UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044481 |
|---|---|
| Receipt number | R000050581 |
| Scientific Title | Effect of a Food Material on Blood Glucose Level |
| Date of disclosure of the study information | 2021/06/10 |
| Last modified on | 2022/06/09 09:21:44 |
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Basic information
Public title
Effect of a Food Material on Blood Glucose Level
Acronym
Effect of a Food Material on Blood Glucose Level
Scientific Title
Effect of a Food Material on Blood Glucose Level
Scientific Title:Acronym
Effect of a Food Material on Blood Glucose Level
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine effect of a food material on blood glucose level.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose level on glucose tolerance test (75g OGTT)
(Screening, Week 0, Week 4:before glucose tolerance test, 30, 60, 90, and 120 minutes after glucose tolerance test).
Key secondary outcomes
*Secondary indexes
[1]Indexes for blood glucose in fasting(2).
[2]Insulin on glucose tolerance test (75 OGTT)(2,5).
[3]Insulinogenic Index(2).
[4]Indexes for lipid in fasting(2).
*Indexes for exploratory research
[1]Watch-type device survey(4).
[2]Questionnaire survey(3).
*Safety
[1]Blood pressure, pulsation(2).
[2]Weight, body fat percentage, BMI(2).
[3]Subject's diary(4).
[4]Doctor's questions(2).
[5]Adverse events: number of cases and expression rate of adverse events(3).
*Other indexes
[1]Hematologic test(1).
[2]Blood biochemical test(1).
[3]Urine analysis(1).
(1):Screening.
(2):Screening, Week 0, Week 4.
(3):Week 0, Week 4.
(4)From the first day of ingestion of a test material to the last day of the test.
(5)Screening, 30, 60, 90, and 120 minutes after glucose intake.
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral intake of the test food (1 capsule / day; 4 weeks).
Interventions/Control_2
Oral intake of the placebo food (1 capsule / day; 4 weeks).
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
[1] ]Healthy Japanese males and females aged 40-64 years.
[2]Individuals with borderline type or elevated postprandial blood glucose levels in glucose tolerance test (75 g OGTT)
[3]Individuals who are healthy and have no chronic physical disease including skin disease.
[4]Individuals whose written informed consent has been obtained.
[5]Individuals judged appropriate for the study by the principal.
Key exclusion criteria
[1]Individuals who use or used a drug to treat a disease in the past 1 month.
[2]Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
[3]Individuals whose fasting blood glucose is over 126mg/dL.
[4]Individuals whose two-hour glucose level is over 200 mg/dL in glucose tolerance test.
[5]Individuals whose HbA1c is over 6.5%.
[6]Individuals whose BMI is less than 18.5kg/m2 or over 30kg/m2.
[7]Individuals who excessively take alcohol.
[8]Individuals who are a smoker.
[9]Individuals who have irregular lifestyles and eating habits, and may change their lifestyles during the test period.
[10]Individuals who experienced unpleasant feeling during blood drawing.
[11]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[12]Individuals who ingest regularly foods for specified health uses, health foods, or foods with functional claims which may be affect the test in the past 3 months or will use or ingest those foods during the test period.
[13]Individuals who may have allergic symptoms to test foods and designated meal, and Individuals who may have serious allergic symptoms to other foods.
[14]Individuals who fall under any of the following criteria when using a wrist-watch device. Individuals
(1) With illness or heart disease,
(2) With photosensitive medication,
(3) who have epilepsy or are sensitive to flashing lights,
(4) with poor blood circulation or who bruise easily,
(5) with tendonitis, carpal tunnel syndrome, or other musculoskeletal disorders, and
(6) who may have allergic symptoms to metals.
[15]Individuals who participated in other clinical studies in the past 3 months.
[16]Individuals who are or are possibly pregnant, or are lactating.
[17]Individuals judged inappropriate for the study by the principal.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Ono |
Organization
Ueno-Asagao Clinic
Division name
Head
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6240-1162
info@ueno-asagao.clinc
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Maruzen Pharmaceuticals 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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81528382485
i.takahashi@tes-h.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
| 2021 | Year | 06 | Month | 10 | 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
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 09 | Day |
Last modified on
| 2022 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050581
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| Registered date | File name |
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