 11:35:27 |
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Basic information
Public title
A verification study of suppressive effect on the postprandial blood glucose level by sugar-restricted diet
Acronym
A verification study of suppressive effect on the postprandial blood glucose level by sugar-restricted diet
Scientific Title
A verification study of suppressive effect on the postprandial blood glucose level by sugar-restricted diet
Scientific Title:Acronym
A verification study of suppressive effect on the postprandial blood glucose level by sugar-restricted diet
Region
| Japan |
Condition
Condition
Healthy subjects whose HbA1c level is 5.5% to 6.5%
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the suppressive effect on the elevation of blood glucose level with sugar-restricted diet diet
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
the postprandial blood glucose level(2 hours after meals)
Key secondary outcomes
Correlation between postprandial blood glucose level and blood pressure, body weight, BMI, waist circumference, blood results (total cholesterol, triglycerides, HDL-C, LDL-C, HbA1c)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) 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
To eat a sugar-restricted diet for lunch amd measure the postprandial blood glucose for 2 hours
Interventions/Control_2
To eat a not sugar-restricted diet for lunch amd measure the postprandial blood glucose for 2 hours
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
HbA1c level is 5.5% to 6.5%
Key exclusion criteria
1)Persons who are suffering from illness and taking medication.
2)Persons who have past and current medical history of impaired glucose tolerance, psychiatric disorders, sleep disorders, hypertension, diabetes, hyperlipidemia, and other serious illnesses
3)Persons whose fasting blood sugar level is over 126 mg/dL or HbA1c (NGSP) level is over 6.5%.
4)Persons who have taken medication for the purpose of disease treatment within the last month (excluding headache, menstrual cramps, colds, etc.)
5)Persons have a past and current medical history of serious diseases about liver, kidney, heart, lung, blood, etc.
6)Persons have a past and current medical history about the digestive system disease (excluding history of appendectomy)
7)Persons whose BMI is over 30 kg/m2.
8)Persons who have donated more than 200 mL of blood within the last month and more than 400 mL within the last 3 months.
9)Persons have severe anemia
10)Persons who might have allergic symptoms on the test meal, and those who may have serious allergic symptoms to foods and pharmaceuticals.
11)Persons who might not have all test meal (including because of palatability)
12)Persons who are pregnant, breastfeeding or willing to breastfeed on the study period
13)Persons who drink more than 40 g/day in terms of average alcohol per day
14)Persons who may change their eating habits and lifestyle on the study period (ex, long-term travel)
15) Persons who have a habit of continuously taking foods with functional claims and health foods that claim to be related to sugar metabolism, and those who plan to take them during the test period with the last 3 months (Not including taking those for health maintenance)
17)Persons who are participating in the other tests with taking food and drugs
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hayato |
| Middle name | |
| Last name | Tamenori |
Organization
Ezaki Glico Co., Ltd
Division name
Health Innovation Division
Zip code
5558502
Address
4-6-5 Utajima, Nishi-Yodogawa-ku, Osaka, Japan
TEL
+80-8311-4309
hayato.tamenori@glico.com
Public contact
Name of contact person
| 1st name | Midori |
| Middle name | |
| Last name | Matayoshi |
Organization
Ezaki Glico Co., Ltd
Division name
Health Innovation Division
Zip code
5558502
Address
4-6-5 Utajima, Nishi-Yodogawa-ku, Osaka, Japan
TEL
+80-2474-9950
Homepage URL
midori.matayoshi@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
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review Board of Glico Group
Address
4-6-5 Utajima, Nishi-Yodogawa-ku, Osaka, Japan
Tel
+81-6-6477-8793
toshihiko.koike@glico.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 | 01 | Month | 12 | 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
10
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
| 2022 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 03 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 03 | Day |
Date analysis concluded
| 2023 | Year | 05 | Month | 19 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 12 | Day |
Last modified on
| 2023 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056970
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