UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053341 |
|---|---|
| Receipt number | R000060879 |
| Scientific Title | A study to verify the effects of consumption of the test food on blood glucose control index |
| Date of disclosure of the study information | 2025/02/17 |
| Last modified on | 2025/01/20 17:39:04 |
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Basic information
Public title
A study to verify the effects of consumption of the test food on blood glucose control index
Acronym
A study to verify the effects of consumption of the test food on blood glucose control index
Scientific Title
A study to verify the effects of consumption of the test food on blood glucose control index
Scientific Title:Acronym
A study to verify the effects of consumption of the test food on blood glucose control index
Region
| Japan |
Condition
Condition
Healthy participants
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify exploratory the effect of consumption of the test food on glycometabolism functions in high blood glucose level subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Urinary glucose by 24 hours pooled urine
Key secondary outcomes
The following index in the OGTT test
[1] plasma intact incretin (GLP-1 and GIP) levels
[2] Incremental area under the curve of blood insulin
[3] Maximum blood insulin level
[4] HOMA-beta
[5] Incremental area under the curve of blood glucose
[6] Maximum blood glucose level
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] Oral ingestion of a test food (once)
[2] Observation
[3] Wash-out (2 weeks)
[4] Oral ingestion of a placebo food (once)
[5] Observation
Interventions/Control_2
[1] Oral ingestion of a placebo food (once)
[2] Observation
[3] Wash-out (2 weeks)
[4] Oral ingestion of a test food (once)
[5] Observation
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
[1] Those who have a high blood glucose level at screening test.
[2] Those who can give their consent to participate in the study voluntarily in writing.
Key exclusion criteria
[1] Those who have any dietary supplements, quasi drugs or medicines which cause same or similar efficacy with the effect evaluated in this study.
[2] Those who have changed their habitats to take supplements within past 4 weeks.
[3] Those who work in night shift or in day and night shift.
[4] Those who have been treated their illness or prevention in a clinic at their informed consent.
[5] Those with their medical histories as follows: serious diseases of sugar metabolism, lipid metabolism, hepatic function, renal function, heart, circulatory, respiratory, endocrine system, or immune system of the nervous system.
[6] Those with the medical histories of alcoholism or drug dependence.
[7] Those who might be developed allergic reaction to foods (especially citrus fruits).
[8] Those who donated blood over 200mL in the past 4 weeks or over 400mL in the past 12 weeks [men] or 16 weeks [women].
[9] Those who have experience of worsening physical condition due to blood sampling or have been pointed out the blood sampling difficulty due to narrow blood vessels.
[10] Those who routinely use or cannot refrain from using health food, supplements, and medications that claim to contain dietary fiber.
[11] Those with serious anemia.
[12] Those who are pregnant, breast-feeding, or hope to be pregnant during the study period.
[13] Those who had always participated in or will participate in any other clinical trial (to use foods/medicine/quasi medicine/medical device) in the past 4 weeks.
[14] Those who will not be judged suitable to the participants by the investigator.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Sumio |
| Middle name | |
| Last name | Kondo |
Organization
Medicial Corporation Kenshokai
Division name
Fukushima Healthcare Center
Zip code
553-0004
Address
Tamagawa 2-12-16, Fukushima-ku, Osaka-shi, Osaka, 553-0004, Japan
TEL
06-6441-6848
drc_shokuhin@drc-web.co.jp
Public contact
Name of contact person
| 1st name | Kazumi |
| Middle name | |
| Last name | Naganuma |
Organization
DRC Co., Ltd.
Division name
Product Testing Department
Zip code
530-0044
Address
No.9 Tabuchi Bldg. 3F, 2-10-31, Higashi-Temma, Kita-ku, Osaka 530-0044, Japan
TEL
06-6882-1130
Homepage URL
naganuma@drc-web.co.jp
Sponsor or person
Institute
DRC 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
Brain Care Clinic Ethics Review Committee
Address
2F, Shiratori Building, 1-2, Shinjuku 2-chome, Shinjuku-ku, Tokyo
Tel
03-4405-1899
ethics_board@drc-web.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
DRCクリニック(DRC Clinic)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 17 | 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
| 2023 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 02 | 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
| 2024 | Year | 01 | Month | 12 | Day |
Last modified on
| 2025 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060879
