UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049414 |
|---|---|
| Receipt number | R000056256 |
| Scientific Title | A confirmation study of the suppressive effect of the test food consumption on the increase of blood glucose |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2023/11/07 20:03:11 |
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Basic information
Public title
A confirmation study of the suppressive effect of the test food consumption on the increase of blood glucose
Acronym
A confirmation study of the suppressive effect of the test food consumption on the increase of blood glucose
Scientific Title
A confirmation study of the suppressive effect of the test food consumption on the increase of blood glucose
Scientific Title:Acronym
A confirmation study of the suppressive effect of the test food consumption on the increase of blood glucose
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of low-dose wheat albumin ingestion on blood glucose increase under the carrageenan
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incremental Area Under the Curve of blood glucose level
delta Cmax of blood glucose level
delta Blood glucose level at each blood sampling time point
Key secondary outcomes
Area under the curve of blood glucose level
Tmax of blood glucose level
Cmax of blood glucose level
Blood glucose level at each blood sampling time point
Incremental Area Under the Curve of serum insulin level
Area under the curve of serum insulin level
Cmax of serum insulin level
Tmax of serum insulin level
delta Serum insulin level at each blood sampling time point
Serum insulin level at each blood sampling time point
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
1. Single intake of the test food
2. 1 week washout period
3. Single intake of the placebo food
Interventions/Control_2
1. Single intake of the placebo food
2. 1 week washout period
3. Single intake of the test 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 Males and females aged of 20-64 years
2) Subjects whose fasting blood glucose levels are less than 126 mg/dL, postprandial blood glucose levels are 140 mg/dL or more at 30, 45 or 60 minutes after meal and 199 mg/dL or less at 120 minutes after meal
3) Possible study volunteer to visit
4) Individuals whose written informed consent has been obtained
Key exclusion criteria
1) Subjects who develop diabetes
2) Subjects who have a history of large surgery (gastrectomy,gastrointestinal suture, intestinal resection) on the gastrointestinal except who resect the cecum
3) Subjects who have marked impairment of heart, liver, kidney, thyroid, and other diseases
4) Subjects who experienced unpleasant feeling by drawing blood in the past
5) Subjects who have difficulty drawing blood from the peripheral vein
6) Subjects who donated 400 ml of blood within 12weeks or component blood donation 200 ml of blood within 4weeks prior to the study
7) Subjects who are allergic to the test food or who have serious drugs or food allergies
8) Shift worker and night worker
9) Subjects whose eating habits are extremely irregular
10) Heavy drinkers(Average of the amount of pure alcohol per day 40 g or more)
11) Heavy Smokers(More than 21 on average per day)
12) Subjects who are positive for one or more items in the results of virus / immunologic serology examination at the time of prior to the study
13) Pregnant women or breast-feeding women
14) Subjects who regularly use medicines, health foods, those who will use them during the period of the study, or those who need to take foods listed in Attachment 1
15) Subjects who was judged ineligibles by clinician in this trial
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Hoshino |
Organization
Medical Corporation Jikokai Shiroishi Internal Medicine Clinic
Division name
General Medicin Clinical Departments: Internal Medicine Respiratory Medicine Allergy
Zip code
003-0011
Address
7-10-30 Chuo-1 jo, Shiroishi-ku, Sapporo, Hokkaido, Japan
TEL
011-868-2711
n-abe@medi-ate.jp
Public contact
Name of contact person
| 1st name | Shimpei |
| Middle name | |
| Last name | Tomita |
Organization
New drug research center, Inc.
Division name
Research Dept.
Zip code
061-1405
Address
452-1 Toiso,Eniwa,Hokkaido, Japan
TEL
0123-34-0412
Homepage URL
s-tomita@ndrcenter.co.jp
Sponsor or person
Institute
Nissin Pharma Inc.
Institute
Department
Personal name
Funding Source
Organization
Nissin Pharma Inc.
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
Medical Corporation Jikokai Fukuzumi Internal Medicine Clinic Clinical Trial Review Committee
Address
1-2-5 Itoyokado Fukuzumiten-5F Fukuzumi-2jo, Toyohira-ku, Sapporo, Hokkaido, Japan
Tel
011-836-3531
s-fukui@jikokai.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
| 2023 | Year | 11 | 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
26
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 | 10 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 03 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 02 | Day |
Last modified on
| 2023 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056256
