UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050450 |
|---|---|
| Receipt number | R000057442 |
| Scientific Title | Verification test of blood glucose level fluctuation by intake of test food |
| Date of disclosure of the study information | 2023/06/30 |
| Last modified on | 2023/08/22 11:56:49 |
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Basic information
Public title
Verification test of blood glucose level fluctuation by intake of test food
Acronym
Verification test of blood glucose level fluctuation by intake of test food
Scientific Title
Verification test of blood glucose level fluctuation by intake of test food
Scientific Title:Acronym
Verification test of blood glucose level fluctuation by intake of test food
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this test is to examine the effect of ingestion of the test food on blood glucose level fluctuation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose levels
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
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single ingestion of test food-washout period-single ingestion of placebo food.
Interventions/Control_2
Single ingestion of placebo food-washout period-single ingestion of 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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Healthy males and females aged 20 - 39 years.
2) Individuals who are healthy and are not suffered from a chronic malady.
3) Individuals who are able to come to the clinic and take the examination on the specified day.
4) Individuals who are fully informed about this study, have the ability to agree, participate voluntarily with good understanding, and agree informed consent in writing.
4) Individuals who can visit an inspection facility and be inspected in designated days.
5) Individuals who can draw blood from a fingertip.
6) Individuals judged appropriate for this study by the principal investigator.
Key exclusion criteria
1) Individuals using medical products.
2) Individuals who used a drug for treatment of disease in the past 1 month.
3) Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease.
4) Individuals who contract or have a history of serious gastrointestinal disease.
5) Individuals with serious anemia.
6) Individuals who contract or have a history of food allergy. (milk, gelatin)
7) Females who are or are possibly pregnant, or are lactating.
8) Individuals who have an addiction to alcohol or a mental illness.
9) Individuals who are a smoker.
10) Individuals with high blood glucose (fasting blood glucose over 110 mg/dL).
11) Individuals whose life style will change during the test period.
12) Individuals with probable seasonal allergy, such as pollinosis, during the test period.(Betulaceae: alder, oba alnus firma, shirakaba, Taxodiaceae: cryptomeria, hinoki cypress, Asteraceae: ragweed, Artemisia vulgaris indica, Gramineae:Dactylis glomerata, Phleum pratense)
13) )Individuals who had a habit to ingest foods claiming to effect on blood glucose level improvement , foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period.
14) Individuals who have a habit to use drug claiming to effect on blood glucose level improvement in the past 3 months.
15) Individuals who conducted hormone replacement therapy in the past 6 months or have a history of conducting hormone replacement therapy.
16) Individuals who were hospitalized and received treatment in the past 6 months, or will be hospitalized during the test period.
17) Individuals who participated in other clinical studies in the past 1 months.
18) Individuals judged inappropriate for the study by the principal.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Toshihiro |
| Middle name | |
| Last name | Kawama |
Organization
Morinaga & Co., Ltd.
Division name
Health Science and Research Center, R&D institute
Zip code
230-8504
Address
2-1-1, Shimodueyoshi, Tsurumi-ku, Yokohama
TEL
045-571-6140
t-kawama-jb@morinaga.co.jp
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Saito |
Organization
Morinaga & Co., Ltd.
Division name
Health Science and Research Center, R&D institute
Zip code
230-8504
Address
2-1-1, Shimodueyoshi, Tsurumi-ku, Yokohama
TEL
045-571-6140
Homepage URL
e-saito-jd@morinaga.co.jp
Sponsor or person
Institute
Morinaga & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Morinaga & 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
General Incorporated Association Crinical Research Review Center
Address
2972-8-603 Ishikawamachi Hachioji-shi, Tokyo, 192-0032, JAPAN
Tel
0426-48-4368
crrctakashima@kpd.biglobe.ne.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 | 06 | Month | 30 | 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
| 2022 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 17 | 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 | 02 | Month | 28 | Day |
Last modified on
| 2023 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057442
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| Registered date | File name |
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